[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Proposed Rules]
[Pages 49497-49500]
[FR Doc No: 2021-19019]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2021-0307; FRL-8894-01-R3]

Air Plan Approval; Pennsylvania; Allegheny County Area Fine
Particulate Matter Clean Data Determination

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
determine that the Allegheny County, Pennsylvania nonattainment area
has clean data for the 2012 annual fine particulate matter
(PM2.5) National Ambient Air Quality Standard (NAAQS). This
proposed clean data determination (CDD) under EPA's Clean Data Policy
is based upon quality-assured, quality-controlled, and certified
ambient air quality monitoring data showing that the area has attained
the 2012 PM2.5 NAAQS based on 2018-2020 data available in
EPA's Air Quality System (AQS) database. Based on the proposed clean
data determination, EPA is also proposing to determine that the
requirements for Pennsylvania to make submissions to meet certain Clean
Air Act (CAA or the Act) requirements related to attainment of the
NAAQS for this area are not applicable for as long as the area
continues to attain the 2012 annual PM2.5 NAAQS. This action
is being taken under the CAA.

DATES: Written comments must be received on or before October 4, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2021-0307 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Brian Rehn, Planning & Implementation
Branch (3AD30), Air & Radiation Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
The telephone number is<PHONE_NUMBER>. Mr. Rehn can also be reached
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we'',
``us'' or ``our'' are used, it is intended to refer to the EPA.

Table of Contents

I. Background
II. Clean Data Determination for the Allegheny County, Pennsylvania
2012 PM2.5 NAAQS Nonattainment Area
III. Proposed Action
IV. Statutory and Executive Order Reviews

I. Background

    On December 14, 2012, EPA promulgated a revised primary annual
PM2.5 NAAQS to provide increased protection of public health
from fine particle pollution (2012 PM2.5 NAAQS).\1\ In that
action, EPA strengthened the primary annual PM2.5 standard,
lowering the level from 15.0 micrograms per cubic meter ([micro]g/m\3\)
to 12.0 [micro]g/m\3\, and retained the 24-hour PM2.5 NAAQS
at a level of 35 [micro]g/m\3\. The 2012 annual PM2.5 NAAQS
is attained when the 3-year average of the annual arithmetic means does
not exceed 12.0 [micro]g/m\3\.\2\ Effective April 15, 2015, EPA
established air quality designations, as required by section 107(d)(1)
of the CAA, for the 2012 annual PM2.5 NAAQS.\3\ In that
action, EPA designated the Allegheny County Area in Pennsylvania as
Moderate nonattainment for the 2012 annual PM2.5 NAAQS.
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    \1\ 78 FR 3086, January 15, 2013.
    \2\ See 40 CFR 50.18 and 40 CFR part 50, appendix N.
    \3\ 80 FR 2206 (January 15, 2015).
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    On August 24, 2016, EPA issued the Fine Particulate Matter National
Ambient Air Quality Standards: State Implementation Plan Requirements
(PM2.5 SIP Requirements Rule).\4\ The PM2.5 SIP
Requirements Rule is codified at 40 CFR part 51, subpart Z and

provides rules for the implementation of current and future
PM2.5 NAAQS.
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    \4\ 81 FR 58010, effective October 24, 2016.
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    On April 6, 2018, EPA issued a finding of failure to submit under
section 110(k) of the CAA finding that several states, including
Pennsylvania, failed to submit specific moderate area SIP elements for
the 2012 annual PM2.5 NAAQS required under subpart 4 of part
D of Title I of the CAA.\5\ In particular, Pennsylvania was late in
submitting the following specific moderate area SIP elements for the
Allegheny County Area: An attainment demonstration; control strategies,
including reasonably available control measures (RACM) and reasonably
available control technologies (RACT); a reasonable further progress
(RFP) plan; quantitative milestones; and contingency measures. That
finding triggered the sanctions clock under section 179 of the CAA, as
well as an obligation under section 110(c) of the CAA for EPA to
promulgate a Federal Implementation Plan (FIP) no later than two years
from the effective date of the finding, if Pennsylvania did not submit,
and EPA had not approved, the required SIP element submission(s).
Pennsylvania submitted the required Allegheny County Area
PM2.5 Plan on September 30, 2019. On November 1, 2019, EPA
determined the submitted PM2.5 Plan for the Allegheny County
Area to be technically and administratively complete, per the
requirements in accordance with CAA section 110(k) and 40 CFR part 51,
appendix V. This completeness determination corrected the deficiency
identified in EPA's April 6, 2018 (83 FR 14759) document finding that
Pennsylvania failed to submit certain nonattainment area planning
requirements for the Allegheny County Area for the 2012
PM2.5 NAAQS, turning off the sanctions clock (but not the
FIP clock) triggered by the April 6, 2018 finding. On May 14, 2021 (86
FR 26388), EPA approved most required elements of the Allegheny County
Area PM2.5 Plan, except for the contingency measures element
of the plan, which EPA conditionally approved. That action terminated
EPA's FIP obligation for all CAA required nonattainment plan elements
except for the contingency measures element. As to the contingency
measures element of the Allegheny County Area PM2.5 Plan,
EPA's May 14, 2021 conditional approval action suspended EPA's FIP
obligation for the duration of the conditional approval. Upon EPA's
approval of a SIP submission fulfilling the State commitment that had
provided the basis for the conditional approval, EPA's FIP obligation
with respect to the contingency measures element of the Allegheny
County Area Plan will be terminated.
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    \5\ 83 FR 14759 (April 6, 2018).
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    In accordance with the requirements of 40 CFR 51.1015, EPA may
issue a clean data determination for a specific area if we determine
the area has attained the relevant NAAQS based on three years of
quality-assured, certified air quality monitoring data.\6\ Over the
past two decades, EPA has consistently applied its Clean Data Policy
interpretation to attainment related provisions of subparts 1, 2, and 4
of the CAA. EPA codified portions of the longstanding Clean Data Policy
approach in the PM2.5 SIP Requirements Rule (40 CFR
51.1015(a)) for the implementation of current and future
PM2.5 NAAQS.\7\ For a complete discussion of the history of
EPA's Clean Data Policy and our longstanding interpretation of that
policy under the CAA, please refer to the August 24, 2016
PM2.5 SIP Requirements Rule (81 FR 58010).
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    \6\ Per the requirements for determining whether an area has
attained the annual PM2.5 NAAQS at 40 CFR 50.18(c) and 40
CFR Appendix N to part 50.
    \7\ See 81 FR 58010, 58161 (August 24, 2016).
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    As provided in 40 CFR 51.1015, so long as an area continues to meet
the NAAQS, finalization of a CDD suspends the requirements for a
nonattainment area to submit an attainment demonstration, associated
RACM and RACT, an RFP plan, quantitative milestones, contingency
measures, and any other SIP planning requirements related to the
attainment of the 2012 annual PM2.5 NAAQS. The requirement
to submit a projected attainment inventory as part of an attainment
demonstration or RFP plan is also suspended by this determination. As
discussed in the 2016 PM2.5 SIP Requirements Rule, the
nonattainment base year emissions inventory required by section
172(c)(3) of the CAA is not suspended by this determination because the
base inventory is a requirement independent of planning for an area's
attainment.\8\ Additionally, as discussed in the PM2.5 SIP
Requirements Rule (and required by sections 110(a)(2)(C); 172(c)(5);
173; 189(a), and 189(e) of the CAA), nonattainment New Source Review
(NNSR) requirements are not suspended by a CDD because this requirement
is independent of the area's attainment planning.\9\
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    \8\ See 81 FR 58009 at 58028 and 58127-8 (August 24, 2016) and
80 FR 15340 at 15441-2 (March 23, 2015).
    \9\ See 81 FR 58010 at 58107 and 58127 (August 24, 2016).
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    By extension, the requirement to submit a motor vehicle emissions
budget (MVEB) for the attainment year for the purposes of
transportation conformity is also suspended. A MVEB is that portion of
the total criteria pollutant emissions associated with allowable
highway and transit vehicle use, as defined in the submitted or
approved control strategy implementation plan revision or maintenance
plan, for a certain date. The MVEB serves as a cap on highway mobile
source section emissions for the purpose of meeting RFP milestones or
demonstrating attainment or maintenance of the NAAQS. For purposes of
the transportation conformity regulations, the control strategy
implementation plan revision is the implementation plan which contains
specific strategies for controlling the emissions of, and reducing
ambient levels of, pollutants in order to satisfy CAA requirements for
demonstrations of RFP and attainment. Given that MVEBs are required to
support RFP and attainment demonstration requirements in the attainment
plan, suspension of the RFP and attainment demonstration requirements
through a CDD also suspends the requirement to submit MVEBs for
attainment and RFP milestone years. Suspension of planning requirements
under the clean data policy (pursuant to 40 CFR 51.1015) does not
preclude the state from submitting suspended elements of its moderate
area attainment plan for EPA approval for the purposes of strengthening
the state's SIP, nor does issuance of a CDD compel the state to
withdraw previously submitted or SIP-approved elements of its moderate
area attainment plan.
    A CDD is not equivalent to a redesignation under CAA section
107(d)(3), and the state must still meet the statutory requirements for
redesignation in order to be redesignated to attainment. In accordance
with 40 CFR 51.1015(a)(1) and (2), a CDD suspends the aforementioned
SIP obligations until the area is redesignated to attainment (after
which time such requirements are permanently discharged); or until EPA
determines that the area has re-violated the PM2.5 NAAQS. In
the event the area re-violates the NAAQS, the state shall once again be
required to submit all required attainment plan elements for the
Moderate nonattainment area, by a deadline established by EPA through
publication in the Federal Register of the determination that the area
is once

again violating the 2012 annual PM2.5 NAAQS.

II. Clean Data Determination for the Allegheny County, Pennsylvania
2012 PM2.5 NAAQS Nonattainment Area

    Under EPA regulations at 40 CFR 50.18 and part 50, appendix N, the
2012 annual PM2.5 NAAQS is met when the 3-year average of
PM2.5 annual mean mass concentrations for each eligible
monitoring site is less than or equal to 12.0 [micro]g/m\3\. Three
years of valid, annual means are required to produce a valid annual
PM2.5 NAAQS design value. A year of data meets data
completeness requirements when quarterly data capture rates for all
four quarters are at least 75 percent from eligible monitoring
sites.\10\ By a letter to EPA dated March 08, 2021, Allegheny County
Health Department (ACHD) certified its 2020 ambient air quality
monitoring data. EPA issued final 2018-2020 design values on May 24,
2021.\11\ There are nine PM2.5 eligible Federal Reference
Method (FRM) or Federal Equivalent Method (FEM) monitoring sites in the
Allegheny County nonattainment area. Table 1 in this document shows the
Allegheny County Area design values for the 2012 annual
PM2.5 NAAQS for the years 2018-2020 at all area monitoring
sites.
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    \10\ See 40 CFR part 50, appendix N.
    \11\ See EPA's Air Quality Design Values web page, at https://www.epa.gov/air-trends/air-quality-design-values.

                                   Table 1--2018-2020 Annual PM2.5 Values for the Allegheny County, Pennsylvania Area
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                                                                                Weighted mean ([micro]g/      Complete quarters      Certified annual
                                                                                m\3\)           ---------------------------   design value
                          Monitor name                              Monitor ID   ---------------------------                                2018-2020
                                                                                2018     2019     2020     2018     2019     2020    ([micro]g/m\3\)
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Avalon..........................................................       420030002     9.61     9.89     8.57        4        4        4               9.4
Lawrenceville...................................................       420030008     8.97     8.97     7.66        4        4        4               8.5
South Fayette...................................................       420030067     8.12     7.65     6.56        4        4        4               7.4
North Park......................................................       420030093    * 7.2     6.81   * 5.74        3        4        3             * 6.6
Harrison........................................................       420031008     9.25     8.64     7.32        4        4        4               8.4
North Braddock..................................................       420031301    10.17     9.85     9.03        4        4        4               9.7
Clairton........................................................       420033007     8.80     7.87     7.34        4        4        4               8.0
Liberty.........................................................       420030064    11.52    12.16     9.76        4        4        4              11.1
Parkway East....................................................       420031376    10.25    10.79     8.97        4        4        4              10.0
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* North Park has incomplete data sets for 2018 and 2020.

                      Table 2--Data Capture Rates (%) and Creditable Samples by Quarter (Q) for the North Park Monitor [420030093]
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                                                                       2018                            2019                            2020
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                                                            Q1      Q2      Q3      Q4      Q1      Q2      Q3      Q4      Q1      Q2      Q3      Q4
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Creditable Samples......................................      15      15      16       5      14      15      15      14      15      14      15       2
Capture Rate............................................     100     100     100      33      93     100      94      93     100      93      94      13
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    As shown in Table 1 in this document, for monitors in the Allegheny
County area, all but the North Park monitoring location have complete
2018-2020 reporting data capture rates of at least 75%. At the North
Park monitoring site, the fourth quarter in 2018 and the fourth quarter
in 2020 for the North Park monitor [Monitor ID 420030093] had a data
capture rate of 33% and 13%, respectively. The North Park monitor data
was incomplete in fourth quarter 2018 because of a roof replacement
taking place at the monitor location and North Park was approved for
shut down in the third quarter of 2020 in ACHD's ``Annual Monitoring
Plan for Calendar Year 2021.''
    Consistent with the requirements contained in 40 CFR part 58, EPA
has reviewed the PM2.5 ambient air quality monitoring data
for the monitoring period from 2018 through 2020 for the Allegheny
County nonattainment area, as recorded in the AQS database, and has
determined the data meet the quality assurance requirements set forth
in 40 CFR part 58. In this respect, the data has been deemed usable by
EPA for regulatory compliance purposes. As shown in Table 1 in this
document, each quarter from 2018 through 2020 is complete, with all
four quarters reporting data capture rates of at least 75 percent (with
the exception of the North Park monitor, as noted above). The highest
certified annual design value for 2018-2020 is 11.1 [micro]g/m3, with
all nine ambient monitors below the 2012 annual PM2.5 NAAQS
of 12.0 [micro]g/m3. Therefore, the Allegheny County nonattainment area
has attained the 2012 annual PM2.5 NAAQS in accordance with
the requirements in 40 CFR 50.18 and appendix N.

III. Proposed Action

    Pursuant to the PM2.5 Clean Data Policy codified at 40
CFR 51.1015, EPA proposes to determine that based on three years of
certified, valid monitoring data between 2018 and 2020, the Allegheny
County nonattainment area has attained the 2012 annual PM2.5
NAAQS. Pursuant to 40 CFR 51.1015(a), and based upon our proposed clean
data determination that the Allegheny County Area has attained the
NAAQS, EPA proposes to determine that the CAA requirements to submit
attainment-related SIP revisions arising from classification of the
Area as Moderate nonattainment under subpart 4 of part D, of title I of
the Act for the 2012 annual PM2.5 NAAQS are not applicable
for so long as the area continues to attain the 2012 annual
PM2.5 NAAQS. In particular, if EPA finalizes this
determination, it will suspend the requirements for the area to submit
an attainment demonstration, RACM and RACT, RFP plan, quantitative
milestones, contingency measures, and any other SIP requirements
related to the attainment

of the 2012 annual PM2.5 NAAQS, so long as the area
continues to meet the NAAQS, until the area is redesignated to
attainment. If this proposed CDD action is finalized, the FIP clock
triggered by the EPA's April 6, 2018 finding of failure to submit will
be suspended for these plan elements for as long as the CDD remains in
effect.\12\
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    \12\ See 83 FR 14759.
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    EPA's May 14, 2021 conditional approval of the contingency measures
element of the Allegheny County Area PM2.5 Plan suspended
EPA's FIP obligation with respect to this element of the plan for the
duration of the conditional approval. If EPA approves a SIP submission
fulfilling the State commitment that had provided the basis for the
conditional approval, the FIP obligation triggered by EPA's April 6,
2018 finding of failure to submit will be terminated. Alternatively, if
the State fails to fulfill its commitment and EPA converts the
conditional approval to a disapproval, the conditional approval would
no longer provide a basis for suspending EPA's FIP obligation, because
the State would have failed to correct the deficiency identified in
EPA's April 6, 2018 finding of failure to submit.\13\ If, however, EPA
finalizes our proposed CDD for the area, the CDD would provide an
independent basis for continued suspension of the FIP obligation, for
so long as the area continues to attain the 2012 PM2.5
NAAQS. If the area then violates the NAAQS and EPA rescinds the CDD,
the CDD would also no longer provide a basis for suspending EPA's FIP
obligation, and EPA would have an immediate obligation to promulgate a
FIP addressing the contingency measure requirement for the 2012
PM2.5 NAAQS in the Allegheny County area.
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    \13\ 83 FR 14759 (April 6, 2018) (noting that ``EPA is obligated
to promulgate a federal implementation plan (FIP) to address any
outstanding SIP requirements, if a state does not submit, and EPA
does not approve, a state's submission within 24 months of the
effective date of these findings'').
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    This proposed clean data determination does not constitute a
redesignation to attainment of the NAAQS. The Allegheny County Area
will remain designated nonattainment for the 2012 annual
PM2.5 NAAQS until such time that EPA determines the
Allegheny County nonattainment area meets the CAA requirements for
redesignation to attainment, including an approved maintenance plan,
pursuant to CAA sections 107 and 175A. EPA is soliciting public
comments on this proposed action, which we will consider prior to
taking final action.

IV. Statutory and Executive Order Reviews

    This rulemaking action makes a clean data determination for
attainment of the 2012 PM2.5 NAAQS based on air quality and
does not impose additional requirements. For that reason, this clean
data determination:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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 CAA; 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 proposed clean data determination for the
Allegheny County Area for the 2012 annual PM2.5 NAAQS 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.

List of Subjects in 40 CFR Part 52

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

    Dated: August 26, 2021.
Diana Esher,
Acting Regional Administrator, Region III.
[FR Doc. 2021-19019 Filed 9-2-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]
[Page 18392-18395]
[DOCID:fr11ap06-148]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53596; File No. SR-NASD-2004-044]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Order Approving Proposed Rule Change and Amendment Nos.
1 and 2 Thereto Relating to Short Sale Delivery Requirements

April 4, 2006.

I. Introduction

    On March 10, 2004, the National Association of Securities Dealers,
Inc. (``NASD'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to apply a delivery framework to
certain non-reporting equity securities similar to that imposed on
reporting equity securities by Regulation SHO.\3\ The NASD submitted
Amendment No. 1 to its proposed rule change on October 6, 2005 and
submitted Amendment No. 2 to its proposed rule change on October 28,
2005.\4\ The proposed rule change, as amended, was published for notice
and comment in the Federal Register on November 16, 2005.\5\ The
Commission received nine comment letters on the proposal.\6\ The NASD
filed a response to the comment letters on March 15, 2006.\7\

This order approves the proposed rule change, as amended.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Exchange Act Release No. 50103 (July 28, 2004), 69 FR
48008 (Aug. 6, 2004) (``Regulation SHO Adopting Release''). The
Commission adopted Regulation SHO to, among other things, impose a
requirement on a participant of a registered clearing agency to take
action to close out fail to deliver positions in ``threshold
securities.'' Regulation SHO defines a ``threshold security'' as any
equity security that is registered under Section 12 of the Act, or
where the issuer of such security is required to file reports under
Section 15(d) of the Act, and which security has, for five
consecutive settlement days, had aggregate fails to deliver at a
registered clearing agency of at least 10,000 shares that are also
equal to at least 0.5% of the issuer's total shares outstanding
(``TSO''). See 17 CFR 242.203(c)(6). In the Regulation SHO Adopting
Release, the Commission noted that because the calculation of the
threshold that would trigger the delivery requirements under the
rule depends on identifying the aggregate fails to deliver as a
percentage of the TSO, the Commission believed it was necessary to
limit the close out requirement to companies that are subject to the
reporting requirements of the Act. See Regulation SHO Adopting
Release, 69 FR at 48016, fn. 82.
    \4\ On account of the adoption of Regulation SHO, Amendment No.
1, among other things, narrowed the scope of the proposal to those
equity securities not otherwise covered by the delivery requirements
of Rule 203(b) of Regulation SHO. Amendment No. 2 replaced and
superseded Amendment No. 1 in its entirety and made technical
changes to the proposed rule change.
    \5\ See Securities Exchange Act Release No. 52752 (Nov. 8,
2005), 70 FR 69614 (Nov. 16, 2005) (``Proposing Release'').
    \6\ See Letter from Paul Vuksich, II, dated December 22, 2005;
letter from Amal Aly, Vice President and Associate General Counsel,
Securities Industry Association, on behalf of the Securities
Industry Association Regulation SHO Working Group, dated December
14, 2005 (``SIA Letter''); letter from Jim L. Hoch, dated December
14, 2005; letter from Paul Vuksich, II, dated December 12, 2005
(``Vuksich Letter''); letter from Donald J. Stoecklein, President,
Stoecklein Law Group, dated December 13, 2005 (``Stoecklein Law
Group Letter''); letter from Peter J. Chepucavage, General Counsel,
Plexus Consulting, dated December 1, 2005; letter from Bob O'Brien,
dated November 17, 2005; letter from David Patch, dated November 14,
2005; and letter from Richard M. Rosenthal, Esq, dated November 10,
2005.
    \7\ See letter from Andrea D. Orr, Assistant General Counsel,
NASD, to Nancy M. Morris, Secretary, SEC, dated March 15, 2006
(``Response to Comments'').
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II. Description of the Proposal

    The proposed rule change would require participants \8\ of
registered clearing agencies \9\ to take action to immediately close
out fail to deliver positions that exist for thirteen consecutive
settlement days in non-reporting threshold securities by purchasing
securities of like kind and quantity. A ``non-reporting threshold
security'' is ``any equity security of an issuer that is not registered
pursuant to Section 12 of the Act \10\ and for which the issuer is not
required to file reports pursuant to Section 15(d) of the Act: \11\ (A)
For which there is an aggregate fail to deliver position for five
consecutive settlement dates at a registered clearing agency of 10,000
shares or more and for which on each settlement day during the five
consecutive day period, the reported last sale during the normal market
hours for the security on that settlement day would value the aggregate
fail to deliver position at $50,000 or more, provided that, if there is
no reported last sale on a particular settlement day, then the price
used to value the position on such settlement day would be the
previously reported last sale; and (B) is included on a list published
by the NASD.''
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    \8\ A ``participant'' means a participant as defined in Section
3(a)(24) of the Act, that is an NASD member. See Proposing Release,
supra note 5, 70 FR at 69615.
    \9\ A ``registered clearing agency'' is a clearing agency, as
defined in Section 3(a)(23)(A) of the Act, that is registered with
the SEC pursuant to Section 17A of the Act.
    \10\ 15 U.S.C. 78l.
    \11\ 15 U.S.C. 78o(d).
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    In addition, if the fail to deliver position is not closed out in
the requisite time period, a participant or any broker-dealer for which
it clears transactions, including market-makers, would be prohibited
from accepting any short sale order in the non-reporting threshold
security from another person, or effecting a short sale in the non-
reporting threshold security for its own account, without borrowing the
security or entering into a bona-fide arrangement to borrow the
security, until the participant has closed out the fail to deliver
position by purchasing securities of like kind and quantity.
    Under the proposed rule change, NASD would publish a list daily of
the non-reporting threshold securities.\12\ In order to be removed from
the non-reporting threshold securities list, a security must not meet
or exceed the threshold requirements in the proposed rule change for
five consecutive settlement days.\13\
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    \12\ Proposing Release, supra note 5, 70 FR at 69616.
    \13\ Id., 70 FR at 69615.
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III. Summary of Comments

    The Commission received nine comment letters on the proposal.\14\
Several commenters supported the proposal.
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    \14\ See supra note 6.
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A. Delivery Requirements for Non-Reporting Threshold Securities

    Several commenters supported applying a delivery framework to non-
reporting threshold securities. Some commenters, however, objected to
certain provisions of the proposed rule change.
i. Uniform Short Sale Delivery Requirements
    One commenter asserted that a uniform short sale delivery
requirement for reporting and non-reporting equity securities would be
preferable.\15\ This commenter argued that the adoption of the proposed
rule change would upset the regulatory uniformity that Regulation SHO
\16\ was intended to create because it would result in additional rules
that apply only to NASD member firms.\17\ In addition, this commenter
expressed concern that separate rules for reporting and non-reporting
equity securities could be subject to disparate revisions and/or
interpretations, thereby subjecting member firms to different delivery
requirements, depending on which securities are at issue.\18\
---------------------------------------------------------------------------

    \15\ See Letter, supra note 6, at 3.
    \16\ Id.
    \17\ Id.
    \18\ Id.
---------------------------------------------------------------------------

    This commenter urged the Commission to amend the Regulation SHO
delivery requirements to also address non-reporting equity
securities.\19\
---------------------------------------------------------------------------

    \19\ Id.
---------------------------------------------------------------------------

    In its Response to Comments, NASD agreed that uniformity with
respect to rulemaking across self-regulatory organizations (``SROs'')
is preferable to the extent possible and practicable.\20\ In addition,
NASD noted that if, in the future, the SEC determines to amend the
Regulation SHO delivery requirements to apply to non-reporting equity
securities, NASD would consider repealing its rule.\21\ NASD also
stated in its Response to Comments that, although NASD believes that
the vast majority of trading in non-reporting securities occurs through
NASD members, uniformity in this area can be achieved if other SROs
propose similar requirements. NASD also noted that it did not believe
it was appropriate to forestall an SRO proposal solely because other
SROs have not put forth comparable requirements.\22\
---------------------------------------------------------------------------

    \20\ Response to Comments, supra note 7, at 4.
    \21\ Id.
    \22\ Id.
---------------------------------------------------------------------------

ii. $50,000 Threshold Requirement
    Some commenters opposed the $50,000 value threshold requirement
contained in the definition of a ``non-reporting threshold security.''
For example, one commenter argued that the dollar threshold value is
inappropriate, stating that it is not an accurate indicator of non-
reporting securities with excessive fails to deliver.\23\ Another
commenter believed that the dollar threshold value was too high, noting
that such a value would harm small companies,\24\ while another
commenter argued that the dollar threshold value was too low and would
capture a vastly expanded universe of threshold securities.\25\
---------------------------------------------------------------------------

    \23\ See Stoecklein Law Group Letter, supra note 6, at 1.
    \24\ See Vuksich Letter, supra note 6, at 1.
    \25\ See SIA Letter, supra note 6, at 5.
---------------------------------------------------------------------------

    In its Response to Comments, NASD noted that it proposed the dollar
threshold value to ensure that the non-reporting threshold security
list would not be overly broad or impracticable.\26\ NASD noted that it
was concerned that having a security on the non-reporting threshold
security list solely based on whether the failure to deliver position
is equal to, or greater than, 10,000 shares may not represent a
significant failure to deliver position relative to the price of the
security, particularly given that many non-reporting securities trade
at less than $1.00.\27\ Thus, NASD believes that the $50,000 value
threshold strikes an appropriate balance to ensure that the threshold
list is not overly broad or narrow.\28\
---------------------------------------------------------------------------

    \26\ Response to Comments, supra note 7, at 3.
    \27\ Id.
    \28\ Id. In addition, in its Response to Comments, NASD noted
that NASD staff analyzed data relating to non-reporting securities
over a five-day settlement period in February 2006 to get an
indication of the number of non-reporting securities that would meet
the proposed threshold requirements. During this time period, the
analysis indicated that 44 securities would be deemed non-reporting
threshold securities under the proposed threshold requirements. See
Response to Comments, supra note 7, at fn. 20.
---------------------------------------------------------------------------

iii. Impact on Liquidity in the Marketplace
    One commenter believed that the proposed rule change may result in
negative consequences for this class of securities, such as further
reducing liquidity in already illiquid securities and having a greater
impact on price

than would be the case with reporting equity securities.\29\
---------------------------------------------------------------------------

    \29\ See SIA Letter, supra note 6, at 4.
---------------------------------------------------------------------------

    In its Response to Comments, NASD noted that similar concerns were
raised in the context of Regulation SHO, to which the SEC responded
that the requirements would only apply to a limited number of
securities and would not apply to any fail to deliver positions
existing prior to the security meeting the threshold requirements.\30\
NASD noted in its Response to Comments that it believes these same
assertions apply in the context of the proposed rule change as well,
given the Commission's Office of Economic Analysis' (``OEA'') estimates
on non-reporting securities with fails to deliver of 10,000 shares or
greater,\31\ and that NASD's proposal would further reduce this
estimate due to the proposed additional $50,000 value threshold
requirement.\32\
---------------------------------------------------------------------------

    \30\ Response to Comments, supra note 7, at 5.
    \31\ In its Response to Comments, NASD noted that general
estimates relating to the number of non-reporting securities with
fails to deliver in excess of 10,000 shares were made publicly
available as part of the Regulation SHO Adopting Release. NASD noted
that the Regulation SHO Adopting Release provided that the
Commission's OEA analyzed NSCC data on fails to deliver in excess of
10,000 shares for non-reporting issuers and estimated that only an
additional 1% of all securities would be added to its estimate of
the number of securities that would be subject to the close out
requirements of Regulation SHO. See Response to Comments supra note
7, at 4 (referencing the Regulation SHO Adopting Release at fn. 86).
    \32\ See id. at 5.
---------------------------------------------------------------------------

iv. Exemptive Authority
    One commenter raised concerns with the provision that permits NASD
to grant exemptive relief under certain specified conditions, arguing
that NASD may abuse such discretion or the provision may provide a
blanket exemption to firms.\33\
---------------------------------------------------------------------------

    \33\ See Stoecklein Law Group Letter, supra note 6, at 1.
---------------------------------------------------------------------------

    In its Response to Comments, NASD commented that it believes this
comment is without merit.\34\ NASD believes that it is important to
have the ability to address, through the exemptive process, situations
that may warrant relief.\35\ In addition, NASD noted that the proposed
exemptive authority, by its terms, is specifically limited to those
situations where granting such relief is consistent with the protection
of investors and the public interest, and NASD will execute such
authority consistent with this requirement.\36\
---------------------------------------------------------------------------

    \34\ Response to Comments, supra note 7, at 4.
    \35\ Id.
    \36\ Id.
---------------------------------------------------------------------------

B. Defined Terms

    NASD proposed that the term ``non-reporting threshold security''
means ``any equity security of an issuer that is not registered
pursuant to Section 12 of the Act \37\ and for which the issuer is not
required to file reports pursuant to Section 15(d) of the Act:\38\ (A)
for which there is an aggregate fail to deliver position for five
consecutive settlement dates at a registered clearing agency of 10,000
shares or more and for which on each settlement day during the five
consecutive day period, the reported last sale during the normal market
hours for the security on that settlement day that would value the
aggregate fail to deliver position at $50,000 or more, provided that,
if there is no reported last sale on a particular settlement day, then
the price used to value the position on such settlement day would be
the previously reported last sale; and (B) is included on a list
published by the NASD.'' \39\
---------------------------------------------------------------------------

    \37\ 15 U.S.C. 78l.
    \38\ 15 U.S.C. 78o(d).
    \39\ Proposing Release, supra note 5, 70 FR at 69615.
---------------------------------------------------------------------------

    The Commission agrees with NASD that imposing a lower dollar value
threshold requirement, or eliminating it altogether, as some commenters
suggested, might be impracticable or an overly-broad method of
addressing any potential abuses in this sector of the marketplace.
Similarly, the Commission agrees with NASD that increasing the dollar
value threshold requirement could be too limiting. As noted above, a
five-day settlement period analysis by NASD staff found that under the
proposed threshold requirements, only approximately 44 securities would
qualify as non-reporting threshold securities.\40\
---------------------------------------------------------------------------

    \40\ See supra note 28.
---------------------------------------------------------------------------

C. Implementation

    NASD suggests that the effective date of the proposed rule change
will be 30 days following publication of NASD's Notice to Members
announcing Commission approval \41\ and the Commission believes that
this is reasonable.
---------------------------------------------------------------------------

    \41\ NASD will announce the effective date of the proposed rule
change in a Notice to Members to be published no later than 60 days
following Commission approval.
---------------------------------------------------------------------------

IV. Discussion and Commission Findings

    After careful review, the Commission finds, as discussed more fully
below, that the proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities association. The Commission finds
specifically that the proposed rule change, as amended, is consistent
with Sections 15A(b)(6) and 15A(b)(9) of the Act.\42\
---------------------------------------------------------------------------

    \42\ 15 U.S.C. 78o-3(b)(6) and (b)(9).
---------------------------------------------------------------------------

    Section 15A(b)(6) of the Act requires that NASD's rules are
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 regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest.\43\ Section
15A(b)(9) of the Act requires that NASD's rules do not impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.\44\
---------------------------------------------------------------------------

    \43\ See 15 U.S.C. 78o-3(b)(6).
    \44\ See 15 U.S.C. 78o-3(b)(9).
---------------------------------------------------------------------------

    Section 3(f) of the Act directs the Commission to consider, in
addition to the protection of investors, whether approval of a rule
change will promote efficiency, competition, and capital formation.\45\
In approving the proposed rule change, the Commission has considered
its impact on efficiency, competition, and capital formation. In
particular, the Commission determined that requiring a delivery
framework for non-reporting threshold securities similar to that
required under Regulation SHO would increase investor confidence in
this sector of the marketplace by helping to reduce fails to deliver
which, in turn, would promote capital formation.
---------------------------------------------------------------------------

    \45\ 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    When the Commission adopted Regulation SHO, it did not apply the
Regulation SHO delivery requirements to non-reporting threshold
securities because the calculation of the threshold that would trigger
the delivery requirements under Regulation SHO depends on identifying
the aggregate fails to deliver as a percentage of the TSO that is
generally obtained from periodic reports filed with the Commission.
Thus, the Commission believed it was necessary to limit the delivery
requirement to companies that are subject to the reporting requirements
of the Act.
    The Commission believes that applying a delivery framework similar
to that contained in Regulation SHO to non-reporting threshold
securities will protect investors and the public interest by helping to
reduce fails to deliver in

this sector of the marketplace. Thus, the Commission finds that the
proposed rule change is consistent with Sections 15A(b)(6) and
15A(b)(9) of the Act.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\46\ that the proposed rule change (SR-NASD-2004-044), as amended,
be, and it hereby is, approved.
---------------------------------------------------------------------------

    \46\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\47\
---------------------------------------------------------------------------

    \47\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-5236 Filed 4-10-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: September 21, 2010 (Volume 75, Number 182)]
[Notices]
[Page 57503-57504]
[DOCID:fr21se10-105]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0029]

Application for Training Grant; Extension of the Office of
Management and Budget's (OMB) Approval of Information Collection
(Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comment.

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

SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements contained in the Training Grant
Application.

DATES: Comments must be submitted (postmarked, sent, or received) by
November 22, 2010.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket Number OSHA-2010-
0029, U.S. Department of Labor, Room N-2625, 200 Constitution Avenue,
NW., Washington, DC 20210. Deliveries (hand, express mail, messenger,
and courier service) are accepted during the Department of Labor's and
Docket Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for this Information Collection Request (ICR) (OSHA-2010-
0029). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. To obtain a copy of the ICR, you may
contact Theda Kenney or Todd Owen at the Directorate of Standards and
Guidance, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution
Avenue, NW., Washington, DC 20210; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Technical: Kimberly A. Newell, OSHA
Directorate of Training and Education, 2020 S. Arlington Heights Road,
Arlington Heights, IL 60005-4102; telephone:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (29 U.S.C. 657).
    Section 21 of the OSH Act (29 U.S.C. 670) authorizes the
Occupational Safety and Health Administration (``OSHA'' or the
``Agency'') to conduct directly, or through grants and contracts,
education and training courses. These courses must ensure an adequate
number of qualified personnel to fulfill the purposes of the Act,
provide them with short-term training, inform them of the importance
and proper use of safety and health equipment, and train employers and
workers to recognize, avoid, and prevent unsafe and unhealthful working
conditions.
    Under Section 21, the Agency awards grants to non-profit
organizations to provide part of the required training. To obtain such
a grant, an organization must complete the training grant application.
OSHA uses the information in this application to evaluate: The
organization's competence to provide the proposed training (including
the qualifications of the personnel who manage and implement the
training); the goals and objectives of the proposed training program; a
workplan that describes in detail the tasks that the organization will
implement to meet these goals and objectives; the appropriateness of
the proposed costs; and compliance with Federal regulations governing
nonprocurement debarment and suspension, maintaining a drug-free
workplace, and lobbying activities. Also required is a program summary
that Agency officials use to review and evaluate the highlights of the
overall proposal.
    After awarding a training grant, OSHA uses the work plan and budget
information provided in the application to monitor the organization's
progress in meeting training goals and objectives, as well as planned
expenditures. The initial grant award is for one year.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of the Agency's estimate of the burden (time
and costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Training Grant Application.
The Agency is requesting to increase its current

burden hour estimate associated with the Training Grant Application ICR
from 10,166 hours to 11,480 hours for a total increase of 1,314 hours.
The increase mainly results from an increase in the number of grant
applications received during the last three fiscal years (FY07-FY09).
The Agency will summarize the comments submitted in response to this
notice, and will include this summary in the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Application for Training Grant.
    OMB Number: 1218-0020.
    Affected Public: Not-for-profit institutions.
    Number of Respondents: 205.
    Frequency: Annually.
    Total Responses: 205.
    Average Time per Response: 56 hours.
    Estimated Total Burden Hours: 11,480 hours.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for this ICR (OSHA Docket No. OSHA-2010-
0029). You may supplement electronic submissions by uploading document
files electronically. If you wish to mail additional materials in
reference to an electronic or a facsimile submission, you must submit
them to the OSHA Docket Office (see the section of this notice titled
ADDRESSES). The additional materials must clearly identify your
electronic comments by your name, date, and docket number so the Agency
can attach them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger or courier service, please contact the OSHA
Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://
www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site, and for assistance in
using the Internet to locate docket submissions.
    Electronic copies of this Federal Register document are available
at  http://www.regulations.gov. This document, as well as news releases
and other relevant information, also are available at OSHA's Web page
at http://www.osha.gov.

V. Authority and Signature

    David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2007
(72 FR 31160).

    Signed at Washington, DC, on September 8, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-23491 Filed 9-20-10; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9028-9029]
[FR Doc No: 2011-3461]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0069]

Training Program for Regulatory Project Managers; Information
Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) Center for Drug
Evaluation and Research (CDER) is announcing the continuation of the
Regulatory Project Management Site Tours and Regulatory Interaction
Program (the Site Tours Program). The purpose of this document is to
invite pharmaceutical companies interested in participating in this
program to contact CDER.

DATES: Pharmaceutical companies may submit proposed agendas to the
Agency by April 18, 2011.

FOR FURTHER INFORMATION CONTACT:  Beth Duvall-Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993-0002, 301-

796-0700, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this primary goal, CDER
has initiated various training and development programs to promote high
performance in its regulatory project management staff. CDER seeks to
significantly enhance review efficiency and review quality by providing
the staff with a better understanding of the pharmaceutical industry
and its operations. To this end, CDER is continuing its training
program to give regulatory project managers the opportunity to tour
pharmaceutical facilities. The goals are to provide the following: (1)
Firsthand exposure to industry's drug development processes and (2) a
venue for sharing information about project management procedures (but
not drug-specific information) with industry representatives.

II. The Site Tours Program

    In this program, over a 2- to 3-day period, small groups (five or
less) of regulatory project managers, including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, tracking mechanisms, and regulatory submission
operations. The overall benefit to regulatory project managers will be
exposure to project management, team techniques, and processes employed
by the pharmaceutical industry. By participating in this program, the
regulatory project manager will grow professionally by gaining a better
understanding of industry processes and procedures.

III. Site Selection

    All travel expenses associated with the site tours will be the
responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Selection
will also be based on firms having a favorable facility status as
determined by FDA's Office of Regulatory Affairs District Offices in
the firms' respective regions. Firms interested in offering a site tour
or learning more about this training opportunity should respond by
submitting a proposed agenda to Beth Duvall-Miller (see DATES and FOR
FURTHER INFORMATION CONTACT).

    Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3461 Filed 2-15-11; 8:45 am]
BILLING CODE 4160-01-P