[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34949-34952]
[FR Doc No: 2015-14970]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75167; File No. SR-NYSEMKT-2015-40]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change to Sections 401, 402
and 404 of the NYSEMKT Company Guide To (i) Provide That Companies Can
Comply With the Exchange's Immediate Release Policy by Disseminating
the Information Required To Be Disseminated Pursuant to This Policy by
Any Regulation Fair Disclosure Compliant Method or Combination of
Methods, (ii) Clarify the Procedures Taken by the Exchange in the Event
of Unusual Market Activity and (iii) Update References to Exchange
Departments and Personnel and Make Other Non-Substantive Conforming
Updates

June 12, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on June 3, 2015, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 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 amend Sections 401, 402 and 404 of the
Company Guide to provide that companies can comply with the Exchange's
immediate release policy by disseminating the information required to
be disseminated pursuant to this policy by any Regulation Fair
Disclosure (``Regulation FD'') compliant method or combination of
methods, (ii) clarify the procedures taken by the Exchange in the

event of unusual market activity and (iii) update references to
Exchange departments and personnel and make other non-substantive
conforming updates. The text of the proposed rule change is available
on the Exchange's Web site at www.nyse.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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those 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 parts of such statements.

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

1. Purpose
Immediate Release Policy Changes
    Section 401(a) of the Company Guide requires a listed company to
make immediate public disclosure of all material information concerning
its affairs (the ``immediate release policy''). Section 401(b) provides
that companies should comply with the immediate release policy by
releasing material information to the public in a manner designed to
obtain the widest possible public dissemination. Section 402(b)(ii)
specifies that any public disclosure of material information should be
made by an announcement released to the national business and financial
news-wire services. Section 404 specifies the Exchange's surveillances
procedures when unusual market activity occurs.
    The Exchange proposes to (i) amend Sections 401, 402 and 404 of the
Company Guide to provide that companies can comply with the Exchange's
immediate release policy by disseminating the material information by
any Regulation FD compliant method or combination of methods, (ii)
clarify the procedures taken by the Exchange in the event of unusual
market activity and (iii) update references to Exchange departments and
personnel and make other non-substantive conforming updates.
    Regulation FD was adopted by the Commission in 2000 in order to
curb the selective disclosure of material non-public information by
issuers to analysts and institutional investors.\4\ Generally,
Regulation FD requires that when an issuer discloses material
information, it do so publicly. Public disclosure under Regulation FD
can be accomplished by filing a Form 8-K with the Commission or through
another method of disclosure that is reasonably designed to provide
broad, non-exclusionary distribution of the information to the public
(e.g. press releases, conference calls, press conferences and webcasts,
so long as the public is provided adequate notice and granted
access).\5\
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    \4\ See Securities Exchange Act Release No. 43154 (August 15,
2000), 65 FR 51716 (August 24, 2000) (``Regulation FD Adopting
Release'').
    \5\ See Regulation FD Adopting Release at pages 51723-51724.
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    The Exchange now proposes to amend Sections 401 and 402 of the
Company Guide to provide that companies may comply with the immediate
release policy by disseminating the information using any method (or
combination of methods) that constitutes compliance with Regulation FD,
thus companies will no longer be required to announce material news via
a simultaneous release to the national business and financial news-wire
services. Foreign private issuers are subject to the immediate release
policy but they are not required to comply with Regulation FD.
Notwithstanding their exemption from Regulation FD, Section 402(b)(ii)
will allow foreign private issuers to comply with the Exchange's
immediate release policy by any method (or combination of methods) that
would constitute compliance with Regulation FD for a domestic U.S.
issuer. While the Exchange continues to believe that there are benefits
to the market and investors generally if companies issue press releases
when disclosing material information, the Exchange nonetheless believes
that it is appropriate to harmonize its requirements in this regard
with Regulation FD, as well as with Section 202.06 of the Listed
Company Manual of New York Stock Exchange LLC (``NYSE'') and Nasdaq
Stock Market LLC (``Nasdaq'') Rule 5250(b)(1), thereby eliminating the
confusion inherent in having different regimes applied by different
listing exchanges and the Commission. The Exchange believes that many
companies will continue to issue press releases in relation to material
news events, and Section 402(b)(ii) of the proposed amendment includes
language that encourages companies to disclose material news via a
press release. However, the Exchange also believes that it is
appropriate to enable companies to utilize the flexibility and
discretion with respect to the method of disclosure provided by
Regulation FD.
    Section 401(a) of the Company Guide currently provides that, when
the announcement of news of a material event which calls for immediate
release is made during trading hours it is essential that the company
notify the Stock Watch Department prior to the announcement. This
timely notification enables the Exchange to consider whether, in the
opinion of the Exchange, trading in the security should be temporarily
halted. The Exchange proposes to amend Section 401(a) to codify its
long-standing interpretation of the rule that listed companies must
notify the Exchange if they intend to release material information
shortly before the opening as well as during trading hours which is
consistent with the approach that the New York Stock Exchange takes as
well. The Exchange also proposes to amend Section 401(a) to specify
that notification to the Exchange must be made at least ten minutes
prior to the announcement.
    The Exchange also proposes to amend Section 401(b) to permit
companies to comply with the Exchange's immediate release policy by any
Regulation FD-compliant method. The Exchange proposes to make a
corresponding change in Section 402(b) and to require the listed
company when contacting the Exchange to (i) inform the Exchange of the
substance of the announcement and (ii) identify to the Exchange the
Regulation FD-compliant method it intends to use to disseminate the
news and provide the Exchange with the information necessary to locate
the information upon publication. Further, the Exchange proposes to
amend Section 402(b) to state that, when the announcement is in written
form, the company must provide the text of the announcement to the
Exchange at least ten minutes prior to its release via email or web-
based system as specified on the Exchange's Web site.\6\ Because
companies will be required to submit the text of their announcement to
the Exchange via email or web-based system,\7\ the Exchange proposes to

delete an obsolete reference in Section 402(b) requiring companies to
send the Exchange three copies of their announcement.
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    \6\ The proposed amendment will specify that in emergency
situations--for instance, lack of computer or internet access,
technical problems at the Exchange or company or incompatibility
between Exchange and company systems--Section 402(b) will specify
that companies may provide required notifications by telephone and
confirmed by facsimile, as specified by the Exchange on its Web
site.
    \7\ The proposed amendment will specify that the Exchange will
promptly update and prominently display that posting if the
applicable web portal or email address changes at any time.
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    Section 401(a) of the Company Guide states that a company must
notify the Exchange's Stock Watch Department prior to the announcement
of material information. It has been the Exchange's long-standing
practice to require that companies call the Exchange when such
situations occur. The Exchange, therefore, proposes to codify this
practice in Section 402(b)(i), clarifying that a company must call,
rather than simply notify, the Exchange prior to the announcement. If a
listed company intends to comply with the immediate release policy by
issuing a press release, the proposed amendment to Section 402(b)(ii)
will specify that in order to ensure adequate coverage the press
release should be given to Dow Jones & Company, Inc., Reuters Economic
Services and Bloomberg Business News. The proposed amendment to Section
402(b)(ii) will also specify that foreign private issuers can comply
with the Exchange's immediate release policy by any Regulation FD
method (or combination of methods). The Exchange also proposes to amend
Section 402(b)(ii) to specify that listed companies may disseminate
information via their Web site, as opposed to the Internet generally,
and social media as permitted by Regulation FD. However, the proposed
amendment will state that if a company utilizes its Web site or social
media to disseminate information it must comply with the Commission's
guidelines applicable thereto.\8\ Because listed companies will be
required to comply with the Commission's guidelines in this regard, the
Exchange proposes to delete a sentence requiring companies to transmit
information to traditional news vendor services prior [sic] making it
available on the Internet as this requirement is no longer necessary.
The Exchange proposes to amend Section 402(b)(ii) to delete references
to private networks such as PR Newswire as they are obsolete and to
change a reference from ``newspapers'' to ``media'' to encompass the
multiple forms of media in which material news can be disseminated.
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    \8\ See Securities Exchange Act Release No. 58288 (August 7,
2008) and Securities Exchange Act Release No. 69279 (April 2, 2013).
The Exchange will remind listed companies of the Commission's
guidelines with respect to the use of Web sites and social media to
disseminate material information.
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    The Exchange will continue to evaluate the materiality of these
disclosures and implement temporary trading halts, where appropriate,
to facilitate the orderly dissemination of certain issuer announcements
having a potentially material impact on the price of securities or
trading activity to ensure fair and orderly markets.
Clarification of Procedures Taken by the Exchange in the Event of
Unusual Market Activity
    Consistent with Section 202.06 of the NYSE Listed Company Manual
and Rule 5250(b)(1) of the Nasdaq Stock Market Rules, the Exchange
proposes to include a statement in Section 402(d) of the Company Guide
to indicate that, in the event of unusual market activity or rumors,
the Exchange may contact the listed company to inquire about any
company developments that have not been publicly announced but that
could be responsible for the activity. If it is determined that the
market appears to reflect undisclosed information, the Exchange will
normally request that such information be publicly disclosed
immediately.
    Because the procedures for contacting the Exchange will be set
forth on the Exchange's Web site, the Exchange proposes to delete a
paragraph in Section 402(g) that now includes outdated contact
information.
    Lastly, the Exchange proposes to delete a reference to its Market
Surveillance Department in Section 404 of the Company Guide. The
Exchange notes that certain of its market oversight responsibilities
are currently performed by the Financial Industry Regulatory Authority
(``FINRA'') pursuant to a regulatory services agreement, including
responsibility relating to the surveillance, investigation and
enforcement of insider trading rules.\9\ Accordingly, the Exchange does
not currently maintain a Market Surveillance Department that checks
with brokerage firms as to the reasons behind unusual trading activity,
as this function is performed by FINRA. The Exchange remains
responsible for FINRA's performance under the regulatory services
agreement.
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    \9\ See Securities Exchange Act Release No. 58536 (September 12,
2008), 73 FR 54646 (September 22, 2008). See also Securities
Exchange Act Release Nos. 58806 (October 17, 2008), 73 FR 63216
(October 23, 2008); 61919 (April 15, 2010), 75 FR 21051 (April 22,
2010); 63103 (October 14, 2010), 75 FR 64755 (October 20, 2010);
63750 (January 21, 2011), 76 FR 4948 (January 27, 2011); and 65991
(December 16, 2011), 76 FR 79714 (December 22, 2011).
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Changes in References to Exchange Departments and Personnel and Other
Conforming Updates
    Since the acquisition of the American Stock Exchange (the ``Amex'')
by NYSE Euronext and its renaming as NYSE MKT, the references to the
Listing Qualifications Department, Listing Qualifications Analysts and
the Exchange's Stock Watch Department are no longer accurate. It is
proposed that these legacy Amex-related references in Sections 401 and
402, including phone numbers, should be replaced. Companies will be
directed to contact the Exchange and a statement that will include the
relevant contact information to be used when contacting Exchange staff
can be found on the Exchange's Web site at nyse.com. References to
``specialists'' are changed throughout Section 402 to refer to
Designated Market Makers (``DMMs''). Lastly, Sections 402 and 404 of
the Company Guide previously referred to market action and market
activity inconsistently. The Exchange proposes to change all references
to ``market action'' to ``market activity.''
 2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Exchange Act,\10\ in general, and furthers the objectives
of Section 6(b)(5) of the Act,\11\ in particular, in that it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. The Exchange believes the proposed amendment is consistent
with the investor protection objectives of the Exchange Act in that it
harmonizes the Exchange's immediate release policy with the
Commission's requirements in Regulation FD. The Exchange further
believes that specifying that public disclosures which may
significantly affect trading should be submitted to the Exchange via
email or web-based system enables the Exchange to promptly determine
whether a trading halt is appropriate to allow for dissemination of
such material news to the marketplace thereby protecting investors and
the public interest. Lastly, the Exchange believes that the remaining
proposed amendments are consistent with Section 6(b)(5) of the Act, as
none of them make substantive changes to the Exchange's listing
requirements.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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 B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not

necessary or appropriate in furtherance of the purposes of the Act. The
proposed amendment simply harmonizes the Exchange's immediate release
policy with the Commission's requirements in Regulation FD and the
immediate release policies of the NYSE and Nasdaq, harmonizes the
method of compliance with the Exchange's immediate release policy with
the methods of compliance for the NYSE and Nasdaq immediate release
policies and makes other non-substantive changes to the Company Guide.
Accordingly, there will be no burden on competition as a result of the
amendment.

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

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

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

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act and Rule 19b-4(f)(6) thereunder.
    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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-NYSEMKT-2015-40 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-NYSEMKT-2015-40.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-NYSEMKT-2015-40 and should
be submitted on or before July 9, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-14970 Filed 6-17-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 3, 2008 (Volume 73, Number 129)]
[Rules and Regulations]
[Page 38110-38113]
[DOCID:fr03jy08-2]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 530

[Docket No. FDA-2008-N-0326]

New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug
Use; Order of Prohibition

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
prohibiting the extralabel use of cephalosporin antimicrobial drugs in
food-producing animals. We are issuing this order based on evidence
that extralabel use of these drugs in food-producing animals will
likely cause an adverse event in humans and, as such, presents a risk
to the public health.

DATES: This rule becomes effective October 1, 2008. Submit written or
electronic comments on this document by September 2, 2008.

ADDRESSES: You may submit comments, identified by [Docket No. FDA-2008-
N-0326], by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD, 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. AMDUCA

    The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
(Public Law 103-396) was signed into law on October 22, 1994. It
amended the Federal Food, Drug, and Cosmetic Act (the act) to permit
licensed veterinarians to prescribe extralabel uses of approved animal
and human drugs in animals. In the Federal Register of November 7, 1996
(61 FR 57732), we published the implementing regulations (codified at
part 530 (21 CFR part 530)) for AMDUCA. The sections regarding
prohibition of extralabel use of drugs in animals are Sec.  Sec.
530.21, 530.25, and 530.30. These sections describe the basis for
issuing an order prohibiting an extralabel drug use in animals and the
procedure to be followed in issuing an order of prohibition.
    We may issue a prohibition order if we find that extralabel use of
a drug in animals presents a risk to the public health. Under Sec.
530.3(e), this means that we have evidence demonstrating that the use
of the drug has caused, or likely will cause an adverse event.
    Section 530.25 provides for a public comment period of not less
than 60 days. It also provides that the order of prohibition become
effective 90 days after the date of publication, unless we revoke or
modify the order, or extend the period of public comment. The list of
drugs prohibited from extralabel use is found in Sec.  530.41.

B. Cephalosporins

    Cephalosporins are members of the [beta]-lactam class of
antimicrobials. These antimicrobials work by targeting synthesis of the
bacterial cell wall, resulting in increased permeability and eventual
hydrolysis of the cell. Members of the cephalosporin class have a
[beta]-lactam ring fused to a sulfur-containing ring-expanded system
(Ref. 1).
    Certain cephalosporins are currently approved for use in a number
of animal species. These approved uses include the treatment of
respiratory disease in cattle, swine, sheep, and goats, as well as
acute bovine interdigital necrobacillosis, acute metritis, and clinical
and sub-clinical mastitis in cattle. They are also approved for the
control of bovine respiratory disease, and the control of early
mortality associated with Escherichia coli infections in day-old chicks
and poults. Furthermore, approved animal uses of cephalosporins include
the treatment of skin and soft tissue infections in dogs and cats,
genitourinary tract infections (cystitis) in dogs, and respiratory
tract infections in horses.
    Cephalosporins are also some of the most widely used antimicrobial
agents in human medicine. Older agents are widely used as therapy for
skin and soft tissue infections caused by Staphylococcus aureus and
Streptococcus pyogenes, as well as treatment of upper respiratory tract
infections, intra-abdominal infections, pelvic inflammatory disease,
and diabetic foot infections. Newer cephalosporins, with or without
aminoglycosides, have been considered drugs of choice for serious
infections caused by Klebsiella, Enterobacter, Proteus, Providencia,
Serratia, and Haemophilus spp. These cephalosporins are also used to
treat systemic salmonellosis, although not specifically approved for
this purpose. Fourth

generation cephalosporins are indicated for treatment of urinary tract
infections, febrile neutropenia, intra-abdominal infections, pneumonia,
and skin and skin structure infections (Ref. 2).
    FDA is concerned that the extralabel use of cephalosporins in food-
producing animals is likely to lead to the emergence of cephalosporin-
resistant strains of foodborne bacterial pathogens. If these drug-
resistant bacterial strains infect humans, it is likely that
cephalosporins will no longer be effective for treating disease in
those people. Therefore, FDA is issuing an order prohibiting the
extralabel use of cephalosporins because, as discussed in section II of
this document, the agency has determined that such extralabel use will
likely cause an adverse event and as such presents a risk to the public
health.

II. Basis for Prohibiting the Extralabel Use of Cephalosporins

A. Cephalosporin-Resistant Zoonotic Foodborne Bacteria

    A recent review of [beta]-lactam resistance in bacteria of animal
origin states that an emerging issue of concern is the increase in
reports of broad-spectrum [beta]-lactamases (CMY-2 and CTX-M) (Ref. 3).
Acquired resistance to [beta]-lactams in animal isolates has been
observed in surveillance programs such as the Canadian Integrated
Program for Antimicrobial Resistance Surveillance (CIPARS), Danish
Integrated Antimicrobial Resistance Monitoring and Research Programme
(DANMAP), and the U.S. National Antimicrobial Resistance Monitoring
System (NARMS).
    The 2005 European Antimicrobial Resistance Surveillance System
(EARSS) report indicated that most European countries reported less
than 5 percent resistance to third generation cephalosporins in
foodborne pathogens including Enterococcus faecalis, E. faecium, and E.
coli. However, the report noted that resistance was rising in 23 of 28
countries, with significant trends identified for 15 countries. The
EARSS report states that third generation cephalosporin resistance
appears to be increasing rapidly, even in countries with formerly very
low levels of resistance (Ref. 4).
    Ceftiofur is a third generation cephalosporin approved for certain
uses in animals. Since 1997, the NARMS program has monitored ceftiofur
resistance in Salmonella isolated from food-producing animals at
slaughter. In 1997, no isolates from cattle or swine were resistant to
ceftiofur, while ceftiofur resistance among isolates from chickens and
turkeys was 0.5 percent and 3.7 percent, respectively. By 2006, the
prevalence of ceftiofur resistance among Salmonella slaughter isolates
increased to 18.8 percent for cattle, 2.0 percent for swine, 12.8
percent for chickens, and 5.3 percent for turkeys (Ref. 5).
    Food-producing animals have been shown to be a source of resistant
Salmonella infections in humans (Ref. 6). Data collected as part of
NARMS have shown an increase in multi-drug resistance among Salmonella
isolates from humans, including resistance to third generation
cephalosporins. The prevalence of ceftiofur resistance among non-Typhi
Salmonella isolates from humans rose from 0.2 percent in 1996 to 3.4
percent in 2004. A similar trend was observed over this same period
(i.e., 1996 to 2004) for decreased susceptibility to ceftriaxone, a
third generation cephalosporin approved for use in humans (Ref. 7).
    Although ceftiofur is not used in human medicine, the observed
trend of increasing resistance to this drug in human isolates
highlights concerns about the movement of foodborne bacterial pathogens
between animals and humans. In particular, as discussed in more detail
in this document, resistance to certain cephalosporins is of public
health concern in light of the evidence of cross-resistance among drugs
in the cephalosporin class. Expanded-spectrum cephalosporins (e.g.,
ceftriaxone and cefotaxime) are the antimicrobial agents of choice for
invasive Salmonella infections of pediatric patients (Ref. 8). FDA
believes that the surveillance data cited supports the finding that
certain cephalosporin use in animals is likely contributing to an
increase in cephalosporin-resistant human pathogens.

B. Scope of Order of Prohibition

    The cephalosporins are one of the most diverse classes of
antimicrobials, and have been subject to several different
classification schemes, including those using chemical structure,
microbial activity, pharmacokinetics, or marketing date to divide the
various molecular entities into distinct groups. While there is
considerable overlap among proposed schemes, individual cephalosporin
drugs do not always fall into the same groups in all classifications.
For example, a commonly used scheme that classifies cephalosporins into
``generations'' provides some general idea of the first marketing date
for the various cephalosporins. However, classification by generation
does not necessarily group together cephalosporins with similar
microbiological or pharmacokinetic characteristics. Therefore, because
classification into ``generations'' is not based on specific properties
of individual cephalosporins, there can be disagreement on which drugs
belong in which generation.
    FDA considered the possibility of limiting the order of prohibition
to certain individual cephalosporin drugs or to certain generations of
cephalosporins. However, given the potential for confusion regarding
the classification of individual cephalosporin drugs into various
generations, FDA concluded that it would be problematic to define the
scope of the prohibition based on cephalosporin ``generation.''
Furthermore, as discussed in more detail in this document, data
regarding mechanisms by which bacteria become resistant to
cephalosporins have demonstrated cross-resistance among various
individual cephalosporin drugs and among various generations of
cephalosporin drugs.
    In general, there are three mechanisms by which bacteria become
resistant to antimicrobial agents: (1) Alteration of the antimicrobial
target, (2) efflux of the antimicrobial or changes in permeability of
the bacterial cell, and (3) inactivation of the antimicrobial agent
itself. Gram negative bacterial resistance to cephalosporins occurs
mainly through inactivation of the cephalosporin by [beta]-lactamases.
These enzymes can be both innate and acquired (Ref. 9).
    Among bacteria of human health concern, the two most important
classes of [beta]-lactamase enzymes are the AmpC cephalosporinases and
the extended-spectrum [beta]-lactamases (ESBL). AmpC enzymes are found
on the chromosome of most Enterobacteriaceae, and are also currently
found on promiscuous plasmids in Salmonella and E. coli. These enzymes
provide resistance to first, second, and third generation
cephalosporins. ``Fourth generation'' cephalosporins are active in
vitro against AmpC producing bacteria, but there is some disagreement
as to the clinical significance of that activity. The AmpC enzymes are
currently the predominant [beta]-lactamases associated with Salmonella
collected from animals and humans in the United States displaying
resistance to ceftiofur and decreased susceptibility to ceftriaxone
(Ref. 3).
    ESBLs present in bacteria of human health concern include members
of the TEM, SHV, and CTX-M families. These enzymes are plasmid mediated
and have the potential to provide resistance to all

cephalosporins. Different ESBLs hydrolyze different cephalosporins at
different efficiencies and rates, thus leading to varying patterns of
in vitro susceptibility. However, although a particular ESBL may not
raise the minimum inhibitory concentration (MIC) for a given
cephalosporin to a level above the breakpoint for resistance, these
strains commonly prove to be resistant in vivo (Ref. 9). Therefore,
there are specific guidelines for screening bacterial isolates for the
presence of ESBLs when MIC's fall in the susceptible range. Any
bacterial isolate which produces either an AmpC enzyme or an ESBL is
reported to clinicians as resistant to all cephalosporins even though
susceptibility testing may show in vitro susceptibility to some of the
cephalosporins (Ref. 10). Thus, regardless of in vitro susceptibility
results, the effect of resistance mediated by an AmpC enzyme or ESBL is
that the organism is treated as if it is cross-resistant to all
cephalosporins.
    In a review of the CTX-M family of ESBLs, Livermore et al. (Ref.
11) noted that until the late 1990s, European surveys found the TEM and
SHV families of ESBLs almost exclusively. CTX-M enzymes were recorded
rarely, although large outbreaks of Salmonella Typhimurium with CTX-M-4
and CTX-M-5 were reported in Latvia, Russia, and Belarus in the mid
1990s. However, CTX-M enzymes are now the predominant ESBLs in many
European countries, and E. coli has joined Klebsiella pneumoniae as a
major host. CTX-M enzymes are supplanting TEM and SHV in East Asia as
well as in Europe. Only in North America do TEM and SHV still
predominate, although CTX-M enzymes have been occasionally detected.
Once mobilized, CTX-M enzymes can be hosted by many different genetic
elements, but are most often found on large multi-drug resistance
plasmids. Therefore, FDA is concerned that if CTM-X becomes prevalent
in the United States, as has occurred in other countries, cephalosporin
resistance may escalate.
    Given that [beta]-lactamases have been identified in zoonotic
bacteria of human health concern, and given that [beta]-lactamases can
impart cross-resistance among cephalosporins (Ref. 12), FDA concluded
that measures to prohibit extralabel use should be directed at the
entire cephalosporin class of drugs.

C. Extralabel Use of Cephalosporins in Animals

    As summarized previously, certain cephalosporins are currently
approved for use in a number of animal species for a variety of
indications. However, under the provisions of AMDUCA, cephalosporins
that are approved for use in animals or humans may be used in an
extralabel manner in animals provided certain conditions are met.
Although few data are available regarding the extent to which such
extralabel use currently occurs in the various food-producing animal
species, evidence exists that extralabel use is occurring. FDA
conducted inspections at U.S. poultry hatcheries in 2001 and examined
records relating to the hatcheries' antimicrobial use during the 30-day
period prior to inspection. FDA found that six of the eight hatcheries
inspected that used ceftiofur during that period were doing so in an
extralabel manner (Ref. 13). For example, ceftiofur was being
administered at unapproved dosing levels or by unapproved methods of
administration. In particular, ceftiofur was being administered by egg
injection, rather than by the approved method of administering the drug
to day-old chicks.
    As is recognized for the use of antimicrobial drugs in general, the
use of cephalosporins provides selection pressure that favors expansion
of resistant variants. FDA believes the extralabel use of
cephalosporins likely will contribute to the emergence of resistance
and compromise human therapy. Given the importance of the cephalosporin
class of drugs for treating disease in humans, FDA believes that
preserving the effectiveness of such drugs is critical. Therefore, FDA
believes it is necessary to take action to limit the extent to which
extralabel use of cephalosporin in animals may be contributing to the
emergence of resistant variants.
    FDA is particularly concerned about the extralabel use of
cephalosporins in food-producing animals given that such animals are
known reservoirs of foodborne bacterial pathogens such as Salmonella.
Based on information regarding cephalosporin resistance as discussed
previously, FDA believes it is likely that the extralabel use of
cephalosporins in food-producing animals is contributing to the
emergence of cephalosporin-resistant zoonotic foodborne bacteria.
Therefore, FDA has determined that such extralabel use likely will
cause an adverse event and, as such, presents a risk to the public
health.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

IV. Order of Prohibition

    Therefore, I hereby issue the following order under Sec.  Sec.
530.21 and 530.25. We find that extralabel use of the cephalosporin
class of antimicrobial drugs in food-producing animals likely will
cause an adverse event, which constitutes a finding that extralabel use
of these drugs presents a risk to the public health. Therefore, we are
prohibiting the extralabel use of the cephalosporin class of
antimicrobial drugs in food-producing animals.

V. 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. Livermore, D. M. and L. D. Williams, ``[beta]-Lactams: Mode
of Action and Mechanisms of Resistance,'' pp. 502-578, Victor Lorian
(ed.), Antibiotics in Laboratory Medicine, Williams & Wilkins,
Baltimore, 1991.
    2. U.S. Food and Drug Administration, Maxipime (cefepime
hydrochloride) for injection, NDA 50-679/S-021, http://www.fda.gov/
medwatch/SAFETY/2003/03MAR_PI/Maxipime_PI.pdf (accessed March 13,
2007).
    3. Li, X. Z., M. Mehrotra, S. Ghimire, and L. Adewoye, ``[beta]-
Lactam Resistance and [beta]-Lactamases in Bacteria of Animal
Origin,'' Veterinary Microbiology, 121:197-214, 2007.
    4. European Antimicrobial Resistance Surveillance System, EARSS
Annual Report 2005, pp. 1-147, Bilthoven, The Netherlands, 2006.
    5. U.S. Department of Health and Human Services, National
Antimicrobial Resistance Monitoring System/Enteric Bacteria (NARMS/
EB) Salmonella Annual Veterinary Isolates Data, U.S. Department of
Agriculture, http://www.ars.usda.gov/Main/
docs.htm?docid=6750&page=4, 2006.
    6. Holmberg, S. D., J. G. Wells, and M. L. Cohen, ``Animal-to-
Man Transmission of Antimicrobial-Resistant Salmonella:
Investigations of U.S. Outbreaks, 1971-1983,'' Science, 225:833-835,
1984.

    7. CDC, ``National Antimicrobial Resistance Monitoring System
for Enteric Bacteria (NARMS): Human Isolates Final Report,'' 2004,
Atlanta, GA, U.S. Department of Health and Human Services, CDC,
2007.
    8. Giles, W.P. , A. K. Benson, M. E. Olson, R. W. Hutkins, J. M.
Whichard, P. L. Winokur, and P. D. Fey, ``DNA Sequence Analysis of
Regions Surrounding blaCMY-2 From Multiple Salmonella Plasmid
Backbones,'' Antimicrobial Agents and Chemotherapy, 48:2845-2852,
2004.
    9. Livermore, D. M., ``Beta-Lactamases in Laboratory and
Clinical Resistance,'' Clinical Microbiology Review, 8:557-584,
1995.
    10. Clinical and Laboratory Standards Institute, Performance
Standards for Antimicrobial Susceptibility Testing: Sixteenth
Informational Supplement, M100-S16, Wayne, PA, USA: CLSI, 2006.
    11. Livermore, D. M., R. Canton, M. Gniadkowski, P. Nordmann, G.
M. Rossolini, G. Arlet, J. Ayala, T. M. Coque, I. Kern-Zdanowicz, F.
Luzzaro, L. Poirel, and N. Woodford, ``CTX-M: Changing the Face of
ESBLs in Europe,'' Journal of Antimicrobial Chemotherapy, 59:165-
174, 2007.
    12. Jacoby, G. A. and L. S. Munoz-Price, ``The New B-
Lactamases,'' New England Journal of Medicine, 352:380-391, 2005.
    13. U.S. Food and Drug Administration, Center for Veterinary
Medicine, unpublished report, Summary of Data From Hatchery
Inspections Conducted September-October 2001, April 15, 2002.

List of Subjects in 21 CFR Part 530

    Administrative practice and procedure, Advertising, Animal drugs,
Labeling, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director of the Center for Veterinary Medicine, 21
CFR part 530 is amended as follows:

PART 530--EXTRALABEL DRUG USE IN ANIMALS

0
1. The authority citation for 21 CFR part 530 continues to read as
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351,
352, 353, 355, 357, 360b, 371, 379e.

0
2. In Sec.  530.41, add paragraph (a)(13) to read as follows:

Sec.  530.41  Drugs prohibited for extralabel use in animals.

    (a) * * *
    (13) Cephalosporins.
* * * * *

    Dated: June 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-15052 Filed 7-2-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Notices]
[Pages 78052-78054]
[FR Doc No: 2011-32169]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-29881; 812-13987]

Wells Fargo Bank, N.A., et al.; Notice of Application and
Temporary Order

December 9, 2011.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Temporary order and notice of application for a permanent order
under section 9(c) of the Investment Company Act of 1940 (``Act'').

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SUMMARY: Summary of Application: Applicants have received a temporary
order exempting them from section 9(a) of the Act, with respect to an
injunction entered against Wells Fargo Bank, N.A. (``Wells Fargo
Bank'') on December 9, 2011 by the United States District Court for the
District of New Jersey (``Injunction'') until the Commission

takes final action on an application for a permanent order. Applicants
also have applied for a permanent order. Applicants: Wells Fargo Bank,
First International Advisors, LLC (``First International''),
Metropolitan West Capital Management, LLC (``Metropolitan West''),
Golden Capital Management, LLC (``Golden Capital''), Alternative
Strategies Brokerage Services, Inc. (``Alternative Strategies
Brokerage''), Alternative Strategies Group, Inc. (``Alternative
Strategies''), Wells Fargo Funds Management, LLC (``WF Funds
Management''), Wells Capital Management Incorporated (``Wells Capital
Management''), Peregrine Capital Management, Inc. (``Peregrine''),
Galliard Capital Management, Inc. (``Galliard''), Nelson Capital
Management (``Nelson''), and Wells Fargo Funds Distributor, LLC (``WF
Funds Distributor'') (each an ``Applicant'' and collectively, the
``Applicants'').\1\
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    \1\ Applicants request that any relief granted pursuant to the
application also apply to any existing company of which Wells Fargo
Bank is or may become an affiliated person within the meaning of
section 2(a)(3) of the Act (together with the Applicants, the
``Covered Persons'').
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    Filing Date: The application was filed on December 8, 2011 and two
amendments were filed on December 9, 2011.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on January 3, 2012, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090; Applicants: Wells Fargo Bank,
101 North Phillips Avenue, Sioux Falls, SD 57104; First International,
30 Fenchurch Street, London, England, UK EC3M 3BD; Metropolitan West,
610 Newport Center Drive, Suite 1000, Newport Beach, CA 92660; Golden
Capital, 5 Resource Square, Suite 400, 10715 David Taylor Drive,
Charlotte, NC 28262; Alternative Strategies Brokerage, 401 South Tryon
Street, Charlotte, NC 28288; Alternative Strategies, 401 South Tryon
Street, TH3, Charlotte, NC 28288; WF Funds Management and WF Funds
Distributor, 525 Market Street, 12th Floor, San Francisco, CA 94105;
Wells Capital Management, 525 Market Street, 10th Floor, San Francisco,
CA 94105; Peregrine, 800 LaSalle Avenue, Suite 1850, Minneapolis, MN
55402; Galliard, 800 LaSalle Avenue, Suite 1100, Minneapolis, MN 55402;
and Nelson, 1860 Embarcadero Road, 140, Palo Alto, CA 94303.

FOR FURTHER INFORMATION CONTACT: Jean E. Minarick, Senior Counsel, at
(202) 551-6811 or Daniele Marchesani, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

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

Applicants' Representations

    1. Wells Fargo Bank is a national banking association. On March 20,
2010, Wachovia Bank, N.A. (``Wachovia Bank'') merged with and into
Wells Fargo Bank. Wells Fargo Bank is registered as an investment
adviser under the Investment Advisers Act of 1940, as amended (the
``Advisers Act'') and serves as an investment adviser to a Fund (as
defined below). No existing company of which Wells Fargo Bank is an
affiliated person (other than the Applicants) currently serves as
investment adviser, sub-adviser, or depositor of any registered
investment company or business development company (``BDC'') or
principal underwriter for any registered open-end investment company,
registered unit investment trust (``UIT''), or registered face amount
certificate company, or investment adviser of any employees' securities
company, as defined in section 2(a)(13) of the Act (``ESC'') (``Fund
Service Activities''). ``Funds'' refers to the registered investment
companies, BDCs or ESCs for which a Covered Person provides Fund
Service Activities. Wells Fargo & Company (``Wells Fargo'') directly
owns 37.51% of Wells Fargo Bank and indirectly owns the remainder.
Through its direct and indirect subsidiaries, Wells Fargo, a registered
financial holding company and bank holding company under the Bank
Holding Company Act of 1956, as amended, offers banking, brokerage,
advisory and other financial services to institutional and individual
customers worldwide. Wells Fargo also is the ultimate parent of the
other Applicants, who, as direct or indirect subsidiaries of the same
ultimate parent, are under common control with Wells Fargo Bank.
    2. First International, Metropolitan West, Golden Capital,
Alternative Strategies, WF Funds Management, Wells Capital Management,
Peregrine, Galliard and Nelson are registered as investment advisers
under the Advisers Act and serve as investment advisers or sub-advisers
to various Funds. Alternative Strategies Brokerage and WF Funds
Distributor are registered as broker-dealers under the Securities
Exchange Act of 1934, as amended and each serves as principal
underwriter to various Funds.
    3. On December 9, 2011, the United States District Court for the
District of New Jersey entered a judgment, which included the
Injunction, against Wells Fargo Bank (``Judgment'') in a matter brought
by the Commission.\2\ The Commission alleged in the complaint
(``Complaint'') that from at least 1997 through at least 2005, Wachovia
Bank engaged in fraudulent practices and made misrepresentations and
omissions in connection with bidding on and sale of municipal
reinvestment instruments. The Complaint alleged that these fraudulent
practices, misrepresentations, and omissions affected the prices of
certain reinvestment instruments, deprived certain municipalities of a
presumption that their reinvestment instruments were purchased at fair
market value, and/or jeopardized the tax-exempt status of certain
securities. Based on the alleged misconduct described above, the
Complaint alleged that Wachovia Bank violated section 17(a) of the
Securities Act of 1933. Without admitting or denying any of the
allegations in the Complaint (other than those relating to the
jurisdiction of the District Court over it and the subject matter,
solely for purposes of this action), Wells Fargo Bank consented to the
entry of the Injunction and other relief, including disgorgement and
civil monetary penalties.
---------------------------------------------------------------------------

    \2\ U.S. Securities and Exchange Commission v. Wells Fargo Bank,
N.A., Case No. 2:11-cv-07135-WJM-MF (D.N.J. Dec. 9, 2011).
---------------------------------------------------------------------------

Applicants' Legal Analysis

    1. Section 9(a)(2) of the Act, in relevant part, prohibits a person
who has been enjoined from engaging in or continuing any conduct or
practice in connection with the purchase or sale of

a security, or in connection with activities as an underwriter, broker
or dealer, from acting, among other things, as an investment adviser or
depositor of any registered investment company or BDC or a principal
underwriter for any registered open-end investment company, registered
UIT, or registered face-amount certificate company or as investment
adviser of an ESC. Section 9(a)(3) of the Act makes the prohibition in
section 9(a)(2) applicable to a company, any affiliated person of which
has been disqualified under the provisions of section 9(a)(2). Section
2(a)(3) of the Act defines ``affiliated person'' to include, among
others, any person directly or indirectly controlling, controlled by,
or under common control, with the other person. Applicants state that
Wells Fargo Bank is an affiliated person of each of the other
Applicants within the meaning of section 2(a)(3) of the Act. Applicants
state that, as a result of the Injunction, they would be subject to the
prohibitions of section 9(a) of the Act.
    2. Section 9(c) of the Act provides that the Commission shall grant
an application for exemption from the disqualification provisions of
section 9(a) of the Act if it is established that these provisions, as
applied to the Applicants, are unduly or disproportionately severe or
that the conduct of the Applicants has been such as not to make it
against the public interest or the protection of investors to grant the
exemption. Applicants have filed an application pursuant to section
9(c) seeking a temporary and permanent order exempting them and other
Covered Persons from the disqualification provisions of section 9(a).
    3. Applicants believe they meet the standard for exemption
specified in section 9(c). Applicants state that the prohibitions of
section 9(a) as applied to them would be unduly and disproportionately
severe and that the conduct of the Applicants has been such as not to
make it against the public interest or the protection of investors to
grant the exemption from section 9(a).
    4. Applicants state that the alleged conduct giving rise to the
Injunction did not involve any of the Applicants engaging in Fund
Service Activities. Applicants also state (i) None of the current or
former directors, officers, or employees of the Applicants (other than
Wells Fargo Bank) had any knowledge of, or had any involvement in, the
conduct alleged in the Complaint to have constituted the violations
that provided a basis for the Injunction; (ii) the personnel at Wells
Fargo Bank who were involved in the conduct that constituted the
violations that provided a basis for the Injunction have had no, and
will not have any future, involvement in providing Fund Service
Activities to the Funds on behalf of the Applicants or other Covered
Persons; and (iii) because the personnel of the Applicants (other than
Wells Fargo Bank) did not have any involvement in the alleged
misconduct, shareholders of Funds that received Fund Service Activities
from the Applicants were not affected any differently than if those
Funds had received services from any other non-affiliated investment
adviser, depositor or principal underwriter.
    5. Applicants state that the inability of the Applicants to engage
in Fund Service Activities would result in potentially severe financial
hardships for the Funds they serve and the Funds' shareholders.
Applicants state that they will distribute written materials, including
an offer to meet in person to discuss the materials, to the boards of
directors of the Funds (the ``Boards''), including the directors who
are not ``interested persons,'' as defined in section 2(a)(19) of the
Act, of such Funds, and their independent legal counsel as defined in
rule 0-1(a)(6) under the Act, if any, describing the circumstances that
led to the Injunction, any impact on the Funds, and the application.
Applicants state that they will provide the Boards with the information
concerning the Injunction and the application that is necessary for the
Funds to fulfill their disclosure and other obligations under the
federal securities laws.
    6. Applicants also state that, if they were barred from providing
Fund Service Activities to registered investment companies, BDCs and
ESCs, the effect on their businesses and employees would be severe.
Applicants state that they have committed substantial resources to
establish an expertise in providing Fund Service Activities. Applicants
further state that prohibiting them from providing Fund Service
Activities would not only adversely affect their businesses, but would
also adversely affect more than 1600 employees that are involved in
those activities.
    7. Applicants state that Applicants and certain other affiliated
persons of the Applicants have previously received orders under section
9(c) of the Act, as the result of conduct that triggered section 9(a),
as described in greater detail in the application.

Applicants' Condition

    Applicants agree that any order granting the requested relief will
be subject to the following condition:
    Any temporary exemption granted pursuant to the application shall
be without prejudice to, and shall not limit the Commission's rights in
any manner with respect to, any Commission investigation of, or
administrative proceedings involving or against, Covered Persons,
including without limitation, the consideration by the Commission of a
permanent exemption from section 9(a) of the Act requested pursuant to
the application or the revocation or removal of any temporary
exemptions granted under the Act in connection with the application.

Temporary Order

    The Commission has considered the matter and finds that the
Applicants have made the necessary showing to justify granting a
temporary exemption.
    Accordingly,
    It is hereby ordered, pursuant to section 9(c) of the Act, that
Applicants and any other Covered Persons are granted a temporary
exemption from the provisions of section 9(a), solely with respect to
the Injunction, subject to the condition in the application, from
December 9, 2011, until the Commission takes final action on their
application for a permanent order.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-32169 Filed 12-14-11; 8:45 am]
BILLING CODE 8011-01-P


Comment Info: =================

General Comment:I would like to request as a consumer of e cigarette products, an extention of the comment period on 2014-09491. I belive this will allow more time for the average person to speak his/her mind on this subject. There are a lot of ex-smokers I know including myself that have benefitted greatly from the use of e-cigs. I am not talking about cheap disposable ones from China, but ones that use usp and fema/gras ingredients.  I am 42 years old and I don't need other people deciding what's right or good for me. As an American I am offended that someone else is allowed to decide what I can and cannot purchase when all the ingredients are FDA approved. Especially flavors, You CANNOT tell someone in America what flavors he's allowed to choose from. I understand not selling to minors but I am not one.
                                                                    Thank You,
                                                                                Jason Sabin


[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Notices]
[Pages 25858-25859]
[FR Doc No: 2014-10318]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP14-773-000]

City of Las Cruces, New Mexico, City of Mesa, Arizona,
ConocoPhillips Company, Freeport-McMoRan Corporation, Navajo Tribal
Utility Authority, New Mexico Gas Company, Inc., Southwest Gas
Corporation, Complainants v. El Paso Natural Gas Company, L.L.C.,
Respondent; Notice of Complaint

    Take notice that on April 25, 2014, pursuant to Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206, City of Las Cruces, New Mexico, City of
Mesa, Arizona, ConocoPhillips Company, Freeport-McMoRan Corporation,
Navajo Tribal Utility Authority, New Mexico Gas Company, Inc., and
Southwest Gas Corporation (Complainants) jointly and severally filed a
formal complaint against El Paso Natural Gas Company, L.L.C.
(Respondent) alleging that, Respondent has illegally terminated
Complainant's respective Transportation Service Agreements (TSA), which
are subject to Article 11.2(a) of the 1996 Settlement Agreement.\1\
---------------------------------------------------------------------------

    \1\ El Paso Natural Gas Co., Docket No. RP96-363-000, et al.
Offer of Settlement and Request for Approval of Stipulation and
Agreement. (submitted March 15, 1996); El Paso Natural Gas Co., 79
FERC ] 61, 028, reh'g denied 80 FERC ] 61, 084 (1997).

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

    The Complainant certifies that copies of the complaint were served
on the Respondent as listed on the Commission's list of Corporate
Officials.
    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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    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 5 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on May 15, 2014.

    Dated: April 29, 2014.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-10318 Filed 5-5-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 2, 2008 (Volume 73, Number 1)]
[Notices]
[Page 201-203]
[DOCID:fr02ja08-66]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2007-0180]

Information Collection Request to Office of Management and
Budget; OMB Control numbers: 1625-0001, 1625-0013, and 1625-0096

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit Information Collection Requests
(ICRs) and Analyses to the Office of Management and Budget (OMB)
requesting an extension of their approval for the following collections
of information: (1) 1625-0001, Marine Casualty Information & Periodic
Chemical Drug and Alcohol Testing of Commercial Vessel Personnel; (2)
1625-0013, Plan Approval and Records for Load Lines, and (3) 1625-0096,
Report of Oil or Hazardous Substance Discharge; and Report of
Suspicious Maritime Activity. Before submitting these ICRs to OMB, the
Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before March 3, 2008.

ADDRESSES: You may submit comments identified by Coast Guard docket
number USCG-2007-0180 to the Docket Management Facility at the U.S.
Department of Transportation. To avoid

duplication, please use only one of the following methods:
    (1) On-line: http://www.regulations.gov.

    (2) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand delivery: Room W12-140 on the Ground Floor of the West
Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>.
    The Docket Management Facility maintains the public docket for this
notice. Comments and material received from the public, as well as
documents mentioned in this notice as being available in the docket,
will become part of this docket and will be available for inspection or
copying at room W12-140 on the West Building Ground Floor, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. You may also find this docket
on the Internet at http://www.regulations.gov.

    Copies of complete ICRs are available through this docket on the
Internet at http://www.regulations.gov. Additionally, copies are

available from Commandant (CG-611), U.S. Coast Guard Headquarters,
(Attn: Mr. Arthur Requina), 2100 2nd Street, SW., Washington, DC 20593-
0001. The telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public participation and request for comments.

    We encourage you to respond to this request by submitting comments
and related materials. We will post all comments received, without
change, to http://www.regulations.gov. They will include any personal

information you provide. We have an agreement with DOT to use their
Docket Management Facility. Please see the paragraph on DOT's ``Privacy
Act Policy'' below.
    Submitting comments: If you submit a comment, please include the
docket number [USCG-2007-0180], indicate the specific section of the
document to which each comment applies, providing a reason for each
comment. We recommend you include your name, mailing address, an e-mail
address, or a phone number in the body of your document so that we can
contact you if we have questions regarding your submission. You may
submit your comments and material by electronic means, mail, fax, or
delivery to the Docket Management Facility at the address under
ADDRESSES; but please submit them by only one means. If you submit them
by mail or delivery, submit them in an unbound format, no larger than
8\1/2\ by 11 inches, suitable for copying and electronic filing. If you
submit them by mail and would like to know that they reached the
Facility, please enclose a stamped, self-addressed postcard or
envelope. We will consider all comments and material received during
the comment period. We may change the documents supporting this
collection of information or even the underlying requirements in view
of them.
    Viewing comments and documents: Go to http://www.regulations.gov to

view documents mentioned in this notice as being available in the
docket. Click on ``Search for Dockets,'' and enter the docket number
(USCG-2007-0180) in the Docket ID box, and click enter. You may also
visit the Docket Management Facility in room W12-140 on the West
Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone can search the electronic form of all comments
received in dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review the Privacy
Act Statement of DOT in the Federal Register published on April 11,
2000 (65 FR 19477), or you may visit http://DocketsInfo.dot.gov.

Information Collection Request

    1. Title: Marine Casualty Information & Periodic Chemical Drug and
Alcohol Testing of Commercial Vessel Personnel.
    OMB Control Number: 1625-0001.
    Summary: Marine casualty information is needed for CG
investigations of commercial vessel casualties involving death, vessel
damage, etc., as mandated by Congress. Chemical testing information is
needed to improve CG detection/reduction of drug use by mariners. The
following forms are associated with this collection: CG-2692, CG-2692A,
and CG-2692B.
    Need: Section 6101 of 46 U.S.C., as delegated by the Secretary of
Homeland Security to the Commandant, authorizes the Coast Guard to
prescribe regulations for the reporting of marine casualties involving
death, serious injury, material loss of property, material damage
affecting the seaworthiness of a vessel, or significant harm to the
environment. It also requires information on the use of alcohol be
included in a marine casualty report. Section 7503 of 46 U.S.C.
authorizes the Coast Guard to deny the issuance of licenses,
certificates of registry, and merchant mariner's documents (seaman's
papers) to users of dangerous drugs. Similarly, 46 U.S.C. 7704 requires
the Coast Guard to revoke such papers when a holder of the same has
been shown to be a drug user unless the holder provides satisfactory
proof that the holder is cured.
    Respondents: Vessel owners and operators.
    Frequency: On occasion.
    Burden Estimate: The estimated burden has decreased from 18,876
hours to 15,753 hours a year.
    2. Title: Plan Approval and Records for Load Lines.
    OMB Control Number: 1625-0013.
    Summary: This information collection is required to ensure certain
vessels are not overloaded--as evidenced by the submerging of their
assigned load line. In general, vessels over 150 gross tons or 24
meters (79 feet) in length engaged in commerce on international or
coastwise voyages by sea, are required to obtain a Load Line
Certificate. This collection also incorporates the Great Lakes load
lines rule.
    Need: Title 46 U.S.C. 5101 to 5116 provides the Coast Guard with
the authority to enforce provisions of the International Load Line
Convention, 1966. Title 46 CFR chapter I, subchapter E--Load Lines,
contain the relevant regulations.
    Respondents: Owners and operators of vessels.
    Frequency: On occasion.
    Burden Estimate: The estimated burden has increased from 1,681
hours to 1,699 hours a year.
    3. Title: Report of Oil or Hazardous Substance Discharge; and
Report of Suspicious Maritime Activity.
    OMB Control Number: 1625-0096.
    Summary: Any discharge of oil or a hazardous substance must be
reported to the National Response Center (NRC) so that the pre-
designated on-scene coordinator can be informed and appropriate spill
mitigation action carried out. The NRC also receives

suspicious activity reports from the public and disseminates this
information to appropriate entities.
    Need: Titles 33 CFR 153.203, 40 CFR 263.30 and 264.56; and 49 CFR
171.15 mandates NRC to be the central place for the public to report
all pollution spills. Title 33 CFR 101.305 mandates owners/operators of
vessels or facilities required, have security plans report activities
that may result in a Transportation Security Incident (TSI) and
breaches of security to the NRC. Voluntary reports are also accepted.
    Respondents: Persons-in-charge of a vessel or onshore/offshore
facility; owners or operators of vessels or facilities required to have
security plans; and the public.
    Frequency: On occasion.
    Burden: The estimated burden has increased from 9,105 hours to
13,017 hours a year.

    Dated: December 21, 2007.
D.T. Glenn,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
 [FR Doc. E7-25491 Filed 12-31-07; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Rules and Regulations]
[Pages 8519-8520]
[FR Doc No: 2015-03318]

=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 730 and 744

[Docket No. 150123073-5073-01]
RIN 0694-AG48

Updated Statements of Legal Authority for the Export
Administration Regulations To Include Presidential Notice of January
21, 2015

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: This rule updates the Code of Federal Regulations (CFR) legal
authority paragraphs in the Export Administration Regulations (EAR) to
cite a Presidential notice that extended an emergency declared pursuant
to the International Emergency Economic Powers Act. This is a
procedural rule that only updates authority paragraphs of the EAR. It
does not alter any right, obligation or prohibition that applies to any
person under the EAR.

DATES: The rule is effective February 18, 2015.

FOR FURTHER INFORMATION CONTACT: William Arvin, Regulatory Policy
Division, Bureau of Industry and Security, Email
<EMAIL_ADDRESS>Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The authority for parts 730 and 744 of the EAR (15 CFR parts 730
and 744) rests, in part, on Executive Order 12947 of January 23, 1995--
Prohibiting Transactions With Respect to Terrorists Who Threaten To
Disrupt the Middle East Peace Process (60 FR 5079, 3 CFR, 1995 Comp.,
p. 356) and on annual notices by the President continuing the emergency
declared in that order. This rule updates the authority paragraphs in
15 CFR parts 730 and 744 to cite the Notice of January 21, 2015, 80 FR
3461 (January 22, 2015), which is the most

recent notice continuing that emergency.
    This rule is purely procedural and makes no changes other than to
revise CFR authority paragraphs for the purpose of making the authority
citations current. It does not change the text of any section of the
EAR, nor does it alter any right, obligation or prohibition that
applies to any person under the EAR.

Export Administration Act

    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March
8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of
August 7, 2014, 79 FR 46959 (August 11, 2014), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act (50 U.S.C. 1701). BIS continues to carry out the
provisions of the Export Administration Act, as appropriate and to the
extent permitted by law, pursuant to Executive Order 13222 as amended
by Executive Order 13637.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). This rule
does not impose any regulatory burden on the public and is consistent
with the goals of Executive Order 13563. This rule has been determined
not to be significant for purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid Office of Management and Budget (OMB) Control Number. This rule
does not involve any collection of information.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. The Department finds that there is good cause under 5 U.S.C.
553(b)(3)(B) to waive the provisions of the Administrative Procedure
Act requiring prior notice and the opportunity for public comment
because they are unnecessary. This rule only updates legal authority
citations. It clarifies information and is non-discretionary. This rule
does not alter any right, obligation or prohibition that applies to any
person under the EAR. Because these revisions are not substantive
changes, it is unnecessary to provide notice and opportunity for public
comment. In addition, the 30-day delay in effectiveness required by 5
U.S.C. 553(d) is not applicable because this rule is not a substantive
rule. Because neither the Administrative Procedure Act nor any other
law requires that notice of proposed rulemaking and an opportunity for
public comment be given for this rule, the analytical requirements of
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not
applicable.

List of Subjects

15 CFR Part 730

    Administrative practice and procedure, Advisory committees,
Exports, Reporting and recordkeeping requirements, Strategic and
critical materials.

15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, parts 730 and 744 of the EAR (15 CFR parts 730-774)
are amended as follows:

PART 730--[AMENDED]

0
1. The authority citation for 15 CFR part 730 is revised to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151
note; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s),
185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C.
1824a; 50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 12002, 42
FR 35623, 3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12214, 45 FR 29783, 3 CFR, 1980 Comp., p.
256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12854,
58 FR 36587, 3 CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 28205, 3
CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp.,
p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O.
12981, 60 FR 62981, 3 CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR
54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p.
208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224,
66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 26751, 3
CFR, 2004 Comp., p 168; E.O. 13637 of March 8, 2013, 78 FR 16129
(March 13, 2013); Notice of May 7, 2014, 79 FR 26589 (May 9, 2014);
Notice of August 7, 2014, 79 FR 46959 (August 11, 2014); Notice of
September 17, 2014, 79 FR 56475 (September 19, 2014); Notice of
November 7, 2014, 79 FR 67035 (November 12, 2014); Notice of January
21, 2015, 80 FR 3461 (January 22, 2015).

PART 744--[AMENDED]

0
2. The authority citation for 15 CFR part 744 is revised to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179;
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222,
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3
CFR, 2001 Comp., p. 786; Notice of January 21, 2014, 79 FR 3721
(January 22, 2014); Notice of August 7, 2014, 79 FR 46959 (August
11, 2014); Notice of September 17, 2014, 79 FR 56475 (September 19,
2014); Notice of January 21, 2015, 80 FR 3461 (January 22, 2015).

    Dated: February 9, 2015.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2015-03318 Filed 2-17-15; 8:45 am]
BILLING CODE 3510-33-P