Epidemiology Program for American Indian/Alaska Native Tribes and Urban Indian Communities, 33314-33321 [2011-14131]
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TABLE 1—Continued
Application No.
Drug
ANDA 087569 ......................
Hydrocortisone Sodium Succinate for Injection USP,
EQ 1 g (base)/Vial.
Potassium Chloride for Injection Concentrate USP ........
Aminophylline Injection USP, 25 mg/mL ........................
Vitamin K1 (phytonadione injection emulsion USP), 10
mg/mL.
Meperidine HCl Injection USP, 25 mg/mL ......................
Meperidine HCl Injection USP, 50 mg/mL ......................
Meperidine HCl Injection USP, 75 mg/mL ......................
Meperidine HCl Injection USP, 100 mg/mL ....................
Lidocaine HCl Injection USP, 1.5% ................................
Lidocaine HCl Injection USP, 2% ...................................
Lidocaine HCl Injection USP, 20% .................................
Cyclophosphamide for Injection USP, 100 mg/Vial ........
Cyclophosphamide for Injection USP, 200 mg/Vial ........
Cyclophosphamide for Injection USP, 500 mg/Vial ........
Cyclophosphamide for Injection USP, 1 g/Vial ...............
Lidocaine HCl and Epinephrine Injection ........................
Prochlorperazine Edisylate Injection USP, EQ 5 mg
(base)/mL.
Perphenazine Tablets USP, 2 mg ..................................
ANDA 087584 ......................
ANDA 087601 ......................
ANDA 087956 ......................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
088279
088280
088281
088282
088326
088331
088368
088371
088372
088373
088374
089649
089703
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ANDA 089707 ......................
ANDA 090954 ......................
Applicant
Cromolyn Sodium Oral Solution Concentrate, 100 mg/5
mL.
Do.
Luitpold Pharmaceuticals, Inc.
Hospira, Inc.
Do.
Baxter Healthcare Corp.
Do.
Do.
Do.
Hospira, Inc.
Do.
Do.
Baxter Healthcare Corp.
Do.
Do.
Do.
Hospira, Inc.
Do.
Ivax Pharmaceuticals Inc., 400 Chestnut Ridge Rd.,
Woodcliff Lake, NJ 07677.
Pack Pharmaceuticals, LLC, 1110 West Lake Cook
Rd., suite 152, Buffalo Grove, IL 60089.
1 This product was an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer
be used as a propellant for any metaproterenol sulfate or fluticasone propionate metered-dose inhalers (see 75 FR 19213–19241, April 14, 2010;
71 FR 70870–70873, December 7, 2006).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 31, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
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Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of the applications
listed in table 1 of this document, and
all amendments and supplements
thereto, is hereby withdrawn, effective
July 8, 2011. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the FD&C Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in
table 1 of this document that are in
inventory on the date that this notice
becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Statutory Authority
[FR Doc. 2011–14164 Filed 6–7–11; 8:45 am]
BILLING CODE 4160–01–P
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Indian Health Service
Background
Epidemiology Program for American
Indian/Alaska Native Tribes and Urban
Indian Communities
Division of Epidemiology and Disease
Prevention; Epidemiology Program for
American Indian/Alaska Native Tribes
and Urban Indian Communities
Announcement Type: New.
Funding Opportunity Number: HHS–
2011–IHS–EPI–0001.
Catalog of Federal Domestic
Assistance Number: 93.231
DATES: Key Dates:
Application Deadline Date: July 15,
2011;
≤Review Date: August 16–17, 2011;
Anticipated Start Date: September 16,
2011.
I. Funding Opportunity Description
The Indian Health Service (IHS) is
accepting competitive cooperative
agreement applications to establish
Tribal Epidemiology Centers serving
American Indian/Alaska Native (AI/AN)
Tribes and urban Indian communities.
This program is managed by the IHS
Division of Epidemiology and Disease
Prevention (DEDP). This program is
authorized under the Snyder Act, 25
U.S.C. 13, and 25 U.S.C. 1621m of the
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Indian Health Care Improvement Act.
To obtain details regarding eligibility,
please refer to Section III below.
The Tribal Epidemiology Center (TEC)
program was authorized by Congress in
1998 as a way to provide public health
support to multiple Tribes and urban
Indian communities in each of the IHS
Areas. The funding opportunity
announcement is open to eligible
Tribes, Tribal organizations, intertribal
consortia, and urban Indian
organizations, including currently
funded TECs.
TECs are uniquely positioned within
Tribes, Tribal and urban Indian
organizations to conduct disease
surveillance, research, prevention and
control of disease, injury, or disability,
and to assess the effectiveness of AI/AN
public health programs. In addition,
they can fill gaps in data needed for
Government Performance and Results
Act (GPRA) and Healthy People 2020
measures. Some of the existing TECs
have already developed innovative
strategies to monitor the health status of
Tribes and urban Indian communities,
including development of Tribal health
registries and use of sophisticated
record linkage computer software to
correct existing state data sets for racial
misclassification. TECs work in
partnership with IHS DEDP to provide
a more accurate national picture of
Indian health status.
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TECs provide critical support for
activities that promote Tribal selfgovernance and effective management of
Tribal and urban Indian health
programs. Data generated locally and
analyzed by TECs enable Tribes and
urban Indian communities to effectively
plan and make decisions that best meet
the needs of their communities. In
addition, TECs can immediately provide
feedback to local data systems which
will lead to improvements in Indian
health data overall.
As more Tribes choose to operate
health programs in their communities,
TECs ultimately will provide additional
public health services such as disease
control and prevention programs. Some
existing centers provide assistance to
Tribal and urban Indian communities in
such areas as sexually transmitted
disease control and cancer prevention.
They also assist Tribes and urban Indian
communities to establish baseline data
for successfully evaluating intervention
and prevention activities through
activities such as conducting Behavioral
Risk Factor Surveillance Surveys
(BRFSS).
The TEC program will continue to
enhance the ability of the Indian health
system to collect and manage data more
effectively and to better understand and
develop the link between public health
problems and behavior, socioeconomic
conditions, and geography. The TEC
program will also support Tribal and
urban Indian communities by providing
technical training in public health
practice and prevention-oriented
research and by promoting public health
career pathways.
Purpose
The purpose of this cooperative
agreement program is to fund Tribes,
Tribal and urban Indian organizations,
and intertribal consortia to provide
epidemiological support for the AI/AN
population served by IHS. TEC activities
should include, but are not limited to,
enhancement of surveillance for disease
conditions; research, prevention and
control of disease, injury, or disability;
assessment of the effectiveness of AI/AN
public health programs; epidemiologic
analysis, interpretation, and
dissemination of surveillance data;
investigation of disease outbreaks;
development and implementation of
epidemiologic studies; development and
implementation of disease control and
prevention programs; and coordination
of activities of other public health
authorities in the region. It is the intent
of IHS to fund several TECs that will
serve Tribes and urban Indian
communities in all 12 IHS
Administrative Areas.
Each TEC selected for funding will act
under a cooperative agreement with the
IHS. During funded activities, the TECs
may receive Protected Health
Information (PHI) for the purpose of
preventing or controlling disease, injury
or disability, including, but not limited
to, reporting of disease, injury, vital
events, such as birth or death, and the
conduct of public health surveillance,
public health investigation, and public
health interventions for the Tribal and
urban Indian communities that they
serve. TECs acting under a cooperative
agreement with IHS are public health
authorities for which the disclosure of
PHI by covered entities is authorized by
the Privacy Rule. 45 CFR 164.512(b).
To achieve the purpose of this
program, the recipient will be
responsible for the activities under item
number 1. Recipient Activities and IHS
will be responsible for conducting
activities under item number 2. IHS
Activities.
II. Award Information
Type of Award: Cooperative
Agreement.
Estimated Funds Available:
The total amount identified for FY
2011 is approximately $4.5 million.
Competing and continuation awards
issued under this announcement are
subject to the availability of funds. In
the absence of funding, the agency is
under no obligation to fund any awards
under this announcement. The program
will be awarded for five years with 12
months per budget period. Future year
funding levels will be determined based
on availability of funds. The average
award is approximately $350,000 to
$1,000,000, depending on the
applicant’s score and the size of the area
covered by the TEC.
Anticipated Number of Awards:
Approximately 12 awards may be
issued under this program
announcement.
Project Period:
This will be a 5-year project from
September 16, 2011 to September 15,
2016.
Funding Information:
As part of an effort to establish TECs
throughout the nation, these funds will
be used to support activities on an IHS
Area basis. Successful applicants must
agree to provide services for all AI/AN
populations in the respective IHS Area.
Collaborative efforts among Tribal,
local, State, and Federal health
organizations are encouraged.
Funding will be based on scoring
levels from the review process. An
example is outlined below. Detailed
explanations of Review Criteria are
described in Section V.
Total
Points
Review Criteria
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Introduction, Current Capacity, and Need for Assistance ...............................................................................
Program Objectives-Recipient Activities ..........................................................................................................
Program Evaluation .........................................................................................................................................
Organizational Capabilities & Qualification .....................................................................................................
Behavioral Risk Factor Surveillance Surveys .................................................................................................
Budget ..............................................................................................................................................................
Total .................................................................................................................................................................
Cooperative Agreements will be
funded annually during the project
period of five years, contingent on
required continuation applications with
an approved scope of work. Renewals of
cooperative agreements will be based on
the following:
•
• Satisfactory progress.
• Availability of funds.
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• Program priorities of IHS.
Programmatic Involvement:
IHS will have substantial involvement
in all of the TECs (See IHS Activities).
Recipient Activities:
a. Assist and facilitate AI/AN
communities, Tribes, Tribal
organizations, and urban Indian
organizations in identifying Tribal and
urban Indian community health status
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Points
Awarded
25
35
10
10
15
5
100
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priorities for building public health
capacity at the local level based on
epidemiologic data. Assist and facilitate
Tribal and urban Indian communities
with implementing and conducting
disease surveillance, research,
prevention and control of disease,
injury, or disability, to assess the
effectiveness of AI/AN public health
programs, monitoring progress toward
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meeting each of the health status
objectives, developing and
implementing epidemiologic studies
that have practical application in
improving the health status of
constituent communities, reporting of
notifiable disease conditions to public
health authorities and to local Tribes
and urban Indian communities in the
region, and address emerging public
health and epidemiological issues as
identified by Tribal and urban Indian
community priorities.
b. Develop and disseminate health
specific data and Community Health
Profiles (CHPs) based on Tribal and
urban Indian community health status
priorities as follows:
1. Develop CHPs specific for each
Tribal and urban Indian community
entity served by the TEC. Provide a
dissemination plan that includes a
project overview, dissemination goals,
and health indicators.
2. Develop a regional CHP
encompassing all Tribal and urban
Indian communities served by the TEC.
Provide a dissemination plan that
includes a project overview,
dissemination goals, and health
indicators.
3. Participate in the national TEC CHP
Working Group to develop and
implement a national CHP.
c. Recipient will need to maintain
outbreak response capacity by:
1. Establishing and maintaining
relationships with local authorities
(Tribal, County, State, etc.) to be able to
participate in outbreak response
activities on a national or regional
scope.
2. Obligating a minimum of one
program staff per year to attend IHS
training in either the ‘‘Outbreak
Response Review’’ or ‘‘Epidemiology
Ready’’ course.
3. Explaining how recipient will
collaborate and assist in public health
emergencies with the IHS, DEDP, State,
local, County, Tribal, and other Federal
health authorities.
d. Develop a BRFSS project to
evaluate health risk behaviors of AI/AN
populations served by the TEC, to
include, at a minimum, CDC’s ‘‘core’’
BRFSS, as follows:
1. Develop a protocol for conducting
the BRFSS;
2. Develop a sampling method and
recruitment strategy;
3. Meet with the Tribal Health
Director, Health Board, and/or the
Tribal Council, as appropriate, for
review and approval of the BRFSS
project;
4. Obtain IRB approval or exempt
status;
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5. Develop a training protocol for
interviewers for the BRFSS;
6. Develop a database to enter data
collected from the BRFSS;
7. Develop a dissemination plan that
includes a project overview,
dissemination goals, targeted audiences,
key messages, details of the
dissemination plan and how the plan
will be evaluated; and
8. Create a separate budget for the
BRFSS project.
e. Establish a Data Sharing Agreement
(DSA) with the IHS Area Office that
delineates:
1. ‘‘Routine’’ activities for which the
TEC will have access to de-identified
data from IHS Epidemiology Data Mart/
National Data Warehouse (NDW).
2. Activities for which they will need
additional permission such as special
studies or research involving PHI.
3. Language which outlines
compliance with Health Insurance
Portability and Accountability Act
(HIPAA) and Privacy Act protection.
4. Use of the IHS Epidemiology Data
Mart User Tracking System (EDMUTS)
by the recipient to track both #1 and #2
above.
5. Use of security measures,
including:
• How security measures will be in
place for data usage;
• How recipient will be a steward of
the data;
• Completion of the IHS/OIT yearly
security training and security training
required by their respective
organization; and
• An annual report on the outcomes
of TECs access to IHS data.
f. Participate in national public health
priorities and committees, as
appropriate, with additional Department
of Health and Human Services (HHS)
agencies.
g. Explain how recipient will support
the IHS Agency’s priorities:
1. To renew and strengthen our
partnership with Tribes.
2. To bring reform to IHS.
3. To improve the quality of and
access to care.
4. To make all our work accountable,
transparent, fair and inclusive.
You may access information on IHS
priorities via the Internet at the
following Web site: https://www.ihs.gov/
PublicAffairs/DirCorner/index.cfm.
h. Establish an advisory council that
can provide overall program direction
and guidance. The advisory council
should include some members with
technical expertise in epidemiology and
public health (i.e. state health
departments, county health
departments, etc.) and representation
from the Tribal health and urban Indian
health programs served by the TEC.
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i. Provide an annual report (no more
than 10 pages) at the end of each project
year to DEDP.
j. Ensure that TEC staff includes key
personnel with appropriate expertise in
epidemiology, health sciences, and
program management. The TEC must
also demonstrate access to specialized
expertise such as a doctoral level
epidemiologist and/or a biostatistician.
IHS Activities:
a. Provide funded TECs with ongoing
consultation and technical assistance to
plan, implement, and evaluate each
component of the TEC as described
under Recipient Activities above.
Consultation and technical assistance
will include, but not be limited to, the
following areas:
1. Interpretation of current scientific
literature related to epidemiology,
statistics, surveillance, Healthy People
2020 objectives, and other public health
issues;
2. Design and implementation of each
program component such as
surveillance, epidemiologic analysis,
outbreak investigation, development of
epidemiologic studies, development of
disease control programs, and
coordination of activities; and
3. Overall operational planning and
program management.
b. Coordinate all IHS epidemiologic
activities on a national scope including
investigation of disease outbreaks and
CHPs.
c. Conduct site visits to TECs and/or
coordinate TEC visits to IHS to ensure
data security; confirm compliance with
applicable laws and regulations; assess
program activities; and to mutually
resolve problems, as needed.
d. Convene an annual TEC meeting
for information sharing, problem solving
or training.
e. Provide opportunities for training
of TEC staff. Examples include: IHS
Outbreak Response Review course;
Webinars on NDW Technical
Assistance; Introduction to SAS;
Fellowship opportunities.
III. Eligibility Information
1. Eligibility
AI/AN Tribes, Tribal organizations,
and eligible intertribal consortia or
urban Indian organizations as defined
by 25 U.S.C. 1603(e) may be eligible for
a TEC cooperative agreement. Such
entities must represent or serve a
population of at least 60,000 AI/AN to
be eligible as demonstrated by Tribal
resolutions or the equivalent
documentation from urban Indian clinic
directors/Chief Executive Officers
(CEOs). Applicants must describe the
population of AI/ANs and Tribes that
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will be represented. The number of AI/
ANs served must be substantiated by
documentation describing IHS user
populations, United States Census
Bureau data, clinical catchment data, or
any method that is scientifically and
epidemiologically valid. An intertribal
consortium or urban Indian organization
is eligible to receive a cooperative
agreement if it is incorporated for the
primary purpose of improving AI/AN
health, and represents the Tribes, AN
villages, or urban Indian communities
in which it is located. Resolutions from
each Tribe, AN village and equivalent
documentation from each urban Indian
community represented must be
included in the application package.
Collaborations with IHS Areas, Federal
agencies such as the Centers for Disease
Control and Prevention (CDC), State,
academic institutions or other
organizations are encouraged (letters of
support and collaboration should be
included in the application).
Definitions:
Federally-recognized Indian Tribe
means any Indian Tribe, band, nation,
or other organized group or community,
including any Alaska Native village or
group or regional or village corporation
as defined in or established pursuant to
the Alaska Native Claims Settlement Act
(85 Stat. 688) [43 U.S.C. 1601, et seq.],
which is recognized as eligible for the
special programs and services provided
by the United States to Indians because
of their status as Indians. 25 U.S.C. 1603
(d).
Tribal organization means the elected
governing body of any Indian Tribe or
any legally established organization of
Indians which is controlled by one or
more such bodies or by a board of
directors elected or selected by one or
more such bodies or elected by the
Indian population to be served by such
organization and which includes the
maximum participation of Indians in all
phases of its activities. 25 U.S.C.
1603(e).
Urban Indian organization means a
non-profit corporate body situated in an
urban center governed by an urban
Indian controlled board of directors, and
providing for the maximum
participation of all interested Indian
groups and individuals, which body is
capable of legally cooperating with
other public and private entities for the
purpose of performing the activities. 25
U.S.C. 1603(h).
An intertribal consortium or AI/AN
organization is eligible to receive a
cooperative agreement if it is
incorporated for the primary purpose of
improving AI/AN health. Collaborations
with regional IHS, CDC, State and local
health departments, and academic
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institutions are encouraged. Proper
tribal resolutions or equivalent
documentation from urban Indian
organizations is required.
2. Cost Sharing or Matching
DEDP does not require matching
funds or cost sharing.
3. Other Requirements
(a) If an applicant’s budget exceeds
the highest stated award amount that is
outlined within this announcement
($1,000,000.00), that application will
not be considered for funding.
(b) A letter of intent is required (See
section IV(3)).
(c) Tribal Resolution—A resolution of
all Indian Tribes served by the project
must accompany the application
submission. This can be attached to the
electronic application. An Indian Tribe
that is proposing a project with other
Indian Tribes must include resolutions
from all Tribes to be served.
Applications by Tribal organizations
representing multiple Tribes will not
require specific Tribal resolutions if the
current Tribal resolution(s) under which
they operate would encompass the
proposed grant activities. Draft
resolutions are acceptable in lieu of an
official resolution. However, all official
signed Tribal resolutions must be
received by the Division of Grants
Management (DGM) prior to the
beginning of the Objective Review. If
official signed resolutions are not
received by August 15, 2011, the
application will be considered
incomplete, ineligible for review, and
returned to the applicant without
further consideration. Applicants
submitting additional documentation
after the initial application submission
are required to ensure the information
was received by the IHS by obtaining
documentation confirming delivery (i.e.
FedEx tracking, postal return receipt,
etc.).
(d) Urban Indian clinic director/CEO
equivalent Letter of Support (LoS)—a
LoS from the Clinic Director or CEO of
all urban Indian clinics served by the
TEC must be provided.
(e) Tribal resolutions supportive of
the epidemiology cooperative agreement
proposal from the Indian Tribe(s) or
urban Indian clinic director/CEO
equivalent LoS served by the project
must accompany the application and
the applicant must demonstrate how
these documents meet the minimum
requirement of 60,000 AI/AN
population to be eligible for the
cooperative agreement.
(f) Applications with established data
sharing agreements (DSAs) or
statements acknowledging the
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33317
importance of future DSAs from IHS/
Tribal/Urban Indian (I/T/Us) will be
given priority in scoring. Likewise,
applicants with established DSAs with
respective IHS Area Offices will be
given priority in scoring. DSAs will be
scored within the ‘‘Program Objectives’’
(See Review Criteria in Section II).
(g) Non-profit organizations must
provide proof of non-profit status. The
applicant must submit a current valid
Internal Revenue Service (IRS) tax
exemption certificate or a copy of the
501(c)(3) form, as proof of status.
IV. Application and Submission
Information
1. Obtaining Application Materials
The application package and
instructions may be located at https://
www.Grants.gov or
https://www.ihs.gov/
NonMedicalPrograms/gogp/index.cfm?
module=gogp_funding.
2. Content and Form Application
Submission
Documents for all applications
include:
• Application forms:
• SF–424.
• SF–424A.
• SF–424B.
• Table of Contents.
• Program Executive Summary (one
page or less).
• Program Narrative (must not exceed
10 single-spaced pages. See Section
IV(2)(a)).
• Line-item budget.
• Budget narrative (must be singlespaced).
• Program Objectives(s) to include a
spreadsheet with Objective TimeLine, Approach, and Results &
Benefits.
• Applicant’s organizational
capabilities addressing Recipient’s
Activities.
• Organizational chart.
• Position Descriptions and
Biographical sketches for all key
personnel.
• Data Sharing Agreements (if
applicable).
• Tribal Resolutions or equivalent from
urban Indian clinic directors/CEOs.
• Letters of support from collaborating
agencies.
• Copy of current Negotiated Indirect
Cost rate (IDC) agreement (required)
in order to receive IDC.
• Map of the areas to benefit from the
program.
• Disclosure of Lobbying Activities (SF–
LLL).
• Documentation of current OMB A–
133 required Financial Audit.
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Acceptable forms of documentation
include:
• E-mail confirmation from Federal
Audit Clearinghouse (FAC) that
audits were submitted; or
• Face sheets from audit reports.
These can be found on the FAC
Website:https://harvester.
census.gov/fac/dissem/
accessoptions.html?submit=
Retrieve+Records
Policy Requirements: All Federalwide public policies apply to IHS
grantees with exception of the
Discrimination policy. See attached link
for all public policies. https://
www.acf.hhs.gov/programs/ofs/grants/
sf424b.pdf
all letters of intent via fax (301) 443–
9602. Your LoI must reference the
funding opportunity number,
application deadline date, and your
eligibility status. The letter must be
signed by the authorized organizational
official within your entity.
Requirements for Program and Budget
Narratives
6. Electronic Submission
A. Program Narrative: This narrative
should be a separate Word document
that is no longer than 10 pages, singlespaced (see page limitations for each
Part noted below) with consecutively
numbered pages. If the narrative
exceeds the page limit, only the first 10
pages will be reviewed. There are three
parts to the narrative:
Section 1: Program Information—(2
Pages)
(1) Introduction and organizational
capabilities.
(2) Need for assistance.
(3) User Population.
Section 2: Recipient Activities:
Program Planning and Evaluation—(6
Pages)
(1) Program Plans. (2) Program
Evaluation. Section 3: Program Report—
(2 pages) (1) Describe major
accomplishments over the last 24
months. (2) Describe major activities
over the last 24 months.
B. Budget Narrative: This narrative
must describe the budget requested and
match the program plans and evaluation
described in the program narrative.
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3. Submission Dates and Times
Applications must be submitted
electronically through Grants.gov by
Friday, July 15, 2011 at 12 a.m.
midnight Eastern Time. Any application
received after the application deadline
will not be accepted for processing, and
it will be returned to the applicant(s)
without further consideration for
funding.
Letters of Intent: A Letter of Intent
(LoI) is required from each entity that
plans to apply for funding under this
announcement. The LoI must be
submitted to the Division of Grants
Management to the attention of Andrew
Diggs by June 10, 2011. Please submit
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4. Intergovernmental Review
Executive Order 12372 requiring
intergovernmental review is not
applicable to this program.
5. Funding Restrictions
• Pre-award costs are not allowable
for this announcement.
• The available funds are inclusive of
direct and appropriate indirect costs.
Use the https://www.Grants.gov Web
site to submit an application
electronically and select the ‘‘Find Grant
Opportunities’’ link on the homepage.
Download a copy of the application
package, complete it offline, and then
upload and submit the application via
the Grants.gov website. Electronic
copies of the application may not be
submitted as attachments to e-mail
messages addressed to IHS employees or
offices.
Please search for the application
package in Grants.gov by entering the
CFDA number or the Funding
Opportunity Number. Both numbers are
located in the header of this
announcement.
After you electronically submit your
application, you will receive an
automatic acknowledgment from
Grants.gov that contains a Grants.gov
tracking number. The DGM will
download your application from
Grants.gov and provide necessary copies
to the appropriate agency officials.
Neither the DGM nor the DEDP will
notify applicants that the application
has been received.
Applicants that do not adhere to the
timelines for Central Contractor Registry
(CCR) and/or Grants.gov registration
and/or request timely assistance with
technical issues will not be considered
for a waiver to submit a paper
application.
Technical Challenges:
• If technical challenges arise and
assistance is required with the
electronic application process, contact
the Grants.gov Customer Support via email at support@grants.gov or at (800)
518–4726. Customer Support is
available to address questions 24 hours
a day, 7 days a week (except on Federal
holidays). If problems persist, contact
Paul Gettys, DGM () at (301) 443–
5204.Paul.Gettys@ihs.gov
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• Upon contacting Grants.gov, obtain
a tracking number as proof of contact.
The tracking number is helpful if there
are technical issues that cannot be
resolved and a waiver from the agency
must be obtained.
• Please be sure to contact Mr. Gettys
at least ten days prior to the application
deadline.
Paper Submission (Waiver
Requirements):
Paper applications are not the
preferred method for submitting
applications. If an applicant needs to
submit a paper application instead of
submitting electronically via Grants.gov,
prior approval must be requested and
obtained from the DGM. The waiver
request must be documented in writing
(e-mails are acceptable), before
submitting a paper application. A copy
of the written approval must be
submitted along with the hardcopy
application that is mailed to the DGM.
The mailing address for your paper
application will be included in your
approved waiver request. Paper
applications that are submitted without
an approved waiver will be returned to
the applicant without review or further
consideration. Late applications will not
be accepted for processing or considered
for funding and will be returned to the
applicant. Applicants that receive a
waiver to submit paper application
documents must follow the rules and
timelines of this funding
announcement. The applicant must seek
assistance at least ten days prior to the
application deadline.
• If it is determined that a waiver is
needed, you must submit a request in
writing (e-mails are acceptable) to
GrantsPolicy@ihs.gov with a copy to
Tammy.Bagley@ihs.gov. Please include
a clear justification for the need to
deviate from our standard electronic
submission process.
• If the waiver is approved, the
application should be sent directly to
the DGM by the deadline date of July 15,
2011.
• Applicants are strongly encouraged
not to wait until the deadline date to
begin the application process through
Grants.gov as the registration process for
CCR and Grants.gov could take up to
fifteen working days.
E-mail applications will not be
accepted under this announcement.
Dun and Bradstreet (D&B) Data
Universal Numbering System (DUNS)
All IHS applicants and grantee
organizations are required to obtain a
DUNS number and maintain an active
registration in the CCR database.
Additionally, all IHS grantees must
notify potential first-tier subrecipients
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that no entity may receive a first-tier
subaward unless the entity has provided
its DUNS number to the prime grantee
organization. These requirements will
ensure use of a universal identifier to
enhance the quality of information
available to the public. On October 1,
2010 recipients began to report
information on subawards, as required
by the Federal Funding Accountability
and Transparency Act of 2006, as
amended (‘‘the Transparency Act’’). The
DUNS number is a unique nine digit
identification number provided by D&B,
which uniquely identifies your entity.
The DUNS number is site specific;
therefore each distinct performance site
may be assigned a DUNS number.
Obtaining a DUNS number is easy and
there is no charge. To obtain a DUNS
number, you may access it through the
following website https://
fedgov.dnb.com/webform or to expedite
the process, call (866) 705–5711.
whether the applicant has an adequate
health department, how long it has been
operating, what programs or services are
currently provided, and interactions
with other public health authorities in
the regions (State, local, or Tribal), how
long it has been operating, and what
programs or services are currently
provided. Specifically describe current
epidemiologic capacity and history of
support for such activities.
b. Provide a physical location of the
TEC and area to be served by the
proposed program including a map
(include the map in the attachments),
and specifically describe the office
space and how it is going to be paid for.
c. If applicable, identify the past three
years of grants relevant to public health
and/or epidemiology, including past
awarded cooperative agreements from
the DEDP, dates of funding, and key
project accomplishments (do not
include copies of reports).
Central Contractor Registry (CCR)
(2) Program Objective(s) (35 Points)
Organizations that have not registered
with CCR will need to obtain a DUNS
number first and then access the CCR
online registration through the CCR
home page at https://www.bpn.gov/ccr/
default.aspx (U.S. organizations will
also need to provide an Employer
Identification Number from the IRS that
may take an additional 2–5 weeks to
become active). Completing and
submitting the registration takes
approximately one hour and your CCR
registration will take approximately 3–
5 business days to process. Registration
with the CCR is free of charge.
Applicants may register online at https://
www.ccr.gov. Additional information on
implementing the Transparency Act,
including the specific requirements for
DUNS and CCR, can be found on the
IHS Grants Policy website:
https://www.ihs.gov/
NonMedicalPrograms/gogp/
index.cfm?module=gogp_policy_topics.
Approach, Results and Benefits for
the entire 5-year funding period by year.
a. State in measurable and realistic
terms the objectives and appropriate
activities to achieve each objective for
the projects as listed in the Recipient
Activities.
b. Identify the expected results,
benefits, and outcomes or products to be
derived from each objective of the
project.
c. Include a work-plan for each
objective that indicates when the
objectives and major activities will be
accomplished and who will conduct the
activities by each year for the entire
five-year period.
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V. Application Review Information
Evaluation criteria will be used in
reviews of applications. Points will be
assigned to each evaluation criterion
adding up to a total of 100 points. A
minimum score of 65 points is required
for funding. Points are assigned to the
extent that the applicant is able to
demonstrate that they met the following
criteria.
A. Evaluation Criteria: Program
Narrative
(1) Introduction, Current Capacity, and
Need for Assistance (25 Points)
a. Describe the applicant’s current
public health activities including
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(3) Program Evaluation (10 Points)
a. Define the criteria to be used to
evaluate activities listed in the workplan under the Recipient Activities and
BRFSS project.
b. Explain the methodology that will
be used to determine if the needs
identified for the objectives are being
met and if the outcomes identified are
being achieved.
c. Describe how evaluation findings
will be disseminated to stakeholders.
(4) Organization Capabilities and
Qualifications (10 Points)
a. Explain the management and
administrative structure of the
organization including documentation
of current certified financial
management systems either from the
Bureau of Indian Affairs, IHS, or a
Certified Public Accountant and an
updated organizational chart (include
chart in the attachments).
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33319
b. Describe the ability of the
organization to manage a program of the
proposed scope.
c. Provide position descriptions and
biographical sketches of key personnel,
including those of consultants or
contractors in the Appendix. Position
descriptions should very clearly
describe each position and its duties,
indicating desired qualification and
experience requirements related to the
project. Resumes should indicate that
the proposed staff is qualified to carry
out the project activities. Applicants
with expertise in epidemiology will
receive priority.
(5) Behavioral Risk Factor Surveillance
System (BRFSS) (15 Points)
a. Describe the BRFSS project
specifically for AI/AN populations to
evaluate the health risk behaviors to
include, at a minimum, CDC’s ‘‘core’’
BRFSS.
b. Identify a statistically
representative sample of Tribal and
urban communities that will participate
in the BRFSS.
c. Describe how the applicant will
define and complete the following items
as part of their proposal: develop a
protocol for conducting the BRFSS;
develop a sampling method and
recruitment strategy; meet with the
Tribal Health Director, Health Board,
and Tribal Council for review and
approval; submit protocols for IRB
review; select and train interviewers for
the BRFSS.
d. Describe how to develop a data
base to enter data collected on the
BRFSS.
e. Provide a dissemination plan that
includes a project overview,
dissemination goals, targeted audiences,
key messages, details of the
dissemination plan and evaluation.
f. Complete a separate budget for the
BRFSS project.
(6) Budget (5 Points)
a. Provide a categorical budget by line
item and by each year for the entire fiveyear period, including a separate budget
for the BRFSS project.
b. Provide a justification by line item
in the budget including sufficient cost
and other details to facilitate the
determination of cost allowability and
relevance of these costs to the proposed
project. The funds requested should be
appropriate and necessary for the scope
of the project.
c. If use of consultants or contractors
are proposed or anticipated, provide a
detailed budget and scope of work that
clearly defines the deliverables or
outcomes anticipated.
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B. Review and Selection Process
Each application will be prescreened
by the DGM staff for eligibility and
completeness as outlined in the funding
announcement. Incomplete applications
and applications that are nonresponsive to the eligibility criteria will
not be referred to the Objective Review
Committee (ORC).
To obtain a minimum score for
funding by the ORC, applicants must
address all program requirements and
provide all required documentation.
Applicants that receive less than a
minimum score and/or are incomplete
will be considered to be ‘‘Disapproved’’
and will be informed via e-mail or
regular mail by the IHS Program Office
of their application’s deficiencies. A
summary statement outlining the
strengths and weaknesses of the
application will be provided to each
disapproved applicant. The summary
statement will be sent to the Authorized
Organizational Representative (AOR)
that is identified on the face page of the
application within 60 days of the
completion of the objective review.
Award Date(s): September 16, 2011.
The DEDP will recommend successful
applicants for funding based on the
results of the objective review.
VI. Award Administration Information
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1. Award Notices
The Notice of Award (NoA) will be
initiated by DGM and will be mailed via
postal mail or e-mailed to each entity
that is approved for funding under this
announcement. The NoA will be signed
by the Grants Management Officer and
is the authorizing document for which
funds are dispersed to the approved
entities. The NoA will serve as the
official notification of the grant award
and will reflect the amount of Federal
funds awarded, the purpose of the grant,
the terms and conditions of the award,
the effective date of the award, and the
budget/project period. The NoA is the
legally binding document and is signed
by an authorized grants official within
the IHS.
2. Administrative Requirements
Grants are administered in accordance
with the following regulations, policies,
and OMB cost principles:
A. The criteria as outlined in this
Program Announcement.
B. Administrative Regulations for
Grants:
• 45 CFR, part 92, Uniform
Administrative Requirements for Grants
and Cooperative Agreements to State,
Local and Tribal Governments.
• 45 CFR, part 74, Uniform
Administrative Requirements for
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Awards and Subawards to institutions
of Higher Education, Hospitals, Other
Non-profit Organizations, and
Commercial Organizations.
C. Grants Policy:
• HHS Grants Policy Statement,
Revised 01/07.
D. Cost Principles:
• Title 2: Grants and Agreements, Part
225—Cost Principles for State, Local,
and Indian Tribal Governments (OMB
A–87).
• Title 2: Grants and Agreements, Part
230—Cost Principles for Non-Profit
Organizations (OMB Circular A–122).
E. Audit Requirements:
• OMB Circular A–133, Audits of
States, Local Governments, and Nonprofit Organizations.
3. Indirect Costs
This section applies to all grant
recipients that request reimbursement of
indirect costs in their grant application.
In accordance with HHS Grants Policy
Statement, Part II–27, IHS requires
applicants to obtain a current indirect
cost rate agreement prior to award. The
rate agreement must be prepared in
accordance with the applicable cost
principles and guidance as provided by
the cognizant agency or office. A current
rate covers the applicable grant
activities under the current award’s
budget period. If the current rate is not
on file with the DGM at the time of
award, the indirect cost portion of the
budget will be restricted. The
restrictions remain in place until the
current rate is provided to the DGM.
Generally, indirect costs rates for IHS
grantees are negotiated with the
Division of Cost Allocation https://
rates.psc.gov/and the Department of
Interior (National Business Center)
https://www.aqd.nbc.gov/services/
ICS.aspx. If your organization has
questions regarding the indirect cost
policy, please call (301) 443–5204 to
request assistance.
4. Reporting Requirements
Failure to submit required reports
within the time allowed may result in
suspension or termination of an active
grant, withholding of additional awards
for the project, or other enforcement
actions such as withholding of
payments or converting to the
reimbursement method of payment.
Continued failure to submit required
reports may result in one or both of the
following: (1) The imposition of special
award provisions; and (2) the nonfunding or non-award of other eligible
projects or activities. This requirement
applies whether the delinquency is
attributable to the failure of the grantee
organization or the individual
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responsible for preparation of the
reports.
The reporting requirements for this
program are noted below.
A. Progress Reports
Program progress reports are required
annually. These reports will include a
brief comparison of actual
accomplishments to the goals
established for the period, or, if
applicable, provide sound justification
for the lack of progress, and other
pertinent information as required. A
final report must be submitted within 90
days of expiration of the budget/project
period.
B. Financial Reports
Federal Financial Report, (FFR- SF–
425), Cash Transaction Reports are due
every calendar quarter to the Division of
Payment Management, Payment
Management Branch, HHS at: https://
www.dpm.gov Failure to submit timely
reports may cause a disruption in timely
payments to your organization.
Grantees are responsible and
accountable for accurate information
being reported on all required reports;
the Progress Reports, Financial Status
Reports and Federal Financial Report.
C. Federal Subaward Reporting System
(FSRS)
This award may be subject to the
Transparency Act subaward and
executive compensation reporting
requirements of 2 CFR Part 170.
The Transparency Act requires the
Office of Management and Budget to
establish a single searchable database,
accessible to the public, with
information on financial assistance
awards made by Federal agencies. The
Transparency Act also includes a
requirement for recipients of Federal
grants to report information about firsttier subawards and executive
compensation under Federal assistance
awards.
Effective as of October 1, 2010, IHS
implemented new Terms of Award. All
New (Type 1) IHS grant and cooperative
agreement awards issued on or after
October 1, 2010 may be subject to the
Transparency Act Subaward and
Executive Compensation reporting
requirements. Additionally, all IHS
Renewal (Type 2) grant and cooperative
agreement awards and Competing
Revision awards (Competing T–3s)
issued on or after October 1, 2010 may
also be subject to the following award
term. Further guidance on Renewal and
Competing Revision awards is expected
to be provided as it becomes available.
Please visit the IHS Grants Policy Web
site at https://www.ihs.gov/NonMedical
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Programs/gogp for additional
information on award applicability
information.
Telecommunication for the hearing
impaired is available at: TTY (301) 443–
6394.
VII. Agency Contacts
For program-related information: Selina
T. Keryte, Project Officer, Division of
Epidemiology & Disease Prevention,
Indian Health Service, 5300
Homestead NE, Albuquerque, NM
87110, (505) 248–4132 or
Selina.keryte@ihs.gov.
For specific grant-related and business
management information: Andrew
Diggs, Grants Management Specialist,
Division of Grants Management,
Indian Health Service, 801 Thompson
Avenue, TMP 360, Rockville, MD
20852, (301) 443–2262 or
Andrew.diggs@ihs.gov.
The PHS strongly encourages all grant
and contract recipients to provide a
smoke-free workplace and promote the
non-use of all tobacco products. In
addition, Public Law 103–227, the ProChildren Act of 1994, prohibits smoking
in certain facilities (or in some cases,
any portion of the facility) in which
regular or routine education, library,
day care, health care or early childhood
development services are provided to
children. This is consistent with the
HHS mission to protect and advance the
physical and mental health of the
American people.
Dated: May 31, 2011.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2011–14131 Filed 6–7–11; 8:45 am]
BILLING CODE 4165–16–P
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors for Basic Sciences National
Cancer Institute.
Date: July 11, 2011.
Time: 8:30 a.m. to 4 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
National Cancer Institute, 9000 Rockville
Pike, Building 31, Conference Room 6,
Bethesda, MD 20892.
Contact Person: Florence E. Farber, PhD,
Executive Secretary, Office of the Director,
National Cancer Institute, National Institutes
of Health, 6116 Executive Boulevard, Room
2205, Bethesda, MD 20892, 301–496–7628,
ff6p@nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/bsc/bs/bs.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Dated: May 31, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–14161 Filed 6–7–11; 8:45 am]
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National Cancer Institute; Notice of
Closed Meeting
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors for Basic
Sciences National Cancer Institute.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel
qualifications and performance, and the
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Institutes of Health
National Cancer Institute; 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 a meeting of the Board
of Scientific Counselors for Clinical
Sciences and Epidemiology National
Cancer Institute.
The meeting will be closed to the
public as indicated below in accordance
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with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors for Clinical Sciences and
Epidemiology, National Cancer Institute.
Date: July 12, 2011.
Time: 9 a.m. to 4 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes Of Health,
National Cancer Institute, 9000 Rockville
Pike, Building 31, Conference Room 10,
Bethesda, MD 20892.
Contact Person: Brian E. Wojcik, PhD,
Senior Review Administrator, Institute
Review Office, Office of the Director,
National Cancer Institute, 6116 Executive
Boulevard, Room 2201, Bethesda, Md 20892,
(301) 496–7628, wojcikb@mail.nih.gov.
In the interest of security, NIH has instituted
stringent procedures for entrance onto the
NIH campus. All visitor vehicles, including
taxicabs, hotel, and airport shuttles will be
inspected before being allowed on campus.
Visitors will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.deainfo.nci.nih.gov/advisory/bsc.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: May 31, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–14158 Filed 6–7–11; 8:45 am]
BILLING CODE 4140–01–P
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Agencies
[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33314-33321]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14131]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Epidemiology Program for American Indian/Alaska Native Tribes and
Urban Indian Communities
Division of Epidemiology and Disease Prevention; Epidemiology Program
for American Indian/Alaska Native Tribes and Urban Indian Communities
Announcement Type: New.
Funding Opportunity Number: HHS-2011-IHS-EPI-0001.
Catalog of Federal Domestic Assistance Number: 93.231
DATES: Key Dates:
Application Deadline Date: July 15, 2011;
>Review Date: August 16-17, 2011;
Anticipated Start Date: September 16, 2011.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is accepting competitive
cooperative agreement applications to establish Tribal Epidemiology
Centers serving American Indian/Alaska Native (AI/AN) Tribes and urban
Indian communities. This program is managed by the IHS Division of
Epidemiology and Disease Prevention (DEDP). This program is authorized
under the Snyder Act, 25 U.S.C. 13, and 25 U.S.C. 1621m of the Indian
Health Care Improvement Act. To obtain details regarding eligibility,
please refer to Section III below.
Background
The Tribal Epidemiology Center (TEC) program was authorized by
Congress in 1998 as a way to provide public health support to multiple
Tribes and urban Indian communities in each of the IHS Areas. The
funding opportunity announcement is open to eligible Tribes, Tribal
organizations, intertribal consortia, and urban Indian organizations,
including currently funded TECs.
TECs are uniquely positioned within Tribes, Tribal and urban Indian
organizations to conduct disease surveillance, research, prevention and
control of disease, injury, or disability, and to assess the
effectiveness of AI/AN public health programs. In addition, they can
fill gaps in data needed for Government Performance and Results Act
(GPRA) and Healthy People 2020 measures. Some of the existing TECs have
already developed innovative strategies to monitor the health status of
Tribes and urban Indian communities, including development of Tribal
health registries and use of sophisticated record linkage computer
software to correct existing state data sets for racial
misclassification. TECs work in partnership with IHS DEDP to provide a
more accurate national picture of Indian health status.
[[Page 33315]]
TECs provide critical support for activities that promote Tribal
self-governance and effective management of Tribal and urban Indian
health programs. Data generated locally and analyzed by TECs enable
Tribes and urban Indian communities to effectively plan and make
decisions that best meet the needs of their communities. In addition,
TECs can immediately provide feedback to local data systems which will
lead to improvements in Indian health data overall.
As more Tribes choose to operate health programs in their
communities, TECs ultimately will provide additional public health
services such as disease control and prevention programs. Some existing
centers provide assistance to Tribal and urban Indian communities in
such areas as sexually transmitted disease control and cancer
prevention. They also assist Tribes and urban Indian communities to
establish baseline data for successfully evaluating intervention and
prevention activities through activities such as conducting Behavioral
Risk Factor Surveillance Surveys (BRFSS).
The TEC program will continue to enhance the ability of the Indian
health system to collect and manage data more effectively and to better
understand and develop the link between public health problems and
behavior, socioeconomic conditions, and geography. The TEC program will
also support Tribal and urban Indian communities by providing technical
training in public health practice and prevention-oriented research and
by promoting public health career pathways.
Purpose
The purpose of this cooperative agreement program is to fund
Tribes, Tribal and urban Indian organizations, and intertribal
consortia to provide epidemiological support for the AI/AN population
served by IHS. TEC activities should include, but are not limited to,
enhancement of surveillance for disease conditions; research,
prevention and control of disease, injury, or disability; assessment of
the effectiveness of AI/AN public health programs; epidemiologic
analysis, interpretation, and dissemination of surveillance data;
investigation of disease outbreaks; development and implementation of
epidemiologic studies; development and implementation of disease
control and prevention programs; and coordination of activities of
other public health authorities in the region. It is the intent of IHS
to fund several TECs that will serve Tribes and urban Indian
communities in all 12 IHS Administrative Areas.
Each TEC selected for funding will act under a cooperative
agreement with the IHS. During funded activities, the TECs may receive
Protected Health Information (PHI) for the purpose of preventing or
controlling disease, injury or disability, including, but not limited
to, reporting of disease, injury, vital events, such as birth or death,
and the conduct of public health surveillance, public health
investigation, and public health interventions for the Tribal and urban
Indian communities that they serve. TECs acting under a cooperative
agreement with IHS are public health authorities for which the
disclosure of PHI by covered entities is authorized by the Privacy
Rule. 45 CFR 164.512(b).
To achieve the purpose of this program, the recipient will be
responsible for the activities under item number 1. Recipient
Activities and IHS will be responsible for conducting activities under
item number 2. IHS Activities.
II. Award Information
Type of Award: Cooperative Agreement.
Estimated Funds Available:
The total amount identified for FY 2011 is approximately $4.5
million. Competing and continuation awards issued under this
announcement are subject to the availability of funds. In the absence
of funding, the agency is under no obligation to fund any awards under
this announcement. The program will be awarded for five years with 12
months per budget period. Future year funding levels will be determined
based on availability of funds. The average award is approximately
$350,000 to $1,000,000, depending on the applicant's score and the size
of the area covered by the TEC.
Anticipated Number of Awards:
Approximately 12 awards may be issued under this program
announcement.
Project Period:
This will be a 5-year project from September 16, 2011 to September
15, 2016.
Funding Information:
As part of an effort to establish TECs throughout the nation, these
funds will be used to support activities on an IHS Area basis.
Successful applicants must agree to provide services for all AI/AN
populations in the respective IHS Area. Collaborative efforts among
Tribal, local, State, and Federal health organizations are encouraged.
Funding will be based on scoring levels from the review process. An
example is outlined below. Detailed explanations of Review Criteria are
described in Section V.
------------------------------------------------------------------------
Review Criteria Total Points Points Awarded
------------------------------------------------------------------------
Introduction, Current Capacity, and 25 ................
Need for Assistance................
Program Objectives-Recipient 35 ................
Activities.........................
Program Evaluation.................. 10 ................
Organizational Capabilities & 10 ................
Qualification......................
Behavioral Risk Factor Surveillance 15 ................
Surveys............................
Budget.............................. 5 ................
Total............................... 100 ................
------------------------------------------------------------------------
Cooperative Agreements will be funded annually during the project
period of five years, contingent on required continuation applications
with an approved scope of work. Renewals of cooperative agreements will
be based on the following:
Satisfactory progress.
Availability of funds.
Program priorities of IHS.
Programmatic Involvement:
IHS will have substantial involvement in all of the TECs (See IHS
Activities).
Recipient Activities:
a. Assist and facilitate AI/AN communities, Tribes, Tribal
organizations, and urban Indian organizations in identifying Tribal and
urban Indian community health status priorities for building public
health capacity at the local level based on epidemiologic data. Assist
and facilitate Tribal and urban Indian communities with implementing
and conducting disease surveillance, research, prevention and control
of disease, injury, or disability, to assess the effectiveness of AI/AN
public health programs, monitoring progress toward
[[Page 33316]]
meeting each of the health status objectives, developing and
implementing epidemiologic studies that have practical application in
improving the health status of constituent communities, reporting of
notifiable disease conditions to public health authorities and to local
Tribes and urban Indian communities in the region, and address emerging
public health and epidemiological issues as identified by Tribal and
urban Indian community priorities.
b. Develop and disseminate health specific data and Community
Health Profiles (CHPs) based on Tribal and urban Indian community
health status priorities as follows:
1. Develop CHPs specific for each Tribal and urban Indian community
entity served by the TEC. Provide a dissemination plan that includes a
project overview, dissemination goals, and health indicators.
2. Develop a regional CHP encompassing all Tribal and urban Indian
communities served by the TEC. Provide a dissemination plan that
includes a project overview, dissemination goals, and health
indicators.
3. Participate in the national TEC CHP Working Group to develop and
implement a national CHP.
c. Recipient will need to maintain outbreak response capacity by:
1. Establishing and maintaining relationships with local
authorities (Tribal, County, State, etc.) to be able to participate in
outbreak response activities on a national or regional scope.
2. Obligating a minimum of one program staff per year to attend IHS
training in either the ``Outbreak Response Review'' or ``Epidemiology
Ready'' course.
3. Explaining how recipient will collaborate and assist in public
health emergencies with the IHS, DEDP, State, local, County, Tribal,
and other Federal health authorities.
d. Develop a BRFSS project to evaluate health risk behaviors of AI/
AN populations served by the TEC, to include, at a minimum, CDC's
``core'' BRFSS, as follows:
1. Develop a protocol for conducting the BRFSS;
2. Develop a sampling method and recruitment strategy;
3. Meet with the Tribal Health Director, Health Board, and/or the
Tribal Council, as appropriate, for review and approval of the BRFSS
project;
4. Obtain IRB approval or exempt status;
5. Develop a training protocol for interviewers for the BRFSS;
6. Develop a database to enter data collected from the BRFSS;
7. Develop a dissemination plan that includes a project overview,
dissemination goals, targeted audiences, key messages, details of the
dissemination plan and how the plan will be evaluated; and
8. Create a separate budget for the BRFSS project.
e. Establish a Data Sharing Agreement (DSA) with the IHS Area
Office that delineates:
1. ``Routine'' activities for which the TEC will have access to de-
identified data from IHS Epidemiology Data Mart/National Data Warehouse
(NDW).
2. Activities for which they will need additional permission such
as special studies or research involving PHI.
3. Language which outlines compliance with Health Insurance
Portability and Accountability Act (HIPAA) and Privacy Act protection.
4. Use of the IHS Epidemiology Data Mart User Tracking System
(EDMUTS) by the recipient to track both 1 and 2
above.
5. Use of security measures, including:
How security measures will be in place for data usage;
How recipient will be a steward of the data;
Completion of the IHS/OIT yearly security training and
security training required by their respective organization; and
An annual report on the outcomes of TECs access to IHS
data.
f. Participate in national public health priorities and committees,
as appropriate, with additional Department of Health and Human Services
(HHS) agencies.
g. Explain how recipient will support the IHS Agency's priorities:
1. To renew and strengthen our partnership with Tribes.
2. To bring reform to IHS.
3. To improve the quality of and access to care.
4. To make all our work accountable, transparent, fair and
inclusive.
You may access information on IHS priorities via the Internet at
the following Web site: https://www.ihs.gov/PublicAffairs/DirCorner/index.cfm.
h. Establish an advisory council that can provide overall program
direction and guidance. The advisory council should include some
members with technical expertise in epidemiology and public health
(i.e. state health departments, county health departments, etc.) and
representation from the Tribal health and urban Indian health programs
served by the TEC.
i. Provide an annual report (no more than 10 pages) at the end of
each project year to DEDP.
j. Ensure that TEC staff includes key personnel with appropriate
expertise in epidemiology, health sciences, and program management. The
TEC must also demonstrate access to specialized expertise such as a
doctoral level epidemiologist and/or a biostatistician.
IHS Activities:
a. Provide funded TECs with ongoing consultation and technical
assistance to plan, implement, and evaluate each component of the TEC
as described under Recipient Activities above. Consultation and
technical assistance will include, but not be limited to, the following
areas:
1. Interpretation of current scientific literature related to
epidemiology, statistics, surveillance, Healthy People 2020 objectives,
and other public health issues;
2. Design and implementation of each program component such as
surveillance, epidemiologic analysis, outbreak investigation,
development of epidemiologic studies, development of disease control
programs, and coordination of activities; and
3. Overall operational planning and program management.
b. Coordinate all IHS epidemiologic activities on a national scope
including investigation of disease outbreaks and CHPs.
c. Conduct site visits to TECs and/or coordinate TEC visits to IHS
to ensure data security; confirm compliance with applicable laws and
regulations; assess program activities; and to mutually resolve
problems, as needed.
d. Convene an annual TEC meeting for information sharing, problem
solving or training.
e. Provide opportunities for training of TEC staff. Examples
include: IHS Outbreak Response Review course; Webinars on NDW Technical
Assistance; Introduction to SAS; Fellowship opportunities.
III. Eligibility Information
1. Eligibility
AI/AN Tribes, Tribal organizations, and eligible intertribal
consortia or urban Indian organizations as defined by 25 U.S.C. 1603(e)
may be eligible for a TEC cooperative agreement. Such entities must
represent or serve a population of at least 60,000 AI/AN to be eligible
as demonstrated by Tribal resolutions or the equivalent documentation
from urban Indian clinic directors/Chief Executive Officers (CEOs).
Applicants must describe the population of AI/ANs and Tribes that
[[Page 33317]]
will be represented. The number of AI/ANs served must be substantiated
by documentation describing IHS user populations, United States Census
Bureau data, clinical catchment data, or any method that is
scientifically and epidemiologically valid. An intertribal consortium
or urban Indian organization is eligible to receive a cooperative
agreement if it is incorporated for the primary purpose of improving
AI/AN health, and represents the Tribes, AN villages, or urban Indian
communities in which it is located. Resolutions from each Tribe, AN
village and equivalent documentation from each urban Indian community
represented must be included in the application package. Collaborations
with IHS Areas, Federal agencies such as the Centers for Disease
Control and Prevention (CDC), State, academic institutions or other
organizations are encouraged (letters of support and collaboration
should be included in the application).
Definitions:
Federally-recognized Indian Tribe means any Indian Tribe, band,
nation, or other organized group or community, including any Alaska
Native village or group or regional or village corporation as defined
in or established pursuant to the Alaska Native Claims Settlement Act
(85 Stat. 688) [43 U.S.C. 1601, et seq.], which is recognized as
eligible for the special programs and services provided by the United
States to Indians because of their status as Indians. 25 U.S.C. 1603
(d).
Tribal organization means the elected governing body of any Indian
Tribe or any legally established organization of Indians which is
controlled by one or more such bodies or by a board of directors
elected or selected by one or more such bodies or elected by the Indian
population to be served by such organization and which includes the
maximum participation of Indians in all phases of its activities. 25
U.S.C. 1603(e).
Urban Indian organization means a non-profit corporate body
situated in an urban center governed by an urban Indian controlled
board of directors, and providing for the maximum participation of all
interested Indian groups and individuals, which body is capable of
legally cooperating with other public and private entities for the
purpose of performing the activities. 25 U.S.C. 1603(h).
An intertribal consortium or AI/AN organization is eligible to
receive a cooperative agreement if it is incorporated for the primary
purpose of improving AI/AN health. Collaborations with regional IHS,
CDC, State and local health departments, and academic institutions are
encouraged. Proper tribal resolutions or equivalent documentation from
urban Indian organizations is required.
2. Cost Sharing or Matching
DEDP does not require matching funds or cost sharing.
3. Other Requirements
(a) If an applicant's budget exceeds the highest stated award
amount that is outlined within this announcement ($1,000,000.00), that
application will not be considered for funding.
(b) A letter of intent is required (See section IV(3)).
(c) Tribal Resolution--A resolution of all Indian Tribes served by
the project must accompany the application submission. This can be
attached to the electronic application. An Indian Tribe that is
proposing a project with other Indian Tribes must include resolutions
from all Tribes to be served. Applications by Tribal organizations
representing multiple Tribes will not require specific Tribal
resolutions if the current Tribal resolution(s) under which they
operate would encompass the proposed grant activities. Draft
resolutions are acceptable in lieu of an official resolution. However,
all official signed Tribal resolutions must be received by the Division
of Grants Management (DGM) prior to the beginning of the Objective
Review. If official signed resolutions are not received by August 15,
2011, the application will be considered incomplete, ineligible for
review, and returned to the applicant without further consideration.
Applicants submitting additional documentation after the initial
application submission are required to ensure the information was
received by the IHS by obtaining documentation confirming delivery
(i.e. FedEx tracking, postal return receipt, etc.).
(d) Urban Indian clinic director/CEO equivalent Letter of Support
(LoS)--a LoS from the Clinic Director or CEO of all urban Indian
clinics served by the TEC must be provided.
(e) Tribal resolutions supportive of the epidemiology cooperative
agreement proposal from the Indian Tribe(s) or urban Indian clinic
director/CEO equivalent LoS served by the project must accompany the
application and the applicant must demonstrate how these documents meet
the minimum requirement of 60,000 AI/AN population to be eligible for
the cooperative agreement.
(f) Applications with established data sharing agreements (DSAs) or
statements acknowledging the importance of future DSAs from IHS/Tribal/
Urban Indian (I/T/Us) will be given priority in scoring. Likewise,
applicants with established DSAs with respective IHS Area Offices will
be given priority in scoring. DSAs will be scored within the ``Program
Objectives'' (See Review Criteria in Section II).
(g) Non-profit organizations must provide proof of non-profit
status. The applicant must submit a current valid Internal Revenue
Service (IRS) tax exemption certificate or a copy of the 501(c)(3)
form, as proof of status.
IV. Application and Submission Information
1. Obtaining Application Materials
The application package and instructions may be located at https://www.Grants.gov or
https://www.ihs.gov/NonMedicalPrograms/gogp/index.cfm?module=gogp_funding.
2. Content and Form Application Submission
Documents for all applications include:
Application forms:
SF-424.
SF-424A.
SF-424B.
Table of Contents.
Program Executive Summary (one page or less).
Program Narrative (must not exceed 10 single-spaced pages. See
Section IV(2)(a)).
Line-item budget.
Budget narrative (must be single-spaced).
Program Objectives(s) to include a spreadsheet with Objective
Time-Line, Approach, and Results & Benefits.
Applicant's organizational capabilities addressing Recipient's
Activities.
Organizational chart.
Position Descriptions and Biographical sketches for all key
personnel.
Data Sharing Agreements (if applicable).
Tribal Resolutions or equivalent from urban Indian clinic
directors/CEOs.
Letters of support from collaborating agencies.
Copy of current Negotiated Indirect Cost rate (IDC) agreement
(required) in order to receive IDC.
Map of the areas to benefit from the program.
Disclosure of Lobbying Activities (SF-LLL).
Documentation of current OMB A-133 required Financial Audit.
[[Page 33318]]
Acceptable forms of documentation include:
E-mail confirmation from Federal Audit Clearinghouse (FAC)
that audits were submitted; or
Face sheets from audit reports. These can be found on the
FAC Website:https://harvester.census.gov/fac/dissem/
accessoptions.html?submit=Retrieve+Records
Policy Requirements: All Federal-wide public policies apply to IHS
grantees with exception of the Discrimination policy. See attached link
for all public policies. https://www.acf.hhs.gov/programs/ofs/grants/sf424b.pdf
Requirements for Program and Budget Narratives
A. Program Narrative: This narrative should be a separate Word
document that is no longer than 10 pages, single-spaced (see page
limitations for each Part noted below) with consecutively numbered
pages. If the narrative exceeds the page limit, only the first 10 pages
will be reviewed. There are three parts to the narrative:
Section 1: Program Information--(2 Pages)
(1) Introduction and organizational capabilities.
(2) Need for assistance.
(3) User Population.
Section 2: Recipient Activities: Program Planning and Evaluation--
(6 Pages)
(1) Program Plans. (2) Program Evaluation. Section 3: Program
Report--(2 pages) (1) Describe major accomplishments over the last 24
months. (2) Describe major activities over the last 24 months.
B. Budget Narrative: This narrative must describe the budget
requested and match the program plans and evaluation described in the
program narrative.
3. Submission Dates and Times
Applications must be submitted electronically through Grants.gov by
Friday, July 15, 2011 at 12 a.m. midnight Eastern Time. Any application
received after the application deadline will not be accepted for
processing, and it will be returned to the applicant(s) without further
consideration for funding.
Letters of Intent: A Letter of Intent (LoI) is required from each
entity that plans to apply for funding under this announcement. The LoI
must be submitted to the Division of Grants Management to the attention
of Andrew Diggs by June 10, 2011. Please submit all letters of intent
via fax (301) 443-9602. Your LoI must reference the funding opportunity
number, application deadline date, and your eligibility status. The
letter must be signed by the authorized organizational official within
your entity.
4. Intergovernmental Review
Executive Order 12372 requiring intergovernmental review is not
applicable to this program.
5. Funding Restrictions
Pre-award costs are not allowable for this announcement.
The available funds are inclusive of direct and
appropriate indirect costs.
6. Electronic Submission
Use the https://www.Grants.gov Web site to submit an application
electronically and select the ``Find Grant Opportunities'' link on the
homepage. Download a copy of the application package, complete it
offline, and then upload and submit the application via the Grants.gov
website. Electronic copies of the application may not be submitted as
attachments to e-mail messages addressed to IHS employees or offices.
Please search for the application package in Grants.gov by entering
the CFDA number or the Funding Opportunity Number. Both numbers are
located in the header of this announcement.
After you electronically submit your application, you will receive
an automatic acknowledgment from Grants.gov that contains a Grants.gov
tracking number. The DGM will download your application from Grants.gov
and provide necessary copies to the appropriate agency officials.
Neither the DGM nor the DEDP will notify applicants that the
application has been received.
Applicants that do not adhere to the timelines for Central
Contractor Registry (CCR) and/or Grants.gov registration and/or request
timely assistance with technical issues will not be considered for a
waiver to submit a paper application.
Technical Challenges:
If technical challenges arise and assistance is required
with the electronic application process, contact the Grants.gov
Customer Support via e-mail at support@grants.gov or at (800) 518-4726.
Customer Support is available to address questions 24 hours a day, 7
days a week (except on Federal holidays). If problems persist, contact
Paul Gettys, DGM () at (301) 443-5204.Paul.Gettys@ihs.gov
Upon contacting Grants.gov, obtain a tracking number as
proof of contact. The tracking number is helpful if there are technical
issues that cannot be resolved and a waiver from the agency must be
obtained.
Please be sure to contact Mr. Gettys at least ten days
prior to the application deadline.
Paper Submission (Waiver Requirements):
Paper applications are not the preferred method for submitting
applications. If an applicant needs to submit a paper application
instead of submitting electronically via Grants.gov, prior approval
must be requested and obtained from the DGM. The waiver request must be
documented in writing (e-mails are acceptable), before submitting a
paper application. A copy of the written approval must be submitted
along with the hardcopy application that is mailed to the DGM. The
mailing address for your paper application will be included in your
approved waiver request. Paper applications that are submitted without
an approved waiver will be returned to the applicant without review or
further consideration. Late applications will not be accepted for
processing or considered for funding and will be returned to the
applicant. Applicants that receive a waiver to submit paper application
documents must follow the rules and timelines of this funding
announcement. The applicant must seek assistance at least ten days
prior to the application deadline.
If it is determined that a waiver is needed, you must
submit a request in writing (e-mails are acceptable) to
GrantsPolicy@ihs.gov with a copy to Tammy.Bagley@ihs.gov. Please
include a clear justification for the need to deviate from our standard
electronic submission process.
If the waiver is approved, the application should be sent
directly to the DGM by the deadline date of July 15, 2011.
Applicants are strongly encouraged not to wait until the
deadline date to begin the application process through Grants.gov as
the registration process for CCR and Grants.gov could take up to
fifteen working days.
E-mail applications will not be accepted under this announcement.
Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS)
All IHS applicants and grantee organizations are required to obtain
a DUNS number and maintain an active registration in the CCR database.
Additionally, all IHS grantees must notify potential first-tier
subrecipients
[[Page 33319]]
that no entity may receive a first-tier subaward unless the entity has
provided its DUNS number to the prime grantee organization. These
requirements will ensure use of a universal identifier to enhance the
quality of information available to the public. On October 1, 2010
recipients began to report information on subawards, as required by the
Federal Funding Accountability and Transparency Act of 2006, as amended
(``the Transparency Act''). The DUNS number is a unique nine digit
identification number provided by D&B, which uniquely identifies your
entity. The DUNS number is site specific; therefore each distinct
performance site may be assigned a DUNS number. Obtaining a DUNS number
is easy and there is no charge. To obtain a DUNS number, you may access
it through the following website https://fedgov.dnb.com/webform or to
expedite the process, call (866) 705-5711.
Central Contractor Registry (CCR)
Organizations that have not registered with CCR will need to obtain
a DUNS number first and then access the CCR online registration through
the CCR home page at https://www.bpn.gov/ccr/default.aspx (U.S.
organizations will also need to provide an Employer Identification
Number from the IRS that may take an additional 2-5 weeks to become
active). Completing and submitting the registration takes approximately
one hour and your CCR registration will take approximately 3-5 business
days to process. Registration with the CCR is free of charge.
Applicants may register online at https://www.ccr.gov. Additional
information on implementing the Transparency Act, including the
specific requirements for DUNS and CCR, can be found on the IHS Grants
Policy website:
https://www.ihs.gov/NonMedicalPrograms/gogp/index.cfm?module=gogp_policy_topics.
V. Application Review Information
Evaluation criteria will be used in reviews of applications. Points
will be assigned to each evaluation criterion adding up to a total of
100 points. A minimum score of 65 points is required for funding.
Points are assigned to the extent that the applicant is able to
demonstrate that they met the following criteria.
A. Evaluation Criteria: Program Narrative
(1) Introduction, Current Capacity, and Need for Assistance (25 Points)
a. Describe the applicant's current public health activities
including whether the applicant has an adequate health department, how
long it has been operating, what programs or services are currently
provided, and interactions with other public health authorities in the
regions (State, local, or Tribal), how long it has been operating, and
what programs or services are currently provided. Specifically describe
current epidemiologic capacity and history of support for such
activities.
b. Provide a physical location of the TEC and area to be served by
the proposed program including a map (include the map in the
attachments), and specifically describe the office space and how it is
going to be paid for.
c. If applicable, identify the past three years of grants relevant
to public health and/or epidemiology, including past awarded
cooperative agreements from the DEDP, dates of funding, and key project
accomplishments (do not include copies of reports).
(2) Program Objective(s) (35 Points)
Approach, Results and Benefits for the entire 5-year funding period
by year.
a. State in measurable and realistic terms the objectives and
appropriate activities to achieve each objective for the projects as
listed in the Recipient Activities.
b. Identify the expected results, benefits, and outcomes or
products to be derived from each objective of the project.
c. Include a work-plan for each objective that indicates when the
objectives and major activities will be accomplished and who will
conduct the activities by each year for the entire five-year period.
(3) Program Evaluation (10 Points)
a. Define the criteria to be used to evaluate activities listed in
the work-plan under the Recipient Activities and BRFSS project.
b. Explain the methodology that will be used to determine if the
needs identified for the objectives are being met and if the outcomes
identified are being achieved.
c. Describe how evaluation findings will be disseminated to
stakeholders.
(4) Organization Capabilities and Qualifications (10 Points)
a. Explain the management and administrative structure of the
organization including documentation of current certified financial
management systems either from the Bureau of Indian Affairs, IHS, or a
Certified Public Accountant and an updated organizational chart
(include chart in the attachments).
b. Describe the ability of the organization to manage a program of
the proposed scope.
c. Provide position descriptions and biographical sketches of key
personnel, including those of consultants or contractors in the
Appendix. Position descriptions should very clearly describe each
position and its duties, indicating desired qualification and
experience requirements related to the project. Resumes should indicate
that the proposed staff is qualified to carry out the project
activities. Applicants with expertise in epidemiology will receive
priority.
(5) Behavioral Risk Factor Surveillance System (BRFSS) (15 Points)
a. Describe the BRFSS project specifically for AI/AN populations to
evaluate the health risk behaviors to include, at a minimum, CDC's
``core'' BRFSS.
b. Identify a statistically representative sample of Tribal and
urban communities that will participate in the BRFSS.
c. Describe how the applicant will define and complete the
following items as part of their proposal: develop a protocol for
conducting the BRFSS; develop a sampling method and recruitment
strategy; meet with the Tribal Health Director, Health Board, and
Tribal Council for review and approval; submit protocols for IRB
review; select and train interviewers for the BRFSS.
d. Describe how to develop a data base to enter data collected on
the BRFSS.
e. Provide a dissemination plan that includes a project overview,
dissemination goals, targeted audiences, key messages, details of the
dissemination plan and evaluation.
f. Complete a separate budget for the BRFSS project.
(6) Budget (5 Points)
a. Provide a categorical budget by line item and by each year for
the entire five-year period, including a separate budget for the BRFSS
project.
b. Provide a justification by line item in the budget including
sufficient cost and other details to facilitate the determination of
cost allowability and relevance of these costs to the proposed project.
The funds requested should be appropriate and necessary for the scope
of the project.
c. If use of consultants or contractors are proposed or
anticipated, provide a detailed budget and scope of work that clearly
defines the deliverables or outcomes anticipated.
[[Page 33320]]
B. Review and Selection Process
Each application will be prescreened by the DGM staff for
eligibility and completeness as outlined in the funding announcement.
Incomplete applications and applications that are non-responsive to the
eligibility criteria will not be referred to the Objective Review
Committee (ORC).
To obtain a minimum score for funding by the ORC, applicants must
address all program requirements and provide all required
documentation. Applicants that receive less than a minimum score and/or
are incomplete will be considered to be ``Disapproved'' and will be
informed via e-mail or regular mail by the IHS Program Office of their
application's deficiencies. A summary statement outlining the strengths
and weaknesses of the application will be provided to each disapproved
applicant. The summary statement will be sent to the Authorized
Organizational Representative (AOR) that is identified on the face page
of the application within 60 days of the completion of the objective
review.
Award Date(s): September 16, 2011.
The DEDP will recommend successful applicants for funding based on
the results of the objective review.
VI. Award Administration Information
1. Award Notices
The Notice of Award (NoA) will be initiated by DGM and will be
mailed via postal mail or e-mailed to each entity that is approved for
funding under this announcement. The NoA will be signed by the Grants
Management Officer and is the authorizing document for which funds are
dispersed to the approved entities. The NoA will serve as the official
notification of the grant award and will reflect the amount of Federal
funds awarded, the purpose of the grant, the terms and conditions of
the award, the effective date of the award, and the budget/project
period. The NoA is the legally binding document and is signed by an
authorized grants official within the IHS.
2. Administrative Requirements
Grants are administered in accordance with the following
regulations, policies, and OMB cost principles:
A. The criteria as outlined in this Program Announcement.
B. Administrative Regulations for Grants:
45 CFR, part 92, Uniform Administrative Requirements for
Grants and Cooperative Agreements to State, Local and Tribal
Governments.
45 CFR, part 74, Uniform Administrative Requirements for
Awards and Subawards to institutions of Higher Education, Hospitals,
Other Non-profit Organizations, and Commercial Organizations.
C. Grants Policy:
HHS Grants Policy Statement, Revised 01/07.
D. Cost Principles:
Title 2: Grants and Agreements, Part 225--Cost Principles
for State, Local, and Indian Tribal Governments (OMB A-87).
Title 2: Grants and Agreements, Part 230--Cost Principles
for Non-Profit Organizations (OMB Circular A-122).
E. Audit Requirements:
OMB Circular A-133, Audits of States, Local Governments,
and Non-profit Organizations.
3. Indirect Costs
This section applies to all grant recipients that request
reimbursement of indirect costs in their grant application. In
accordance with HHS Grants Policy Statement, Part II-27, IHS requires
applicants to obtain a current indirect cost rate agreement prior to
award. The rate agreement must be prepared in accordance with the
applicable cost principles and guidance as provided by the cognizant
agency or office. A current rate covers the applicable grant activities
under the current award's budget period. If the current rate is not on
file with the DGM at the time of award, the indirect cost portion of
the budget will be restricted. The restrictions remain in place until
the current rate is provided to the DGM.
Generally, indirect costs rates for IHS grantees are negotiated
with the Division of Cost Allocation https://rates.psc.gov/and the
Department of Interior (National Business Center) https://www.aqd.nbc.gov/services/ICS.aspx. If your organization has questions
regarding the indirect cost policy, please call (301) 443-5204 to
request assistance.
4. Reporting Requirements
Failure to submit required reports within the time allowed may
result in suspension or termination of an active grant, withholding of
additional awards for the project, or other enforcement actions such as
withholding of payments or converting to the reimbursement method of
payment. Continued failure to submit required reports may result in one
or both of the following: (1) The imposition of special award
provisions; and (2) the non-funding or non-award of other eligible
projects or activities. This requirement applies whether the
delinquency is attributable to the failure of the grantee organization
or the individual responsible for preparation of the reports.
The reporting requirements for this program are noted below.
A. Progress Reports
Program progress reports are required annually. These reports will
include a brief comparison of actual accomplishments to the goals
established for the period, or, if applicable, provide sound
justification for the lack of progress, and other pertinent information
as required. A final report must be submitted within 90 days of
expiration of the budget/project period.
B. Financial Reports
Federal Financial Report, (FFR- SF-425), Cash Transaction Reports
are due every calendar quarter to the Division of Payment Management,
Payment Management Branch, HHS at: https://www.dpm.gov Failure to submit
timely reports may cause a disruption in timely payments to your
organization.
Grantees are responsible and accountable for accurate information
being reported on all required reports; the Progress Reports, Financial
Status Reports and Federal Financial Report.
C. Federal Subaward Reporting System (FSRS)
This award may be subject to the Transparency Act subaward and
executive compensation reporting requirements of 2 CFR Part 170.
The Transparency Act requires the Office of Management and Budget
to establish a single searchable database, accessible to the public,
with information on financial assistance awards made by Federal
agencies. The Transparency Act also includes a requirement for
recipients of Federal grants to report information about first-tier
subawards and executive compensation under Federal assistance awards.
Effective as of October 1, 2010, IHS implemented new Terms of
Award. All New (Type 1) IHS grant and cooperative agreement awards
issued on or after October 1, 2010 may be subject to the Transparency
Act Subaward and Executive Compensation reporting requirements.
Additionally, all IHS Renewal (Type 2) grant and cooperative agreement
awards and Competing Revision awards (Competing T-3s) issued on or
after October 1, 2010 may also be subject to the following award term.
Further guidance on Renewal and Competing Revision awards is expected
to be provided as it becomes available.
Please visit the IHS Grants Policy Web site at https://www.ihs.gov/NonMedical
[[Page 33321]]
Programs/gogp for additional information on award applicability
information.
Telecommunication for the hearing impaired is available at: TTY
(301) 443-6394.
VII. Agency Contacts
For program-related information: Selina T. Keryte, Project Officer,
Division of Epidemiology & Disease Prevention, Indian Health Service,
5300 Homestead NE, Albuquerque, NM 87110, (505) 248-4132 or
Selina.keryte@ihs.gov.
For specific grant-related and business management information: Andrew
Diggs, Grants Management Specialist, Division of Grants Management,
Indian Health Service, 801 Thompson Avenue, TMP 360, Rockville, MD
20852, (301) 443-2262 or Andrew.diggs@ihs.gov.
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of the facility) in which regular or routine education,
library, day care, health care or early childhood development services
are provided to children. This is consistent with the HHS mission to
protect and advance the physical and mental health of the American
people.
Dated: May 31, 2011.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2011-14131 Filed 6-7-11; 8:45 am]
BILLING CODE 4165-16-P