Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Special Protocol Assessment, 65636-65638 [2010-26985]
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65636
Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Notices
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Clearance Officer.
[FR Doc. 2010–26955 Filed 10–25–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology; HIT
Standards Committee Advisory
Meeting; Notice of Meeting
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meeting.
emcdonald on DSK2BSOYB1PROD with NOTICES
AGENCY:
This notice announces a forthcoming
meeting of a public advisory committee
of the Office of the National Coordinator
for Health Information Technology
(ONC). The meeting will be open to the
public.
Name of Committee: HIT Standards
Committee.
General Function of the Committee:
To provide recommendations to the
National Coordinator on standards,
implementation specifications, and
certification criteria for the electronic
exchange and use of health information
for purposes of adoption, consistent
with the implementation of the Federal
Health IT Strategic Plan, and in
accordance with policies developed by
the HIT Policy Committee.
Date and Time: The meeting will be
held on November 30, 2010, from 9 a.m.
to 3 p.m./Eastern Time.
Location: The meeting will be
conducted virtually only. Dial into the
meeting: 1–877–705–6006; webcast:
https://altarum.adobeconnect.com/
HITstandards.
Contact Person: Judy Sparrow, Office
of the National Coordinator, HHS, 330 C
Street, SW., Washington, DC 20201,
202–205–4528, Fax: 202–690–6079,
e-mail: judy.sparrow@hhs.gov. Please
call the contact person for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Agenda: The committee will hear
reports from its workgroups, including
the Clinical Operations, Vocabulary
Task Force, Implementation, and
Enrollment Workgroups. ONC intends
to make background material available
to the public no later than two (2)
business days prior to the meeting. If
ONC is unable to post the background
material on its Web site prior to the
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18:09 Oct 25, 2010
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meeting, it will be made publicly
available at the location of the advisory
committee meeting, and the background
material will be posted on ONC’s Web
site after the meeting, at https://
healthit.hhs.gov.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 24, 2010.
Oral comments from the public will be
scheduled between approximately 2 and
3 p.m./Eastern Time. Time allotted for
each presentation will be limited to
three minutes each. If the number of
speakers requesting to comment is
greater than can be reasonably
accommodated during the scheduled
open public hearing session, ONC will
take written comments after the meeting
until close of business.
Persons attending ONC’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
ONC welcomes the attendance of the
public at its advisory committee
meetings. Seating is limited at the
location, and ONC will make every
effort to accommodate persons with
physical disabilities or special needs. If
you require special accommodations
due to a disability, please contact Judy
Sparrow at least seven (7) days in
advance of the meeting.
ONC is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://healthit.hhs.gov for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: October 18, 2010.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2010–26918 Filed 10–25–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0541]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Special Protocol
Assessment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
26, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0470. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Guidance for Industry on Special
Protocol Assessment—OMB Control
Number 0910–0470—Extension
The ‘‘Guidance for Industry on Special
Protocol Assessment’’ describes Agency
procedures to evaluate issues related to
the adequacy (e.g., design, conduct,
analysis) of certain proposed studies.
The guidance describes procedures for
sponsors to request special protocol
assessment and for the Agency to act on
such requests. The guidance provides
information on how the Agency
interprets and applies provisions of the
Food and Drug Administration
E:\FR\FM\26OCN1.SGM
26OCN1
65637
Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Notices
Modernization Act of 1997 and the
specific Prescription Drug User Fee Act
of 1992 (PDUFA) goals for special
protocol assessment associated with the
development and review of PDUFA
products. The guidance describes the
following two collections of
information: (1) The submission of a
notice of intent to request special
protocol assessment of a carcinogenicity
protocol and (2) the submission of a
request for special protocol assessment.
Notification for a Carcinogenicity
Protocol
As described in the guidance, a
sponsor interested in Agency
assessment of a carcinogenicity protocol
should notify the appropriate division
in FDA’s Center for Drug Evaluation and
Research (CDER) or the Center for
Biologics Evaluation and Research
(CBER) of an intent to request special
protocol assessment at least 30 days
prior to submitting the request. With
such notification, the sponsor should
submit relevant background information
so that the Agency may review reference
material related to carcinogenicity
protocol design prior to receiving the
carcinogenicity protocol.
Request for Special Protocol Assessment
emcdonald on DSK2BSOYB1PROD with NOTICES
The guidance asks that a request for
special protocol assessment be
submitted as an amendment to the
investigational new drug application
(IND) for the underlying product and
that it be submitted to the Agency in
triplicate with Form FDA 1571 attached.
The guidance also suggests that the
sponsor submit the cover letter to a
request for special protocol assessment
via facsimile to the appropriate division
in CDER or CBER. Agency regulations
(21 CFR 312.23(d)) state that
information provided to the Agency as
part of an IND is to be submitted in
triplicate and with the appropriate cover
form, Form FDA 1571. An IND is
submitted to FDA under existing
regulations in part 312 (21 CFR part
312), which specifies the information
that manufacturers must submit so that
FDA may properly evaluate the safety
and effectiveness of investigational
drugs and biological products. The
information collection requirements
resulting from the preparation and
submission of an IND under part 312
have been estimated by FDA and the
reporting and recordkeeping burden has
been approved by OMB under OMB
control number 0910–0014.
FDA suggests that the cover letter to
the request for special protocol
assessment be submitted via facsimile to
the appropriate division in CDER or
CBER to enable Agency staff to prepare
for the arrival of the protocol for
assessment. The Agency recommends
that a request for special protocol
assessment be submitted as an
amendment to an IND for two reasons:
(1)To ensure that each request is kept in
the administrative file with the entire
IND and (2) to ensure that pertinent
information about the request is entered
into the appropriate tracking databases.
Use of the information in the Agency’s
tracking databases enables the
appropriate Agency official to monitor
progress on the evaluation of the
protocol and to ensure that appropriate
steps will be taken in a timely manner.
The guidance recommends that the
following information should be
submitted to the appropriate Center
with each request for special protocol
assessment so that the Center may
quickly and efficiently respond to the
request:
• Questions to the Agency concerning
specific issues regarding the protocol;
and
• All data, assumptions, and
information needed to permit an
adequate evaluation of the protocol,
including: (1) The role of the study in
the overall development of the drug; (2)
information supporting the proposed
trial, including power calculations, the
choice of study endpoints, and other
critical design features; (3) regulatory
outcomes that could be supported by
the results of the study; (4) final labeling
that could be supported by the results
of the study; and (5) for a stability
protocol, product characterization and
relevant manufacturing data.
Description of Respondents: A
sponsor, applicant, or manufacturer of a
drug or biologic product regulated by
the Agency under the Federal Food,
Drug, and Cosmetic Act or section 351
of the Public Health Service Act (42
U.S.C. 262) who requests special
protocol assessment.
Burden Estimate: Table 1 of this
document provides an estimate of the
annual reporting burden for requests for
special protocol assessment.
Notification for a Carcinogenicity
Protocol. Based on data collected within
CDER and CBER, including the number
of notifications for carcinogenicity
protocols and the number of
carcinogenicity protocols submitted in
fiscal years (FY) 2007, 2008, and 2009,
CDER estimates that it will receive
approximately 60 notifications of an
intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately 28
sponsors. CBER estimates that it will
receive approximately one notification
of an intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately one
sponsor. The hours per response, which
is the estimated number of hours that a
sponsor would spend preparing the
notification and background
information to be submitted in
accordance with the guidance, is
estimated to be approximately 8 hours.
Requests for Special Protocol
Assessment. Based on data collected
within CDER and CBER, including the
number of requests for special protocol
assessment submitted in FY 2007, 2008,
and 2009, CDER estimates that it will
receive approximately 372 requests for
special protocol assessment per year
from approximately 216 sponsors. CBER
estimates that it will receive
approximately 10 requests from
approximately 10 sponsors. The hours
per response is the estimated number of
hours that a respondent would spend
preparing the information to be
submitted with a request for special
protocol assessment, including the time
it takes to gather and copy questions to
be posed to the Agency regarding the
protocol and data, assumptions, and
information needed to permit an
adequate evaluation of the protocol.
Based on the Agency’s experience with
these submissions, FDA estimates
approximately 15 hours on average
would be needed per response.
In the Federal Register of July 13,
2010 (75 FR 39949), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
Notification for Carcinogenicity Protocols ................................
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Annual
frequency per
response
29
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Total annual
responses
2.10
E:\FR\FM\26OCN1.SGM
61
26OCN1
Hours per
response
Total hours
8
488
65638
Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of
respondents
Requests for Special Protocol Assessment ............................
Annual
frequency per
response
226
Total annual
responses
1.69
Hours per
response
382
Total hours
15
Total ..................................................................................
1 There
[FR Doc. 2010–26985 Filed 10–25–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Award of a Single-source Program
Expansion Supplement Grant to the
Research Foundation of the State
University of New York (SUNY) at
Albany, NY, for the National Child
Welfare Workforce Institute (NCWWI)
Children’s Bureau, ACYF, ACF,
HHS.
emcdonald on DSK2BSOYB1PROD with NOTICES
ACTION:
6,218
are no capital costs or operating and maintenance costs associated with this collection.
Dated: October 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
5,730
Notice.
CFDA Number: 93.648.
Legislative Authority: Section
426(a)(1)(C) of the Social Security Act,
as amended [42 U.S.C. 626(a)(1)(C)].
Amount of Award: $480,000.
Project Period: September 30, 2010
through September 29, 2011.
Summary: The Administration for
Children and Families (ACF), Children’s
Bureau (CB) announces the award of a
single-source program expansion
supplement grant to the Research
Foundation at the State University of
New York (SUNY) at Albany, National
Child Welfare Workforce Institute
(NCWWI), Albany, NY, to support
additional Bachelor’s of Social Work
(BSW) and Master’s of Social Work
(MSW) traineeship programs at three
universities.
The NCWWI was awarded a
cooperative agreement in FY 2008 as the
result of a competition. Under the
cooperative agreement, NCWWI
identifies promising practices in child
welfare workforce development,
identifies and facilitates leadership
training for middle managers and child
welfare supervisors, administers BSW
and MSW traineeships at multiple
universities, engages national peer
networks, supports strategic
dissemination of effective and
promising workforce practices, and
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18:09 Oct 25, 2010
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advances knowledge through
collaboration and evaluation.
As part of the program, NCWWI
provides stipend to public and/or nonprofit institutions of higher education
with accredited social work education
programs for traineeships for
professional education for current or
prospective child welfare practitioners
enrolled in BSW or MSW social work
programs. During the course of
traineeship and after obtaining the
degree for which the stipend was
awarded, stipend recipients must
participate in regular training at a child
welfare agency and work for a child
welfare agency for a period that is
equivalent to the period of the
supported traineeship.
The three programs to be awarded
traineeships with the expansion
supplement award are:
Northeastern State University,
Tahlequah, OK. This program provides
for a child welfare specialization at the
BSW level. Students are recruited from
American Indian Tribes for work in
Tribal child welfare agencies.
University of South Dakota,
Vermillion, SD. The BSW program
includes a special emphasis on serving
rural and Native American populations.
Distance education is being used to
reach remote geographic areas.
New Mexico State University, Las
Cruces, NM. This combined BSW and
MSW program is selecting trainees that
are sensitive to Hispanic/Chicano
heritage and are Spanish speaking. With
special field instructors who can
address child welfare skills, Hispanic
culture, and the Spanish language, this
project is serving an overrepresented
population in the child welfare system.
Contact for Further Information: Jane
Morgan, Children’s Bureau, 1250
Maryland Avenue, SW., Washington,
DC 20024. Telephone: 202–205–8807. Email: jane.morgan@acf.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 14, 2010.
Bryan Samuels,
Commissioner, Administration on Children,
Youth and Families.
Dated: October 20, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–26936 Filed 10–25–10; 8:45 am]
[FR Doc. 2010–27040 Filed 10–25–10; 8:45 am]
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National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Auditory Neuroscience.
Date: October 27, 2010.
Time: 2:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: John Bishop, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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]]>Agencies
[Federal Register Volume 75, Number 206 (Tuesday, October 26, 2010)]
[Notices]
[Pages 65636-65638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26985]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0541]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Special Protocol Assessment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 26, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0470.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Special Protocol Assessment--OMB Control
Number 0910-0470--Extension
The ``Guidance for Industry on Special Protocol Assessment''
describes Agency procedures to evaluate issues related to the adequacy
(e.g., design, conduct, analysis) of certain proposed studies. The
guidance describes procedures for sponsors to request special protocol
assessment and for the Agency to act on such requests. The guidance
provides information on how the Agency interprets and applies
provisions of the Food and Drug Administration
[[Page 65637]]
Modernization Act of 1997 and the specific Prescription Drug User Fee
Act of 1992 (PDUFA) goals for special protocol assessment associated
with the development and review of PDUFA products. The guidance
describes the following two collections of information: (1) The
submission of a notice of intent to request special protocol assessment
of a carcinogenicity protocol and (2) the submission of a request for
special protocol assessment.
Notification for a Carcinogenicity Protocol
As described in the guidance, a sponsor interested in Agency
assessment of a carcinogenicity protocol should notify the appropriate
division in FDA's Center for Drug Evaluation and Research (CDER) or the
Center for Biologics Evaluation and Research (CBER) of an intent to
request special protocol assessment at least 30 days prior to
submitting the request. With such notification, the sponsor should
submit relevant background information so that the Agency may review
reference material related to carcinogenicity protocol design prior to
receiving the carcinogenicity protocol.
Request for Special Protocol Assessment
The guidance asks that a request for special protocol assessment be
submitted as an amendment to the investigational new drug application
(IND) for the underlying product and that it be submitted to the Agency
in triplicate with Form FDA 1571 attached. The guidance also suggests
that the sponsor submit the cover letter to a request for special
protocol assessment via facsimile to the appropriate division in CDER
or CBER. Agency regulations (21 CFR 312.23(d)) state that information
provided to the Agency as part of an IND is to be submitted in
triplicate and with the appropriate cover form, Form FDA 1571. An IND
is submitted to FDA under existing regulations in part 312 (21 CFR part
312), which specifies the information that manufacturers must submit so
that FDA may properly evaluate the safety and effectiveness of
investigational drugs and biological products. The information
collection requirements resulting from the preparation and submission
of an IND under part 312 have been estimated by FDA and the reporting
and recordkeeping burden has been approved by OMB under OMB control
number 0910-0014.
FDA suggests that the cover letter to the request for special
protocol assessment be submitted via facsimile to the appropriate
division in CDER or CBER to enable Agency staff to prepare for the
arrival of the protocol for assessment. The Agency recommends that a
request for special protocol assessment be submitted as an amendment to
an IND for two reasons: (1)To ensure that each request is kept in the
administrative file with the entire IND and (2) to ensure that
pertinent information about the request is entered into the appropriate
tracking databases. Use of the information in the Agency's tracking
databases enables the appropriate Agency official to monitor progress
on the evaluation of the protocol and to ensure that appropriate steps
will be taken in a timely manner.
The guidance recommends that the following information should be
submitted to the appropriate Center with each request for special
protocol assessment so that the Center may quickly and efficiently
respond to the request:
Questions to the Agency concerning specific issues
regarding the protocol; and
All data, assumptions, and information needed to permit an
adequate evaluation of the protocol, including: (1) The role of the
study in the overall development of the drug; (2) information
supporting the proposed trial, including power calculations, the choice
of study endpoints, and other critical design features; (3) regulatory
outcomes that could be supported by the results of the study; (4) final
labeling that could be supported by the results of the study; and (5)
for a stability protocol, product characterization and relevant
manufacturing data.
Description of Respondents: A sponsor, applicant, or manufacturer
of a drug or biologic product regulated by the Agency under the Federal
Food, Drug, and Cosmetic Act or section 351 of the Public Health
Service Act (42 U.S.C. 262) who requests special protocol assessment.
Burden Estimate: Table 1 of this document provides an estimate of
the annual reporting burden for requests for special protocol
assessment.
Notification for a Carcinogenicity Protocol. Based on data
collected within CDER and CBER, including the number of notifications
for carcinogenicity protocols and the number of carcinogenicity
protocols submitted in fiscal years (FY) 2007, 2008, and 2009, CDER
estimates that it will receive approximately 60 notifications of an
intent to request special protocol assessment of a carcinogenicity
protocol per year from approximately 28 sponsors. CBER estimates that
it will receive approximately one notification of an intent to request
special protocol assessment of a carcinogenicity protocol per year from
approximately one sponsor. The hours per response, which is the
estimated number of hours that a sponsor would spend preparing the
notification and background information to be submitted in accordance
with the guidance, is estimated to be approximately 8 hours.
Requests for Special Protocol Assessment. Based on data collected
within CDER and CBER, including the number of requests for special
protocol assessment submitted in FY 2007, 2008, and 2009, CDER
estimates that it will receive approximately 372 requests for special
protocol assessment per year from approximately 216 sponsors. CBER
estimates that it will receive approximately 10 requests from
approximately 10 sponsors. The hours per response is the estimated
number of hours that a respondent would spend preparing the information
to be submitted with a request for special protocol assessment,
including the time it takes to gather and copy questions to be posed to
the Agency regarding the protocol and data, assumptions, and
information needed to permit an adequate evaluation of the protocol.
Based on the Agency's experience with these submissions, FDA estimates
approximately 15 hours on average would be needed per response.
In the Federal Register of July 13, 2010 (75 FR 39949), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
FDA estimates the burden of this collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
No. of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity 29 2.10 61 8 488
Protocols.........................
[[Page 65638]]
Requests for Special Protocol 226 1.69 382 15 5,730
Assessment........................
----------------------------------------------------------------------------
Total.......................... .............. .............. .............. .............. 6,218
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Dated: October 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26985 Filed 10-25-10; 8:45 am]
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