Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile, 26867-26869 [E9-13041]
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26867
Federal Register / Vol. 74, No. 106 / Thursday, June 4, 2009 / Notices
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The health burden of Intimate Partner
Violence (IPV), Sexual Violence (SV)
and stalking are substantial.
Approximately 1.5 million women and
834,700 men are raped and/or
physically assaulted by an intimate
partner each year. Women are more
likely than men to be victimized by
almost every type of IPV, including
rape, physical assault, and stalking by a
current or former intimate partner. The
health care costs of IPV exceed $5.8
billion each year, nearly $3.9 billion of
which is for direct medical and mental
health care services.
SV also has a profound and long-term
impact on the physical and mental
health of the victim. Existing estimates
of lifetime experiences of rape range
from 15% to 36% for females. Sexual
violence against men, although less
prevalent, is also a public health
problem; approximately, 1 in 6 women
and 1 in 33 men have experienced an
attempted or completed rape in their
lifetime. Over 302,000 women and
92,000 men were raped in the past 12
months. Thirty percent of rape victims
experience major depressions at some
time in their lives; 33% of victimized
women and 24.2% of victimized men
are counseled by a health professional;
31% develop post traumatic stress
disorder; 33% contemplate suicide; and
13% attempt suicide.
Each year, approximately 1 million
women and 371,000 men in the United
States are stalked. There is a strong link
between stalking and other forms of
violence in intimate relationships; 81%
of women who were stalked by a current
or former intimate partner were also
physically assaulted by that partner and
31% were sexually assaulted by that
partner. Furthermore, 76% of female
victims of intimate partner homicides
were stalked by their partners before
they were killed.
Currently, the United States lacks a
national data source that systematically
and routinely collects valid and reliable
information on the magnitude and
trends in IPV, SV and stalking. Such a
system is needed to (1) help formulate
public policies and prevention strategies
related to IPV, SV and stalking; (2) guide
and evaluate progress in reducing the
huge health and social burden
associated with IPV, SV and stalking;
and (3) improve the effectiveness of
federal agencies responding to IPV, SV
and stalking.
In order to address this important
public health problem, CDC plans to
develop a national surveillance system
that will generate national and state
level estimates of IPV, SV and stalking.
A total of 73,318 eligible households
will be screened; out of the households
screened approximately 38,318 will not
consent or agree to participate and
35,000 will complete the survey each
year. The survey will be conducted
among English and/or Spanish speaking
male and female adults (18 years and
older) living in the United States.
There are no costs to respondents
other than their time. The total
estimated annual burden hours are
18,249.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
Type of respondent
Form name
Households .....................................................
Screened ........................................................
Surveyed ........................................................
Dated: May 28, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–13044 Filed 6–3–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0246]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining a List of U.S. Dairy
Product Manufacturers/Processors
With Interest in Exporting to Chile
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
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information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the guidance document entitled
‘‘Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/
Processors With Interest in Exporting to
Chile.’’
DATES: Submit written or electronic
comments on the collection of
information by August 3, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
73,318
35,000
Number of responses per
respondent
1
1
Average
burden per
response
(in hours)
3/60
25/60
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
E:\FR\FM\04JNN1.SGM
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Federal Register / Vol. 74, No. 106 / Thursday, June 4, 2009 / Notices
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/
Processors With Interest in Exporting to
Chile (OMB Control Number 0910–
0509)—Extension
As a direct result of discussions that
have been adjunct to the U.S./Chile Free
Trade Agreement, Chile has recognized
FDA as the competent U.S. food safety
authority and has accepted the U.S.
regulatory system for dairy inspections.
Chile has concluded that it will not
require individual inspections of U.S.
firms by Chile as a prerequisite for
trade, but will accept firms identified by
FDA as eligible to export to Chile.
Therefore, in the Federal Register of
June 22, 2005 (70 FR 36190), FDA
announced the availability of a revised
guidance document entitled
‘‘Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/
Processors With Interest in Exporting to
Chile.’’ The guidance can be found at
https://www.cfsan.fda.gov/
guidance.html. The guidance document
explains that FDA has established a list
that is provided to the Government of
Chile and posted on https://
www.cfsan.fda.gov/~comm/
expcllst.html, which identifies U.S.
dairy product manufacturers/processors
that have expressed interest to FDA in
exporting dairy products to Chile, are
subject to FDA jurisdiction, and are not
the subject of a pending judicial
enforcement action (i.e., an injunction
or seizure) or a pending warning letter.
The term ‘‘dairy products,’’ for purposes
of this list, is not intended to cover the
raw agricultural commodity raw milk.
Application for inclusion on the list is
voluntary. However, Chile has advised
that dairy products from firms not on
this list could be delayed or prevented
by Chilean authorities from entering
commerce in Chile. The guidance
explains what information firms should
submit to FDA in order to be considered
for inclusion on the list and what
criteria FDA intends to use to determine
eligibility for placement on the list. The
document also explains how FDA
intends to update the list and how FDA
intends to communicate any new
information to Chile. Finally, the
guidance notes that FDA considers the
information on this list, which is
provided voluntarily with the
understanding that it will be posted on
FDA’s Web site and communicated to,
and possibly further disseminated by,
Chile, to be information that is not
protected from disclosure under 5
U.S.C. 552(b)(4). Under the guidance,
FDA recommends that U.S. firms that
want to be placed on the list send the
following information to FDA: (1) Name
and address of the firm and the
manufacturing plant; (2) name,
telephone number, and e-mail address
(if available) of the contact person; (3)
a list of products presently shipped and
expected to be shipped in the next 3
years; (4) identities of agencies that
inspect the plant and the date of last
inspection; (5) plant number and copy
of last inspection notice; and, (6) if other
than an FDA inspection, a copy of last
inspection report. FDA requests that this
information be updated every 2 years.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
New written requests to be
placed on the list
15
1
15
1.5
23
Biannual update
88
1
88
1.0
88
Occasional updates
25
1
25
0.5
13
Total
1 There
124
are no capital or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms
that will submit new written requests to
be placed on the list, biannual updates
and occasional updates is based on the
FDA’s experience maintaining the list
over the past 4 years. The estimate of
the number of hours that it will take a
firm to gather the information needed to
be placed on the list or update its
information is based on FDA’s
experience with firms submitting
similar requests. FDA believes that the
information to be submitted will be
readily available to the firms.
To date, over 175 producers have
sought to be included on the list. FDA
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estimates that, each year, approximately
15 new firms will apply to be added to
the list. We estimate that a firm will
require 1.5 hours to read the guidance,
to gather the information needed, and to
prepare a communication to FDA that
contains the information and requests
that the firm be placed on the list for a
total of 22.5 hours, rounded to 23.
Under the guidance, every 2 years each
producer on the list must provide
updated information in order to remain
on the list. FDA estimates that each year
approximately half of the firms on the
list, 88 firms (175 × 0.5 = 87.5, rounded
to 88), will resubmit the information to
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
remain on the list. We estimate that a
firm already on the list will require 1.0
hours to biannually update and
resubmit the information to FDA,
including time reviewing the
information and corresponding with
FDA, for a total of 88 hours. In addition,
FDA expects that, each year,
approximately 25 firms will need to
submit an occasional update and each
firm will require 0.5 hours to prepare a
communication to FDA reporting the
change, for a total of 12.5 hours,
rounded to 13.
E:\FR\FM\04JNN1.SGM
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26869
Federal Register / Vol. 74, No. 106 / Thursday, June 4, 2009 / Notices
Dated: May 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–13041 Filed 6–3–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Emergency Contingency Fund
for Temporary Assistance for Needy
Families (TANF) Programs.
OMB No.: New Collection.
Description: On February 17, 2009,
the President signed the American
Recovery and Reinvestment Act of 2009
(Recovery Act), which establishes the
Emergency Contingency Fund for State
TANF Programs (Emergency Fund) as
section 403(c) of the Social Security Act
(the Act). This legislation provides up to
$5 billion to help States, Territories, and
Tribes in fiscal year (FY) 2009 and FY
2010 that have an increase in assistance
caseloads and basic assistance
expenditures, or in expenditures related
to short-term benefits or subsidized
employment. The Recovery Act made
additional changes to TANF—extending
supplemental grants through FY 2010,
expanding flexibility in the use of TANF
funds carried over from one fiscal year
to the next, and adding a hold-harmless
provision to the caseload reduction
credit for States and Territories serving
more TANF families.
The Emergency Fund is intended to
build upon and renew the principles of
work and responsibility that underlie
successful welfare reform initiatives.
The Emergency Fund provides
resources to States, Territories, and
Tribes to support work and families
during this difficult economic period.
We plan to issue a Program
Instruction accompanied by the
Emergency Fund Request Form (OFA–
100), and instructions for jurisdictions
to complete the OFA–100 to apply for
emergency funds.
Failure to collect this data would
compromise ACF’s ability to monitor
caseload and expenditure data that must
increase in order for jurisdictions to
receive awards under the Emergency
Fund.
Documentation maintenance on
financial reporting for the Emergency
Fund is governed by 45 CFR 92.20 and
45 CFR 92.42.
Respondents: State, Territory, and
Tribal agencies administering the
Temporary Assistance for Needy
Families (TANF) Program that are
applying for the Emergency Fund.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
per respondent
Average
burden hours
per response
Total
burden hours
TANF Emergency Fund Request Form, OFA–100 .......................................
93
5
24
11,160
Estimated Total Annual Burden
Hours: 11,160.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
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15:16 Jun 03, 2009
Jkt 217001
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: June 1, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–13017 Filed 6–3–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meetings
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 meetings.
The meetings 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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences, Special Emphasis
Panel; Minority Biomedical Research
Support.
Date: June 25–26, 2009.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency-Bethesda, One
Bethesda Metro Center, Bethesda, MD 20814.
Contact Person: John J. Laffan, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18J, Bethesda,
MD 20892, 301–594–2773,
laffanjo@mail.nih.gov.
Name of Committee: National Institute of
General Medical Sciences, Special Emphasis
Panel; ARRA Wound Healing Grant
Applications.
Date: July 1, 2009.
Time: 3 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3AN12, 45 Center
Drive, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Meredith D. TempleO’Connor, PhD, Scientific Review Officer,
Office of Scientific Review, National Institute
of General Medical Sciences, National
E:\FR\FM\04JNN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 106 (Thursday, June 4, 2009)]
[Notices]
[Pages 26867-26869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13041]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0246]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Establishing and Maintaining a List of U.S. Dairy
Product Manufacturers/Processors With Interest in Exporting to Chile
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the guidance document entitled ``Establishing and
Maintaining a List of U.S. Dairy Product Manufacturers/Processors With
Interest in Exporting to Chile.''
DATES: Submit written or electronic comments on the collection of
information by August 3, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB
[[Page 26868]]
for approval. To comply with this requirement, FDA is publishing notice
of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Establishing and Maintaining a List of U.S. Dairy Product
Manufacturers/Processors With Interest in Exporting to Chile (OMB
Control Number 0910-0509)--Extension
As a direct result of discussions that have been adjunct to the
U.S./Chile Free Trade Agreement, Chile has recognized FDA as the
competent U.S. food safety authority and has accepted the U.S.
regulatory system for dairy inspections. Chile has concluded that it
will not require individual inspections of U.S. firms by Chile as a
prerequisite for trade, but will accept firms identified by FDA as
eligible to export to Chile. Therefore, in the Federal Register of June
22, 2005 (70 FR 36190), FDA announced the availability of a revised
guidance document entitled ``Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/Processors With Interest in Exporting
to Chile.'' The guidance can be found at https://www.cfsan.fda.gov/guidance.html. The guidance document explains that FDA has established
a list that is provided to the Government of Chile and posted on http:/
/www.cfsan.fda.gov/~comm/expcllst.html, which identifies U.S. dairy
product manufacturers/processors that have expressed interest to FDA in
exporting dairy products to Chile, are subject to FDA jurisdiction, and
are not the subject of a pending judicial enforcement action (i.e., an
injunction or seizure) or a pending warning letter. The term ``dairy
products,'' for purposes of this list, is not intended to cover the raw
agricultural commodity raw milk. Application for inclusion on the list
is voluntary. However, Chile has advised that dairy products from firms
not on this list could be delayed or prevented by Chilean authorities
from entering commerce in Chile. The guidance explains what information
firms should submit to FDA in order to be considered for inclusion on
the list and what criteria FDA intends to use to determine eligibility
for placement on the list. The document also explains how FDA intends
to update the list and how FDA intends to communicate any new
information to Chile. Finally, the guidance notes that FDA considers
the information on this list, which is provided voluntarily with the
understanding that it will be posted on FDA's Web site and communicated
to, and possibly further disseminated by, Chile, to be information that
is not protected from disclosure under 5 U.S.C. 552(b)(4). Under the
guidance, FDA recommends that U.S. firms that want to be placed on the
list send the following information to FDA: (1) Name and address of the
firm and the manufacturing plant; (2) name, telephone number, and e-
mail address (if available) of the contact person; (3) a list of
products presently shipped and expected to be shipped in the next 3
years; (4) identities of agencies that inspect the plant and the date
of last inspection; (5) plant number and copy of last inspection
notice; and, (6) if other than an FDA inspection, a copy of last
inspection report. FDA requests that this information be updated every
2 years.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
New written 15 1 15 1.5 23
requests to
be placed on
the list
----------------------------------------------------------------------------------------------------------------
Biannual 88 1 88 1.0 88
update
----------------------------------------------------------------------------------------------------------------
Occasional 25 1 25 0.5 13
updates
----------------------------------------------------------------------------------------------------------------
Total 124
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms that will submit new written
requests to be placed on the list, biannual updates and occasional
updates is based on the FDA's experience maintaining the list over the
past 4 years. The estimate of the number of hours that it will take a
firm to gather the information needed to be placed on the list or
update its information is based on FDA's experience with firms
submitting similar requests. FDA believes that the information to be
submitted will be readily available to the firms.
To date, over 175 producers have sought to be included on the list.
FDA estimates that, each year, approximately 15 new firms will apply to
be added to the list. We estimate that a firm will require 1.5 hours to
read the guidance, to gather the information needed, and to prepare a
communication to FDA that contains the information and requests that
the firm be placed on the list for a total of 22.5 hours, rounded to
23. Under the guidance, every 2 years each producer on the list must
provide updated information in order to remain on the list. FDA
estimates that each year approximately half of the firms on the list,
88 firms (175 x 0.5 = 87.5, rounded to 88), will resubmit the
information to remain on the list. We estimate that a firm already on
the list will require 1.0 hours to biannually update and resubmit the
information to FDA, including time reviewing the information and
corresponding with FDA, for a total of 88 hours. In addition, FDA
expects that, each year, approximately 25 firms will need to submit an
occasional update and each firm will require 0.5 hours to prepare a
communication to FDA reporting the change, for a total of 12.5 hours,
rounded to 13.
[[Page 26869]]
Dated: May 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13041 Filed 6-3-09; 8:45 am]
BILLING CODE 4160-01-S
