[Federal Register: January 12, 2010 (Volume 75, Number 7)]
[Notices]
[Page 1676-1678]
[DOCID:fr12ja10-97]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61291; File No. SR-NYSEAmex-2009-95]

 Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Amex LLC To Establish
Registered Representative Fees

January 5, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on December 28, 2009, NYSE Amex LLC (``NYSE Amex'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to end its waiver of registered
representative fees

for member organizations that acquired their memberships solely by
operation of NYSE Amex Equities Rule 2 in connection with the
acquisition of the American Stock Exchange by the New York Stock
Exchange (``NYSE''). The waiver will end on December 31, 2009 and all
member organizations will be subject to registered representative fees
commencing January 1, 2010. The text of the proposed rule change is
available at the Exchange, the Commission's Public Reference Room, and
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
    In connection with the acquisition of the American Stock Exchange
(renamed NYSE Amex after the acquisition) by NYSE Euronext, all
equities trading conducted on or through the American Stock Exchange
legacy trading systems and facilities located at 86 Trinity Place, New
York, New York, was moved on December 1, 2008, to the NYSE trading
facilities and systems located at 11 Wall Street, New York, New York
(the ``NYSE Amex Trading Systems''), which are operated by the NYSE on
behalf of NYSE Amex (the ``Equities Relocation''). At the time of the
Equities Relocation, by operation of NYSE Amex Equities Rule 2, all
NYSE member organizations automatically became NYSE Amex member
organizations. By acquiring NYSE Amex membership, the NYSE member
organizations that were not previously NYSE Amex members would become
subject to the NYSE Amex registration fees for all of their employees
who serve as registered representatives. As these NYSE member
organizations that had no NYSE Amex business prior to the Equities
Relocation became NYSE Amex members without any action on their own
part, NYSE Amex waived the application of its registered representative
fees to those firms for the month of December.
    At the time of its original adoption of the waiver, NYSE Amex
stated that it expected to submit a filing to adopt a revised
registered representative fee commencing January 1, 2009.\3\ The waiver
was extended through June 30, 2009,\4\ and was subsequently extended
again through September 30, 2009,\5\ at which time it expired. The
expiration of the waiver on September 30, 2009, resulted from an
oversight on the part of Exchange staff as the Exchange had not yet
reached a conclusion as to a more permanent approach to registered
representative fees at that time. Consequently, the Exchange intends to
submit a filing in which it seeks to re-establish the waiver with
retroactive effect from October 1, 2009, ending on December 31, 2009.
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    \3\ See Exchange Act Release 59045 (December 3, 2008), 73 FR
75151 (December 10, 2008) (SR-NYSEALTR-2008-09).
    \4\ See Exchange Act Release 59170 (December 29, 2008), 74 FR
486 (January 6, 2009) (SR-NYSEALTR-2008-19).
    \5\ See Exchange Act Release 60176 (June 26, 2009), 74 FR 32021
(July 6, 2009) (SR-NYSAmex-2009-30).
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    NYSE Amex proposes to end the waiver on December 31, 2009, and will
require all NYSE Amex member organizations to pay registered
representative fees as of January 1, 2010, regardless of whether they
were members of NYSE Amex prior to the Equities Relocation.\6\ It has
been NYSE Amex's experience that member organizations that have
benefitted from the waiver have traded comparable volumes of NYSE Amex
equities since the Equities Relocation to those traded by member
organizations that are currently subject to the registered
representative fees. Consequently, NYSE Amex believes it is equitable
to charge the same registered representative fees to all member
organizations regardless of how they acquired their membership. The
Exchange also notes that, while NYSE Amex benefits to a large degree
from the NYSE's regulatory program and all NYSE Amex members pay
regulatory fees to the NYSE, the revenues generated from NYSE
regulatory fees are significantly less than is needed to fund the NYSE
and NYSE Amex equities regulatory program. As such, the Exchange
believes it is appropriate to charge registered representative fees to
those member organizations that have benefitted from the waiver, as a
contribution to the costs of regulating their NYSE Amex equities
trading activities.
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    \6\ See e-mail from John Carey, Chief Counsel US Equities, NYSE
Euronext, Inc. to Leah Mesfin, Special Counsel, Division of Trading
and Markets, Commission, on January 4, 2010, clarifying that the
waiver ended on December 31, 2009.
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    The rule change will become operative as of January 1, 2010.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\7\ in general, and Section
6(b)(4) of the Act,\8\ 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 proposal does not constitute an inequitable
allocation of dues, fees and other charges as all member organizations
will pay the same fees and the fees charged to member organizations
that previously benefitted from the waiver will be sufficient to fund
only a portion of the costs of NYSE Amex's regulation of those member
organizations' NYSE Amex equities trading activities.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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) \9\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \10\ thereunder, because it establishes a due, fee, or other charge
imposed by NYSE Amex.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2009-95 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-2009-95. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for 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 publicly available. All
submissions should refer to File Number SR-NYSEAmex-2009-95 and should
be submitted on or before February 2, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-298 Filed 1-11-10; 8:45 am]
BILLING CODE 8011-01-P


TXR NO. 0051051 August 13, 2002 MEMORANDUM SUBJECT: FENARIMOL  2nd Report of the FQPA Safety Factor Committee.

NOTE: THIS REPORT REPLACES THE PREVIOUS REPORT OF THE FQPA SAFETY FACTOR COMMITTEE DATED SEPT. 28, 2001 ( HED DOC. NO. 014688).

FROM: Brenda Tarplee, Executive Secretary FQPA Safety Factor Committee Health Effects Division ( 7509C)

THROUGH: Ed Zager, Chairman FQPA Safety Factor Committee Health Effects Division ( 7509C)

TO: Barry O'Keefe, Risk Assessor Reregistration Branch 3 Health Effects Division ( 7509C)

PC Code: 206600 The Health Effects Division ( HED) FQPA Safety Factor Committee ( SFC) met on July 29, 2002 to evaluate the hazard and exposure data for Fenarimol with regard to making a decision on the additional safety factor for the protection of infants and children. The SFC concluded that, based on reliable data, an additional safety factor of 3X is necessary to protect the safety of infants and children in assessing Fenarimol exposures and risks. This report replaces the previous report of the FQPA Safety Factor Committee dated Sept. 28, 2001 ( HED Doc. No. 014688 ). 2 I. HAZARD ASSESSMENT ( Extracted from the THIRD Report of the Hazard Identification Assessment Review Committee for Fenarimol dated July 29, 2002; HED DOC No. 0050977 )

1. Adequacy of the Toxicology Database The HED Hazard Identification Assessment Review Committee ( HIARC) concluded that the Fenarimol toxicology database is complete with respect to FQPA with the exception of a special developmental toxicity study to assess for potential hormonal effects.

At the July 10, 2001 HIARC meeting, it was determined that a developmental neurotoxicity ( DNT) study in rat that incorporated a special provision to assess for hormonal effects is required ( TXR. No. 014662). The Registrant responded with a request " that the Agency rescind the requirement for a developmental neurotoxicity study of unproven design" since the DNT is not designed to investigate the endpoints mentioned ( mating behavior in male and difficult labor in females) ( Letter from Gowan, dated April 10, 2002). On May 23, 2002, the HIARC concurred with the Registrant's rationale and rescinded their previous request for the DNT. The HIARC, instead is requesting a special developmental toxicity study that assesses the hormonal effects in rats especially related to inhibition of aromatase. The protocol for this study should be submitted to HED for review prior to initiating the study. The HIARC concluded that a 3X database uncertainty factor ( UF DB) is needed in the absence of this study. The committee considered 3X ( as opposed to10X) to be adequate since there is a 2 fold difference between the NOAEL/ LOAEL for the most sensitive indicator and it is considered unlikely that the results of the special developmental toxicity study ( tested at comparable doses of the twogeneration reproduction study) will demonstrate a NOAEL three times lower than the current NOAEL of 0.6 mg/ kg/ day from the two generation reproduction study used for establishing the chronic RfD ( HED DOC No. 0050977).

2. Determination of Susceptibility The data provided no indication of increased susceptibility of rats or rabbits to in utero and/ or postnatal exposure to Fenarimol.

3. Degree of Concern and Residual Uncertainties The HIARC concluded that there are no residual uncertainties for pre and/ or post natal toxicity in any of the available studies with Fenarimol.

4. Other Studies There are several studies conducted as both non guideline studies by the registrant as well as reports in the published literature that investigate the mechanism of the reduced fertility 3 in males and dystocia in females caused by Fenarimol. These studies indicate that Fenarimol inhibits aromatase the enzyme that converts androgens to estrogens. Thus, Fenarimol is regarded as affecting hormonal balance in mammals. Fenarimol also acts as a fungicide by adversely affecting the formation of the fungal sterol, ergosterol. The HED Mechanism of Toxicity Assessment Review Committee concluded that inhibition of aromatase activity and its expression ( i. e. reduced fertility and dystocia in rats) should be regarded as endpoints for human risk assessment ( June 21, 2001).

II. EXPOSURE ASSESSMENT 1. Dietary ( Food) Exposure Considerations ( Correspondence: S. Knizner to B. Tarplee dated 08/ 13/ 01) No changes since the last review per Fenarimol Team.

Fenarimol is a fungicide registered for use on many foods considered to be highly consumed by infants and children including apples, bananas, and pears. The HED Metabolism Assessment Review Committee ( MARC) concluded that the tolerance expression for Fenarimol should be expressed as Fenarimol per se. For risk assessment purposes, residues of parent and two metabolites [ alpha( 2 chlorophenyl) alpha( 4 chlorophenyl 1,4 dihydro 5 pyrimidinemethanol and 5[( 2 chlorophenyl( 4 chlorophenyl) methyl 3,4 dihydro 4 pyrimidinol measured as the total of 5[( 2 chlorophenyl)( 4 chlorophenyl methyl] pyrimidine] should be included for bananas and grapes. Current tolerances are established at levels ranging from 0.01 ppm to 3.0 ppm ( 40CFR § 180.421). There are established Codex MRLs for Fenarimol per se.

The available data bases for Fenarimol consist of crop field trial data, FDA monitoring data, and Total Diet Survey data. FDA monitoring data ( 1997 through 1999; LOD = 0.003 ppm, parent only) include: more than 300 apple samples with no detects; more than 500 grape samples with no detects; more than 300 pear samples with no detects; more than 600 banana samples with no detects; and more than 100 cherry samples with 6 detects and a maximum detection of 0.214 ppm.

A Quantitative Usage Analysis for Fenarimol was prepared by BEAD ( J. Alsadek; dated 05/ 01/ 01). The sources cited in this analysis include EPA data ( 90 99), USDA/ NASS ( 90 99), Cal DPR ( 93 95) and National Center for Food and Agricultural Policy ( c. 92).

The HED Dietary Exposure Evaluation Model ( DEEM) is used to assess the risk from dietary exposure to Fenarimol residues in food ( no acute RfD is established). The chronic DEEM analysis will be refined using FDA data and anticipated residues from field trial data with the available percent of crop treated estimates and processing data.

The Committee recognizes that further refinement to the dietary food exposure analyses may be required as the risk assessment is developed. Therefore, provided the final dietary food exposure assessment includes all metabolic residues of concern and does not 4 underestimate the potential risk for infants and children, the safety factor recommendations of this Committee stand.

2. Dietary ( Drinking Water) Exposure Considerations ( Correspondence: N. Birchfield to B. Tarplee dated July 24, 2002)

The environmental fate database is complete enough to provide a Tier 1 assessment of drinking water exposure. The data are based on studies done in the late 1970s and early 1980s so are somewhat uncertain. Based on current standards most of the studies would be judged to be unacceptable but they appear to provide useable information. If a higher tier assessment is required new studies must be done. The data indicate that parent Fenarimol is stable and moderately mobile in the environment. It has been shown to persist in treated field for several years, and accumulation in soil and groundwater over time is possible. EFED concluded that the only significant degradation pathway appears to be aqueous photolysis and one significant degradate has been identified, 4 chloro 2( 5 pyrimidyl) 2' clorobenzophenone. Because of limitations in analytical methodology in the 1970s and early 1980s when the fate studies were conducted, the identification and quantification of degradation products is limited. No information is available on the fate and transport properties of this or other possible degradates.

The HED MARC concluded that the aqueous photolysis degradate of Fenarimol [ 4 chloro 2( 5 pyrimidyl) 2' chlorobenzophenone] should be included in the drinking water risk assessment.

Only very limited monitoring data are available and the studies have not been reviewed. Therefore, Tier 1 screening models were used to determine estimated environmental concentrations ( EECs) for use in drinking water risk assessment: FIRST for surface water and SCIGROW for groundwater. For surface water, combined EECs for Fenarimol and all aqueous photolysis degradates ( major and minor) were included in the most recent drinking water assessment by modeling Fenarimol as being stable in surface water. The SCIGROW modeling did not include degradates but the aqueous photoproduct is expected to occur predominately in surface water.

3. Residential Exposure Considerations ( Correspondence: B. O'Keefe to B. Tarplee dated July 25, 2002)

Fenarimol is currently registered for use on ornamental trees, shrubs, lawns, and turf including golf courses. Postapplication dermal and incidential oral exposures to children and infants are possible; mainly from exposure to treated turf. It is possible that Fenarimol could be applied twice in a season to residential turf by resident or professional applicators; i. e. once or twice at the maximum application rate ( 2.73 lb ai/ acre) or twice as a split application ( half max. rate). Additionally, Fenarimol could be applied to residential turf as many as 12 times per season at significantly lower rates; i. e.

0.51 lb ai/ acre. However, based upon conversations with the registrants, only one to two applications per season are anticipated to turf, since users rotate and switch between different systemic and 5 contact fungicides, and applications are only anticipated when conditions are suitable for fungal growth. It is also possible that Fenarimol could be applied up to seven times per season to residential ornamentals ( 0.04875 lb ai/ acre) and backyard orchards ( 0.09375 lb ai/ acre); although these scenarios are considered unlikely based upon label language.

Only short term non cancer risks to residential handlers were anticipated. The assessment uses the revised draft Standard Operating Procedures ( SOPs) for Residential Exposure Assessment, and includes surrogate data from the Pesticide Handlers Exposure Database ( PHED) for loading/ applying with a belly grinder type granular spreader and applying by hand, and the Outdoor Residential Exposure Task Force ( ORETF) for loading/ applying with a push type granular spreader.

Short term non cancer risks from residential postapplication exposures were estimated for Fenarimol. The scenarios assessed for the purpose of screening level risk estimates included adults and children performing high contact play or work activities on treated lawns, and adults mowing lawns or golfing. Small children were also assessed for incidental oral exposure from hand to mouth activities while playing on a treated lawn. Some of these exposures were combined, where it was deemed reasonably likely activities would co occur. Residential risk estimates utilized dissipation rate data from a turf transferable residue ( TTR) study, as well as the EPA's original and revised Draft SOPs for Residential Exposure Assessment. The TTR data from the submitted turf study had several limitations and were considered unacceptable. However, a dissipation rate ( 8% daily) derived from these data was used to calculate exposure after day zero. This is a slower dissipation rate than the 10% rate listed in HED's SOP. Also, the data showed that 6.1%, 0.85%, and 0.59% ( for CA, IN & MS, respectively) of the applied Fenarimol was detected on DAT 0. By comparison, the Agency's SOP uses a transfer efficiency ( percent of application rate) of 5%. The more conservative data will be used in the assessment.

NOTE: Since the time of this meeting, the FQPA SFC has been informed that the registrant has agreed to drop all residential uses from the label.

III. SAFETY FACTOR RECOMMENDATION AND RATIONALE 1. FQPA Safety Factor Recommendations The FQPA SFC recommends that OPP depart from the default 10X additional safety factor and instead use a different additional safety factor of 3X. This recommendation is based on reliable data supporting the findings set forth below.

A. Traditional Additional Safety Factor ( Addressing Data Deficiencies)

The HIARC concluded, and the FQPA SFC concurred, that a 3X additional traditional database uncertainty factor to address the data deficiency for the developmental 6 neurotoxicity study. The rationale for why reliable data support the safety of using a 3X to address this data deficiency is discussed above in § I. 1.

B. Special FQPA Safety Factors Taking into account the recommendation regarding the data deficiency, the FQPA SFC recommends that no Special FQPA Safety Factor is necessary to protect the safety of infants and children in assessing Fenarimol exposure and risks.

2. Rationale and Findings Regarding Recommendation on Special FQPA Safety Factor No special FQPA safety factor was needed because:

There is no evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure in the developmental studies with Fenarimol. There is no evidence of increased susceptibility of young rats in the reproduction study with Fenarimol. HIARC concluded there are no residual uncertainties for pre and/ or postnatal exposure.

There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment ( chronic only; no acute endpoint was identified) is refined using FDA data and anticipated residues from field trial data with the available percent of crop treated estimates and processing data. EFED has provided conservative surface water modeling estimates which include Fenarimol and all aqueous photolysis degradates ( which are expected to occur predominately in surface water). The HED Residential SOPs and dissipation rate data from a TTR study will be used to assess post application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by Fenarimol.

NOTE: Since the time of this meeting, the FQPA SFC has been informed that the registrant has agreed to drop all residential uses from the label.

3. Application of the FQPA Safety Factors ( Population Subgroups / Risk Assessment Scenarios)

The FQPA safety factor recommendation is for a 3X traditional database uncertainty factor to address data deficiencies and no additional Special FQPA safety factor. The 3X safety factor should be applied to all dietary and residential non dietary exposure scenarios. No other FQPA safety factor would be appropriate for Fenarimol.

4. Summary of FQPA Safety Factors Summary of FQPA Safety Factors for Fenarimol 7 LOAEL to NOAEL ( UF L) Subchronic to Chronic ( UFS) Incomplete Database ( UFDB) Special FQPA Safety Factor ( Hazard and Exposure)

Magnitude of Factor 1X 1X 3X 1X Rationale for the Factor No LOAEL to NOAEL extrapolations performed No subchronic to Chronic extrapolations performed For the lack of a special developmental toxicity study to assess for potential hormonal effects No residual concerns regarding preor post natal toxicity or completeness of the toxicity or exposure databases Endpoints to which the Factor is Applied Not Applicable Not Applicable All Dietary and Residential Non Dietary exposure assessments. Not Applicable


[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Rules and Regulations]
[Pages 27908-27910]
[FR Doc No: 2011-11722]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2010-0445; A-1-FRL-9305-1]

Approval and Promulgation of Air Quality Implementation Plans;
Massachusetts; Revised Carbon Monoxide Maintenance Plan for Lowell

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the State of Massachusetts. This SIP submittal contains
revisions to the carbon monoxide (CO) maintenance plan for Lowell,
Massachusetts. Specifically, Massachusetts has revised the contingency
plan portion of the original maintenance plan. The intended effect of
this action is to approve this revision to the Lowell CO maintenance
plan. This action is being taken in accordance with the Clean Air Act.

DATES: Effective Date: This rule is effective on June 13, 2011.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2010-0445. All documents in the docket
are listed on the http://www.regulations.gov web site. 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
through http://www.regulations.gov or in hard copy at the Office of
Ecosystem Protection, U.S. Environmental Protection Agency, EPA New
England Regional Office, Office of Ecosystem Protection, Air Quality
Planning Unit, 5 Post Office Square--Suite 100, Boston, MA. EPA
requests that if at all possible, you contact the contact listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding legal holidays.
    Copies of the documents relevant to this action are also available
for public inspection during normal business hours, by appointment at
Division of Air Quality Control, Department of Environmental
Protection, One Winter Street, 8th Floor, Boston, MA 02108.

FOR FURTHER INFORMATION CONTACT: Anne K. McWilliams, Air Quality
Planning Unit, U.S. Environmental Protection Agency, EPA New England
Regional Office, Office of Ecosystem Protection, 5 Post Office Square--
Suite 100, (mail code OEP05-2), Boston, MA 02109--3912, telephone
number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, email
mcwilliams.anne@epa,gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Purpose
II. What action is EPA taking?
III. Summary of SIP Revision
IV. Final Action
V. Statutory and Executive Order Reviews

I. Background and Purpose

    On April 14, 2010, the Massachusetts Department of Environmental
Protection (DEP) submitted a revision to its State Implementation Plan
(SIP) for Massachusetts. The SIP revision consists of a minor
modification to the carbon monoxide (CO) maintenance plan for Lowell,
Massachusetts. (A redesignation request and a maintenance plan for the
Lowell CO nonattainment area were approved by EPA on February 19, 2002
(67 FR 7272).) The modification changes the triggering mechanism which
will be used by the State to determine if contingency measures need to
be implemented in Lowell.
    On February 17, 2011, EPA proposed approval of this SIP revision
(76 FR 9281). EPA received no comments on the proposed rulemaking.

II. What action is EPA taking?

    EPA is approving revisions to the Lowell carbon monoxide
maintenance plan submitted by the State of Massachusetts on April 14,
2010. Specifically, EPA is approving the State's modification of the
portion of the maintenance plan used to determine when contingency
measures need to be triggered to reduce CO concentrations in Lowell.
This action will allow the discontinuation of CO monitoring in the
Lowell maintenance area. Other specific requirements of the revised
carbon monoxide plan for Lowell, Massachusetts and the rationale for
EPA's proposed action are explained in the Notice of Proposed
Rulemaking (NPR) and will not be restated here.

III. Summary of SIP Revision

    On April 14, 2010, the Massachusetts Department of Environmental
Protection submitted a SIP revision to EPA that contains a modification
to its CO maintenance plan for the Lowell CO maintenance area. The
modifications to the maintenance plan change the triggering mechanism
by which contingency measures would be implemented and will allow the
State to discontinue CO monitoring in the Lowell maintenance area. CO
concentrations measured in Lowell have

been below the National Ambient Air Quality Standard (NAAQS) for nearly
25 years, and in recent years, maximum measured concentrations have
been less than 30% of the 9 parts per million (ppm) 8-hour CO
standard.\1\ In this SIP revision, the State of Massachusetts is
establishing an alternative triggering mechanism, which will rely on CO
data from a nearby CO monitor in Worcester, Massachusetts (MA).
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    \1\ On January 28, 2011, EPA proposed to retain the existing CO
standard. In this action, EPA has also proposed an increase in near-
road CO monitoring. Due to the low CO concentrations recorded at the
Lowell monitor and applicable siting criteria, this monitor would
not meet the requirements for a near-road monitor.
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    Under the previous maintenance plan, contingency measures in Lowell
were triggered when a violation of the CO NAAQS was measured in Lowell.
Under the revised maintenance plan, Massachusetts will rely on data
from the Worcester CO monitor to determine when and if monitoring will
be re-established in the Lowell maintenance area, and, in some
circumstances, when contingency measures will be triggered in the
Lowell maintenance area.
    Massachusetts will discontinue CO monitoring in Lowell.
Massachusetts DEP will continue to collect and review CO monitoring
data from nearby Worcester, MA on an on-going basis. In the event the
second highest CO concentration in any calendar year monitored in
Worcester reaches 75 percent of the federal 1-hour or 8-hour NAAQS for
CO (35 and 9 ppm, respectively), Massachusetts will, within 9 months of
recording such concentrations, re-establish a CO monitoring site in
Lowell consistent with EPA siting criteria, and resume analyzing and
reporting those data. Massachusetts will continue to commit to
implement its contingency program in Lowell in the event that a CO
violation (the ``contingency trigger'') is monitored at the re-
established Lowell monitoring site at any time during the maintenance
period and to consider one or more of the other EPA-approved measures
listed in the 2001 Maintenance Plan if necessary to reduce CO levels.
    If the Worcester CO monitor measures a violation of the either the
federal 1-hour or 8-hour NAAQS for CO, the contingency measures in 2001
Maintenance Plan for Lowell will be implemented in Lowell, as well as
triggering contingency measures in Worcester under the terms of the
existing Maintenance Plan for Worcester, until a re-established Lowell
CO monitor shows that the area is in attainment of the CO standard.
    When implementing contingency measures, Massachusetts will review
and implement the measures necessary to remedy the violation, including
transportation control measures (TCM) or other additional vehicle or
fuel controls.

IV. Final Action

    EPA is approving the revisions to the Lowell CO maintenance plan
submitted by the State of Massachusetts on April 14, 2010.
Specifically, EPA is approving the State's request to modify the
portion of the maintenance plan used to determine when contingency
measures need to be implemented in Lowell. As described in more detail
above, the State will shut down the Lowell CO monitor and rely on data
from the CO monitor in Worcester to determine when and if monitoring
will be reestablished in the Lowell maintenance area, and, in some
circumstances, when contingency measures will be triggered in the
Lowell maintenance area.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 12, 2011. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference,

Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: April 29, 2011.
Ira W. Leighton,
Acting Regional Administrator, EPA Region 1.
    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart W--Massachusetts

0
2. Section 52.1132 is amended by adding paragraph (e) to read as
follows:

Sec.  52.1132  Control strategy: Carbon Monoxide.

* * * * *
    (e) Approval--On April 14, 2010, the Massachusetts Department of
Environmental Protection submitted a modification to the Lowell
maintenance plan approved in paragraph (c) of this section.
Massachusetts will not conduct CO monitoring in Lowell, but instead
commits to continue to collect and review CO monitoring data from
nearby Worcester, MA on an on-going basis. In the event the second
highest CO concentration in any calendar year monitored in Worcester
reaches 75 percent of the federal 1-hour or 8-hour national ambient air
quality standard for CO, Massachusetts will, within 9 months of
recording such concentrations, re-establish a CO monitoring site in
Lowell consistent with EPA citing criteria, and resume analyzing and
reporting those data. Massachusetts commits to implement its
contingency program in Lowell in the event that a CO violation is
monitored at the re-established Lowell monitoring site at any time
during the maintenance period. If the Worcester CO monitor measures a
violation of either the federal 1-hour or 8-hour NAAQS for CO,
contingency measures will be implemented in Lowell as well, until a re-
established CO monitor in Lowell shows that the area is in attainment
of the CO standard.

[FR Doc. 2011-11722 Filed 5-12-11; 8:45 am]
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[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26805-26806]
[FR Doc No: 2016-10390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1170]

Chronic Hepatitis C Virus Infection: Developing Direct-Acting
Antiviral Drugs for Treatment; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Chronic
Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs
for Treatment.'' The purpose of this draft guidance is to assist
sponsors in all phases of development of direct-acting antiviral (DAA)
drugs for the treatment of chronic hepatitis C. This draft guidance
revises the draft guidance of the same name that was issued on October
23, 2013.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the

manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-1170 for ``Chronic Hepatitis C Virus Infection: Developing
Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for
Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, 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.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-
Acting Antiviral Drugs for Treatment.'' This draft guidance addresses
nonclinical development, early phases of clinical development, and
phase 3 protocol designs. Important issues addressed in this draft
guidance include: Trial design options, noninferiority margin for
active-controlled phase 3 trials in the evaluation of interferon (IFN)-
free regimens, and trial design options and safety evaluation for
specific populations, including patients with decompensated cirrhosis,
patients either pre- or post-liver transplant, patients with chronic
kidney disease, and clinical virology considerations.
    This draft guidance revises the draft guidance of the same name
that issued October 23, 2013 (78 FR 63218). Significant changes in this
draft guidance compared to the previous version are:
     Modification of several sections to focus on IFN-free DAA
regimens.
     Additional details on phase 2 and phase 3 trial design
options for the evaluation of IFN-free regimens in treatment-na[iuml]ve
and treatment-experienced populations, including DAA-experienced
populations. Specifically, the guidance now recommends that each
marketing application contain at least one active-controlled
comparative trial.
     Additional clarification on DAA drug development in
specific populations, including trial design options for human
immunodeficiency virus/hepatitis C virus co-infected patients,
pediatric patients, patients with advanced chronic kidney disease,
patients with decompensated cirrhosis, patients either pre- or post-
liver transplantation, and patients who failed to respond to a prior
DAA-based regimen.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on developing DAA
drugs for treatment of chronic hepatitis C virus infection. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 312 have been approved
under 0910-0014, the collections of information in 21 CFR part 314 have
been approved under 0910-0001, and the collections of information
referred to in the guidance for industry ``Establishment and Operation
of Clinical Trial Data Monitoring Committees'' have been approved under
0910-0581.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10390 Filed 5-3-16; 8:45 am]
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