	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2008-0257; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Determination of Attainment of the Fine Particle Standard

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to determine that the
Harrisburg-Lebanon-Carlisle, Pennsylvania nonattainment area for the
1997 fine particle (PM2.5) National Ambient Air Quality Standard (NAAQS)
has attained the 1997 PM2.5 NAAQS.  This proposed determination is based
upon quality assured, quality controlled, and certified ambient air
monitoring data that show that the area has monitored attainment of the
1997 PM2.5 NAAQS since the 2004 - 2006 monitoring period, and continues
to monitor attainment of the standard based on 2005 - 2007 data.  In
addition, quality controlled and quality assured monitoring data for
2008 that are available in the EPA Air Quality System (AQS) database,
but not yet certified, show this area continues to attain the 1997 PM2.5
NAAQS.  If this proposed determination is made final, the requirements
for this area to submit an attainment demonstration and associated
reasonably available measures, a reasonable further progress plan,
contingency measures, and other planning State Implementation Plans
(SIPs) related to attainment of the standard shall be suspended for so
long as the area continues to attain the 1997 PM2.5 NAAQS.

DATES: Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2008-0257 by one of the following methods:

 www.regulations.gov.  Follow the on-line instructions for submitting
comments.

B.    	E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.    	Mail:  EPA- R03-OAR-2008-0257, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.   	Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket(s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2008-0257.  EPA's policy is that all comments received will
be included in the public docket without change, and may be made
available online at   HYPERLINK "http://www.regulations.gov"
www.regulations.gov , including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.  Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov website is an (anonymous access( system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment.  If you send an e-mail comment
directly to EPA without going through  www.regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet.  If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit.  If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.  Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT:  Rose Quinto,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:  Throughout this document whenever “we”,
“us”, or “our” is used, we mean EPA.

Organization of this document.  The following outline is provided to aid
in locating information in this preamble.

I.    What Action is EPA Taking?

II.   What is the Effect of This Action?

III.  What is the Background for This Action?

IV.  What is EPA’s Analysis of the Relevant Air Quality Data?

V.   Proposed Action

VI.  Statutory and Executive Order Reviews

I.  What Action is EPA Taking?

EPA is proposing to determine that the Harrisburg-Lebanon-Carlisle,
Pennsylvania PM2.5 nonattainment area has attained the 1997 PM2.5 NAAQS.
 This determination is based upon quality assured, quality controlled,
and certified ambient air monitoring data that show the area has
monitored attainment of the 1997 PM2.5 NAAQS since the 2004 – 2006
monitoring period, and monitoring data that continue to show attainment
of the 1997 PM2.5 NAAQS based on the 2005 – 2007 data.  In addition,
quality controlled and quality assured monitoring data for 2008 that are
available in the EPA AQS database, but not yet certified, show this area
continues to attain the 1997 PM2.5 NAAQS.

II.  What is the Effect of This Action?

If this determination is made final, under the provisions of EPA’s
PM2.5 implementation rule (see 40 CFR section 51.1004(c)), the
requirements for the Harrisburg-Lebanon-Carlisle, Pennsylvania PM2.5
nonattainment area to submit an attainment demonstration and associated
reasonably available control measures, a reasonable further progress
plan, contingency measures, and any other planning SIPs related to
attainment of the 1997 PM2.5 NAAQS would be suspended for so long as the
area continues to attain the 1997 PM2.5 NAAQS.

As further discussed below, the proposed determination would:  (1) for
the Harrisburg-Lebanon-Carlisle, Pennsylvania nonattainment area,
suspend the requirements to submit an attainment demonstration and
associated reasonably available control measures (RACM) (including
reasonably available control technologies (RACT)), a reasonable further
progress plan (RFP), contingency measures, and any other planning SIPs
related to attainment of  the 1997 PM2.5 NAAQS; (2) continue until such
time, if any, that EPA subsequently determines that the area has
violated the 1997 PM2.5 NAAQS; (3) be separate from, and not influence
or otherwise affect, any future designation determination or
requirements for the Harrisburg-Lebanon-Carlisle, Pennsylvania area
based on the 2006 PM2.5 NAAQS; and (4) remain in effect regardless of
whether EPA designates this area as a nonattainment area for purposes of
the 2006 PM2.5 NAAQS.  Furthermore, as described below, any such final
determination would not be equivalent to the redesignation of the area
to attainment based on the 1997 PM2.5 NAAQS.

In accordance with 40 CFR section 51.1004(c) (72 FR 20586, 20665), this
proposed determination would suspend the requirement for the
Harrisburg-Lebanon-Carlisle, Pennsylvania nonattainment area to submit
an attainment demonstration and associated RACM, including RACT, related
to the 1997 PM2.5 NAAQS.  Recently  SEQ CHAPTER \h \r 1  EPA noted that
certain language in the preamble of its PM2.5 implementation rule, 72 FR
20586, 20603 (April 25, 2007), contradicts the regulatory text in 40 CFR
section 51.1004(c).  On May 22, 2008, EPA issued a memorandum “to
eliminate any confusion that could result from this erroneous
statement.”  Memorandum from William T. Harnett, Director, Air Quality
Policy Division to Regional Air Division Directors, “PM2.5 Clean Data
Policy Clarification.”  This memorandum stated:

“Section 51.1004(c) provides that:  ‘Upon a determination by EPA
that an area designated nonattainment for the PM2.5 NAAQS has attained
the standard, the requirements for such area to submit attainment
demonstrations and associated reasonably available control measures,
reasonable further progress plans, contingency measures, and other
planning SIPs related to attainment of the PM2.5 NAAQS shall be
suspended….’

Section 51.1010 provides in part:  ‘For each PM2.5 nonattainment area,
the State shall submit with the attainment demonstration a SIP revision
demonstrating that it has adopted all reasonably available control
measures (including RACT for stationary sources) necessary to
demonstrate attainment as expeditiously as practicable and to meet any
RFP requirements.’

Thus the regulatory text defines RACT as included in RACM, and provides
that it is only required insofar as it is necessary to advance
attainment.  See also section 51.1010(b).  As a result, when an area is
attaining the standard, the suspension of the RACM requirement pursuant
to 51.1004(c) necessarily includes the suspension of the RACT
requirement.

However, the preamble to the PM2.5 implementation rule, including a
response to comments, contains language that is at odds with the
explicit provisions of the regulatory text.  The preamble states that
‘The EPA wishes to clarify that the Clean Data Policy does not provide
for suspension of the requirements for NSR nor for RACT.’  72 FR 20603
(April 25, 2007.)    SEQ CHAPTER \h \r 1 Thus, the preamble erroneously
states that SIP submissions to meet RACT obligations are not suspended,
while the regulatory text provides that RACT, as a subset of RACM, is
suspended when an area is attaining the standard.    SEQ CHAPTER \h \r 1
The purpose of this section of the preamble was to correct a
misstatement in the preamble to the proposed rule concerning the status
of NSR requirements in areas subject to the Agency’s Clean Data Policy
and to respond to comments on that policy. When this preamble text was
drafted, EPA was considering several formulations of RACT, some of which
would have resulted in a freestanding RACT requirement beyond RACM for
certain areas.  72 FR 20610-20612.  Those options were not selected in
the final rulemaking, which adopted the formulation found in section
51.1010.  EPA thus adopted a combined approach to RACT and RACM.
Accordingly, pursuant to section 51.1004(c), areas with clean data are
not required to make a RACT submission.  However, the contrary draft
preamble language inadvertently was not revised to conform to the
regulatory option that had been selected.  Thus, the preamble language
is irreconcilable with and was never intended to interpret the
regulatory text that was chosen for the final rule.”

EPA further stated that its “memorandum does not change the
regulation published in the Federal Register on April 25, 2007.  Because
the promulgated regulation is clear, we believe it is clear that the
preamble statement is an error.  National Wildlife Federation v. EPA,
286 F.3d 554 (D.C. Cir. 2002) (a regulation is controlling over the
language of a preamble.).  Cf. Association of American R.Rs. v. Costle,
562 F.2d 1310, 1316 (D.C. Cir. 1977) (citing Yazoo Railroad Co. v.
Thomas, 132 U.S. 174, 188 (1889)) (‘Where the enacting or operative
parts of a statute are unambiguous, the meaning of the statute cannot be
controlled by language in the preamble.’)  However, because the
preamble statement could cause confusion, we are issuing this memorandum
to explain the misstatement in the preamble and that the regulatory text
is controlling.”

Consequently, if this proposed determination is made final, the
requirement for the Harrisburg-Lebanon-Carlisle, Pennsylvania PM2.5
nonattainment area to make RACT submissions related to attainment of the
1997 PM2.5 nonattainment NAAQS would be suspended for so long as the
area continues to attain the 1997 PM2.5 NAAQS.

If this rulemaking is finalized and EPA subsequently determines, after
notice-and-comment rulemaking in the Federal Register, that the area has
violated the 1997 PM2.5 NAAQS, the basis for the suspension of the
specific requirements, set forth at 40 CFR section 51.1004(c), would no
longer exist, and the area would thereafter have to address the
pertinent requirements.

The determination that EPA proposes with this Federal Register notice,
that the air quality data

show attainment of the 1997 PM2.5 NAAQS, is not equivalent to the
redesignation of the area to attainment.  This proposed action, if
finalized, would not constitute a redesignation to attainment under
section 107(d)(3) of the Clean Air Act (CAA), because we would not yet
have an approved maintenance plan for the area as required under section
175A of the CAA, nor a determination that the area has met the other
requirements for redesignation.  The designation status of the area
would remain nonattainment for the 1997 PM2.5 NAAQS until such time as
EPA determines that it meets the CAA requirements for redesignation to
attainment.

This proposed action, if finalized, is limited to a determination that
the Harrisburg-Lebanon-Carlisle, Pennsylvania PM2.5 area has attained
the 1997 PM2.5 NAAQS.  The 1997 PM2.5 NAAQS became effective on July 18,
1997 (62 FR 36852) and are set forth at 40 CFR section 50.7.  The 2006
PM2.5 NAAQS, which became effective on December 18, 2006 (71 FR 61144)
are set forth at 40 CFR section 50.13.  EPA is currently in the process
of making designation determinations, as required by CAA section
107(d)(1), for the 2006 PM2.5 NAAQS.  EPA has not made any designation
determination for the Harrisburg-Lebanon-Carlisle, Pennsylvania area
based on the 2006 PM2.5 NAAQS.  This proposed determination, and any
final determination, will have no effect on, and is not related to, any
future designation determination that EPA may make based on the 2006
PM2.5 NAAQS for the Harrisburg-Lebanon-Carlisle, Pennsylvania area.
Conversely, any future designation determination of the
Harrisburg-Lebanon-Carlisle, Pennsylvania area, based on the 2006 PM2.5
NAAQS, will not have any effect on the determination proposed by this
notice.

If this proposed determination is made final and the
Harrisburg-Lebanon-Carlisle, Pennsylvania area continues to demonstrate
attainment with the 1997 PM2.5 NAAQS, the requirements for the
Harrisburg-Lebanon-Carlisle, Pennsylvania area to submit an attainment
demonstration and associated reasonably available control measures, a
reasonable further progress plan, contingency measures, and any other
planning SIPs related to attainment of the 1997 PM2.5 NAAQS would remain
suspended, regardless of whether EPA designates this area as a
nonattainment area for purposes of the 2006 PM2.5 NAAQS.  Once the area
is designated for the 2006 NAAQS, it will have to meet all applicable
requirements for that designation.

III.  What is the Background for This Action?

On July 18, 1997 (62 FR 36852), EPA established a health-based PM2.5
NAAQS at 15.0 micrograms per cubic meter (µg/m3) based on a 3-year
average of annual mean PM2.5 concentrations, and a twenty-four hour
standard of 65 µg/m3 based on a 3-year average of the 98th percentile
of 24-hour concentrations.  EPA established the standards based on
significant evidence and numerous health studies demonstrating that
serious health effects are associated with exposures to particulate
matter.  The process for designating areas following promulgation of a
new or revised NAAQS is contained in section 107(d)(1) of the CAA.  EPA
and State air quality agencies initiated the monitoring process for the
1997 PM2.5 NAAQS in 1999, and developed all air quality monitors by
January 2001.  On January 5, 2005 (70 FR 944), EPA published its air
quality designations and classifications for the 1997 PM2.5 NAAQS based
upon air quality monitoring data from those monitors for calendar years
2001-2003.  These designations became effective on April 5, 2005.  The
Harrisburg-Lebanon-Carlisle, Pennsylvania (Cumberland, Dauphin, and
Lebanon Counties) area was designated nonattainment for the 1997 PM2.5
NAAQS (see 40 CFR part 81).

IV.  What is EPA’s Analysis of the Relevant Air Quality Data?

EPA has reviewed the ambient air monitoring data for PM2.5, consistent
with the requirements contained in 40 CFR part 50 and recorded in the
EPA AQS database for the Harrisburg-Lebanon-Carlisle, Pennsylvania PM2.5
nonattainment area from 2004 through the present time.  On the basis of
that review, EPA has concluded that this area attained the 1997 PM2.5
NAAQS since the 2004 – 2006 monitoring period, and continues to
monitor attainment of the NAAQS based on 2005 – 2007 data.  In
addition, quality controlled and quality assured monitoring data for
2008 that are available in the EPA AQS database, but not yet certified,
show this area continues to attain the 1997 PM2.5 NAAQS.

Under EPA regulations at 40 CFR Part 50, section 50.7:

(1) The annual primary and secondary PM2.5 standards are met when the
annual arithmetic mean concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 15.0 µg/m3.

(2) The 24-hour primary and secondary PM2.5 standards are met when the
98th percentile 24-hour concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 65 µg/m3.

Table 1 shows the design values for the 1997 24-hour PM2.5 NAAQS for
Harrisburg-Lebanon-Carlisle, Pennsylvania nonattainment area monitors
for the years 2004 – 2006 and 2005 – 2007.  Table 2 shows the design
values for the 1997 annual PM2.5 NAAQS for these same monitors and the
same 3-year periods.

TABLE 1.  Design Values for the 1997 24-Hour PM2.5 NAAQS for
Harrisburg-Lebanon-Carlisle, Pennsylvania in micrograms per cubic meter
(µg/m3)

Location	AQS site ID	1997 24-Hour Attainment Standard	2004 – 2006

Design Values	2005 – 2007

Design Values

Carlisle/Cumberland County	42-041-0101	65	38	36

Harrisburg/Dauphin County	42-043-0401	65	38	38

TABLE 2.  Design Values for the 1997 Annual PM2.5 NAAQS for
Harrisburg-Lebanon-Carlisle, Pennsylvania in micrograms per cubic meter
(µg/m3)

Location	AQS site ID	1997 Annual Attainment Standard	2004 – 2006

Design Values	2005 – 2007

Design Values

Carlisle/Cumberland County	42-041-0101	15.0	14.4	13.9

Harrisburg/Dauphin County	42-043-0401	15.0	15.0	14.6

EPA’s reviews of these data indicate that the
Harrisburg-Lebanon-Carlisle, Pennsylvania nonattainment area has met and
continues to meet the 1997 PM2.5 NAAQS.  EPA is soliciting public
comments on the issues discussed in this document.  These comments will
be considered before taking final action.

V.   Proposed Action

EPA is proposing to determine that the Harrisburg-Lebanon-Carlisle,
Pennsylvania nonattainment area for the 1997 PM2.5 NAAQS has attained
the 1997 PM2.5 NAAQS and continues to attain the standard based on data
through 2008.  As provided in 40 CFR section 51.1004(c), if EPA
finalizes this determination, it would suspend the requirements for this
area to submit an attainment demonstration and associated reasonably
available control measures, a reasonable further progress plan,
contingency measures, and any other planning SIPs related to attainment
of the 1997 PM2.5 NAAQS so long as the area continues to attain the 1997
PM2.5 NAAQS.

VI.  Statutory and Executive Order Reviews

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a “significant regulatory action” and
therefore is not subject to review by the Office of Management and
Budget.  For this reason, this action is not subject to Executive Order
13211, “Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).
This action proposes to make a determination based on air quality data,
and would, if finalized, result in the suspension of certain Federal
requirements.  Accordingly, the Administrator certifies that this rule
will not have a significant economic impact on a substantial number of
small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.).  Because this rule proposes to make a determination based on air
quality data, and would, if finalized, result in the suspension of
certain Federal requirements, it does not contain any unfunded mandate
or significantly or uniquely affect small governments, as described in
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This proposed rule also does not have tribal applications because it
will 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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000).  This proposed action also does not have
Federalism implications because it does not have substantial direct
effects 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, as specified in
Executive Order 13132 (64 FR 43255, August  10, 1999), because it merely
proposes to make a determination based on air quality data and would, if
finalized result in the suspension of certain Federal requirements, and
does not alter the relationship or the distribution of power and
responsibilities established in the CAA.  This proposed rule also is not
subject to Executive Order 13045 “Protection of Children from
Environmental Health Risks” (62 FR 19885, April 23, 1997) because it
proposes to determine that air quality in the affected area is meeting
Federal standards.

The requirements of section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply because it
would be inconsistent with applicable law for EPA, when determining the
attainment status of an area, to use voluntary consensus standards in
place of promulgated air quality standards and monitoring procedures
other wise satisfy the provisions of the CAA.

This proposed rule does not impose an information collection burden
under the provisions of the Paper Reduction Act of 1995 (44 U.S.C. 3501
et seq.)

Under Executive Order 12898, EPA finds that this rule, pertaining to
Pennsylvania’s determination of attainment of the fine particle
standard for Harrisburg-Lebanon-Carlisle area, involves a proposed
determination of attainment based on air quality data and will not have
disproportionately high and adverse human health or environmental
effects on any communities in the area, including minority and
low-income communities.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Particulate matter,
Reporting and recordkeeping requirements.

Authority: 42 U.S.C. 7401 et seq.

                      /s/

________June_4, 2008_______________      ____________________________

Dated:                                                      	 William T.
Wisniewski, Acting,

Regional Administrator,

Region III.

 On the same page, in a response to a comment, EPA states: “The Clean
Data Policy does not waive requirements for NSR nor for RACT.”

   The statement is accurate as to NSR requirements.

 PAGE

 PAGE   2

 PAGE  15


[Federal Register: August 18, 2008 (Volume 73, Number 160)]
[Notices]
[Page 48258-48259]
[DOCID:fr18au08-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58341; File No. SR-Amex-2008-60]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of a Proposed Rule Change Relating to Margin
Requirements for Fixed Return Options

August 11, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934, as amended (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is
hereby given that on July 21, 2008, the American Stock Exchange LLC
(``Amex'' or ``Exchange'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I, II and III below, which Items have been prepared
by the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \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 462(d)10 to clarify the margin
requirements applicable to Fixed Return Options (``FROs'' or ``Fixed
Return Options'').\3\
---------------------------------------------------------------------------

    \3\ The Exchange commenced the trading of FROs on May 8, 2008.
In August 2007, the Commission approved the Exchange proposal to
list and trade FROs based on individual stocks and exchange-traded
funds (``ETFs''). See Exchange Act Release No. 56251 (August 14,
2007), 72 FR 46523 (August 20, 2007). In connection with the ability
to trade FROs, the Options Clearing Corporation (``OCC'') also filed
proposed rule changes as well as a revision to the Options
Disclosure Document (``ODD''). The Commission recently approved the
ODD revisions so that FROs may commence trading on the Exchange. See
Exchange Act Release No. 57744 (April 30, 2008), 73 FR 25072 (May 6,
2008) (SR-ODD-2008-01). The Commission previously approved proposed
OCC rule changes in December 2007. See Exchange Act Release No.
56875 (November 30, 2007), 72 FR 69274 (December 7, 2007).
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Amex's Web
site at http://www.amex.com, the Office of the Secretary, the Amex 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 Amex included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Amex has prepared summaries, set forth in sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of this proposal is to add clarity regarding the
application of FRO margin requirements in connection with ``spreads''
and ``straddle/combination'' strategies. In addition, the proposal also
seeks to clarify the use of ``cover'' and a ``cash account'' in
connection with FROs.
    Currently, Rule 462(d)10 is silent regarding the use of ``spread''
and ``straddle/combination'' positions. With respect to a ``spread''
position in FROs, the Amex proposes that no margin be required on a
Finish High \4\ FRO (Finish Low \5\ FRO) carried short in a customer's
account that is offset by a long Finish High FRO (Finish Low FRO) for
the same underlying security or instrument that expires at the same
time and has an exercise or strike price that is less than (greater
than) the exercise or strike price of the short Finish High (Finish
Low). As set forth in Rule 462(d)10(B), the long Finish High (Finish
Low) must be paid for in full.
---------------------------------------------------------------------------

    \4\ A ``Finish High'' FRO is defined in Rule 900 FRO(b)(2) as an
option contract which returns $100 if the underlying security closes
above the strike price at expiration.
    \5\ A ``Finish Low'' FRO is defined in Rule 900 FRO(b)(3) as an
option contract which returns $100 if the underlying security closes
below the strike price at expiration.
---------------------------------------------------------------------------

    In connection with a straddle/combination, when a Finish High FRO
is carried short in a customer's account and there is also carried a
short Finish Low FRO that expires at the same time and has an exercise
price or strike price that is less than or equal to the exercise or
strike price of the short Finish High, the initial and maintenance
margin required would be the exercise settlement amount applicable to
one contract.
    With respect to the concept of ``cover'' the Exchange proposes a
clarification that ``cover'' is applicable only to ``cash accounts.''
In such a case, a FRO carried short in a customer's account will be
deemed a covered position, and eligible for the cash account, if either
one of the following is held in the account at the time the FRO is
written or is received into the account promptly thereafter:
     Cash or cash equivalents equal to 100% of the exercise
settlement amount;
     A long FRO of the same type (Finish High or Finish Low)
for the same underlying security or instrument that is paid for in full
and expires at the same time, and has an exercise or strike price that
is less than the exercise or strike price of the short in the case of a
Finish High or greater than the exercise or strike price of the short
in the case of a Finish Low; or
     An escrow agreement.
    The escrow agreement must certify that the bank holds for the
account of the customer as security for the agreement (A) cash, (B)
cash equivalents, (C) one or more qualified equity securities, or (D) a
combination thereof having an aggregate market value of not less than
100% of the exercise settlement amount and that the bank will promptly
pay the member organization the cash settlement amount in the event the
account is assigned an exercise notice.
    The Exchange believes that the proposed revision reducing the
customer margin applicable to ``spread'' and ``straddle/combination''
positions in FROs is appropriate because risk exposure is significantly
reduced under these strategies.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Exchange Act \6\ in general and furthers the
objectives of Section 6(b)(5) \7\ in particular in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities,

and to remove impediments to and perfect the mechanism of a free and
open market and a national market system. The Exchange believes that
the proposal will benefit the marketplace and provide market
participants with greater clarity in connection with their
responsibilities in the trading and handling of FRO transactions.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 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.

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

    The Exchange did not receive any written comments on the proposed
rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-Amex-2008-60 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-Amex-2008-60. 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 at (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
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-Amex-2008-60 and should be
submitted on or before September 8, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence. E. Harmon,
Acting Secretary.
[FR Doc. E8-19030 Filed 8-15-08; 8:45 am]

BILLING CODE 8010-01-P


July 18, 2007

Final edits to ozone RIA proposal, per call with OMB

1. Chapter 3, pages 2-3   	OMB sending suggested revision and placement
suggestion 				for language on PRB

2. Chapter 4			Removed highlighting

3. Table 5.8			Added footnote to explain negative extrapolated costs for
					0.079

4. Chapter 5 			Added “potential” to text EPA added on technology
change

5. Chapter 8			Last section:  added detail to language on cost
effectiveness.

6. Appendix 5			Added number of tons to percent change due to
continuous I/M.

7. Table 3.1			Added text to footnote on illustrative PM 15/35 controls,
					pointing to section of PM NAAQS RIA where these 					controls are
listed.  Added URL.

8. Section 2.1			Deleted text  “….due to the high density of traffic
with 					NOx emissions.”

9. Section 3.1			Made the following edit:  “Some areas, such as  Two
areas 					in Southern California…”

10. Chapter 1			Added CEA language:  “We are investigating options for
					conducting a CEA and expect to provide estimates based

				on that analysis in the final RIA.”

10. Other EPA changes:

				Chapter 3, Fig 3.3  Changed “Best Workplace Commuter
Program” to “Commuter Reduction Strategies”

				Section 4.2 Edited language to more clearly articulate that
sensitivity analyses done for extrapolated tons in final will
include analysis of the geographic application of impact 					ratios.


[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Pages 67763-67765]
[FR Doc No: 2023-21235]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3976]

Support for Clinical Trials Advancing Rare Disease Therapeutics
Pilot Program; Program Announcement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Biologics Evaluation and Research's (CBER) Office of Therapeutic
Products (OTP) and Center for Drug Evaluation and Research's (CDER)
Office of New Drugs are announcing the opportunity for a limited number
of development programs to participate in the Support for clinical
Trials Advancing Rare disease Therapeutics (START) Pilot Program, with
the goal of further accelerating the pace of development of certain
CBER- and CDER-regulated products (novel drug and biological products)
that are intended to treat a rare disease. Because each Center has
identified specific needs concerning regulated products for rare
diseases, the eligibility criteria for the pilot differ between CBER
and CDER. This pilot would augment the currently available formal
meetings between FDA and sponsors by addressing issues related to the
development of individual products through more rapid, ad-hoc
communication mechanisms. Sponsors, if selected for the pilot, would
receive more frequent advice related to such specific issues through
additional interactions to facilitate novel drug and biological product
program development and generate high quality and reliable data
intended to support a Biologics License Application (BLA) or New Drug
Application (NDA). This notice outlines the eligibility criteria, what
to submit in a request to participate in the pilot, selection criteria,
process, and FDA-Sponsor interactions expected to occur for programs
participating in the pilot.

DATES: From January 2, 2024, to March 1, 2024, FDA will accept requests
to participate in the START Pilot Program and select no more than three
participants from each Center (CBER and CDER). See the
``Participation'' section for eligibility criteria, instructions on how
to submit a request to participate, and information regarding the
selection process.

FOR FURTHER INFORMATION CONTACT: Andrew Harvan, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-
402-7911; or Quyen Tran, Center for Drugs Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    For general questions about the START Pilot Program for CBER:
[email protected]. For general questions about the START
Pilot Program for CDER: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the START Pilot Program is to further accelerate the
pace of development of novel drug and biological products that are
intended to address an unmet medical need as a treatment for a rare
disease. The pilot is designed to be milestone-driven (i.e., to
facilitate the progression of a development program to pivotal clinical
study stage or the pre-BLA or pre-NDA meeting stage) where product
development programs selected would benefit from enhanced
communications with FDA. Participation in the pilot will be considered
concluded when the development program has reached a significant
regulatory milestone such as initiation of the pivotal clinical study
stage or the pre-BLA or pre-NDA meeting stage as agreed upon with the
sponsor. Pilot participants will be selected based on demonstrated
development program readiness. The START Pilot Program is intended to
provide a mechanism for addressing clinical development issues that
otherwise would delay or prevent a promising novel drug or biological
product from progressing to the pivotal

clinical trial stage or pre-BLA/pre-NDA meeting stage.
    The pilot would augment the currently available formal meetings
between FDA and sponsors (see FDA's draft guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products'' ((September 2023) (Ref. 1))) through more rapid,
ad-hoc communications with FDA by addressing issues with specific
programmatic needs for individual products. For example, these issues
can be related to clinical study design, choice of control group, fine-
tuning the choice of patient population, selecting appropriate
endpoints for efficacy trials to support marketing approval, selecting
statistical methodology, leveraging nonclinical information, or product
characterization. For eligible development programs sponsors and FDA
could benefit from such additional communication beyond the currently
available formal meeting mechanisms to address specific programmatic
needs that require in-depth discussions. The increased communication
between FDA review staff and sponsors is intended to facilitate program
development for specific products and to help generate high quality and
reliable data intended to support a BLA or NDA.

II. Participation

    From January 2, 2024, to March 1, 2024, FDA will accept requests to
participate in the START Pilot Program and will initially select up to
three participants in each Center. Taking into consideration lessons
and sponsors' experiences from the initial iteration of this program, a
second iteration of the pilot may be conducted to include more
participants in the future. At a later date, FDA may also publish
another notice in the Federal Register to announce a second iteration
of the program.
    Sponsors who are interested in participating in the START Pilot
Program should submit a request to participate as an amendment to their
Investigational New Drug (IND) application.

A. Eligibility Criteria

    To be considered for the START Pilot Program, participants must
meet the following eligibility criteria:
1. Joint CBER and CDER Eligibility Criteria
     IND has been submitted in or converted to Electronic
Common Technical Document (eCTD) format, unless the IND is of a type
granted a waiver from eCTD format (see FDA's guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related
Submissions using the eCTD Specifications'' ((February 2020) (Ref. 2)))
and remains in active status.
     Sponsor has demonstrated substantial effort to ensure that
that Chemistry, Manufacturing, and Controls (CMC) development aligns
with clinical development, for example, through documented control of
manufacturing and testing procedures to ensure clinical and CMC
development timeline are in alignment.
    Given the specific identified needs for the products regulated by
each Center for rare diseases, the following eligibility criteria
differ between CBER and CDER:
2. CBER-Specific Eligibility Criteria
     Existing OTP-regulated IND for a cellular or gene therapy
under which the product is being developed toward a marketing
application.
     Such product is intended to address an unmet medical need
as a treatment for a rare disease \1\ or serious condition, which is
likely to lead to significant disability or death within the first
decade of life.
---------------------------------------------------------------------------

    \1\ A rare disease or condition ``means any disease or condition
which affects less than 200,000 persons in the United States . . .''
(Section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bb(a)(2))). The START Pilot Program in CBER is not
intended to encompass all rare diseases, but only a subset of rare
diseases that are likely to lead to significant disability or death
within the first decade of life.
---------------------------------------------------------------------------

3. CDER-Specific Eligibility Criteria
     Such product is intended to treat rare neurodegenerative
conditions (including those of rare genetic metabolic etiology).

B. What To Submit in a Request To Participate in the START Pilot

    To participate in the START Pilot Program, sponsors should submit a
written request as an amendment to the IND. The cover letter should (1)
state ``Request to participate in the START Pilot Program'', (2) note
whether there is a breakthrough therapy (BT) designation for the
product and for CBER-regulated products only--whether there is a BT
designation and/or regenerative medicine advanced therapy (RMAT)
designation, and (3) provide a point of contact.
    The request should include the initial specific development
issue(s) for a given product for enhanced communication and a proposed
communication plan between the sponsor and review staff. In addition,
the following information should be provided:
    1. Program development plan.
    The plan should describe the current state of program development,
including any ongoing activities not already detailed in the IND.
     CMC development plan and current status.
     Nonclinical development plan and current status.
     Clinical development plan and current status.
    2. Any specific issue(s) (grouped by review disciplines) for which
the prospective applicants are seeking enhanced communications with FDA
review staff to facilitate program development, including, for example,
to ensure a mutual understanding of information needed to facilitate
initiating the pivotal clinical study or to the pre-BLA/pre-NDA meeting
stage.
    3. The planned timeline for initiation of the clinical study(ies)
intended to provide the primary evidence of effectiveness to support a
marketing application or for a pre-BLA/pre-NDA meeting request.
    4. The proposed communication plan for interactions between FDA
review staff and the sponsor, including the proposed timing (i.e.,
month and year) for the initial teleconference and format (e.g., email
or teleconference) of the subsequent communications on a scheduled and/
or as needed basis.

C. Selection Criteria and Process

    FDA intends to select participant CBER and CDER INDs based on the
criteria outlined below. FDA will make its determination of
participants following the close of the application period. FDA intends
to issue a letter to notify each sponsor of FDA's decision on sponsor
requests to participate within 90 days of the application deadline.
    For the initial selection of up to three INDs from each Center for
the START Pilot Program from eligible applicants, FDA intends to
consider factors such as: (1) potential clinical benefits of the
product, (2) whether resolution of the specific issues noted by the
sponsor in their request to participate in the pilot could be
facilitated through enhanced communication to improve efficiency of
program development, (3) whether there is an BT or RMAT designation for
the product, (4) whether CMC development timeline aligns with clinical
development plans, and (5) while INDs for combination products (21 CFR
3.2(e)(1)) may be eligible, products that require significant cross-
Center interactions (e.g., complex combination products) may be less
likely to be

selected for the pilot. Overall, pilot participants will be selected
based on application readiness (e.g., sponsors who demonstrate having
the ability to move the program forward towards a marketing
application).

D. FDA-Sponsor Interactions During the START Pilot Program

    If selected for the START Pilot Program, sponsors will receive
enhanced communications with FDA review staff. These enhanced
communications may vary between CBER and CDER but will include at a
minimum an initial meeting to review features of the pilot, discuss a
pathway intended to support a marketing application, and to discuss
specific issues for which a sponsor requests enhanced communication
with FDA. Additional communications will include ongoing interactions
via email or teleconference that take place on a scheduled and/or as
needed basis as agreed upon by the sponsor and FDA.

III. Paperwork Reduction Act of 1995

    This notice refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 312 have been approved under OMB control number 0910-0014 and
the collections of information in 21 CFR part 601 have been approved
under OMB control number 0910-0338.

IV. References

    The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852,<PHONE_NUMBER>, and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at https://www.regulations.gov.
FDA has verified the website addresses, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    1. FDA Draft Guidance for Industry ``Formal Meetings Between the
FDA and Sponsors or Applicants of PDUFA Products'' (September 2023):
https://www.fda.gov/media/172311/download.
    2. FDA Guidance for Industry ``Providing Regulatory Submissions in
Electronic Format--Certain Human Pharmaceutical Product Applications
and Related Submissions using the eCTD Specifications'' (February
2020): https://www.fda.gov/media/135373/download.

    Dated: September 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21235 Filed 9-29-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Pages 10220-10222]
[FR Doc No: 2014-03783]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71557; File No. SR-BX-2014-010]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Add a
Risk Management Tool Commonly Known as a ``Kill Switch''

February 18, 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 February 4, 2014, NASDAQ OMX BX, Inc. (``BX'' 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 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 add a risk management tool commonly known
as a ``Kill Switch'' as set forth in proposed BX Rule 4764. The new
Kill Switch feature will be optional and will be offered at no charge
effective March 1, 2014. The text of the proposed rule change is below.
Proposed new language is italicized; proposed deletions are in
brackets.
* * * * *

4764. BX Kill Switch

    (a) Definition. The BX Kill Switch is an optional tool offered at
no charge that enables participants to establish a pre-determined level
of Net Notional Risk Exposure (``NNRE''), to receive notifications as
the value of executed orders approaches the NNRE level, and to have
order entry ports disabled and open orders administratively cancelled
when the value of executed orders exceeds the NNRE level.
    (b) Net Notional Risk Exposure. Participants may set a NNRE for
each MPID individually. Each participant is responsible for
establishing and maintaining its NNRE. Participants may adjust NNRE
values intra-day.
    (c) Notification. Participants will receive notifications when the
total value of executed orders associated with an MPID exceeds 50, 75,
85, 90, and 95 percent of the NNRE value. When the NNRE is exceeded,
the notification will include the total number of orders cancelled and
remaining open in the System.
    (d) Operation. When triggered, a Kill Switch shall result in the
immediate cancellation of all open orders of any type or duration
entered by the participant via the affected MPID, and in the immediate
prevention of order entry of any type via the affected MPID. The
participant must request reactivation of the MPID before trading will
be reauthorized.
* * * * *

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
    Background. BX currently offers a Pre-Trade Risk Management
(``PRM'') toolset to assist participants efforts to control risk and
comply with the SEC Market Access Rule.\3\ PRM provides participant
firms with the ability to set a wide range of parameters for orders to
facilitate pre-trade protection by creating a PRM module defined to
represent checks desired. Using PRM, firms can increase controls on
their trading activity and the trading activity of their clients and
customers at the order level, including the opportunity to prevent
potentially erroneous transactions. PRM validates orders entered on
PRM-enabled ports prior to allowing those orders into its matching
engine and, using parameters set by the subscriber, determines if the
order should be sent for fulfillment. PRM users may choose to set PRM
Order Checks, Aggregate Total Checks within a PRM Module, and subscribe
to PRM Workstation Add-ons to an existing BX Workstation or WeblinkACT
2.0. PRM manages risk by checking each order, before it is accepted
into the System, against certain parameters pre-specified by the user
within a module, such as maximum order size or value, order type
restrictions, market session restrictions (pre/post market), security
restrictions, including per-security limits, restricted stock lists,
and certain other criteria.
---------------------------------------------------------------------------

    \3\ SEC Rule 15c3-5.
---------------------------------------------------------------------------

    In order for a Participant to subscribe, at least one PRM Module
per market participant ID (``MPID'') is required, but a user may have
multiple PRM Module subscriptions per MPID, depending on the type and
number of ports designated as PRM ports. A PRM Module is created to
validate individual orders against pre-specified parameters. Aggregate
Total Checks allow users to limit overall daily trading activity based
on Buy, Sell, and/or Net trading limits. These daily trading activity
limits may be established at an aggregate limit and/or security
specific limit per PRM Module. Participant may subscribe to the PRM
Workstation Add-on to an existing BX Workstation or WeblinkACT 2.0 for
a fee.
    Current Proposal. BX will provide a tool to allow market
participants to control, for each Market Participant Identifier
(``MPID''), the total Net Notional Risk Exposure (``NNRE'') they are
prepared to accept per trading session, from 8:00 a.m. to 8:00 p.m.
EST. If a market participant exceeds their pre-established NNRE the
access ports associated with that MPID will be disabled and open
exposure on the BX market under that MPID will be administratively
cancelled.
    The Kill Switch tool will operate on an MPID level, meaning that
participants will need to set a unique NNRE for each MPID used for
order entry. Participants can set limits for none, one, some, or all
MPIDs registered to their firm. The tool will operate on all orders
attributable to each MPID. Therefore, participants that utilize a
single MPID for multiple trading desks will be unable to establish a
different NNRE for each trading desk. Participants may adjust their
NNRE values intraday. The NNRE will be calculated daily, meaning that
it will reset at the start of each trading day.
    The Kill Switch will operate at all times and on all orders when
the BX System is open (i.e., 8:00 a.m. to 8:00 p.m.) and it will cancel
all open interest of all order types and all time-in-force durations.
    The tool will generate and send an email to a market participant as
it approaches and then exceeds the pre-determined NNRE for an MPID. As
a Participant executes trades during the trading session, an email will
be sent to associated Infocenter accounts containing their current
proximity to the NNRE limit they had previously established. Such
notification will occur when the executed value reaches 50, 75, 85, 90,
and 95 percent of the pre-determined NNRE limit.
    In the event the NNRE limit is exceeded, the order entry port
associated with the affected MPID will be disabled and open orders in
the System will be administratively cancelled. A notification will be
sent that indicates that the breach has occurred and that order flow
from that port has been stopped. It will also include a count of the
total number of orders cancelled. The notification will also be
delivered to BX's trading operations team so that BX personnel are
aware and can assist participants in managing their risk exposure.
    After a Kill Switch has been triggered, the participant will be
required to contact BX operations staff in order to re-authorize
trading under the affected MPID. Participants will be required to
explain why a Kill Switch was triggered and why it is safe for the
Exchange to re-authorize the MPID for order entry. Upon such request,
BX operations staff

will be reactivate the order entry port associated with the affected
MPID.
    BX plans to offer the Kill Switch functionality by March 1, 2014.
2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\4\ Specifically, the
proposed change is consistent with Section 6(b)(5) of the Act,\5\
because it would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system, and, in general, protect investors and
the public interest. The Kill Switch is designed to protect firms and
investors alike by limiting the risk and damage of potential
technological or other erroneous trading activity. As such, the Kill
Switch is an important compliance tool that participants may use to
help maintain the regulatory integrity of the markets.
---------------------------------------------------------------------------

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

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

    BX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. To the contrary,
the Exchange does not believe that the provision of Kill Switch
functionality should be the subject of competitive analysis. In that
regard, the Exchange notes that it has coordinated with other national
securities exchanges and the Financial Industry Regulatory Authority to
deliver a standard level of risk management functionality commonly
known as the Kill Switch.

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 from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(ii) of the Act \6\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\7\ 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: (i) Necessary or appropriate in the
public interest; (ii) for the protection of investors; or (iii)
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.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of 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.
---------------------------------------------------------------------------

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 No. SR-BX-2014-010 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-BX-2014-010. 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 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-BX-2014-010 and should be
submitted by March 17, 2014.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-03783 Filed 2-21-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Proposed Rules]
[Pages 54446-54447]
[FR Doc No: 2015-22757]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]
RIN 0910-AF22

Food Labeling: Revision of the Nutrition and Supplement Facts
Labels; Administrative Docket Update; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notification.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of certain documents to update the administrative docket
of the proposed rule to amend FDA's labeling regulations for
conventional foods and dietary supplements to provide updated nutrition
information on the Nutrition Facts and Supplement Facts labels to
assist consumers in maintaining healthy dietary practices.

DATES: We are extending the comment period that was scheduled to close
on September 25, 2015, until October 13, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
(FDA-2012-N-1210) for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Serena Lo, Center for Food Safety and
Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 3, 2014 (79 FR 11879), we
published a proposed rule that would amend our

labeling regulations for conventional foods and dietary supplements to
provide updated nutrition information. More recently, in the Federal
Register of July 27, 2015 (80 FR 44302), we reopened the comment period
through September 25, 2015, for the proposed rule for the sole purpose
of inviting public comments on two consumer studies being added to the
administrative record. The consumer studies pertained to proposed
changes to the Nutrition Facts label formats. We also issued a
supplemental proposed rule (80 FR 44303) with a comment period through
October 13, 2015. The supplemental proposal included two additional
consumer studies pertaining to the declaration of added sugars and
alternative footnote statements. We proposed text for the footnotes to
be used on the Nutrition Facts label, after completing our consumer
research in which we tested various footnote text options for the
label, and to establish a Daily Reference Value of 10 percent of total
energy intake from added sugars. The supplemental proposal also would
require the declaration of the percent Daily Value for added sugars on
the label and provide an additional rationale for the declaration of
added sugars on the label. We explained that we were taking these
actions based, in part, on the science underlying a new report released
by the 2015 Dietary Guidelines Advisory Committee.
    We have received some comments suggesting we are not eliciting
comment on the consumer studies in the supplemental proposal published
in July 2015. We clarify in this notice that: (1) The consumer studies
on the added sugars declaration and the alternative footnote statements
in the supplemental proposal relate to topics on which we sought
comment and (2) the consumer studies on the format published in a
separate notice in July 2015 were included for comment, and were placed
in the docket at that time. We are now responding to additional
requests for the raw data for each of these consumer studies that are
relevant to the summary memoranda for the studies, also now available
for comment.

II. Updated Information

    We are updating the docket for the rulemaking with two additional
documents: A request from the Grocery Manufacturers Association for the
raw data associated with the four consumer studies described in this
document, and our response to that request indicating that we will
provide the raw data underlying the four consumer studies to anyone who
submits a request to<EMAIL_ADDRESS>    These documents may be seen by interested persons at the Division
of Dockets Management, Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday, and are available electronically at http://www.regulations.gov.
    In addition, we are extending to October 13, 2015, the comment
period on the two consumer studies pertaining to proposed changes to
the Nutrition Facts label formats, which had been scheduled to close on
September 25, 2015, to align the comment periods for all consumer
studies.
    We will continue to take comment on the supplemental proposed rule,
including taking comment on the consumer studies on added sugars and
the footnote, until October 13, 2015.

    Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22757 Filed 9-9-15; 8:45 am]
BILLING CODE 4164-01-P