[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Notices]
[Page 28826]
[FR Doc No: 2011-12155]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form 40-F; OMB Control No. 3235-0381; SEC File No. 270-335 .

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for approval of extension of the previously
approved collection of information discussed below.
    Form 40-F (17 CFR 249.240f) is used by certain Canadian issuers to
register a class of securities under Section 12 of the Securities
Exchange Act of 1934 (``Exchange Act'') (15 U.S.C. 78l) or as an annual
report pursuant to Section 13(a) or 15(d) of the Exchange Act (15
U.S.C. 78m(a) or 78o(d)). The information required in the Form 40-F is
used by investors making investment decisions with respect to the
securities of such Canadian companies. All information provided to the
Commission is available for public review. Information provided by Form
40-F is mandatory. We estimate that Form 40-F takes approximately 427
hours per response and is filed by approximately 205 respondents. We
estimate that 25% of the 427 hours per response (106.75 hours) is
prepared by the issuer for a total reporting burden of 21,884 (106.75
hours per response x 205 responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, http://www.reginfo.gov. Comments should be directed to: (i) Desk Officer for
the Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503, or by sending an e-
mail to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312 or send an
e-mail to<EMAIL_ADDRESS>Comments must be submitted to OMB
within 30 days of this notice.

    Dated: May 11, 2011.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-12155 Filed 5-17-11; 8:45 am]
BILLING CODE 8011-01-P


to refusal of admission for failure to provide adequate prior notice.  It also deletes the text in that
provision that states that failure to provide the manufacturer's registration number renders the
identity of the facility incomplete for purposes of prior notice. The final rule retains, with
revisions, the provision that states that if food is from a foreign facility that is not registered and
is imported or offered for import, it is subject to being placed under hold under section 801(l) of
the act.
III. Comments on the IFR
FDA received 320 timely submissions in response to the IFR.  To make it easier to
identify comments and FDA’s responses to the comments, the word “Comment” will appear in
parentheses before the description of the comment, and the word “Response” will appear in
parentheses before FDA’s response.  A summary follows which includes a description of the
appropriate section in the final rule.
A. General Comments
(Comments) Most comments generally support the intent of the Bioterrorism Act and
FDA’s efforts to implement its provisions with the IFR.  Some comments commend FDA for
revising certain proposed requirements to address the needs of international trade by shortening
timeframes, reducing the amount of information required to be submitted, and adding a
reasonable amount of flexibility for the submission of prior notice based on the mode of
transportation in the IFR.  However, several comments assert that the agency has misinterpreted

20
the Bioterrorism Act and some comments suggest that the final rule should be more consistent
with the existing trade practices established in accordance with CBP.
(Response) FDA drafted the IFR in response to the comments to the proposed rule, the
needs of international trade, and the continued threat of international terrorism and other
significant risks to public health posed by imported food.  We also drafted the final rule
accordingly.
(Comments) Several comments support the graduated enforcement policy the agency
used to implement the IFR, noting that this policy facilitated the transition into compliance with
the prior notice requirements.  Comments ask that FDA provide a similar transition period after
publication of the final rule during which time submitters may become familiar with new
requirements, understand the new procedures and adjust business processes and practices.
(Response) After publication of the IFR, FDA published guidance that included a
transition period during which we emphasized education to achieve compliance (the December
2003 Prior Notice Interim Final Rule CPG) (68 FR 69708, December 15, 2003).  FDA agrees
that implementing a graduated enforcement policy using enforcement discretion has assisted
submitters to become accustomed to the new requirements.  The new requirements of the final
rule will not take effect until 180 days after publication.  Since the final rule retains most of the
requirements found in the IFR, and with the 180-day delay in effective date, we are not
implementing a graduated enforcement policy for implementing the final rule.
FDA and CBP have issued elsewhere in this issue of the FEDERAL REGISTER a new
CPG (hereinafter the Prior Notice Final Rule Draft CPG) that explains our proposed policies for
enforcing violations of this final rule.  The draft CPG describes the circumstances under which

21
FDA and CBP should typically consider not taking any regulatory action, the types of violations
FDA and CBP intend to focus on, and other enforcement policies.
(Comments) Several comments thank FDA for providing an opportunity to provide
comments on the provisions of the IFR after a period of active FDA/CBP enforcement.
(Response) FDA agrees that providing several comment periods following publication of
the IFR has permitted affected stakeholders an additional opportunity to offer specific and
informed comments on the new requirements.
(Comments) One comment requests that FDA clarify that prior notices submitted to FDA
will not be subject to public disclosure under the Freedom of Information Act (5 U.S.C. 552, et
seq.) (FOIA) because information contained in a prior notice is confidential business
information.  Alternatively, the comment requests that FDA develop policies to protect
confidential business information contained in prior notices from public disclosure.
(Response) FDA does not believe this is necessary.  FDA already has relatively detailed
regulations, in 21 CFR part 20, governing the disclosure of information under FOIA, including
the disclosure of confidential business information.  Likewise, the agency's general policies,
procedures, and practices relating to the protection of confidential information received from
third parties apply to information received under prior notice.  We do not believe rules, policies,
or procedures specific to prior notice are needed.
(Comments) One comment states that during the period of enforcement discretion,
various ports of arrival took different approaches to enforcement and suggests that FDA ensure
that all ports and all officials act in a similar fashion to achieve a consistent enforcement posture.
The comment also suggests that FDA and CBP conduct “cross-training” of their officials staffing
FDA or CBP help desks.

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(Response) All prior notice field operations and procedures are directed by the FDA Prior
Notice Center (PNC).  The PNC works to ensure a consistent implementation and enforcement
program.  Since the initial implementation of the prior notice rule, FDA staff has received
additional training and guidance on prior notice requirements.
(Comments) Several comments acknowledge the efforts of CBP and FDA to work
together to achieve the common goal of securing the imported food supply.  In particular,
comments congratulate FDA for coordinating with CBP to allow transmission of FDA-required
information through the ABI to CBP's ACS.  In addition, comments support the integration and
cooperation of both agencies in utilizing CBP's targeting system to efficiently and rapidly spot
anomalies in freight crossing our borders; reducing the FDA proposed timeframes for submission
of prior notice in the advance electronic information requirements; and the commissioning of
CBP staff to conduct examinations and investigations.  One comment requests that CBP and
FDA ensure that there are adequate resources at ports of arrival to mitigate anticipated delays at
border crossings when the rule is enforced.  Several comments anticipated that trade would
collapse on December 12, 2003, when the new regulations took effect.
(Response) FDA and CBP are continuously coordinating efforts to receive, review, and
respond to prior notice submissions.  We further note that trade continued without significant
interuption on December 12, 2003, or anytime after that implementation date.  Rather, the
implementation of the prior notice requirements was relatively smooth.
(Comments) Several comments acknowledge the importance and value of FDA’s
educational outreach efforts to the trade industry through scheduled outreach and education
sessions, port-specific flyers, foreign government training and website communications,

23
especially those that summarize certain compliance data.  The comments also applaud the
unprecedented efforts the FDA has made in this regard.
(Response) FDA and CBP will continue outreach and education efforts as resources
permit.  See section III.M entitled “Outreach and Enforcement” later in this document for further
discussion on this subject.
(Comments) Several comments commend FDA for its efforts in developing the prior
notice regulation in an efficient and effective manner, reaching out to affected stakeholders for
input and comment, and acknowledge the tremendous effort put forth by the agency in the
development of the regulation.  Other comments state that the rule lacked real world
international business input and will have both business and government unable to function
because of the amount of paperwork generated, which will not stop a terrorist attack.  In
particular, one comment notes that tracing a grower of a particular shipment is impossible in
many instances.
(Response) FDA and CBP systems have been able to manage the millions of prior notice
submissions received, reviewed, and responded to since December 12, 2003.  The agencies
strove to implement the requirements in the Bioterrorism Act in a manner that required only that
information deemed necessary and appropriate to ensure FDA could meet its statutory obligation
to receive, review and respond to prior notices and target those shipments needing inspection
upon arrival in the United States.  Based on FDA’s and CBP’s experience since December 2003,
the agencies have revised some of the requirements in the IFR and eliminated some of the
information we no longer deem necessary (e.g., HTS codes).  FDA notes that the grower of a
food in its natural state is required only when known.

24
(Comments) One comment suggests that the prior notice IFR is “functionally redundant”
because prior notice has long been a part of FDA protocol long before the Bioterrorism Act.
(Response) While FDA agrees that most of the information required by the IFR has been
submitted to FDA via CBP processes for decades, the information has not been required prior to
arrival of the food, making prior notice a new, unique, and valuable process.
(Comments) One comment suggests that the IFR was unduly costly, ill-considered and
generally more harmful than useful.  An additional comment believes that the prior notice
requirements would restrict trade more than necessary and hopes that the United States will
implement the Bioterrorism Act in the least trade-restrictive manner.  Another comment states
that despite efforts to comply with the new requirements, massive problems seem to constantly
occur.  Another comment complains about accessibility to the Web site, cost and time of the
submission procedures, language barriers, and complexity of the information requested.
(Response) FDA disagrees.  The prior notice process, which allows submission of the
required information via either ABI/ACS or PNSI, has been relatively smooth.  Although there
were some technical problems encountered during the early implementation phase, FDA believes
that the graduated enforcement process coupled with the vigorous education and outreach efforts
by both the government and the industry have supported a relatively smooth transition to the new
procedures and have improved compliance with the new requirements.  FDA also has considered
its international trade obligations under various World Trade Organization agreements, North
America Free Trade Agreement, and other international agreements throughout the rulemaking
development processes for both the IFR and this final rule.  Both rules are consistent with our
international obligations.

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(Comments) Some comments believe there is a disincentive towards product
diversification when exporting articles of food to the United States because the prior notice
requirements put them at a competitive disadvantage compared to shipments that originate in the
United States.
(Response) The requirement for prior notice was established by Congress with the
passage of the Bioterrorism Act to improve the ability of the United States to prevent, prepare
for, and respond to bioterrorism and other public health emergencies. Section 307 of the
Bioterrorism Act requires prior notice of all food imported or offered for import into the United
States.  FDA is aware of the international trade obligations of the United States and has
considered these obligations throughout the rulemaking process for this final rule and the IFR
preceding it. Both are consistent with these international obligations.  FDA and CBP have
actively explored ways to reduce the burden on industry to the extent feasible while fulfilling the
Bioterrorism Act mandates.  Accordingly, we have made a number of changes in the final rule
that minimize the impact of prior notice requirements on the food being imported or offered for
import into the United States.   We also note that the registration requirement applies to domestic
facilities, as well as foreign facilities, and that the registration provisions in the Bioterrorism Act
contain certain exclusions that apply only to foreign facilities.  (See e.g., 21 CFR 1.226(a), which
exempts from the requirement to register a foreign facility, if food from such facility undergoes
further manufacturing/processing (including packaging) by another facility outside the United
States; no similar exclusion applies to facilities within the Unites States.)
(Comments) Other comments suggest that the IFR failed to include a provision that
would ensure that high risk imports arrive at ports staffed by FDA inspection personnel and
notes that this could be accomplished by designating particular ports of entry for accepting high

26
risk products or requiring importers of such products to provide longer notice to ensure adequate
inspection coverage.
(Response) FDA disagrees.  Section 307 of the Bioterrorism Act specifically prohibits
FDA from limiting the port of entry by stating, “Nothing in this section may be construed as a
limitation on the port of entry for an article of food.”  We also disagree that certain shipments
require longer timeframes for submission of prior notice to ensure adequate inspection coverage.
Under a Memorandum of Understanding (MOU) between FDA and CBP, published on January
7, 2004 (69 FR 924), FDA has commissioned thousands of CBP officers in ports and other
locations to conduct, on FDA's behalf, investigations and examinations of imported foods.  This
helps ensure that there is adequate inspection coverage, including at ports where FDA does not
currently have personnel.
B. Comments on the Legal Authority
(Comments) One comment requests that FDA delegate authority to the U.S. Department
of Agriculture (USDA), as it has with CBP, to enable USDA to implement prior notice
requirements on products where the USDA shares jurisdiction.
(Response) FDA disagrees.  FDA has not delegated its authority under section 801(m) of
the act to CBP, although FDA has commissioned CBP officers in ports and other locations to
conduct, on FDA's behalf, investigations and examinations of imported foods.  FDA recognizes
that there are some products over which both FDA and USDA have jurisdiction.  For example,
both FDA and USDA's Animal and Plant Health Inspection Service (APHIS) regulate the
importation of fruits and vegetables into the United States, although the goal of APHIS'
regulation is to safeguard U.S. agriculture and natural resources from the risks associated with
the plant pests.  Nonetheless, FDA does not believe that there is a need to have USDA

27
implement the prior notice requirements for products for which we share jurisdiction, nor do we
believe that doing so would lead to an efficient enforcement of the prior notice requirements.
The Bioterrorism Act mandates that advance notice be given to FDA for any article of food that
is being imported or offered for import into the United States and that the Secretary receive,
review, and appropriately respond to such notifications.  To accomplish this, FDA established
the PNC that operates 24 hours a day, 7 days a week, to receive, review, and respond to these
notices as they are submitted.  The purpose of prior notice is to enable FDA to conduct
inspections of imported foods at U.S. ports upon arrival and target foods that may pose a
significant risk to public health, based on the information submitted.
Prior Notice is submitted electronically to FDA through either Customs’ ABI/ACS or
FDA’s PNSI.  Regardless of the mode of transmission, the prior notice information will undergo
both a validation process and a screening in FDA’s Operational and Administrative System for
Import Support (OASIS) for food safety and security criteria.  If the FDA system does not
indicate that further evaluation of or action on the notice or article of food is necessary for prior
notice, the system will transmit a message through OASIS to the ABI/ACS interface for CBP
that the article of food may be conditionally released.  However, if additional evaluation of the
prior notice information is necessary, personnel at the FDA’s PNC will access the information
provided and determine if that information suggests the potential for a significant risk to public
health.
FDA personnel are able to make this determination by using their experience of imported
foods, utilizing the expertise within the Center for Food Safety and Nutrition (CFSAN), the
Center for Veterinary Medicine (CVM), the inspectional information obtained by the Office of
Regulatory Affairs (ORA), and utilizing the expertise of CBP staff who are co-located with the

28
PNC.  If FDA determines that a potential health risk is present, FDA or CBP will examine the
food or take other appropriate action.
Evaluations of imported articles of food are made on an article-of-food by article-of-food
basis.  CBP and FDA are continuously working together to incorporate further intelligence
gained from this process.  USDA personnel are not trained in these systems, and thus, having
USDA evaluate a subset of FDA (co)regulated products would not be as efficient or effective as
retaining responsibility within FDA.
FDA does note that food items that are under the exclusive jurisdiction of the USDA are
not subject to the requirements of prior notice. (See the discussion on § 1.277 (scope), discussed
infra.)
(Comments) Another comment suggests that to be consistent with the Bioterrorism Act,
FDA should permit an alternative to prior notice for administrative flexibility.  The comments
suggest that this could be accomplished by including in the final rule a provision which states,
"Other measures as appropriate that provide an equivalent level of assurance of compliance with
the requirements of this part."
(Response) FDA disagrees.  Section 801(m) of the act requires the submission of prior
notice for all food imported or offered for import into the United States, except as outlined in
§ 1.277(b).  FDA is to use that information to determine whether it should inspect the food upon
arrival in the United States.  Compliance with prior notice, therefore, means providing the
required information within the specified timeframes.  No other "measures" would "provide an
equivalent level of assurance of compliance" with the prior notice requirements.

29
C. What Definitions Apply to this Subpart? (§ 1.276)
Section 1.276 of the IFR provides definitions for the following terms: The act, calendar
day, country from which the article originates, country from which the article is shipped, FDA
Country of Production, food, grower, international mail, no longer in its natural state, port of
arrival, port of entry, registration number, shipper, United States, and you.  FDA received no
comments on the definitions for the act, calendar day, country from which the article originates,
FDA Country of Production, grower, and United States, and thus, the final rule retains the
definitions for these terms that were in the IFR.  Although no comments were received on the
definitions for “country from which the article is shipped,” “registration number,” and “you,” we
made minor revisions to these definitions.  We also added a definition for the term, “full
address,” although we did not get any comments on this term.
1. The Act (§ 1.276(a))
The final rule defines “the act” to mean “the Federal Food, Drug, and Cosmetic Act.”
2. Calendar Day (§ 1.276(b)(1))
The final rule defines “calendar day” to mean “every day shown on the calendar.”
3. Country From Which the Article Originates (§ 1.276(b)(2))
The final rule defines “country from which the article originates” to mean “FDA Country
of Production.”
4. Country From Which the Article is Shipped (§ 1.276(b)(3))
The final rule defines “country from which the article is shipped” to mean “the country in
which the article of food is loaded onto the conveyance that brings it to the United States or, in
the case of food sent by international mail, the country from which the article is mailed.”  For

30
clarity, we revised the last phrase of this definition to change, “the country in which the article
will be mailed” to “the country from which the article is mailed.”
5. FDA Country of Production (§ 1.276(b)(4))
The final rule defines “FDA Country of Production” to mean, for an article of food that is
in its natural state, the country where the article of food was grown, including harvested or
collected and readied for shipment to the United States.  If an article of food is wild fish,
including seafood that was caught or harvested outside the waters of the United States by a
vessel that is not registered in the United States, the FDA Country of Production is the country in
which the vessel is registered.  If an article of food that is in its natural state was grown,
including harvested or collected and readied for shipment, in a Territory, the FDA Country of
Production is the United States.  For an article of food that is no longer in its natural state, the
country where the article was made; except that, if an article of food is made from wild fish,
including seafood, aboard a vessel, the FDA Country of Production is the country in which the
vessel is registered.  If an article of food that is no longer in its natural state was made in a
Territory, the FDA Country of Production is the United States.
6. Full Address (§ 1.276(b)(6))
The IFR did not have a definition for the term, “full address.”  However, we added this
term to the final rule for clarity since this term is used throughout the rule.  The final rule defines
“full address” to mean “the facility’s street name and number; suite/unit number, as appropriate;
city; province or state as appropriate; mail code as appropriate; and country.”

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7. Grower (§ 1.276(b)(7))
The final rule defines “grower” to mean “a person who engages in growing and
harvesting or collecting crops (including botanicals), raising animals (including fish, which
includes seafood), or both.”
8. Registration Number (§ 1.276(b)(13))
The final rule defines “registration number” to mean “the registration number assigned to
a facility by FDA under section 415 of the act (21 U.S.C. 350d) and 21 CFR part 1, subpart H.”
FDA made a minor change in this definition in the final rule by adding the phrase “to a facility”
after the word “assigned” to clarify that FDA assigns registration numbers by facility.
9. United States (§ 1.276(b)(15))
The final rule defines “United States” to mean “the Customs territory of the United States
(i.e., the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico), but not the
Territories.”
10. You (§ 1.276(b)(16))
The final rule defines “you” to mean “the person submitting the prior notice, i.e., the
submitter or the transmitter, if any.”  We made a minor change to this definition by simplifying
the last phrase of the definition to “i.e., the submitter or the transmitter, if any.”
FDA received comments on the definitions for the following terms in the IFR:  food,
international mail, no longer in its natural state, port of arrival, and shipper.  FDA also received
comments that recommend that FDA include additional definitions for the following terms in the
IFR:  Carrier, manufacturer, trip number, and ultimate consignee.  FDA responds to these
comments in the following paragraphs.

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11. Food (§ 1.276(b)(5))
The IFR defines “food” as having the meaning given in section 201(f) of the act, except
that it does not include food contact substances as defined in section 409(h)(6) of the act (21
U.S.C. 348(h)(6)) or pesticides as defined in 7 U.S.C. 136(u). Examples of food include fruits,
vegetables, fish, including seafood, dairy products, eggs, raw agricultural commodities for use as
food or as components of food, animal feed (including pet food), food and feed ingredients, food
and feed additives, dietary supplements and dietary ingredients, infant formula, beverages
(including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods,
candy, and canned foods.
(Comments) One comment asks FDA to define food contact substances, which are
exempt from the requirements of prior notice, to include secondary direct food additives.  The
comment reasons that secondary direct food additives, many of which are food processing aids,
meet the criteria for food contact substances as defined in section 409(h)(6) of the act (21 U.S.C.
348(h)(6)).  The comment further reasons that secondary direct food additives meet the criteria
that FDA used in the registration IFR to exclude food contact materials from the requirements of
the registration IFR as they are not "food for consumption" in that "they are not intentionally
eaten for their taste, aroma, or nutritive value" (68 FR 58894 at 58911).
(Response) Some secondary direct food additives meet the definition of food contact
substances as given in section 409(h)(6) of the act and, therefore, would not be subject to the
prior notice requirements (§ 1.276(b)(5)(i)(A)).  The comment, however, asks about secondary
direct food additives that are not food contact substances, for example food processing aids.  The
IFR concluded that food processing aids that are not food contact substances are subject to prior
notice “Whether a food processing aid or ‘indirect additive’ is subject to prior notice depends

33
upon whether such a substance is ‘food’ under this rule.  As noted, for purposes of the interim
final rule, ‘food’ excludes ‘food contact substances’ as defined at section 409(h)(6) of the FD&C
Act.  Among other things, unlike food processing aids and ‘indirect additives,’ ‘food contact
substances’ are not ‘intended to have any technical effect in food, ’ [section 409(h)(6) of the act].
In addition, ‘food’ excludes pesticides as defined at 7 U.S.C. 136(u).  Thus, if the substance is
not a pesticide and is intended to have a technical effect in the food being processed, the
substance is not exempt from the definition of ‘food’ under § 1.276(b)(5) in the interim final
rule.  This is a reasonable result in that such processing aids are intentionally and directly added
to ‘traditional’ foods.” (68 FR 58974 at 58986).  We continue to hold this view.  Thus, if a
secondary direct food additive is not a food contact substance but is a food processing aid, then it
would be subject to prior notice.
(Comments) Two comments ask the FDA to clarify the term, “reasonably expected to be
directed to a food use.”  One comment states that seed produced by seed companies is intended
to be used for planting crops, but the production process inevitably results in remnant or culled
seed that is suitable for use as animal feed (and to a far lesser degree, as food for human
consumption), which generally is sold by the seed company as such.  The comment states that a
similar issue arises with some crops, such as onions, for which bulbs sold to farmers may also be
used as feed or, in limited cases, as food if they are determined to be remnant or culled.  The
comment believes that FDA should provide specific limitations on the definitions of "reasonably
believes" and "reasonably expected" that take into consideration that the seed produced by seed
companies is intended to be used for planting crops, even though it is understood that there
inevitably will be some remnant seed and culls.  Without such limitations, the comment believes
the rule is unreasonably broad, imposes a burden on seed companies primarily marketing seeds

34
for planting purposes that is out of proportion to the protective goals of the act, and is subject to
widely varying interpretations.  Another comment notes that the seed industry's research and
development activities generate very small amounts of seed that may be found "unsuitable" for
planting and end up in the food supply, and similarly asks for clarification of the "reasonably
believes" and "reasonably expected" language.
(Response) In the preamble to the IFR, we state that “FDA will consider a product as one
that will be used for food if any of the persons involved in importing or offering the product for
import (e.g., submitter, transmitter, manufacturer, grower, shipper, importer, owner, or ultimate
consignee) reasonably believes that the substance is reasonably expected to be directed to a food
use” (68 FR 58974 at 58987).  The purpose of this statement was to explain when an article of
food would be subject to prior notice if it is capable of multiple uses.  The comments, and our
experience with the IFR, have shown that there is some confusion as to how to determine when a
substance that is capable of a food use and a non-food use is a “food” for purposes of prior
notice.  To clarify, we will consider such a substance to be “food” for the purpose of prior notice
if it is reasonably likely to be directed to a food use.  This should make it clearer that, as
explained in the preamble to the IFR, the determination is not based on the intended use of the
article (68 FR 58974 at 58987).
In one of the comments, the seed will “inevitably" contain remnant seed and culls that
will be diverted to human or animal feed.  In this case, since at the time of import, the seed is
reasonably likely to be directed to a food use, prior notice is required.  FDA believes this is
consistent with the purpose of the Bioterrorism Act.  With respect to the other comment about
seeds found “unsuitable” for planting, there is insufficient detail in the comment to determine
whether these seeds would be considered food.

35
Nonetheless, we note that the Prior Notice Final Rule Draft CPG, announced elsewhere
in this issue of the FEDERAL REGISTER, proposes an enforcement policy regarding seeds for
planting.  Under the draft policy, FDA and CBP would typically consider not taking any
regulatory action regarding seeds that will be used for cultivation.  The policy would apply when
no more than a small portion of that seed is diverted from cultivation to animal feed or other food
use.  It would not apply, however, where the seed is used for the production of edible sprouts,
such as alfalfa seeds for the production of alfalfa sprouts.
(Comments) One comment states that the Bioterrorism Act regulations do not present a
means to provide FDA with certification that any of the indicated persons (i.e., submitter,
transmitter, manufacturer, grower, shipper, importer, owner, or ultimate consignee) do not
reasonably believe that an item is reasonably expected to be directed to a food use prior to arrival
at a U.S. port.  The comment further states that there is no method to avoid classifying their
products as anything other than those flagged as FD4 articles requiring prior notice, thereby
providing no means to avoid refusal of the goods upon arrival because the prior notice was not
filed.
(Response) FDA disagrees.  FDA is continuously reviewing the FD3 and FD4 flags
associated with HTS codes.  The HTS codes are flagged to indicate which products will (FD4) or
may (FD3) require prior notice and which product will or may require FDA review under section
801(a) of the act for admissibility; all FDA-regulated products are covered, not just foods.
2
If
2
HTS codes are "flagged" in ACS as follows to indicate that products are or may be under FDA jurisdiction:
FD0 - Indicates that FDA has determined the article, even though subject to FDA's laws and regulations, is
acceptable for CBP release without further presentation of prior notice or other entry information to FDA.
FD1 - Indicates that the article may be subject to FDA jurisdiction, including FDA review under 801(a) of the act.
For products not subject to FDA jurisdiction, a filer can "Disclaim" product from FDA notification requirements.

36
you believe that an item has been incorrectly flagged, you should contact the FDA and provide a
statement that explains your rationale.  The designation will be reviewed and action taken to
correct the flag if deemed appropriate.  With respect to the comment about providing
certification about the belief of the “indicated persons,” submitters may disclaim articles of food
marked FD3 if the article is not reasonably likely to be directed to a food use by using an
affirmation of compliance in ABI/ACS.
(Comments) Many comments address the FD flags associated with the HTS codes.  Two
comments state that they are currently importing a product that was flagged FD4, which requires
that prior notice be submitted for that article.  However, the item is not an article of food and the
commenter would like the HTS code changed from a FD4 flag to a FD3 flag.  An additional
comment had concerns about multiple use products, where one use would require prior notice
and another use would not.  Another comment states that there is no clear methodology provided
to disclaim an item beyond the initial FD3 designation.  The comment recommends that the
agency outline the elements of a due diligence protocol that would become part of the disclaimer
process.  One comment suggested that the data elements in the prior notice submission be


[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21370-21371]
[FR Doc No: 2016-08222]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2016-0204]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0118

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of
revision to the following collection of information: 1625-0118, Various
International Agreement Certificates and Documents. Our ICR describes
the information we seek to collect from the public. Before submitting
this ICR to OIRA, the Coast Guard is inviting comments as described
below.

DATES: Comments must reach the Coast Guard on or before June 10, 2016.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2016-0204] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR AVE SE., STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek approval of
revisions of the Collection. We will consider all comments and material
received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2016-0204], and
must be received by June 10, 2016.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Various International Agreement Certificates and Documents.
    OMB Control Number: 1625-0118.
    Summary: This information collection is associated with the
Maritime Labour Convention (MLC), 2006. The Coast Guard established a
voluntary inspection program for vessels who wish to document
compliance with the requirements of the MLC. U.S. commercial vessels
that operate on international routes are eligible to participate. The
Coast Guard issues voluntary compliance certificates as proof of
compliance with the MLC.
    Need: This information is needed to determine if a vessel is in
compliance with the Maritime Labour Convention, 2006.
    Forms: CG-16450, Maritime Labour Certificate; CG-16450A, Interim
Maritime Labour Certificate; CG-16450B, Declaration of Maritime Labour
Compliance--Part 1; CG-16450C, Maritime Labour Convention, 2006
Inspection Report.

    Respondents: Vessel owners and operators.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from 4,150
hours a year to 625 hours a year due to a decrease in the estimated
number of responses.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended.

    Dated: April 1, 2016.
Thomas P. Michelli,
U.S. Coast Guard, Deputy Chief Information Officer.
[FR Doc. 2016-08222 Filed 4-8-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Rules and Regulations]
[Pages 34865-34867]
[FR Doc No: 2011-14780]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0374]
RIN 1625-AA00

Safety Zone; Rochester Harbor Festival, Genesee River, Rochester,
NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
Genesee River, Rochester, NY for the Rochester Harbor Festival
fireworks. This zone is intended to restrict vessels from the mouth of
the Genesee River in Rochester during the Rochester Harbor Festival
fireworks on June 25, 2011. This temporary safety zone is necessary to
protect spectators and vessels from the hazards associated with a
firework display.

DATES: This rule is effective from 10 p.m. until 10:30 p.m. on June 25,
2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket, are part of docket USCG-2011-0374 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0374 in the
``Keyword'' box, and then clicking ``Search.'' This material is also
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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail MST3 Rory Boyle, Marine Events
Coordinator, U.S. Coast Guard Sector Buffalo; telephone<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final 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 waiting for a notice and
comment period to run would be impracticable and contrary to the public
interest in that it would inhibit the Captain of the Port (COTP)
Buffalo from protecting the public and vessels from the hazards
associated with fireworks displays on navigable waters.
    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. For the same reasons discussed in
the preceding paragraph, a 30-day notice period would also be
impracticable and contrary to the public interest.

Background and Purpose

    The Rochester Harbor Festival is an event intended to celebrate the
Independence of the United States. The festival will include fireworks,
which be launched on June 25, 2011 between 10 p.m. and 10:30 p.m. from
a waterborne location. The COTP Buffalo has determined that waterborne
fireworks displays present significant hazards to vessels and
spectators in the vicinity of the lunch site.

Discussion of Rule

    Because of the aforesaid hazards, the COTP Buffalo has determined
that a temporary safety zone is necessary to ensure the safety of
spectators and vessels during the setup, loading, and launching of the
fireworks display. Accordingly, all waters within a 1,120-ft radius of
43[deg]15'42.48'' N, 77[deg]36'3.24'' W (NAD83) Genesee River,
Rochester, NY.
    All persons and vessels shall comply with the instructions of the
COTP Buffalo or the designated representative. Entry into, transiting,
or anchoring within the safety zone is prohibited unless authorized by
the COTP Buffalo or his designated representative. The COTP Buffalo or
his designated representative may be contacted via VHF Channel 16.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. It is not ``significant'' under the
regulatory policies and procedures of the Department of Homeland
Security (DHS). We conclude that this rule is not a significant
regulatory action because we anticipate that it will have minimal
impact on the economy, will not interfere with other agencies, will not
adversely alter the budget of any grant or loan recipients, and will
not raise any novel legal or policy issues.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in the mouth of the Genesee River in Rochester, NY on June
25, 2011 from 10 p.m. until 10:30 p.m.
    This safety zone will not have a significant economic impact on a
substantial number of small entities because of the minimal amount of
time in which the safety zone will be enforced. This safety zone will
only be enforced for 90 minutes in a low vessel traffic area. Vessel
traffic can pass safely around the zone. Before the effective period,
we will issue maritime advisories, which include a Broadcast Notice to
Mariners.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    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.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children From Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
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 is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a safety zone.
An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

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:  33 U.S.C. 1231; 46 U.S.C. Chapters 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0374 to read as follows:

Sec.  165.T09-0374  Safety zone; Rochester Harbor Festival, Genesee
River, Rochester, NY.

    (a) Location. The following area is a temporary safety zone: All
waters within a 1,120-ft radius of 43[deg]15'42.48'' N,
77[deg]36'3.24'' W Genesee River, Rochester, NY.
    (b) Effective and enforcement period. This zone will be effective
and enforced from 10 p.m. until 10:30 p.m. on June 25, 2011.
    (c) Regulations. (1) In accordance with the general regulations in
section 165.23 of this part, entry into, transiting, or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port Buffalo, or his designated representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated
representative.
    (3) The ``designated representative'' of the Captain of the Port is
any Coast Guard commissioned, warrant, or petty officer who has been
designated by the Captain of the Port to act on his behalf. The
designated representative of the Captain of the Port will be aboard
either a Coast Guard or Coast Guard Auxiliary vessel.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall

contact the Captain of the Port Buffalo or his designated
representative to obtain permission to do so. The Captain of the Port
or his designated representative may be contacted via VHF Channel 16.
    (5) Vessel operators given permission to enter or operate in the
safety zone must comply with all directions given to them by the
Captain of the Port Buffalo or his designated representative.

    Dated: May 31, 2011.
R.S. Burchell,
Captain, U. S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2011-14780 Filed 6-14-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Notices]
[Pages 78063-78064]
[FR Doc No: 2011-32165]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65928; File No. SR-NYSEAmex-2011-94]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending the NYSE
Amex Options Fee Schedule

December 9, 2011.
    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 December 1, 2011, NYSE Amex LLC (the ``Exchange'' or ``NYSE Amex'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the self-regulatory organization. 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 the NYSE Amex Options Fee Schedule
(``Fee Schedule'') to exclude Strategy Executions from the monthly Firm
fee cap. The proposed change will be operative on December 1, 2011. The
text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and http://www.nyse.com.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received

on the proposed rule change. The text of those statements may be
examined at the places specified in Item IV below. The Exchange has
prepared summaries, set forth in sections A, B, and C below, of the
most significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend the Fee Schedule to exclude Strategy
Executions from the monthly Firm fee cap.
    Strategy Executions include reversals and conversions, dividend
spreads, box spreads, short stock interest spreads, merger spreads, and
jelly rolls. Under the current Fee Schedule, fees for Strategy
Executions are capped at $750 per transaction and $25,000 per month.
Under the proposed change, Firms would continue to benefit from those
two fee caps, but fees for Strategy Executions would be excluded from
the calculation of the monthly Firm fee cap of $100,000.\3\ The
Exchange notes that such treatment would be consistent with the
exclusion of Strategy Executions from the calculation of the Market
Maker monthly fee cap and volume threshold.\4\
---------------------------------------------------------------------------

    \3\ See Fee Schedule at n. 6.
    \4\ See Fee Schedule at n. 5.
---------------------------------------------------------------------------

    The proposed changes will be operative on December 1, 2011.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6(b) \5\ of the Securities Exchange Act
of 1934 (the ``Act''), in general, and Section 6(b)(4) \6\ of the Act,
in particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among its
members and other persons using its facilities. The Exchange believes
that the proposed change is equitably allocated and not unfairly
discriminatory because it will apply equally to all Firms and treat
them in a manner that is more consistent with other capped
participants, i.e., Market Makers. The Exchange believes that the
proposed change is reasonable because Firms will still be able to avail
themselves of the reduced rates for Strategy Trade Executions.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

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

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \7\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \8\ thereunder, because it establishes a due, fee, or other charge
imposed by the Exchange. At any time within 60 days of the filing of
such 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)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2011-94 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-NYSEAmex-2011-94. 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 NW.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEAmex-2011-94 and should
be submitted on or before January 5, 2012.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-32165 Filed 12-14-11; 8:45 am]
BILLING CODE 8011-01-P