Sorn

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Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Notices
are suitable for detecting melamine
contamination in at-risk components
down to 2.5 parts per million (ppm) to
give a high degree of assurance that they
are not contaminated. At this time, FDA
has not established an appropriate level
of melamine in drug products.
As explained in detail in the
guidance, there have been repeated
instances of melamine contamination in
food articles, including in the U.S.
market. In 2007, FDA learned that
certain pet foods were sickening and
killing cats and dogs. In September
2008, FDA received reports of
melamine-contaminated infant formula
in China. These two incidents share the
following similarities:
• Melamine, a nitrogen-based
compound, was apparently added to
bolster the apparent protein content in
foods or in ingredients used in
processed food products intended to
contain protein.
• The recipients of the ingredients
using a test for nitrogen content would
not have been able to distinguish
between melamine and the desired
protein.
• Melamine contamination became
public only after numerous adverse
health events, including deaths, were
reported and associated with the use of
contaminated products.
These incidents illustrate the
potential for drug components to be
contaminated with melamine; therefore,
it is important for drug manufacturers to
be diligent in assuring that no
component used in the manufacture of
any drug is contaminated with
melamine. As of the date of this
guidance, FDA is not aware of any
pharmaceuticals that are contaminated
with melamine. However, because of the
potential risk of drug contamination, it
is important that manufacturers take
steps to ensure that susceptible
components are not contaminated with
melamine.
We are issuing this level 1 guidance
for immediate implementation,
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The agency is not seeking comment
before implementing this guidance
because of the potential for a serious
public health impact if melaminecontaminated pharmaceuticals were to
enter the domestic market. The
guidance represents the agency’s current
thinking on this issue. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.

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II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at http://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, http://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm, or
http://www.regulations.gov.
Dated: July 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18952 Filed 8–6–09; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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: Environmental Health
Sciences Review Committee.
Date: August 25–26, 2009.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Chapel Hill Hotel, One
Europa Drive, Chapel Hill, NC 27517.

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Dated: August 3, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–18993 Filed 8–6–09; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket Number DHS–2008–0159]

Privacy Act of 1974; DHS/FEMA–004
Grant Management Information Files
System of Records
ACTION:

National Institute of Environmental
Health Sciences; Notice of Closed
Meeting

Frm 00101

Contact Person: Linda K Bass, PhD,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research and Training, Nat’l Institute of
Environmental Health Sciences, P.O. Box
12233, MD EC–30, Research Triangle Park,
NC 27709, (919) 541–1307.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)

Privacy Office; DHS.
Notice of Privacy Act system of

AGENCY:

National Institutes of Health

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39705

records.
SUMMARY: In accordance with the
Privacy Act of 1974, the Department of
Homeland Security is giving notice that
it proposes to consolidate into one new
system its inventory of record systems
entitled, Federal Emergency
Management Agency Grant Management
Information Files. This system will
enable the Department of Homeland
Security to better administer the Federal
Emergency Management Agency
Disaster Recovery Assistance Program.
Many Federal Emergency Management
Agency grant programs collect a
minimum amount of contact and grant
project proposal information. The
information contained in the Federal
Emergency Management Agency’s Grant
Management Information Files is
collected in order to determine awards
for both disaster and non disaster grants
and for the issuance of awarded funds.
DATES: The established system of
records will be effective September 8,
2009. Written comments must be
submitted on or before September 8,
2009.

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Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Notices

You may submit comments,
identified by DHS–2008–0159 by one of
the following methods:
• Federal e-Rulemaking Portal:
http://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 703–483–2999.
• Mail: Mary Ellen Callahan, Chief
Privacy Officer, Privacy Office,
Department of Homeland Security,
Washington, DC 20528.
• Instructions: All submissions
received must include the agency name
and docket number for this rulemaking.
All comments received will be posted
without change to http://
www.regulations.gov, including any
personal information, such as email
address, provided.
• Docket: For access to the docket to
read background documents or
comments received go to http://
www.regulations.gov.
ADDRESSES:

For
general questions please contact: Alisa
Turner (202–646–3102), Branch Chief,
Disclosure Office, Federal Emergency
Management Agency, Washington, DC
20472. For privacy issues please
contact: Mary Ellen Callahan (703–235–
0780), Chief Privacy Officer, Privacy
Office, U.S. Department of Homeland
Security, Washington, DC 20528.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:

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I. Background
The goal of FEMA’s grant programs is
to provide funding to enhance the
capacity of state and local jurisdictions
to prevent, respond to, and recover from
disaster and non disaster incidents
including cyber attacks. FEMA’s grant
programs currently provide funds to all
50 states, the District of Columbia, the
Commonwealth of Puerto Rico,
American Samoa, the Commonwealth of
Northern Mariana Islands, Guam, and
the U.S. Virgin Islands. FEMA grant
programs are directed at a broad
spectrum of state and local emergency
responders, including firefighters,
emergency medical services, emergency
management agencies, law enforcement,
and public officials. The source of the
information that FEMA is collecting
generally comes from state, local, and
tribal partners seeking grant funding.
Additional sources of information may
include private and non private
organizations. The nature of the
collected data should illustrate
organizations’ familiarity with the
national preparedness architecture (i.e.
Federal Investment Strategy), identify
how elements of this architecture have
been incorporated into their regional/
state/local planning, operations, and

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investments, and the demonstrated need
for the grant funds.
Many of FEMA’s grant programs
implement objectives addressed in a
series of post-9/11 laws, strategy
documents, plans, and Homeland
Security Presidential Directives
(HSPDs). FEMA management
requirements are incorporated into the
application processes and reflect
changes mandated in the Implementing
Recommendations of the 9/11
Commission Act of 2007 (the ‘‘9/11
Act’’), enacted in August 2007, as well
as the FY 2008 Consolidated
Appropriations Act.
Consistent with DHS’s information
sharing mission, information stored in
the Grants Management Information
Files may be shared with other DHS
components, as well as appropriate
federal, state, local, tribal, foreign, or
international government agencies. This
sharing will take place only after DHS
determines that the receiving
component or agency has a need to
know the information to carry out
national security, law enforcement,
immigration, intelligence, or other
functions consistent with the routine
uses set forth in this system of records
notice.
The information contained in the
FEMA Grant Management Information
Files is collected in order to determine
awards for both disaster and nondisaster grants and for the issuance of
awarded funds.
II. Privacy Act
The Privacy Act embodies fair
information principles in a statutory
framework governing the means by
which the United States Government
collects, maintains, uses, and
disseminates personally identifiable
information. The Privacy Act applies to
information that is maintained in a
‘‘system of records.’’ A ‘‘system of
records’’ is a group of any records under
the control of an agency for which
information is retrieved by the name of
an individual or by some identifying
number, symbol, or other identifying
particular assigned to the individual. In
the Privacy Act, an individual is defined
to encompass United States citizens and
legal permanent residents. As a matter
of policy, DHS extends administrative
Privacy Act protections to all
individuals where systems of records
maintain information on U.S. citizens,
lawful permanent residents, and
visitors. Individuals may request access
to their own records that are maintained
in a system of records in the possession
or under the control of DHS by
complying with DHS Privacy Act
regulations, 6 CFR Part 5.

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The Privacy Act requires each agency
to publish in the Federal Register a
description denoting the type and
character of each system of records that
the agency maintains, and the routine
uses that are contained in each system
in order to make agency record keeping
practices transparent, to notify
individuals regarding the uses to which
personally identifiable information is
put, and to assist individuals to more
easily find such files within the agency.
Below is the description of the FEMA
Grants Management Information Files
system of records.
In accordance with 5 U.S.C. 552a(r),
DHS has provided a report of this new
system of records to the Office of
Management and Budget and to
Congress.
SYSTEM OF RECORDS DHS/FEMA–004
SYSTEM NAME:

DHS/FEMA–004 Grant Management
Information Files.
SECURITY CLASSIFICATION:

Unclassified and sensitive.
SYSTEM LOCATION:

Records are maintained at Federal
Emergency Management Agency
Headquarters in Washington, DC and
field offices.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:

Categories of entities covered by this
system include: Recipients (grantees) of
grant funds. These include state,
territorial, tribal officials, port
authorities, transit authorities, nonprofit organizations, and, in rare
instances, private companies.
CATEGORIES OF RECORDS IN THE SYSTEM:

Categories of records in this system
include:
• Organizational Name;
• Employer Identification Number
(EIN);
• Name of Organization’s Designated
Point of Contact (POC);
• POC work address;
• POC work phone number;
• POC cellphone number;
• POC fax number;
• POC work e-mail address;
• Organization’s Bank Routing
Number;
• Organization’s Bank Account
Number; and
• Grant related information.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Legal authority includes, but is not
limited to:
• The Robert T. Stafford Disaster
Relief and Emergency Assistance Act,
42 U.S.C. 5133

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Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Notices
• The National Flood Insurance Act,
42 U.S.C. 4104c
• Section 2003(a) of the Homeland
Security Act of 2002 (6 U.S.C. 101 et
seq.), as amended by Section 101, Title
I of the Implementing
Recommendations of the 9/11
Commission Act of 2007, (Pub. L. 110–
053)
• Section 2004(a) of the Homeland
Security Act of 2002 (6 U.S.C. 101 et
seq.), as amended by Section 101, Title
I of the Implementing
Recommendations of the 9/11
Commission Act of 2007, (Pub. L. 110–
053)
• Section 1809 of the Homeland
Security Act of 2002 (6 U.S.C. 571 et
seq.), as amended by Section 301(a),
Title III of the Implementing
Recommendations of the 9/11
Commission Act of 2007 (Pub. L. 110–
053)
• The Post-Katrina Emergency
Management Reform Act of 2006 (6
U.S.C. 723)
• Title III of Division D of the
Consolidated Security, Disaster
Assistance, and Continuing
Appropriations Act, 2009 (Pub. L. 110–
329)
• Section 614 of the Robert T.
Stafford Disaster Relief and Emergency
Assistance Act (42 U.S.C. 5196c), as
amended by Section 202, Title II of the
Implementing Recommendations of the
9/11 Commission Act of 2007 (Pub. L.
110–053)
• Title III of Division E of the
Consolidated Appropriations Act, 2008
(Pub. L. 110–161)
• Section 1406, Title XIV of the
Implementing Recommendations of the
9/11 Commission Act of 2007 (Pub. L.
110–053)
• Section 1513, Title XV of the
Implementing Recommendations of the
9/11 Commission Act of 2007 (Pub. L.
110–053)
• Section 1532(a), Title XV of the
Implementing Recommendations of the
9/11 Commission Act of 2007 (Pub. L.
110–053)
• 46 U.S.C. 70107
• Federal Financial Assistance
Management Improvement Act of 1999
(Pub. L. 106–107)
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PURPOSE(S):

The purpose of this system is to assist
in determining awards for both disaster
and non-disaster grants and for the
issuance of awarded funds and allow
DHS to contact individuals to ensure
completeness and accuracy of grants
and applications.

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ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:

In addition to those disclosures
generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, all or a
portion of the records or information
contained in this system may be
disclosed outside DHS as a routine use
pursuant to 5 U.S.C. 552a(b)(3) as
follows:
A. To the Department of Justice or
other Federal agency conducting
litigation or in proceedings before any
court, adjudicative or administrative
body, when:
1. DHS or any component thereof;
2. Any employee of DHS in his/her
official capacity;
3. Any employee of DHS in his/her
individual capacity where DOJ or DHS
has agreed to represent the employee; or
4. The United States or any agency
thereof, is a party to the litigation or has
an interest in such litigation, and DHS
determines that the records are both
relevant and necessary to the litigation
and the use of such records is
compatible with the purpose for which
DHS collected the records.
B. To a congressional office from the
record of an individual in response to
an inquiry from that congressional office
made at the request of the individual to
whom the record pertains.
C. To the National Archives and
Records Administration or other Federal
government agencies pursuant to
records management inspections being
conducted under the authority of 44
U.S.C. 2904 and 2906.
D. To an agency, organization, or
individual for the purpose of performing
audit or oversight operations as
authorized by law, but only such
information as is necessary and relevant
to such audit or oversight function.
E. To appropriate agencies, entities,
and persons when:
1. DHS suspects or has confirmed that
the security or confidentiality of
information in the system of records has
been compromised;
2. The Department has determined
that as a result of the suspected or
confirmed compromise there is a risk of
harm to economic or property interests,
identity theft or fraud, or harm to the
security or integrity of this system or
other systems or programs (whether
maintained by DHS or another agency or
entity) that rely upon the compromised
information; and
3. The disclosure made to such
agencies, entities, and persons is
reasonably necessary to assist in
connection with DHS’s efforts to
respond to the suspected or confirmed

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39707

compromise and prevent, minimize, or
remedy such harm.
F. To contractors and their agents,
grantees, experts, consultants, and
others performing or working on a
contract, service, grant, cooperative
agreement, or other assignment for DHS,
when necessary to accomplish an
agency function related to this system of
records. Individuals provided
information under this routine use are
subject to the same Privacy Act
requirements and limitations on
disclosure as are applicable to DHS
officers and employees.
G. To an appropriate Federal, State,
tribal, local, international, or foreign law
enforcement agency or other appropriate
authority charged with investigating or
prosecuting a violation or enforcing or
implementing a law, rule, regulation, or
order, where a record, either on its face
or in conjunction with other
information, indicates a violation or
potential violation of law, which
includes criminal, civil, or regulatory
violations and such disclosure is proper
and consistent with the official duties of
the person making the disclosure.
H. To an individual’s employer or
affiliated organization to the extent
necessary to verify employment or
membership status.
I. To the news media and the public,
with the approval of the Chief Privacy
Officer in consultation with counsel,
when there exists a legitimate public
interest in the disclosure of the
information or when disclosure is
necessary to preserve confidence in the
integrity of DHS or is necessary to
demonstrate the accountability of DHS’s
officers, employees, or individuals
covered by the system, except to the
extent it is determined that release of
the specific information in the context
of a particular case would constitute an
unwarranted invasion of personal
privacy.
DISCLOSURE TO CONSUMER REPORTING
AGENCIES:

None.
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:

Records in this system are stored
electronically or on paper in secure
facilities in a locked drawer behind a
locked door. The records are stored on
magnetic disc, tape, digital media, and
CD–ROM.
RETRIEVABILITY:

Records may be retrieved by name of
organization or contact person covered
by this system.

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SAFEGUARDS:

Records in this system are
safeguarded in accordance with
applicable rules and policies, including
all applicable DHS automated systems
security and access policies. Strict
controls have been imposed to minimize
the risk of compromising the
information that is being stored. Access
to the computer system containing the
records in this system is limited to those
individuals who have a need to know
the information for the performance of
their official duties and who have
appropriate clearances or permissions.
The system maintains a real-time
auditing function of individuals who
access the system. Additional
safeguards may vary by component and
program.
RETENTION AND DISPOSAL:

In accordance with the Federal
records retention requirements, Grant
administrative records and hard copies
of unsuccessful grant applications files
are destroyed when two years old
(Government Records Schedule (GRS)
No. 3, Procurement, Supply, and Grant
Records, Item 14). Electronically
received and processed copies of
unsuccessful grant application files are
destroyed three years after rejection or
withdrawal (GRS No. 3, Procurement,
Supply, and Grant Records, Item 13).
Grant Project Records are maintained for
three years after the end of the fiscal
year that the grant or agreement is
finalized or when no longer needed,
whichever is sooner. These records are
disposed of IAW FEMA Records
Schedule N1–311–95–1, Item 1. Grant
Final Reports are retired to the Federal
Records Center three years after cutoff,
and then transferred to National
Archives 20 years after cutoff. These
records are maintained IAW FEMA
Records Schedule N1–311–95–1, Item 3.
All other grant (both disaster and non
disaster) records are maintained for six
years and three months after the end of
the fiscal year when grant or agreement
is completed or closed. These records
are disposed of according to IAW FEMA
Records Schedule N1–311–95–1, Item 2;
N1–311–01–8, Item 1; and N1–311–04–
1, Item 1.

component’s FOIA Officer, whose
contact information can be found at
http://www.dhs.gov/foia under
‘‘contacts.’’ If an individual believes
more than one component maintains
Privacy Act records concerning him or
her, the individual may submit the
request to the Chief Privacy Officer,
Department of Homeland Security, 245
Murray Drive, SW., STOP–0655,
Washington, DC 20528.
When seeking records about yourself
from this system of records or any other
Departmental system of records, your
request must conform with the Privacy
Act regulations set forth in 6 CFR Part
5. You must first verify your identity,
meaning that you must provide your full
name, current address and date and
place of birth. You must sign your
request, and your signature must either
be notarized or submitted under 28
U.S.C. 1746, a law that permits
statements to be made under penalty of
perjury as a substitute for notarization.
While no specific form is required, you
may obtain forms for this purpose from
the Director, Disclosure and FOIA,
http://www.dhs.gov or 1–866–431–0486.
In addition you should provide the
following:
• An explanation of why you believe
the Department would have information
on you,
• Identify which component(s) of the
Department you believe may have the
information about you,
• Specify when you believe the
records would have been created,
• Provide any other information that
will help the FOIA staff determine
which DHS component agency may
have responsive records,
• If your request is seeking records
pertaining to another living individual,
you must include a statement from that
individual certifying his/her agreement
for you to access his/her records.
Without this bulleted information the
component(s) will not be able to
conduct an effective search, and your
request may be denied due to lack of
specificity or lack of compliance with
applicable regulations.
RECORD ACCESS PROCEDURES:

See ‘‘Notification procedure’’ above.

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SYSTEM MANAGER AND ADDRESS:

Deputy Assistant Administrator,
Grant Program Directorate, FEMA, 500 C
Street, SW., Washington, DC 20472.

CONTESTING RECORD PROCEDURES:

NOTIFICATION PROCEDURE:

Records are obtained by grantees,
applicants for award, and grant program
monitors.

Individuals or entities seeking
notification of and access to any record
contained in this system of records, or
seeking to contest its content, may
submit a request in writing to the

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See ‘‘Notification procedure’’ above.
RECORD SOURCE CATEGORIES:

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BILLING CODE 9110–17–P

DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
Class III Gaming; Tribal Revenue
Allocation Plans; Gaming on Trust
Lands
AGENCY: Bureau of Indian Affairs,
Interior.
ACTION: Notice of submission of
information collection renewal to the
Office of Management and Budget.
SUMMARY: In compliance with the
Paperwork Reduction Act, the Bureau of
Indian Affairs (BIA) is submitting the
following information collections to the
Office of Management and Budget
(OMB) for renewal: Class III Gaming
Procedures 25 CFR 291, 1076–0149;
Tribal Revenue Allocation Plans 25 CFR
290, 1076–0152; and Gaming On Trust
Lands Acquired After October 17, 1988,
25 CFR 292, 1076–0158. The current
approvals for the first two collections
(1076–1049 and 1076–0152) expire
August 31, 2009 and the current
approval for the third collection (1076–
0158) expires February 28, 2010.
Renewal will allow us to continue to
collect the information necessary to
comply with the Indian Gaming
Regulatory Act (IGRA).
DATES: Submit comments on or before
September 8, 2009.
ADDRESSES: Submit comments on the
information collection to the Desk
Officer for the Department of the
Interior, OIRA, Office of Management
and Budget, by fax at (202) 395–5806 or
e-mail at OIRA_DOCKET@ omb.eop.gov.
Please send a copy of your comments
to: Paula L. Hart, Office of Indian
Gaming, Mail Stop 3657–MIB, 1849 C
Street, NW., Washington, DC 20240,
Facsimile: (202) 273–3153.
FOR FURTHER INFORMATION CONTACT: You
may request further information or
obtain copies of the proposed
information collection request from
Paula L. Hart, Telephone: (202) 219–
4066.
SUPPLEMENTARY INFORMATION:

EXEMPTIONS CLAIMED FOR THE SYSTEM:

None.

Dated: July 31, 2009.
Mary Ellen Callahan,
Chief Privacy Officer, Department of
Homeland Security.
[FR Doc. E9–18931 Filed 8–6–09; 8:45 am]

I. Abstract
This information collection is
necessary for the BIA, Office of Indian
Gaming, to ensure that the applicable
requirements for IGRA, 25 U.S.C. 2701

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