ARRA Prevention Research Centers Comparative Effectiveness Research Program

To support Prevention Research Centers (PRCs) to perform comparative effectiveness research (CER) that compares innovative public health strategies or interventions, in new settings or populations (such as minorities or people with disabilities), and that preferably include new endpoints such as biologic
measures or combined clinical and social interventions.

The emphasis is to develop new scientific evidence that fills important knowledge gaps.

The interventions or strategies should be policy or environmental but are expected to consider what targeted outcome(s) are anticipated and how such outcomes will be achieved and to describe how the intervention will be implemented so it can be replicated by others.

Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.



Program Accomplishments

Fiscal Year 2009: No Current Data Available Fiscal Year 2010: In fiscal year 2010, it is anticipate that 35 applications will be received and 3-5 awards will be granted to perform CER comparing innovative public health strategies or interventions, in new settings or populations. Fiscal Year 2011: No Current Data Available

Uses and Use Restrictions

CDC has designated $10,000,000 in FY 2010 to fund 3-5 cooperative agreements to PRCs to compare innovative public health strategies or interventions, in new settings or populations (such as minorities or people with disabilities), and that preferable include new endpoints such as biologic measures or combined clinical and social interventions.

The use of and use restrictions are as follows: • Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual to support policy and system changes to perform comparative effectiveness research that compares innovative public health strategies or interventions, in new settings or populations (such as minorities or people with disabilities) preferably those that assess the impact of policy and environmental interventions, and includes new endpoints such as biologic measures or combined clinical and social interventions.

• Recipients may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment.

Any such proposed spending must be identified in the budget.

• The recipient must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

• Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protections against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

Federal funds may not be used on human subjects research until appropriate IRB approvals are in place.

.

Eligibility Requirements

Applicant Eligibility

The CDC program limits eligibility only to applicants who have applied for and have been selected as PRCs under Funding Opportunity Announcement DP09-001.

Competition is limited to PRCs under this CDC Program Announcement because (1) they are uniquely positioned to perform, oversee, and coordinate public health-oriented CER that promotes the field of prevention research due to their established relationships with community partners and previous experience with CER and (2) these PRCs recently competed for prevention research funding and were deemed to be the best applicants among research institutions that include all schools of public health and schools of medicine with preventive medicine residency programs.

The current recipients funded under Funding Opportunity Announcement DP09-001 are:
1.

Boston University
2.

Case Western Reserve University
3.

Columbia University
4.

Dartmouth College
5.

Emory University
6.

Harvard University
7.

Johns Hopkins University
8.

Morehouse School of Medicine
9.

New York University School of Medicine
10.

Ohio State University
11.

Oregon Health and Science University
12.

Saint Louis University (with Washington University)
13.

San Diego State University (with University of California at San Diego)
14.

Texas A&M Health Science Center
15.

Tulane University
16.

University of Alabama at Birmingham
17.

University of Arizona
18.

University of Arkansas for Medical Sciences
19.

University of California at Berkeley
20.

University of California at Los Angeles
21.

University of Colorado Denver
22.

University of Kentucky
23.

University of Maryland
24.

University of Massachusetts Medical School
25.

University of Michigan
26.

University of Minnesota
27.

University of New Mexico
28.

University of North Carolina at Chapel Hill
29.

University of Rochester
30.

University of South Carolina
31.

University of South Florida
32.

University of Texas Health Science Center at Houston
33.

University of Washington
34.

West Virginia University
35.

Yale University.

Beneficiary Eligibility

None.

Credentials/Documentation

No Credentials or documentation are required. This program is excluded from coverage under OMB Circular No. A-87.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. The funding opportunity announcement is located on the HHS/CDC website at the following Internet address: http://www.grants.gov. Only the forms package directly attached to a specific Funding Opportunity Announcement (FOA) can be used. Applicants must download the SF424 application forms through Grants.gov/Apply. If an applicant does not have access to the Internet, or if they have difficulty accessing the forms online, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIMS) staff. For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: PGOTIM@cdc.gov. HHS/CDC Telecommunications for the hearing impaired: TTY (770) 488-2783.

Award Procedures

All applications which are complete and responsive to the competitive funding opportunity announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with CDC peer review procedures. Incomplete and/or non-responsive applications or applications not following instructions given in the FOA will be returned to the applicant without further consideration. Applicants will be notified the application did not meet submission requirements. As part of the initial merit peer review, all applications will (1) undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score (2) these applications will be reviewed for scientific merit using current NIH/CDC criteria (a scoring system of 1-9 points) to evaluate the methods and scientific quality of the application; and (3) receive a written critique. A second level of review will be conducted by a panel of senior federal officials. This panel will review the ranked proposals to assure maximal impact and balance of the proposed research. Successful applicants will receive a Notice of Award (NOA) from the CDC Procurement and Grants Office. The NOA shall be the only binding, authorizing document between the recipient and CDC. The NOA will be signed by an authorized Grants Management Officer.

Deadlines

Contact the headquarters or regional office, as appropriate, for application deadlines.

Authorization

This program is authorized under the American Recovery and Reinvestment Act of 2009 (ARRA), Public Law 111-5; Public Health Service Act, 42 U.S.C. 241(a) and 247b(k)2 and Public Health Service Act, Title 42, Part 330u-5, Section 1706 , Public Law 111-5.

Range of Approval/Disapproval Time

From 120 to 180 days.

Appeals

Not Applicable.

Renewals

Not Applicable.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.

Length and Time Phasing of Assistance

Applications may be up to 2 years in duration. Method of awarding/releasing assistance: lump sum.

Post Assistance Requirements

Reports

Recipients of Federal awards from funds authorized under Division A of the ARRA must comply with all requirements specified in Division A of the ARRA Public Law 111-5), including reporting requirements outlined in Section 1512 of the Act.

For purposes of reporting, ARRA recipients must report on ARRA sub-recipient (sub-grantee and sub-contractor) activities as specified below.

Not later than 10 days after the end of each calendar quarter, starting with the quarter ending August 30, 2010 and reporting by September 10, 2010, the recipient must submit quarterly reports to HHS that will be posted to Recovery.gov, containing the following information: The total amount of ARRA funds under this award; (b) The amount of ARRA funds received under this award that were obligated and expended to projects or activities; (c) The amount of unobligated award balances; (d) A detailed list of all projects or activities for which ARRA funds under this award were obligated and expended, including: (1) the name of the project or activity; (2) a description of the project or activity; (3) an evaluation of the completion status of the project or activity; (4) an estimate of the number of jobs created and the number of jobs retained by the project or activity; and (5) for infrastructure investments made by State and local governments, the purpose, total cost, and rationale of the agency for funding the infrastructure investment with funds made available under this Act, and the name of the person to contact at the agency if there are concerns with the infrastructure investment; (e) Detailed information on any sub-awards (sub-contracts or sub-grants) made by the grant recipient to include the data elements required to comply with the Federal Funding Accountability and Transparency Act of 2006 (Public Law 109-282).

For any sub-award equal to or larger than $25,000, the following information will be required: (1) the name of the entity receiving the sub-award; (2) the amount of the sub-award; (3) the transaction type; (4) the North American Industry Classification System code or Catalog of Federal Domestic Assistance (CFDA) number; (5) program source; (6) an award title descriptive of the purpose of each funding action; (7) the location of the entity receiving the award; (8) the primary location of performance under the award, including the city, State, congressional district, and country; and (9) a unique identifier of the entity receiving the award and of the parent entity of the recipient, should the entity be owned by another entity.

(f) All sub-awards less than $25,000 or to individuals may be reported in the aggregate, as prescribed by HHS.

(g) Recipients must account for each ARRA award and sub-award (sub-grant and sub-contract) separately.

Recipients will draw down ARRA funds on an award-specific basis.

Pooling of ARRA award funds with other funds for drawdown or other purposes is not permitted.

(h) Recipients must account for each ARRA award separately by referencing the assigned CFDA number for each award.

Additional reporting requirements will be detailed in Funding Opportunity Announcements and included in the award notice.

Final financial status and performance reports are required 90 days after the end of the project period.

No cash reports are required.

No progress reports are required.

No expenditure reports are required.

An HHS/CDC agency program official or CIO program director will be responsible for the normal scientific ad programmatic stewardship of the award and will be named in the Notice of Award.

Responsibilities will include carrying out continuous review of all activities to ensure objectives are being met; participating in conference calls for the purposed of assessing overall progress and for program evaluation purposes; providing scientific consultation and technical assistance in the conduct of the project; and conducting site visits to determine the adequacy of the research and to monitor performance against project objectives.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133.

Records

Financial records, supporting documents, statistical records, and all other records pertinent to the grant program must be kept readily available for review by personnel authorized to examine HHS grant accounts. Financial records, supporting documentation, statistical records, and all other records pertinent to an award shall be retained for a minimum of 3 years, or until completion and resolution of any audit in process or pending resolution. In all cases records must be retained until resolution of any audit questions. Property records must be retained in accordance with 45 CFR 74.53 requirements.

Financial Information

Account Identification

75-1701-0-1-551.

Obigations

(Salaries) FY 09 $0; FY 10 est $10,000,000; FY 11 est $0

Range and Average of Financial Assistance

A total of $10 million will be awarded with an anticipated 3-5 awards. The total number of awards will depend upon the quality, duration, and costs of the applications received. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award also will vary.

Regulations, Guidelines, and Literature

Code of Federal Regulations 45 CFR Part 74. HHS Grants Policy Statement at: http://www.hhs.asrt/org/grantinformation/hhsgps107.pdf Grantees must also comply with the HHS Standard Terms and Conditions for ARRA funds, which can be found at http://www.hhs.gov/recovery/grantscontracts/recoverytermsconditions.html

Information Contacts

Regional or Local Office

None.

Headquarters Office

Elizabeth K Patterson, 4770 Buford Highway N.E. Mailstop K92, Atlanta, Georgia 30341 Email: BPatterson@cdc.gov Phone: (770) 488-6045.

Criteria for Selecting Proposals

Funding would be specifically directed to Prevention Research Centers to perform comparative effectiveness research that compares innovative public health strategies or interventions, in new settings or populations (such as minorities or people with disabilities), preferably includes CER that assesses the impact of policy and environmental interventions, and includes new endpoints such as biologic measures or combined clinical and social interventions. CDC will require applicants to specifically address in their applications plans for sustaining the impact of ARRA investments beyond the federal funding provided in the next 2 years. The following criteria will be used by the initial merit review panel in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of stated goals: significance, approach, innovation, investigators and environment. In addition, reviewers will consider the following additional items in the determination of the scientific and technical merit: budget, inclusion (adequacy of plans to address the needs of both genders, racial and ethnic minorities); protection of human subjects from research risk and privacy and security protections for patients. The following will be considered in making funding decisions: scientific merit of the proposed project as determined by peer review; availability of funds; relevance to program priorities; focus is on public health interventions or strategies in two or more of the following areas: community-level behavior change, environmental-level, and policy level; research addresses populations with major health disparities; and selected PRCs ensures geographic distribution of awards. PRCs will also need to demonstrate a continued plan for progress toward meeting HHS Action Plan prevention targets as demonstrated through reporting metrics outlined in the Plan.



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