[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Rules and Regulations]
[Pages 43413-43415]
[FR Doc No: 2021-16738]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0616]
RIN 1625-AA87

Security Zone; Corpus Christi Ship Channel, Corpus Christi, TX

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing three 500-yard radius
temporary security zones around Motor Vessel (M/V) ARC ENDURANCE, M/V
LIBERTY PEACE, and M/V OCEAN FREEDOM. These zones are needed to protect
the vessels, which will be carrying military cargo onboard, while they
are transiting the Corpus Christi Ship Channel in Corpus Christi, TX.
Entry of vessels or persons into the zones are prohibited unless
specifically authorized by the Captain of the Port Sector Corpus
Christi (COTP) or a designated representative.

DATES: This rule is effective without actual notice August 9, 2021
through August 20, 2021. For the purposes of enforcement, actual notice
will be used from August 2, 2021 until August 9, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2021-0616 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Anthony Garofalo, Sector Corpus
Christi Waterways Management Division, U.S. Coast Guard; telephone 361-
939-5130, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Corpus Christi
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish these security zones by August 2, 2021 to ensure security of
these vessels and lack sufficient time to provide a reasonable comment
period and then consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is needed to provide for the security of these vessels.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector
Corpus Christi (COTP) has determined that potential hazards associated
with the transit of the M/V ARC ENDURANCE, M/V LIBERTY PEACE, and M/V
OCEAN FREEDOM when loaded with military cargo will be a security
concern within a 500-yard radius of the vessels. This rule is needed to
protect the vessels while they are transiting within Corpus Christi,
TX, from August 2, 2021 through August 20, 2021.

IV. Discussion of the Rule

    The Coast Guard is establishing three 500-yard radius temporary
security zones around M/V ARC ENDURANCE,

M/V LIBERTY PEACE, and M/V OCEAN FREEDOM. The zones for the vessels
will be enforced from the time the first vessel arrives on August 2,
2021, until the last vessel arrives Corpus Christi Ship Channel on
August 14, 2021. The duration of the zones is intended to protect the
vessels and military cargo on board while the vessels are in transit.
No vessel or person will be permitted to enter the security zones
without obtaining permission from the COTP or a designated
representative.
    Entry into these security zones are prohibited unless authorized by
the COTP or a designated representative. A designated representative is
a commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector Corpus
Christi. Persons or vessels desiring to enter or pass through these
zones must request permission from the COTP or a designated
representative on VHF-FM channel 16 or by telephone at<PHONE_NUMBER>. If
permission is granted, all persons and vessels shall comply with the
instructions of the COTP or designated representative. The COTP or a
designated representative will inform the public through Broadcast
Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or
Marine Safety Information Bulletins (MSIBs) as appropriate of the
enforcement times and dates for these security zones.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
duration, and location of the security zones. This rule will impact a
small designated area of the Corpus Christi Ship Channel during the
vessels' transits while loaded with cargo over a nineteen-day period.
Moreover, the Coast Guard will issue BNMs via VHF-FM marine channel 16
about the zones as appropriate and the rule allows vessels to seek
permission to enter the zones.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary security zones may be small entities, for the reasons stated
in section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves security zones lasting for the duration
of time that the M/V ARC ENDURANCE, M/V LIBERTY PEACE, and M/V OCEAN
FREEDOM are within the Corpus Christi Ship Channel. It will prohibit
entry within a 500 yard radius of the M/V ARC ENDURANCE, M/V LIBERTY
PEACE, and M/V OCEAN FREEDOM while the vessels are transiting within
the Corpus Christi Ship Channel. It is categorically excluded from
further review under paragraph L60 in Appendix A, Table 1 of DHS
Instruction

Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket where
indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6,
and 160.5; Department of Homeland Security Delegation No. 00170.1.

0
2. Revision No. 01.2.2. Add Sec.  165.T08-0616 to read as follows:

Sec.  165.T08-0616  Security Zone; Corpus Christi Ship Channel. Corpus
Christi, TX.

    (a) Location. The following areas are a security zone: All
navigable waters encompassing a 500-yard radius around Motor Vessel (M/
V) ARC ENDURANCE, M/V LIBERTY PEACE, and M/V OCEAN FREEDOM while the
vessels are in the Corpus Christi Ship Channel.
    (b) Effective period. This section is from August 2, 2021 through
August 20, 2021.
    (c) Regulations. (1) The general regulations in Sec.  165.33 of
this part apply. Entry into the zones is prohibited unless authorized
by the Captain of the Port Sector Corpus Christi (COTP) or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to units under the
operational control of USCG Sector Corpus Christi.
    (2) Persons or vessels desiring to enter or pass through the zones
must request permission from the COTP Sector Corpus Christi on VHF-FM
channel 16 or by telephone at<PHONE_NUMBER>.
    (3) If permission is granted, all persons and vessels shall comply
with the instructions of the COTP or designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public through Broadcast Notices to Mariners (BNMs),
Local Notices to Mariners (LNMs), and/or Marine Safety Information
Bulletins (MSIBs) as appropriate of the enforcement times and dates for
these security zones.

    Dated: July 31, 2021.
H.C. Govertsen,
Captain, U.S. Coast Guard, Captain of the Port Corpus Christi.
[FR Doc. 2021-16738 Filed 8-6-21; 8:45 am]
BILLING CODE 9110-04-P


179
Some non-ionophoric coccidiostats may persist longer in the environment.
7.5
Alternatives to coccidiostats
During the last fifteen to twenty years concern has been expressed regarding
the future long-term prospects for chemical control of coccidiosis. The rapid
and continuous development of coccidial drug resistance and the slow and
expensive development of new anticoccidial drugs will probably limit the
usefulness of chemical control in the future. Awareness of potential hazards
for feed mill workers, farmers, target and non target animals and the
environment will probably also increase the interest in alternative means of
control. Finally, consumers have become increasingly concerned about feed
additives, food safety, food quality and welfare problems in meat producing
animals and egg laying hens. On the other hand, new housing systems, such
as the keeping of layers in deep litter production systems, are being
introduced, and larger economical demands increase the need for efficient
and safe coccidiosis control. Several possibilities for non-chemical
coccidiosis control are being investigated. These include improved hygienic
conditions, genetic selection of more resistant animals and further
development of immunological control.
7.5.1
Improved hygiene
One of the motives for keeping birds on wire floor is to separate the birds
from their faeces and thereby avoiding contact with oocysts. It is, however,
very difficult to eradicate avian coccidia by means of strict hygienic
measures during commercial farming conditions with birds maintained on the
floor. Once the coccidia have been introduced into the poultry house the
residual oocyst contamination spreads to the following flock of birds (Loyd-
Evans, 1991). Good hygiene and dry litter reduce the number of oocysts, but
do not eliminate the risk of rapid spread of the parasites. Recently, a new
oocidal disinfectant has become commercially available (Sainsbury, 1991).
7.5.2
Genetic resistance to coccidiosis
Infection with coccidia in chickens induces immunity to the parasite as
demonstrated by a reduction of parasite replication in the birds (Horton-
Smith and Long, 1963). The immune response depends on several factors
linked to the parasites as well as to the host. Two important host factors are
the age and breed of the birds. It has been known for some time that the
breed of chickens influence immunity to infection by coccidia (Wakelin,
1978; Lillehoj, 1986; Lillehoj, 1988). Differences are seen both in humoral

7. Coccidiostats
SOU 1997:132
180
and cell mediated immunity. Studies in inbred chickens have confirmed that
this is a genetically heritable trait linked to the MHC genes and modulated by
other genes (Clare
½ET½AL
, 1985; Johnson and Edgar, 1986; Lillehoj
½ET½AL
,
1989).
Although it has been shown in experimental systems that genetically
determined resistance to chicken coccidiosis represents a possible alternative
to chemical prevention, this finding still awaits commercial application.
Commercial broiler and layer hybrids are primarily selected and bred for high
productivity by a limited number of multi-national breeding companies. The
efficacy and low cost of the anticoccidials, and the priority of production
qualities in the breeding programmes of commercial hybrids have impeded
the progress of development of genetic immunity to diseases in the birds.
7.5.3
Immunoprophylaxis
During recent years live vaccines against coccidiosis in chickens have
become commercially available. Vaccines based on infectious and
pathogenic oocysts given at carefully controlled doses followed by post-
exposure chemical prevention with coccidiostats are used in breeders in some
countries. The need for continuous chemical prevention is thereby avoided.
This kind of vaccination programme is not used in broiler chickens.
Live, attenuated vaccines based on oocysts of so-called ”precocious”
strains of the chicken coccidial species are sometimes used in litter-based
production systems, e.g. in breeders and some layer chickens. These vaccines
provide adequate immunity to coccidiosis. Such an attenuated vaccine has
been used with good results in breeders in Sweden. The major drawback of
live vaccines is their relatively high cost which limits their use in broiler
chickens and replacement layers.
In broilers, however, the results of vaccination trials with precocious
strains in a coccidia-free environment have shown that vaccinated chickens
reared without coccidiostats and antibacterial feed additives show
significantly lower live weight at 13, 28 and 36 days of age compared to
animals receiving narasin (70 mg/kg feed) or virginiamycin (20 mg/kg feed).
Both vaccinated birds and unvaccinated controls showed higher numbers of
#½PERFRINGENS
than birds given either narasin or virginiamycin (Waldenstedt
ET½AL
, 1997). Suppression of subclinical necrotic enteritis (NE) by narasin
and virginiamycin is the most likely explanation for the differences in
performance. This indicates that unless subclinical NE can also be properly
controlled, vaccination against coccidiosis may not be economically feasible
in broiler chickens. Further research in the field of non-chemotherapeutic
prevention of coccidiosis and NE will be needed if broilers are to be raised
without coccidiostats.

SOU 1997:132
7. Coccidiostats
181
No non-live vaccines are commercially available at the moment. Subunit
vaccines based on immunogenic polypeptides possibly carried by live vectors
may be a possibility in the future.
Long term prospects for chemical control of coccidiosis are uncertain.
Improved hygiene will reduce coccidiosis.
More research efforts are needed on the development of suitable vaccines
and other preventive methods for the control of coccidiosis and necrotic
enteritis.
7.6
Summary comments on coccidiostats
Coccidiostats are used specifically for the control of coccidiosis, but may
also suppress subclinical necrotic enteritis.
At the moment it does not appear feasible to rear broilers without
coccidiostats.
Breaches in good manufacturing procedures may result in toxic effects of
coccidiostats in both target and non-target species.
In order to achieve an effective coccidiosis control and proper prevention
of NE, anticoccidials must be used carefully and their effectiveness should be
monitored continuously. While alternative measures for the control of
coccidiosis and NE are developed, coccidiostats should be available on
veterinary prescription and used under veterinary supervision.
In spite of the wide use of anticoccidial substances, little is known about
resistance mechanisms. Further research into this area is needed in order to
effectively combat the increasing problem of resistance.
7.7
Addendum: dimetridazole, ipronidazole and
ronidazole
7.7.1 Introduction
Dimetridazole, ipronidazole and ronidazole all belong to the 5-nitroimidazole
group, which also includes metronidazole. These substances are active
against obligate anaerobic and microaerophilic bacteria, amoebas and
flagellated protozoa (Breccia, 1980). In animals, the 5-nitroimidazoles are
used for treatment of infections with anaerobic bacteria and protozoa
(Prescott and Baggot, 1993).

7. Coccidiostats
SOU 1997:132
182
Metronidazole was introduced for the treatment of anaerobic bacteria and
4RICHOMONAS½VAGINALIS
in human medicine. It is mainly used against
anaerobic infections in humans (Prescott and Baggot, 1993). In some
countries, metronidazole is also used in food-producing animals.
The main veterinary use for 5-nitroimidazoles is for the treatment of
histomoniasis, a disease for which few alternative drugs are available.
7.7.2
Histomoniasis - the parasite and the disease
Blackhead, also known as histomoniasis, is a disease of gallinaceous birds
which is caused by unicellular protozoa called
(ISTOMONAS½MELEAGRIDIS
(McDougald, 1991). The organism may infect various bird species, e.g.
turkeys, peafowl, pheasant, quail, grouse, partridge guinea fowl and
chickens. The turkey is, however, the most susceptible species. The birds
develop inflammations of the caeca and liver, and mortality rates may be
high. The parasite is often carried by clinically healthy birds such as
chickens, by earthworms, various arthropods and by the caecal nematode
(ETERAKIS½GALLINARUM
(McDougald, 1991).
The control of histomoniasis is based on appropriate management. Turkeys
should not be reared on ground where chickens have been farmed. Several
years must elapse before turkeys can be kept on land where chickens have
been reared. Confinement rearing of turkeys reduces the incidence of the
disease. Histomonads are extremely delicate organisms and they do not
survive outside their host, earthworms or heterakid eggs for more than a few
minutes (McDougald, 1991).
Preventive chemotherapy is practised in many countries in growing turkeys
but not in chickens, except on problem farms. Chemoprophylactic
medication in the feed with arsenicals, nitrofuran or 5-nitroimidazoles is
often used. Efficient therapeutic and preventive alternative drugs are at
present lacking.
Histomoniasis has not been a problem in Swedish commercial turkey
farming during the last decade. The disease is sometimes diagnosed in small
turkey flocks reared outside, and occasionally in other bird species such as
peafowl and pheasant. Chemoprevention is not applied in Sweden.
7.7.3
Toxicological aspects on 5-nitroimidazoles
Pharmacokinetics
Nitroimidazoles are well absorbed after oral administration to monogastric
animals (Prescott and Baggot, 1993).

SOU 1997:132
7. Coccidiostats
183
Dimetridazole is rapidly absorbed from the gastrointestinal tract in the
target species. In turkeys approximately 88% is eliminated within three days
and in swine approximately 76% of the dose is eliminated within seven days
(FAO/WHO, 1989). The metabolism of dimetronidazole leads to reduction of
the 5-nitro group, fragmentation of the imidazole ring, and formation of
covalently bound residues (FAO/WHO, 1989). At the 34th JECFA meeting
(FAO/WHO, 1990) it was found that the use of dimetridazole at permitted
concentrations to poultry and swine gives rise to residues that deplete below
detectable levels at 2-3 days postdosing. However, due to the possibility of
bound residues, it was stated that the total residue in tissues of poultry and
swine had not been characterised.
After oral administration of radiolabelled ipronidazole to rats,
approximately 92% of the total radioactivity was excreted in urine, bile and
faeces (FAO/WHO, 1989). Two hydroxylated metabolites still containing the
5-nitro group have been identified in the faeces of turkeys and rats after oral
administration of ipronidazole (FAO/WHO, 1989). The total residues have
not been characterised (FAO/WHO, 1989).
Ronidazole is absorbed from the gastrointestinal tract in both laboratory
and target animals (FAO/WHO, 1990). In studies using radiolabelled
ronidazole, the radioactivity was found to be widely distributed in tissues and
eliminated via the urine, faeces and expired air of the animals (FAO/WHO,
1989). The exact nature of ronidazole metabolites has not been determined,
but there appears to be a certain amount of bound residue (FAO/WHO,
1990).
Toxic effects
The antibacterial and antiprotozoal properties of 5-nitroimidazoles involves
the reduction of the 5-nitro group which results in short-lived hydroxylamine
derivatives that bind covalently to proteins and DNA, as a result of which
DNA strands may also break (Edwards, 1977). Following therapeutic
treatment with metronidazole, single strand-breaks have been demonstrated
in the DNA of peripheral human lymphocytes (Reitz
½ET½AL
, 1991a).
For dimetridazole, short-term toxicity in the form of clinical effects on the
nervous system and testicular atrophy has been demonstrated in rats fed high
doses of the substance (FAO/WHO, 1989). Maternal toxicity has been
demonstrated in rabbits fed high doses of dimetridazole (FAO/WHO, 1989).
Dimetridazole and its urinary metabolites gave positive results in
mutagenicity tests on strains of
3ALMONELLA
Typhimurium with nitroreductase
activity, but negative results in a variety of other mutagenicity tests
(FAO/WHO, 1989). In a study evaluating the mutagenic and genotoxic
potential of 48 nitroimidazoles and related imidazole derivatives,
dimetridazole was found to have both mutagenic and genotoxic potential (De

7. Coccidiostats
SOU 1997:132
184
Meo
½ET½AL
, 1992). In this study it was also found that the presence of a nitro
substituent at the 5-position is essential for the genotoxic activity of the
imidazole derivatives. Increased incidence of benign mammary tumours in
rats fed dimetridazole, as compared to nonmedicated control rats, has been
reported, as well as a dose-dependent increase in the incidence of benign
mammary tumours (FAO/WHO, 1989). In the absence of results from
carcinogenicity studies in a second animal species, JECFA could not
establish an ADI (Acceptable Daily Intake) in 1989 (FAO/WHO, 1989)
The 34th JECFA meeting also stated that ipronidazole showed mutagenic
properties in bacterial test systems, but because of inadequate study design of
studies in mammalian test systems the genotoxic potential could not be
properly evaluated (FAO/WHO, 1989). Studies on chronic toxicity and
carcinogenicity indicate an effect of ipronidazole on mammary tumour
formation in female rats given high doses of the substance, and a decrease in
body weight along with other signs of toxicity in rats and dogs fed high doses
(FAO/WHO, 1989). In 1989, JECFA could not establish an ADI, because the
rat carcinogenicity study was inadequate for determining a no-effect level for
ipronidazole.
Ronidazole has been found to have mutagenic potential in various bacterial
assays (Hite
½ET½AL
, 1976; FAO/WHO, 1989). The results of several
IN½VIVO
tests were variable, with both positive and negative results (Hite
ET½AL
, 1976;
FAO/WHO, 1989). However, a range of metabolites gave negative results in
the Ames’ test (FAO/WHO, 1989). Ronidazole has been found to increase
the incidence of benign mammary tumours in rats and lung adenomas and
carcinomas in mice (FAO/WHO, 1989). A temporary ADI was established at
the 34th JECFA meeting (FAO/WHO, 1989), but this was not extended at
the 42nd JECFA meeting, since requested additional data were not made
available (FAO/WHO, 1995).
Metronidazole has been shown to cause DNA strand breaks in human
lymphocytes in both
IN½VITRO
and
IN½VIVO½
studies (Reitz
½ET½AL
, 1991b; Reitz
ET
AL
, 1991a; Elizondo
½ET½AL
, 1996). Similar genotoxic effects have been
demonstrated in lymphocytes from metronidazole-treated sheep (Ostrosky-
Wegman
½ET½AL
, 1994). The study in sheep also showed that increased
susceptibility to the genotoxicity of metronidazole may be associated with
individual variations in pharmacokinetics. In earlier publications it has
sometimes been stated that there was no evidence of any genotoxic effects of
metronidazole in mammalian cells (Olsen and Hebjorn, 1982), but this has
now been disproven in the more recent studies. This may be explained by the
fact that most tests for mutagenicity demonstrate lesions due to a defective
DNA repair, while DNA single strand-breaks partly demonstrate DNA
damage before DNA repair (Reitz
ET½AL
, 1991a). Therefore, detection of
DNA single strand-breaks can be a more sensitive indicator. Such studies on
the other 5-nitroimidazoles have not been found, but there is no evidence that

SOU 1997:132
7. Coccidiostats
185
they would be any different in this aspect, as they all share the reactive 5-
nitro group.
7.7.4
Summary comments on nitroimidazoles
The strong indications of genotoxic and carcinogenic potential of 5-
nitroimidazoles, combined with the lack of appropriate studies needed to
fully evaluate the risk, have been regarded as enough motive for a ban on
their therapeutic use in animals within the EU. Withdrawal times are
supposed to ensure that no residues will be present in meat. However, when
the risk cannot be fully evaluated, neither ADI nor Maximum Residue Limits
(MRL) can be established. Consequently it is not been possible to determine
withdrawal times necessary to mitigate the risk for the 5-nitroimidazoles.
When 5-nitroimidazoles are used as feed additives, the potential hazards to
human health are not restricted to the consumers. Farmers and feedmill
workers will be exposed on a regular basis to these substances. Considering
the strong indications of genotoxicity and carcinogenicity of the 5-
nitroimidazoles, this must be regarded as totally unacceptable.

7. Coccidiostats
SOU 1997:132
186
References
!NGEL¹3¹7EINBERG¹:'¹0OLISHUK¹/¹0LAVNIK¹)¹AND¹"ARTOV¹)
, 1985. A connection
between a dietary coccidiostat and skin tears in female broiler chickens.
0OULTRY
3CIENCE

294-296.
!TEF¹-¹2AMADAN¹!¹9OUSSEF¹3!(¹AND¹!BO¹%L
3OOUD¹+
, 1993. Kinetic
disposition, systemic bioavailability and tissue distribution of salinomycin in
chickens.
2ESERACH½IN½6ETERINARY½3CIENCE

179-183.
!TEF¹-¹3HALABY¹!!¹+NAFAGY¹!¹AND¹!BO
.ORAGE¹-!
, 1989. Fetotoxicity of
some anticoccidial drugs in chickens.
$EUTSCHE½4IER¤RTZLICHE½7OCHENSCHRIFT

296-298.
"ABA¹%¹9AUDA¹4¹&UKATA¹4¹AND¹!RAKAWA¹!
, 1988. Effect of
%IMERIA½TENELLA
infection on the caecal population of lincomycin-resistans
½#LOSTRIDIUM½PERFRINGENS
introduced into chickens.
2ESEARCH½IN½6ETERINARY½3CIENCE

219-221.
"AIRD¹'*¹#ALDOW¹',¹0EEK¹)3¹'RANT¹!
, 1997. Monensin toxicity in a flock of
ostriches.
6ETERINARY½2ECORD

624-626.
"ECK¹"%¹AND¹(ARRIES¹7.
,  1979. The diagnosis of monensin toxicosis: A report on
outbreaks in horses, cattle and chickens.
)N½PROCEEDINGS½OF½½!NNUAL½MEETING½OF
!SSOCIATION½OF½6ETERINARY½,ABORATORY½$IAGNOSIS½
Madison, Wisconsin. pp. 269-282.
"EHR¹+0¹,UKERS¹(¹AND¹%RHORN¹)
, 1988. Anticoccidia Vertraeglichkeit des
Wassergefluegels.
$EUTSCHE½'EFLUEGELWIRTSCHAFT½UND½3CHWEINEPRODUKTION

511-
513.
"ENNO¹9¹%NDO¹+¹3HIRAGAMI¹.¹AND¹-ITSOUKA¹4
, 1988. Susceptibility of faecal
anaerobic bacteria from pigs and chicken to five polyether antibiotics for growth
promotion.
*APANESE½*OURNAL½OF½6ETERINARY½3CIENCE

783-790.
"RAUNIUS¹77
, 1989. [Poisoning of poultry by ionophore anticoccidials].
4IJDSCHRIFT
VOOR½$IERGENEESKUNDE

933-938.
"RECCIA¹!
,  1980. Chemical properties and reaction mechanisms of nitroimidazoles.
)N
PROCEEDINGS½OF½.ITROIMIDAZOLES½½
½#HEMISTRY½0HARMACOLOGY½AND½#LINICAL
!PPLICATION
Plenum Press, New York. pp. 35-48.
#ATHERMAN¹$2¹3ZABO¹*¹"ATSON¹$"¹#ANTOR¹!(¹4UCKER¹2%¹AND¹-ITCHELL
'%
, 1991. Metabolism of narasin in chickens and Japanese quail.
0OULTRY½3CIENCE

120-125.
#HALMERS¹'!
, 1988. Monensin toxicity in dogs.
#ANADIAN½6ETERINARY½*OURNAL

459.
#HAPMAN¹($
, 1993. Resistance to anticoccidial drugs in fowl.
0ARASITOLOGY½4ODAY

159-161.

SOU 1997:132
7. Coccidiostats
187
#HIRASE¹.+¹'REENE¹,7¹,UNT¹$+¹"AKER¹*&¹AND¹+NUTSON¹2%
, 1988. Serum
and ruminal fluid characteristics of beef cows grazing oat pastures and
supplemented with or without lasalocid.
*OURNAL½OF½!NIMAL½3CIENCE

1746-1754.
#HRISTENSEN¹+$¹:IMMERMANN¹.'¹7YATT¹#,¹AND¹'OODMAN¹4.
, 1994.
Dietary and environmental factors affecting skin strength in broiler chickens.
0OULTRY½3CIENCE

224-235.
#IAMPOLINI¹&¹,I¹91¹#RESTI¹-¹#ALZONI¹',¹AND¹3PERANZA¹!
, 1993.
Disorganization of dictyosomes by monensin treatment of
IN
VITRO½
germinated
pollen of
-ALUS½DOMESTICA
Borkh.
!CTA½"OTANICA½.EERLANDICA

349-355.
#LARE¹2!¹3TROUT¹2'¹4AYLOR¹2,¹#OLLIND¹7-¹AND¹"RILES¹7%
, 1985. Major
histocompatibility (B) complex effects on acquired immunity to caecal coccidiosis.
)MMUNOGENETICS

593-599.
#ONFER¹!7¹2EAVIS¹$5¹AND¹0ANCIERA¹2*
, 1983. Light and electron microscopic
changes in cardiac and skeletal muscle of sheep with experimental monensin
toxicosis.
6ETERINARY½0ATHOLOGY

590-602.
$AVIS¹#
, 1983. Narasin toxicity in turkeys.
6ETERINARY½2ECORD

627.
$AVISON¹+,
, 1984. Monensin absorption and metabolism in calves and chickens.
*OURNAL½OF½!GRICULTURAL½AND½&OOD½#HEMISTRY

1273-1277.
$E¹-EO¹-¹6ANELLE¹0¹"ERNADINI¹%¹,AGET¹-¹-ALDONADO¹*¹*ENTZER¹/¹#ROZET
-0¹AND¹$UMENIL¹'
, 1992. Evaluation of the mutagenic and genotoxic activities
of 48 nitroimidazoles and related imidazole derivatives by the Ames test and the
SOS chromotest.
%NVIRONMENTAL½AND½-OLECULAR½-UTAGENESIS

167-181.
$ONOHO¹!,
, 1984. Biochemical studies on the fate of monensin in animals and the
environment.
*OURNAL½OF½!NIMAL½3CIENCE

1528-1539.
$OWLING¹,
, 1992. Ionophore toxicity in chickens: a review of pathology and diagnosis.


[Federal Register: August 24, 2009 (Volume 74, Number 162)]
[Notices]
[Page 42681-42682]
[DOCID:fr24au09-77]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2009-0432]

Certificate of Alternative Compliance for the Offshore Supply
Vessel CHARLES M CALLAIS II

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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

SUMMARY: The Coast Guard announces that a Certificate of Alternative
Compliance was issued for the offshore supply vessel CHARLES M CALLAIS
II as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.

DATES: The Certificate of Alternative Compliance was issued on May 15,
2009.

ADDRESSES: The docket for this notice is available for inspection or
copying at

the 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, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. You may also find this
docket on the Internet by going to http://www.regulations.gov,
inserting USCG-2009-0432 in the ``Keyword'' box, and then clicking
``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call CWO2 David Mauldin, District Eight, Prevention Division, U.S.
Coast Guard, telephone<PHONE_NUMBER>. If you have questions on viewing
or submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    The offshore supply vessel CHARLES M CALLAIS II will be used for
offshore supply operations. The horizontal distance between the forward
and aft masthead lights may be 22'-5''. Placing the aft masthead light
at the horizontal distance from the forward masthead light as required
by Annex I, paragraph 3(a) of the 72 COLREGS, and Annex I, Section
84.05(a) of the Inland Rules Act, would result in an aft masthead light
location directly over the cargo deck where it would interfere with
loading and unloading operations.
    The Certificate of Alternative Compliance allows for the horizontal
separation of the forward and aft masthead lights to deviate from the
requirements of Annex I, paragraph 3(a) of 72 COLREGS, and Annex I,
Section 84.05(a) of the Inland Rules Act.
    This notice is issued under authority of 33 U.S.C. 1605(c), and 33
CFR 81.18.

    Dated: June 11, 2009.
J. W. Johnson,
Commander, U.S. Coast Guard, Chief, Inspections and Investigations
Branch, By Direction of the Commander, Eighth Coast Guard District.
 [FR Doc. E9-20244 Filed 8-21-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: June 14, 2006 (Volume 71, Number 114)]
[Rules and Regulations]
[Page 34262-34263]
[DOCID:fr14jn06-13]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 155

[EPA-HQ-OPP-2004-0404; FRL-8071-5]
RIN 2070-AD29

Pesticides; Procedural Regulations for Registration Review;
Notification to the Secretary of Agriculture

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification to the Secretary of Agriculture.

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

SUMMARY: This document notifies the public that the Administrator of
EPA has forwarded to the Secretary of Agriculture a draft final rule as
required by section 25(a) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). As described in the Agency's semi-annual
Regulatory Agenda, the draft final rule will establish procedures to
implement section 3(g) of FIFRA which provides for periodic review of
pesticide registrations. The goal of these regulations, which are
required by FIFRA section 3(g), is to review a pesticide's registration
every 15 years. The regulations will address the following procedural
aspects of the program: establishing pesticide cases for registration
review; establishing schedules; assembling information to be considered
during the review; deciding on the scope and depth of the review;
calling in data under FIFRA section 3(c)(2)(B) that are needed to
conduct the review; reviewing data and conducting risk assessments or
benefit analyses, as needed; deciding whether a pesticide continues to
meet the standard of registration in FIFRA; and public participation in
the registration review process. If a pesticide does not meet the FIFRA
standard, and cancellation is determined to be needed, the Agency will
follow cancellation procedures in section 6 of FIFRA. This program will
begin after the completion of tolerance reassessment in 2006 and before
the completion of reregistration in 2008. Each pesticide will be
reviewed every

15 years to assure that the it continues to meet the FIFRA standard for
registration, including compliance with any new legislation,
regulations or science policy.

ADDRESSES:  EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2004-0404. All documents in the
docket are listed on the regulations.gov web site. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Vivian Prunier, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. It simply
announces the submission of a draft final rule to the United States
Department of Agriculture (USDA) and does not otherwise affect any
specific entities. This action may, however, be of particular interest
to those persons who register pesticides under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) or who use pesticides. Since
other entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be interested in this
action. If you have any questions regarding the this action, consult
the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at http://www.epa.gov/fedrgstr.

II. What Action is EPA Taking?

    Section 25(a)(2) of FIFRA requires the Administrator to provide the
Secretary of Agriculture with a copy of any final regulation at least
30 days before signing it for publication in the Federal Register. The
draft final rule is not available to the public until after it has been
signed by EPA. If the Secretary comments in writing regarding the draft
final rule within 15 days after receiving it, the Administrator shall
include the comments of the Secretary, if requested by the Secretary,
and the Administrator's response to those comments in the final rule
when published in the Federal Register. If the Secretary does not
comment in writing within 15 days after receiving the draft final rule,
the Administrator may sign the final rule for publication in the
Federal Register anytime after the 15-day period.

III. Do Any Statutory and Executive Order Reviews Apply to this
Notification?

    No. This document is not a rule, it is merely a notification of
submission to the Secretary of Agriculture. As such, none of the
regulatory assessment requirements apply to this document.

IV. Will this Notification be Subject to the Congressional Review Act?

    No. This action is not a rule for purposes of the Congressional
Review Act (CRA), 5 U.S.C. 804(3), and will not be submitted to
Congress and the Comptroller General. EPA will submit the final rule to
Congress and the Comptroller General as required by the CRA.

List of Subjects in Part 155

    Environmental protection, Administrative practice and procedure,
Pesticides and pests

    Dated: June 2, 2006.
 James Jones,
Director, Office of Pesticide Programs.
[FR Doc. E6-9077 Filed 6-13-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 120 (Monday, June 23, 2014)]
[Notices]
[Pages 35604-35605]
[FR Doc No: 2014-14538]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72405; File No. SR-ICEEU-2014-08]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Clearance of New Energy Futures and Options Contracts

June 17, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 5, 2014, ICE Clear Europe Limited (``ICE Clear Europe'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule changes described in Items I, II and III below, which
Items have been prepared primarily by ICE Clear Europe. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The principal purpose of the change is to modify certain aspects of
the ICE Clear Europe Delivery Procedures in connection with the launch
by the ICE Endex market of three energy futures and options contracts
that will be cleared by ICE Clear Europe: The German Power Base Load
Futures Contract, German Power Peak Load Futures Contract, and German
Power Base Load Option Contract (the ``German Power Contracts'').

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

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

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

    The purpose of the rule amendments is to modify certain aspects of
the ICE Clear Europe Delivery Procedures in connection with the launch
by the ICE Endex market of the German Power Contracts that will be
cleared by ICE Clear Europe. ICE Clear Europe does not otherwise
propose to amend its clearing rules or procedures in connection with
the German Power Contracts.
    The amendments adopt a new Part J of the Delivery Procedures
applicable to the German Power Contracts in the case of physical
delivery under a futures contract. The amendments provide, among other
matters, specifications for delivery of power under a German Power
Contract through scheduling with the relevant transmission system
operator (``TSO''), including relevant definitions and a detailed
delivery timetable for the contracts. The amendments also address
invoicing and payment for delivery and certain limitations on liability
of the Clearing House for performance or non-performance by the
relevant TSO. The amendments provide for calculation by the clearing
house of buyer's and seller's security to cover delivery obligations
and related liabilities, costs or charges, as well as procedures to
address failed deliveries. The revised procedures also outline various
documentation requirements for the relevant parties.
    In addition, changes are made to paragraph 5.1 of the Delivery
Procedures to include the German Power Contracts as well as certain
other natural gas and power futures as contracts for which parties may
nominate transferors and transferees to make and take delivery. Part H
of the Delivery Procedures has also been removed as the relevant
contract moved from trading on the ICE Futures exchange to the ICE
Endex exchange and is now covered by Part G of the Delivery Procedures.
    ICE Clear Europe believes that the changes described herein are
consistent with the requirements of Section 17A of the Act \3\ and the
regulations thereunder applicable to it, including the standards under
Rule 17Ad-22,\4\ and are consistent with the prompt and accurate
clearance of and settlement of securities transactions and, to the
extent applicable, derivative agreements, contracts and transactions,
the safeguarding of securities and funds in the custody or control of
ICE Clear Europe or for which it is responsible and the protection of
investors and the public interest, within the meaning of Section
17A(b)(3)(F) of the Act.\5\ The German Power Contracts have similar
characteristics to other ICE Endex and ICE Futures Europe energy
contracts currently cleared by ICE Clear Europe, and ICE Clear Europe
believes that its existing financial resources, risk management,
systems and operational arrangements are sufficient to support clearing
of such products (and address physical delivery under such contracts).
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78q-1.
    \4\ 17 CFR 240.17Ad-22.
    \5\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Specifically, ICE Clear Europe believes that it will be able to
manage the risks associated with acceptance of the German Power
Contracts for clearing and physical delivery in such contracts. The
German Power Contracts present a similar risk profile to other ICE
Endex contracts currently cleared by ICE Clear Europe, and ICE Clear
Europe believes that its existing risk management and margin framework
is sufficient for purposes of risk management of the German Power
Contracts and related deliveries.
    Similarly, ICE Clear Europe has established appropriate standards
for determining the eligibility of contracts submitted to the
clearinghouse for clearing, and ICE Clear Europe believes that its
existing systems are appropriately scalable to handle the German Power
Contracts, which are generally similar from an operational perspective
to the other ICE Endex power contracts currently cleared by ICE Clear
Europe.
    For the reasons noted above, ICE Clear Europe believes that the
proposed rule changes are consistent with the requirements of Section
17A of the Act \6\ and regulations thereunder applicable to it.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

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

    ICE Clear Europe does not believe the proposed changes to the rules
would have any impact, or impose any burden, on competition not
necessary or appropriate in furtherance of the Act. ICE Clear Europe is
adopting the amendments to the Delivery Procedures in connection with
the listing of new contracts for trading on the ICE Endex market. ICE
Clear Europe believes that such contracts will provide additional
opportunities for interested market

participants to engage in trading activity relating to the German power
market. ICE Clear Europe does not believe the adoption of related
Delivery Procedures amendments would adversely affect access to
clearing for clearing members or their customers, or otherwise
adversely affect competition in clearing services.

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

    Written comments relating to the proposed changes to the rules have
not been solicited or received. ICE Clear Europe will notify the
Commission of any written comments received by ICE Clear Europe.

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A) \7\ of the Act and Rule 19b-4(f) \8\ thereunder
because it effects a change in an existing service of a registered
clearing agency that primarily affects the clearing operations of the
clearing agency with respect to products that are not securities,
including futures that are not security futures, swaps that are not
security-based swaps or mixed swaps, and forwards that are not security
forwards, and does not significantly affect any securities clearing
operations of the clearing agency or any rights or obligations of the
clearing agency with respect to securities clearing or persons using
such securities-clearing service. 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.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-ICEEU-2014-08 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICEEU-2014-08. 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 such filings will also be available
for inspection and copying at the principal office of ICE Clear Europe
and on ICE Clear Europe's Web site at https://www.theice.com/notices/Notices.shtml?regulatoryFilings.
    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-ICEEU-2014-08
and should be submitted on or before July 14, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-14538 Filed 6-20-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 43 (Friday, March 4, 2011)]
[Notices]
[Pages 12206-12208]
[FR Doc No: 2011-4885]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63967; File No. SR-Phlx-2011-27]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NASDAQ OMX PHLX LLC Relating
to Amendments to Rules 200(g) and 201 of Regulation SHO Applicable to
Complex Orders

February 25, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on February 23, 2011, NASDAQ OMX PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been substantially prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 1080.08 respecting complex
orders to reflect the marking requirements of Regulation SHO and to
address the handling of certain orders marked ``short'' in compliance
with Rule 201 of Regulation SHO, as explained further below.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
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
    Recently, the Exchange received approval from the Commission to
make various enhancements to its complex orders system, including to
accept complex orders where one component is the underlying security of
the options components.\3\ Specifically, the underlying stock or ETF
can now be one component of a complex order.\4\ Nasdaq Options Services
LLC (``NOS''), a registered broker-dealer and member of Financial
Industry Regulatory Authority, is responsible for the execution of the
stock or ETF component of a complex order as agent of the stock or ETF
component.\5\ This is described in Rule 1080.08(h). A complex order
with one component that is a stock or ETF is received by the Exchange
with a net debit or credit price. The individual option leg(s) and
stock/ETF component prices are not specified; rather, there is a single
net debit or credit price on the order which is used by Phlx and NOS to
determine the price of each component, including the stock/ETF.
Specifically, although Phlx is calculating the price of the options
components, a sophisticated algorithm is simultaneously causing NOS to
calculate and execute the stock or ETF component of the Complex Order,
which has been electronically communicated to NOS by the Exchange.
Thus, because the execution of one component is contingent upon the
execution of all others, the entire package is processed as a single
transaction and both the option leg and stock/ETF components are
simultaneously processed.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 63777 (January 26,
2011), 76 FR 5630 (February 1, 2011) (SR-Phlx-2010-157) (``Complex
Order rule filing'').
    \4\ A complex order is a an order involving the simultaneous
purchase and/or sale of two or more different options series in the
same underlying security or a stock-option order, priced as a net
debit or credit, based on the relative prices of the individual
components, for the same account, for the purpose of executing a
particular investment strategy. See Rule 1080.08(a).
    \5\ The NASDAQ OMX Group, Inc. owns both the Exchange and NOS;
therefore, the Exchange and NOS are affiliates.
---------------------------------------------------------------------------

    In the Complex Order rule filing, the Exchange explained that with
respect to short sale regulation, the proposed handling of the stock/
ETF component of a complex order did not raise any issues of compliance
with the currently operative provisions of Regulation SHO.\6\ When a
complex order has a

stock/ETF component, member organizations must mark, pursuant to
Regulation SHO, whether that order involves a long or short sale.\7\
The Phlx trading System will accept complex orders with a stock/ETF
component marked to reflect either a long or short position;
specifically, orders not currently marked as ``long'' or ``short'' are
rejected by the Phlx trading System.
---------------------------------------------------------------------------

    \6\ 17 CFR 242.200 et seq.
    \7\ 17 CFR 242.200(g).
---------------------------------------------------------------------------

    In 2010, the Commission amended Rule 201 and Rule 200(g) of
Regulation SHO under the Act.\8\ The amendments to Rule 201 adopt a
short sale-related circuit breaker that, if triggered, imposes a
restriction on the prices at which covered securities may be sold short
(``short sale price test restriction'').\9\ Specifically, Rule 201
requires a trading center \10\ to establish, maintain, and enforce
written policies and procedures reasonably designed to prevent the
execution or display of a short sale order of a covered security \11\
at a price that is less than or equal to the current national best bid
\12\ if the price of that covered security decreases by 10% or more
from the covered security's closing price as determined by the listing
market \13\ for the covered security as of the end of regular trading
hours on the prior day; \14\ and impose these requirements for the
remainder of the day and the following day when a national best bid for
the covered security is calculated and disseminated on a current and
continuing basis by a plan processor pursuant to an effective national
market system plan.\15\ The amendments to Rule 200(g) provide that a
broker-dealer may mark certain qualifying short sale orders ``short
exempt.'' \16\ Thereafter, the Commission extended the compliance date
for the amendments to Rule 201 and Rule 200(g) until February 28,
2011.\17\ The Exchange is filing this proposed rule change to address
the new amendments to Regulation SHO.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 61595 (February 26,
2010), 75 FR 11232 (March 10, 2010). See also Division of Trading
and Markets: Responses to Frequently Asked Questions Concerning Rule
201 of Regulation SHO.
    \9\ 17 CFR 242.201.
    \10\ The term ``trading center'' is defined in Rule 201(a)(9) of
Regulation SHO. 17 CFR 242.201(a)(9). Both the Exchange and NOS are
``trading centers'' within the definition of Rule 201(a)(9).
    \11\ The term ``covered security'' is defined in Rule 201(a)(1)
as any NMS stock as defined in Rule 600(b)(47) of Regulation NMS. 17
CFR 242.201(a)(1). See also 17 CFR 242.600(b)(47).
    \12\ The term ``national best bid'' is defined in Rule
201(a)(4). 17 CFR 242.201(a)(4).
    \13\ The term ``listing market'' is defined in Rule 201(a)(3).
17 CFR 242.201(a)(3).
    \14\ 17 CFR 242.201(b)(1)(i).
    \15\ 17 CFR 242.201(b)(1)(ii).
    \16\ 17 CFR 242.200(g)(2).
    \17\ See Securities Exchange Act Release No. 63247 (November 4,
2010), 75 FR 68702 (November 9, 2010) (extending the compliance date
of the amendments to Rules 201 and 200(g) of Regulation SHO from
November 10, 2010 until February 28, 2011).
---------------------------------------------------------------------------

    Accordingly, the purpose of the proposed rule change is to explain
the Exchange's handling of stock/ETF sell components entered as part of
a complex order in accordance with the amendments to Regulation SHO. In
particular, the Exchange is proposing to provide that, if the stock/ETF
leg of a complex order submitted to the Phlx trading System is a sell
order, then the stock/ETF leg must be marked ``long,'' ``short,'' or
``short exempt'' in compliance with Rule 200(g) of Regulation SHO; if
it is not so marked, the order will be rejected. Thus, the Exchange
will now accept complex orders marked ``short exempt'' and Rule
1080.08(b)(iv) is being adopted to reflect this.\18\ The Exchange and
NOS, as trading centers, must comply with Rule 201(b)(1)(iii)(B), which
provides that a trading center must establish, maintain, and enforce
written policies and procedures reasonably designed to permit the
execution or display of a short sale order of a covered security marked
``short exempt'' without regard to whether the order is at a price that
is less than or equal to the current national best bid.\19\
---------------------------------------------------------------------------

    \18\ The Exchange notes that a broker or dealer may mark a sell
order ``short exempt'' only if the provisions of Rule 201(c) or (d)
are met. See 17 CFR 242.200(g)(2). Since NOS and the Exchange do not
display the stock or ETF portion of a complex order, see infra note
20, a broker-dealer should not mark the short sale order ``short
exempt'' under Rule 201(c). See also Division of Trading and
Markets: Responses to Frequently Asked Questions Concerning Rule 201
of Regulation SHO, Q&A Nos. 4.2, 5.4 and 5.5.
    \19\ 17 CFR 242.201(b)(1)(iii)(B).
---------------------------------------------------------------------------

    Furthermore, the Exchange proposes to amend Rule 1080.08(h) to
describe the handling of short sales involving the stock/ETF leg of a
complex order submitted to its Phlx trading System. When the short sale
price test restriction is triggered for a covered security, NOS will
not execute or display \20\ a short sale order in the underlying
covered security component of a complex order if the price is equal to
or below the current national best bid. However, NOS will execute a
short sale order in the underlying covered security component of a
complex order if such order is marked ``short exempt,'' regardless of
whether it is at a price that is equal to or below the current national
best bid. If NOS cannot execute the underlying covered security
component of a complex order in accordance with Rule 201 of Regulation
SHO, the Exchange will cancel back the complex order to the entering
member organization. When a short sale price test restriction is
triggered in a covered security, orders in that security marked
``short'' may be executed by NOS if the order is at a price above the
current national best bid at the time of execution. Thus, the proposal
is narrowly tailored to address Rule 201 by only cancelling orders
marked ``short'' when a short sale price test restriction is triggered
in the covered security and the sell order is at a price equal to or
below the current national best bid at the time of execution.
---------------------------------------------------------------------------

    \20\ The stock or ETF portion of a complex order is not
displayed as an order, because the complex order as a whole is
handled as a single order with multiple contingencies.
---------------------------------------------------------------------------

    The Exchange believes that this approach is consistent with Rule
201. Under this proposal, the Exchange and NOS, as trading centers,
will prevent the execution or display of a short sale of the stock/ETF
component of a complex order priced at or below the current national
best bid when the short sale price test restriction is triggered.
Specifically, while the Exchange and NOS are determining, respectively,
the prices of the options component and of the stock or ETF component
of the complex order, as described above, NOS will check the current
national best bid of the stock or ETF component at the time of
execution. The execution of one component is contingent upon the
execution of all other components and once a complex order is accepted
and validated by the Phlx trading System, the entire package is
processed as a single transaction and both the option leg and stock/ETF
components are simultaneously processed.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \21\ in general, and furthers the objectives of Section
6(b)(5) of the Act \22\ in particular, in that it is designed to
promote just and equitable principles of trade, and, in general to
protect investors and the public interest, by providing clarity on the
short sale order handling procedures of the stock/ETF component of a
complex order when a short sale price test restriction is in effect for
a covered security. Furthermore, the Exchange believes that the
proposed rule change is consistent with Regulation SHO in that it
provides for the handling of short exempt orders as well as short sale
orders when the short sale price test restriction is triggered.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(5).

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

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 not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    Because the foregoing 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 after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \23\ and Rule 19b-4(f)(6) \24\
thereunder. The Exchange has requested that the Commission waive the
30-day pre-operative waiting period contained in Exchange Act Rule 19b-
4(f)(6)(iii) \25\ so that the Exchange may implement the change no
later than February 28, 2011 to coincide with the compliance date for
the amendments to Rules 200(g) and 201 of Regulation SHO. The
Commission believes that waiver of the operative delay is consistent
with the protection of investors and the public interest because the
proposed rule change, among other things, implements the amendments to
Rules 200(g) and 201 of Regulation SHO which have a February 28, 2011
compliance date.\26\ For this reason, the Commission designates the
proposed rule change to be operative upon filing with the
Commission.\27\
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(3)(A).
    \24\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
    \25\ 17 CFR 240.19b-4(f)(6)(iii).
    \26\ See supra note 17.
    \27\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2011-27 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

    All submissions should refer to File Number SR-Phlx-2011-27. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for 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 a.m. and 3
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-Phlx-2011-27
and should be submitted on or before March 25, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-4885 Filed 3-3-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 30, 2010 (Volume 75, Number 229)]
[Notices]
[Page 74037-74038]
[DOCID:fr30no10-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

November 22, 2010.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC11-21-000.
    Applicants: Alta Wind I, LLC, Alta Wind I Holding Company, LLC.
    Description: Application for Authorization of Sale/Leaseback
Transactions of Alta Wind I Holding Company, LLC, et al.
    Filed Date: 11/19/2010.
    Accession Number: 20101119-5204.
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER03-534-011.
    Applicants: Ingenco Wholesale Power, L.L.C.
    Description: Supplement to Notice of Change in Status of Ingenco
Wholesale Power, L.L.C..
    Filed Date: 11/19/2010.
    Accession Number: 20101119-5144.
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Docket Numbers: ER05-1178-015; ER09-838-001.
    Applicants: Gila River Power LP, Entegra Power Services LLC.
    Description: Supplement to Updated Market Power Analysis for
Continued Market-Based Rate Authority in Compliance with Order No. 697
of Gila River Power, L.P., et al.

    Filed Date: 11/19/2010.
    Accession Number: 20101119-5206.
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Docket Numbers: ER10-2235-001.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas and Electric Company submits revised
worksheets and a refund report under ER10-2235.
    Filed Date: 11/08/2010.
    Accession Number: 20101109-0201.
    Comment Date: 5 p.m. Eastern Time on Monday, November 29, 2010.

    Docket Numbers: ER11-1890-000; ER11-1890-001; ER11-1892-000; ER11-
1892-001; ER11-1893-000; ER11-1893-001; ER11-1894-000; ER11-1894-001;
ER11-1881-000; ER11-1881-001; ER11-1882-000; ER11-1882-001; ER11-1883-
000; ER11-1883-001; ER11-1885-000; ER11-1885-001; ER11-1886-000; ER11-
1886-001; ER11-1887-000; ER11-1887-001; ER11-1889-000; ER11-1889-001.
    Applicants: Camp Reed Wind Park, LLC, Payne's Ferry Wind Park, LLC,
Salmon Falls Wind Park, LLC, Yahoo Creek Wind Park, LLC, Burley Butte
Wind Park, LLC, Golden Valley Wind Park, LLC, Milner Dam Wind Park,
LLC, Oregon Trail Wind Park, LLC, Pilgrim Stage Station Wind Park, LLC,
Thousand Springs Wind Park, LLC, Tuana Gulch Wind Park, LLC.
    Description: Second Supplement to the Market-Based Rate
Applications of Burley Butte Wind Park, LLC, et al.
    Filed Date: 11/19/2010.
    Accession Number: 20101119-5212.
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Docket Numbers: ER11-2159-000.
    Applicants: Verso Maine Energy LLC.
    Description: Verso Maine Energy LLC submits tariff filing per
35.12: Verso Maine Energy LLC--MBR Application to be effective 1/18/
2011.
    Filed Date: 11/19/2010.
    Accession Number: 20101119-5157.
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Docket Numbers: ER11-2160-000.
    Applicants: FPL Energy Montezuma Wind, LLC.
    Description: FPL Energy Montezuma Wind, LLC submits tariff filing
per 35.12: FPL Energy Montezuma Wind, LLC MBR Application to be
effective 11/20/2010.
    Filed Date: 11/19/2010.
    Accession Number: 20101119-5172.
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Docket Numbers: ER11-2161-000.
    Applicants: Entergy Texas, Inc.
    Description: Entergy Texas, Inc submits a revised, lower
depreciation rates for their use in all applicable FERC formula rates
relating to steam production accounts.
    Filed Date: 11/19/2010.
    Accession Number: 20101122-0201.
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Docket Numbers: ER11-2162-000.
    Applicants: AP Holdings Southaven, LLC.
    Description: Notice of Cancellation of AP Holdings Southaven, LLC.
    Filed Date: 11/22/2010.
    Accession Number: 20101122-5056.
    Comment Date: 5 p.m. Eastern Time on Monday, December 13, 2010.

    Docket Numbers: ER11-2163-000.
    Applicants: BTEC New Albany LLC.
    Description: Notice of Cancellation of BTEC New Albany LLC.
    Filed Date: 11/19/2010.
    Accession Number: 20101119-5211.
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Docket Numbers: ER11-2164-000.
    Applicants: Comverge Inc.
    Description: Application of Comverge, Inc. Docket for limited
waiver of Section III.<IP_ADDRESS>.1 of Market Rule 1 of ISO New England.
    Filed Date: 11/19/2010.
    Accession Number: 20101119-5173
    Comment Date: 5 p.m. Eastern Time on Friday, December 10, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-30047 Filed 11-29-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 161 (Tuesday, August 20, 2013)]
[Notices]
[Pages 51192-51194]
[FR Doc No: 2013-20215]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0656]

Secure Supply Chain Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the start of the Secure Supply Chain Pilot Program (SSCPP).
The SSCPP is intended to assist FDA in its efforts to prevent the
importation of adulterated, misbranded, or unapproved drugs by allowing
the Agency to focus its resources on imported drugs that fall outside
the program and may pose risks. Such a program would increase the
likelihood of expedited entry for specific finished drug products and
active pharmaceutical ingredients (APIs) imported into the United
States that meet the criteria for selection under the program. This
notice outlines the

eligibility requirements and the process for applying for participation
in the SSCPP.

DATES: FDA will be accepting applications for participation in the
SSCPP beginning September 16, 2013, and continuing through December 31,
2013. The SSCPP will be piloted for 2 years, from February 2014 through
February 2016.

FOR FURTHER INFORMATION CONTACT: Katharine Neckers, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Participation in the SSCPP described in this notice is voluntary.
FDA plans to increase the rate at which entries of the finished drug
products and APIs selected for the pilot program are given a ``May
Proceed'' without human entry review or examination; thus, the Agency
anticipates that participation in the program will increase the
likelihood of expedited entry when products covered by the program are
offered for importation into the United States.
    This pilot program is closely related to section 713(4)(B)(i) of
the recently enacted Food and Drug Administration Safety and Innovation
Act (FDASIA). Section 713 of FDASIA authorizes FDA to require the
submission of drug compliance information as a condition of granting
admission to imported drugs, and subsection (4)(B)(i) specifically
states that in issuing the implementing regulations FDA ``may, as
appropriate, take into account differences among importers and types of
imports, and based on the level of risk posed by the imported drug,
provide for expedited clearance for those importers that volunteer to
participate in partnership programs for highly compliant companies and
pass a review of internal controls. . . .'' Thus, the information
provided through this pilot program will help inform the Agency's
approach to implementing the program mentioned in section 713(4)(B) of
FDASIA.
    To the extent allowed by law, and in a manner consistent with
applicable laws and policies, the Agency intends to share the names of
the participants and information related to these companies with other
Federal Agencies, such as Customs and Border Protection (CBP). FDA is
collaborating with CBP regarding the Customs-Trade Partnership Against
Terrorism (C-TPAT) portion of the application. Nothing in this notice
restricts FDA, CBP, or any other Agency from examining or inspecting
any product or establishment, or affects the legal responsibilities of
participants or the legal requirements of products that they are
importing.
    FDA announced this pilot program in the Federal Register of January
15, 2009 (74 FR 2605), requesting comments on the program and proposed
collection of information. A subsequent request for comments on the
collection of information was issued June 20, 2012 (77 FR 37055). The
2009 and 2012 notices contain further background and clarification
regarding the pilot program. FDA has made a few changes to the pilot
program announced in 2009, and this notice describes the requirements
to participate and other aspects of the program.
    To help determine whether participants in the SSCPP continue to
meet the program's criteria and help evaluate the program, FDA intends
to periodically examine records and conduct random field examinations
to audit shipments. FDA may withdraw its selection of an application if
the applicant, foreign manufacturer, or Ultimate Consignee: (1)
Receives communications, such as an Untitled Letter, Cyber Letter, or
Warning Letter, that cite violations of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) relating to drug products that FDA
otherwise deems to have violated any requirements of the FD&C Act
relating to drug products or (2) fails to comply with the SSCPP.
Termination of participation in the SSCPP will result in a return to
the routine manual drug entry review process.

II. Secure Supply Chain Pilot Program Requirements

    To be selected to participate in the SSCPP, an applicant must meet
the following criteria:
    1. The applicant must submit a complete application using Form FDA
3676 and be the sponsor of the New Drug Application (NDA) or the
Abbreviated New Drug Application (ANDA), or be the foreign manufacturer
of the imported finished drug product or API.
    2. If the Ultimate Consignee identified in the SSCPP application is
an establishment subject to section 510 of the FD&C Act (21 U.S.C.
360), then it must be in compliance with FDA's registration, drug
listing, and current good manufacturing practice requirements, and must
have been in compliance over the past 3 years.
    3. If the drug product identified in the SSCPP is a finished dosage
form, then the firm identified as the Ultimate Consignee for the drug
product must be identified in the approved NDA or ANDA.
    4. If the drug identified in the SSCPP application is an API, then
the source must be an acceptable source per the approved NDA or ANDA,
and the API must be used in the manufacture of the FDA-approved drug
product.
    5. The importation of the finished drug product or API must: (a) Be
from the foreign manufacturer identified in the SSCPP application; (b)
arrive through the identified port of entry and port of arrival; (c)
use the identified Customs House Broker/Entry Filer; and (d) be
intended for the identified Ultimate Consignee.
    6. The foreign manufacturer and the finished drug product or API
identified in the SSCPP application must be in compliance with
requirements of the FD&C Act relating to drugs.
    7. The SSCPP importer of record must have a validated Tier II or
Tier III secure supply chain per the CBP Customs-C-TPAT Program.
    8. The primary and secondary contacts identified in the SSCPP
application must be able to answer questions and resolve issues raised
by FDA. The primary contact must be the sponsor or the U.S. agent for
the sponsor.
    9. The applicant must have a plan in place for promptly correcting
concerns that FDA identifies regarding its secure supply chain or
specific importations.
    10. The applicant must have a sufficient plan in place for
recalling or correcting any finished drug products or APIs that do not
meet, or are discovered not to have been manufactured in accordance
with, FDA requirements. Deviations from the recall procedures for
products associated with the SSCPP must be reported to FDA within 3
business days of identification by the applicant.
    11. Applicants must comply with recordkeeping requirements of the
FD&C Act and its implementing regulations. For the purposes of
participating in this pilot, applicants must make these records readily
available to FDA upon request. Regardless of whether required by law,
applicants must also maintain records that confirm the information
provided in their SSCPP applications, including documentation of their
C-TPAT validation status. These records must be maintained for the
duration of the applicant's participation in the program and be readily
available when requested by FDA. FDA requests, however, that these
records be maintained and be readily available when requested by FDA
for a period of at least 3 years after

the pilot ends or the applicant's participation in the pilot ends. In
addition, regardless of whether required by law, for each shipment of
finished drug product or API, applicants must maintain, for the
duration of the applicant's participation, records that document the
product's movement through the secure supply chain from the point of
manufacture to the point of receipt by the Ultimate Consignee.
    12. The Customs House Broker/Entry Filer identified in the SSC
pilot application must be qualified for paperless entry filing to FDA's
Operational and Administrative System for Import Support.

III. Definitions for the Purposes of This Program

     Affirmation of Compliance (AofC) Code: A code designated
by FDA for use by filers to convey information related to product or
firm compliance with Agency requirements, used to help expedite entry
processing. Some AofC codes require a qualifier to provide additional
information to aid in expedited processing.
     Automated Broker Interface (ABI): An integral part of the
Automated Commercial System, ABI is the means by which brokers or
importers transmit entry data to the U.S. Customs and Border
Protection.
     Automated Commercial System (ACS): The system used by CBP
to track, control, and process all commercial goods imported into the
United States.
     Customs House Broker/Entry Filer: A licensed Customs
broker hired to file entries for another party or a Customs ABI
participant that files its own entries.
     Customs-Trade Partnership Against Terrorism: C-TPAT is the
CBP initiative that partners with members of the trade community on a
voluntary basis to better secure the international product supply chain
to the United States.
     Foreign Shipper: The firm identified or declared as the
shipper at time of entry into the United States.
     Importer of Record: The person, establishment, or
representative responsible for making entry of imported goods in
accordance with all laws affecting such importation.
     ``May Proceed'': This term means that an FDA-regulated
imported product may proceed into domestic commerce after the
electronic screening. This is not a decision by FDA about the product's
regulatory status, and it does not preclude FDA action at a later time.
     Manufacturer ID: Manufacturer identification code
constructed with specific segments of the manufacturer's or shipper's
name and address. Refer to CBP Customs Directive Number 3550-055 (Old
Number 3500-13), dated November 24, 1986, for instructions on
determining the manufacturer ID.
     Ultimate Consignee: The party in the United States, at the
time of entry or release, to whom the overseas shipper sold the
imported merchandise. If at the time of entry the imported merchandise
has not been sold, then the Ultimate Consignee at the time of entry or
release is defined as the party in the United States to whom the
overseas shipper consigned the imported merchandise.

IV. Process for Applying To Participate in the Pilot

    Due to resource constraints, FDA intends to limit the SSCPP to no
more than 100 qualified applicants, with no more than 5 drug products
per applicant. FDA may, at its discretion, increase or decrease the
number of applications that it selects or the number of products per
applicant. The application (Form FDA 3676) to participate in the SSCPP
can be found at http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm.
    The SSCPP application should be submitted electronically as a
document in Portable Document Format (PDF) and using the Electronic
Common Technical Document (eCTD) format and the Electronic Submissions
Gateway (ESG). The SSCPP application form should be referenced and
placed in the 1.2 Cover Letter section. The PDF file name should
contain ``3676'' as part of the file name, and the eCTD leaf title
should include ``3676,'' the sponsor name, and the drug name, e.g.,
``3676 Form--ABC Drug Company for XYZ Pain Pill.'' If a firm is unable
to submit the application electronically, it should submit a hard copy
of the application form via mail to: U.S. Food and Drug Administration,
Attention: OC Office of Drug Security, Integrity, and Recalls, Central
Document Room, 5901B Ammendale Rd., Beltsville, MD 20705-1266.
    For further information regarding eCTD, please refer to the Web
site at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm. For
communications other than the submission of the SSCPP application (Form
FDA 3676), please contact the CDER SSCPP mailbox at
<EMAIL_ADDRESS>    FDA will be accepting applications for participation in the SSCPP
(see DATES). Applications will be processed as they are received, on a
first-come, first-served basis. FDA anticipates finishing its review of
the applications and selection of the participants by February 2014.
All required fields must be completed on the application; incomplete
applications will be returned to the U.S. primary contact named in the
application. Please do not attach additional documents to the
application submission. For the narrative sections of the application,
please use the space provided to respond to the question. Applicants
will be notified in writing as to whether their application has been
selected.
    FDA will assign a qualifier to each selected SSCPP application.
Each Customs House Broker/Entry Filer will transmit the qualifier when
filing the entry for the product. The qualifier will accompany an AofC
code, which FDA has designated as a Secure Supply Chain (SSC). Once
accepted into the SSCPP, the applicant must notify FDA of any changes
to the information contained in Form FDA 3676 by email to the SSCPP
mailbox at<EMAIL_ADDRESS>FDA anticipates responding to the
applicant's modified application within 15 business days after receipt.
Continued participation in the SSCPP is dependent on FDA's
authorization of those changes.

V. Evaluation

    FDA intends to evaluate the SSCPP based on several factors,
including, but not limited to, the following: Timeframes for passage of
drugs through the imports entry process, the level of adherence by the
program participants to the program's criteria, and the impact of the
SSCPP. This evaluation will help FDA determine whether establishment of
an SSC program is supported and, if so, the parameters of such a
program. FDA may also determine that it should extend the pilot program
to continue its evaluation, or may terminate the pilot program before
the close of the 2-year period. Such decisions will be announced in the
Federal Register.

    Dated: August 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20215 Filed 8-19-13; 8:45 am]
BILLING CODE 4160-01-P