Part I Overview Information



U.S.
Department of Health and Human Services (HHS)

Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)

Components of Participating Organizations
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP/CDC), (http://www.cdc.gov/nccdphp/)
Division of Diabetes Translation (DDT), (http://www.cdc.gov/diabetes/)

Title:  Diabetes Prevention and Control in the Americas

The HHS/CDC policies, guidelines, terms, and conditions stated in this announcement can differ from those used by the HHS National Institutes of Health

Authority
This program is authorized under Section 317(k)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2), Section 301(a) of the PHS Act, 42 U.S.C. 241(a), Section 307(a) and (b) of the PHS Act, 42 U.S.C. 242l(a) and (b).  

Announcement Type
New

Request For Applications (RFA) Number: RFA-DP-06-001

Catalog of Federal Domestic Assistance Number(s):  93.068

Key Dates
Release Date:  May 11, 2006
Letter of Intent Receipt Date:  May 22, 2006 
Application Receipt Date: June 20, 2006
Peer Review Date: Week of July 17, 2006    
Council Review Date: Not Applicable
Earliest Anticipated Start Date: August 31, 2006
Expiration Date: 6/21/2006

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
        B. Eligible Individuals
    2.Cost Sharing or Matching
    3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
        A. Receipt and Review and Anticipated Start Dates
            1. Letter of Intent
        B. Sending an Application
        C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
        A. Additional Review Criteria
        B. Additional Review Considerations
        C. Sharing Research Data
        D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements  
        A. Cooperative Agreement Terms and Conditions of Award
            1. Principal Investigator Rights and Responsibilities
            2. CDC Responsibilities
            3. Collaborative Responsibilities

    3. Reporting

Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)
    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

HHS/CDC and its National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area of Diabetes, and is in alignment with the HHS/CDC NCCDPHP performance goal to increase the capacity of diabetes-control programs to address the prevention of diabetes and its complications at the community level.  For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/

The purpose of this funding opportunity is to support research that will expand our knowledge of appropriate and effective surveillance, prevention, and control strategies for implementing and managing diabetes care in two geographically distinct areas in the Americas:  the U.S.-Mexico border region and the countries of Central America (defined as Guatemala, El Salvador, Honduras, Nicaragua, Costa Rica, Panama, and Belize).  This research will increase the capacity of these regions to address the prevention and control of diabetes and its complications at the country, regional, municipal, and local community levels.

The U.S.-Mexico Border Diabetes Prevention and Control Project component of this RFA addresses the objective of “Healthy Border 2010” to reduce morbidity and mortality from diabetes mellitus in the six Mexican States and four U.S. States along the common border.  “Healthy Border 2010” is the first binational program that embraces common health elements from the United States and Mexico.  For more information, see http://www.borderhealth.org/files/res_63.pdf

Nature of the Research Opportunity

This RFA solicits applications in the form of cooperative agreements to conduct research that will expand the preliminary findings of diabetes-research projects in the Americas.  Component 1 of this RFA, the U.S.-Mexico Border Diabetes Prevention and Control Project (U.S.-MXBDPCP), will implement the Community Intervention Pilot Research Study in the ten States along the border between the United States and Mexico.  This project will use the findings from a previous Prevalence Household Study to develop, implement, and evaluate strategies that will improve preventive, self-management behavior of persons with diabetes, and decrease risk behaviors of family members of persons with diabetes.  The U.S.-MXBDPCP will implement the Community Health Worker Model, and evaluate its effectiveness in addressing the needs of persons living with diabetes and in reaching Spanish-speaking populations with messages to help them learn how to prevent and control diabetes.  Findings from the U.S.-MXBDPCP will help develop an evidence-based community intervention program for replication in communities throughout the region. 

The second component of this RFA, the Central America Diabetes Initiative (CAMDI), will use the findings and extend the infrastructure of a previous CAMDI study to develop and pilot new approaches and systems for the surveillance of diabetes that will facilitate the continuous assessment of diabetes risk factors and the prevalence of complications in the countries of Central America.  CAMDI will initiate the establishment of regional centers in Central America that will conduct diabetes studies and additional epidemiologic and economic research that will lead to new knowledge regarding the burden of diabetes in the region for use in public health decision-making.

Background

Diabetes mellitus and lesser forms of glucose intolerance, particularly impaired glucose tolerance, have become increasingly prevalent in many populations around the world.  Complications from diabetes, such as coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure, and blindness often result in increased disabilities, reduced life expectancy, and enormous health-care costs for virtually every society.  The threat of increasing diabetes is particularly challenging in Central and South America, where large segments of the population live in poverty, and the countries in the region lack the public health infrastructure to carry out basic surveillance, health-promotion and disease prevention programs.   

In the U.S.-Mexico border region, Latinos make up approximately 88.2 percent of the population.  Findings from Phase 1 of the five-year U.S.-MXBDPCP revealed an overall prevalence of diabetes in the border region of 15.7 percent in the adult population (11.4 percent diagnosed and 4.3 percent undiagnosed), or approximately 1.2 million people 18 years of age and older.  The study found pre-diabetes in one million, million or approximately 14 percent of adults 18 years of age and older.  The population of approximately 5.4 million overweight or obese adults, who live in an area considered medically underserved, compounds this disproportionate burden of diabetes in the U.S.-Mexico border region.  

The Central American region has few ongoing surveillance systems for diabetes or other chronic disease conditions; however, preliminary data from CAMDI, a five-year study in Guatemala, Nicaragua, Honduras, El Salvador, and Costa Rica, indicate there is a high prevalence of diabetes and related risk factors present in the region.  The lack of surveillance programs, as well as epidemiologic and economic studies in this region, continues to be a barrier to the development of effective public health programs to prevent and control diabetes and its complications in these countries.

Diabetes is certain to be one of the most challenging health problems facing every country, not only from the fiscal aspect, but most important, in the cost in quality of life to persons with diabetes, their families, and society.  Without research to identify appropriate surveillance and prevention and control strategies the burden of diabetes will continue to increase globally.  In many parts of the world, research that leads to regional, culturally relevant approaches and interventions will be necessary to develop sustainable public health programs to prevent and control diabetes and other chronic diseases.

Scientific Knowledge to Be Achieved Through This Funding Opportunity

The research supported by this RFA will expand our knowledge of appropriate and effective surveillance, prevention, and control strategies to support the implementation and management of diabetes care in the U.S.-Mexico border region and in the countries of Central America. 

Component 1: U.S.-Mexico Border Diabetes Prevention and Control Project (U.S.-MXBDPCP)

The U.S.-MXBDPCP will support the implementation of the Community Intervention Pilot Research Study to enhance our understanding of the natural history, complications, and risk factors of diabetes mellitus in the adult border population.  The U.S.-MXBDPCP will use the Community Health Worker Model, a family-based intervention expected to bring about behavioral changes in persons with diabetes and high-risk members of their families.  An essential component of this intervention is the use of Community Health Workers/Promotores de Salud (CHWs/PdS).  Findings from the U.S.-MXBDPCP should provide evidence the Community Health Worker Model has a beneficial impact on the health status and use of preventive health behaviors among persons who have or are at risk for diabetes. 

The U.S.-MXBDPCP will also assess barriers to the expansion and implementation of community-based intervention programs in the U.S.-Mexico border region, particularly as they relate to integrating and sustaining community health workers in the health-care delivery system.  It is the goal of the U.S.-MXBDPCP to expand access to health care for persons with diabetes in communities and municipalities along the border; enhance the development of a binational diabetes network to facilitate communication in both Spanish and English; provide information-exchange and resource-sharing; and provide knowledge on how to implement diabetes-related activities in a more cost-effective manner. 

Component 2: Central America Diabetes Initiative (CAMDI)

In the countries of Central America, CAMDI will support surveillance, epidemiologic, and economic studies that will lead to new knowledge regarding the burden of diabetes, its complications and costs, the identification of modifiable risk factors, and effective interventions that will reduce the impact of the disease in the region.  CAMDI should enhance the region’s capacity for public health research by developing sustainable, national surveillance systems for diabetes.  Additional epidemiologic and economic studies should identify effective interventions at the individual, community, and health system level that will reduce the impact of diabetes and its complications.

It is the long-term goal of CAMDI to support the countries of Central America to reduce morbidity and mortality from diabetes and other chronic disease conditions by facilitating collaboration among Government and public and private organizations, and by encouraging scientific interaction, planning, and resource-sharing at the local, regional, and national level.

Experimental Approach and Research Objectives

Component 1:  U.S.-Mexico Border Diabetes Prevention and Control Project (U.S.-MXBDPCP)

Using an established, standardized, multi-site, population-based approach, the U.S.-MXBDPCP will implement a family-based intervention delivered by Community Health Workers/Promotores de Salud (CHWs/PdS).  The project will use quantitative and qualitative methods to evaluate the Community Health Worker Model and to develop and market a regional, culturally appropriate intervention model that communities and health-care systems can implement, to improve the care of persons with diabetes and those at risk for developing the disease.  The study will conduct a cost study to evaluate the Community Health Worker Model as a population-oriented strategy for diabetes prevention and control intervention in the U.S.-Mexico border region.

The research objectives for the U.S.-MXBDPCP are to accomplish the following:

1.  Increase access to education, information, and care for people with diabetes and those at risk of developing the disease;

2.  Improve preventive self-management behavior by persons with type 2 diabetes;

3.  Improve preventive health behaviors for diabetes among high-risk family members;

4.  Improve the delivery of diabetes health care at the clinic and community levels; and

5.  Increase knowledge of diabetes and improve skills of community, lay health care workers.

The U.S.-MXBDPCP will evaluate the Community Health Worker Model, which uses CHWs/PdS as members of the health care team, by examining the following effectiveness indicators among the intervention populations and a control group:

1.  Changes in indicators of health risk (i.e. overweight/obesity, glycemic control, and smoking) in persons who are living with diabetes;

2.  Adoption of healthy behaviors (i.e. physical activity, better diet, and smoking cessation) in persons who are living with diabetes and their high-risk family members;

3.  Changes in health risk factors (i.e. overweight/obesity and smoking) among relatives at high-risk for diabetes; and

4.  Number of requests for health care among participants and their family members. 

The U.S.-MXBDPCP will use findings from previous research, including data gathered from the  Prevalence Household Study, a household survey used to determine the prevalence of pre-diabetes, diabetes, obesity, overweight, hypertension, and diabetes preventive health practices, to serve as a baseline and evaluate the project.

Component 2:  Central America Diabetes Initiative (CAMDI)

The goals of CAMDI are to accomplish the following: 1) develop and enhance capacity for public health research, and 2) stimulate surveillance, epidemiology and economics studies related to diabetes in the countries of Central America.  CAMDI will establish regional centers in Guatemala, Nicaragua, Honduras, El Salvador, Costa Rica, Panama, and Belize to coordinate multi-center studies, pilot-test new approaches, and implement workshops/training courses for surveillance, epidemiologic, and cost studies.  The objectives for CAMDI are to accomplish the following:

1.  Conduct a planning year during which the study will analyze, review and summarize epidemiologic and surveillance data from Central America (including the previous CAMDI study) and identify key needs for future surveillance and epidemiologic projects;

2.  Establish a one-to-three-year plan that includes operational and planning objectives, a formal workgroup structure, and a timeline for developing sustainable surveillance and epidemiologic research programs;

3.  Establish sustainable systems, infrastructure, and networks for diabetes and related chronic disease surveillance, including epidemiologic and economic research;

4.  Initiate and evaluate new surveillance approaches for diabetes-related complications, costs, and risk factors;

5.  Assess the current burden and trends in pre-diabetes and diabetes, including risk factors and complications (microvascular and macrovascular complications and disability) among the populations of Central America;

6.  Examine the costs related to diabetes and interventions designed to impact the disease;

7.  Identify factors related to the individual, communities, and health systems that could influence risk for diabetes and related complications; and

8.  Test the effectiveness and cost-effectiveness of practical public health programs to influence the incidence of diabetes and its complications.

The awardee should use year-one monies primarily for planning activities for objectives #1 and #2 and implementing the regional coordinating centers.  The awardee should carry out objectives #3-8 during project years two and three, subject to continuation and availability of funding.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the HHS/CDC (U01) cooperative agreement award mechanism.

This funding opportunity uses HHS just-in-time budget concepts.  It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).  Applicants must submit a detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The CDC U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and HHS/CDC staff are substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

This RFA is a one-time solicitation.  The total project period for an application submitted in response to this RFA may not exceed three years.

2. Funds Available

The participating CIO, HHS/CDC/NCCDPHP intends to commit approximately $639,000 in Fiscal Year (FY) 2006 to fund two cooperative agreements.  Approximately $1.8 million is available for the entire three-year project period; however, subject to performance, additional funds may be available for years two through three for CAMDI.  The FY 2006 funding allocation for the two components for the 12-month budget period, in total costs (direct and indirect), is as follows: 

1. Component 1:  U.S.-Mexico Border Diabetes Prevention and Control Project - $539,000

2. Component 2:  Central America Diabetes Initiative - $100,000

Applicants may apply for one or both components of this RFA; however, applicants must submit separate applications for each component.  The budget for each component may not exceed the stated funding allocation for the component.  The anticipated start date for these new awards is August 31, 2006.

All estimated funding amounts are subject to availability of funds.

If applicants request a funding amount greater than the ceiling of the award range, HHS/CDC will consider your application non-responsive, and it will not enter into the review process.  HHS/CDC will notify applicants that their application did not meet the submission requirements.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

Institution eligibility for both components is limited to those that 1) have experience in conducting surveillance, epidemiological studies, and public health intervention programs on chronic disease prevention and control in the Americas; and 2) have the capacity and infrastructure to conduct multi-site/country public health research projects in the Americas.

For Component 1, the U.S.-MXBDPCP, institution eligibility is also limited to those that possess or have access to population-based diabetes datasets within the last five years from the U.S.-Mexico border region.

Institutions interested in translational research to prevent and treat obesity and diabetes in the U.S. should refer to PA 06-068 Planning Grants for Translational Research for the Prevention and Control of Diabetes and Obesity (R34) and PA-02-153 Translational Research for the Prevention and Control of Diabetes (R18) (http://grants.nih.gov/grants/guide/pa-files/PA-02-153.html) issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his or her institution to develop an application for support.  Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for HHS/CDC programs.

Eligible Principal Investigators for both components must have experience in leading international teams in chronic disease research, including surveillance, prevention, and control projects.  Evidence of such experience should be provided in curricula vitae and publications within the last five years.

2. Cost-Sharing or Matching

Cost-sharing or matching funds are not required for this program.   Although matching funds are not required, preference may go to organizations that can leverage additional funds to contribute to program goals.  If applicants receive funding from other sources to underwrite the same or similar activities, or anticipate receiving such funding in the next 12 months, they must detail how the disparate streams of financing complement each other. 

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/gps/

3. Other-Special Eligibility Criteria

HHS/CDC will use the following criteria to determine an applicants’ eligibility, and they will apply to both components: 

For Component 1, the U.S.-MXBDPCP, the following other-special eligibility criteria apply, and will be used to determine applicants’ eligibility:

For Component 2, CAMDI, the following other-special eligibility criteria apply, and will be used to determine applicants’ eligibility:

If an application is incomplete or non-responsive to the special requirements listed in this section, it will not  enter into the review process.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

Section IV. Application and Submission Information


1. Address to Request Application Information

The HHS U.S. Public Health Service (PHS) form 398 application instructions are available on the Internet at the following address:   http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Applicants must prepare their submissions using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System number as the universal identifier when applying for Federal grants or cooperative agreements.  Applicants may obtain a D&B number by calling (866) 705-5711, or through the web at http://www.dnb.com/us/.  Applicants should enter their D&B number on line 11 of the face page of the PHS 398 form.

Applicants must type the title and number of this funding opportunity on line 2 of the face page of the application form, and must check the YES box.

Several special provisions apply to applications submitted by foreign organizations:

3. Submission Dates and Times

All requested information must be received in the HHS/CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date.  If applicants submit materials by the United States Postal Service or commercial delivery service, they must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If HHS/CDC receives your submission after closing due to: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. 

This announcement is the definitive guide on LOI and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it.  You will receive notification that you did not meet the submission requirements.

Otherwise, HHS/CDC will not notify you upon receipt of your submission.  If you have a question about the receipt of your application, first contact your courier.  If you still have a question, contact the PGO-TIMS staff at: 770-488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for HHS/CDC to process and log submissions.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date:  May 22, 2006 
Application Receipt Date:  June 20, 2006
Peer Review Date:  Week of July 17, 2006
Council Review Date:  Not Applicable
Earliest Anticipated Start Date: August 31, 2006  

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A

The letter of intent should be sent to:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-6295
FAX:   (770) 488-8046
Email: bjc4@cdc.gov

3.B. Sending an Application

Applications follow the HHS/PHS 398 instructions for content and formatting of your applications.  If the instructions in this announcement differ in any way from the HHS/PHS 398 instructions, follow the instructions in this announcement.

Applications must be prepared using the research grant applications found in the HHS/PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and one signed photocopy in one package to the following address:

Technical Information Management Section – RFA DP-06-001
CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341

At the time of submission, three additional copies of the application, including the appendix material, must be sent to:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-6295
Email: bjc4@cdc.gov

3.C. Application Processing

HHS/CDC must receive applications on or before the application receipt date(s) described above (Section IV.3.A.).  If HHS/CDC receives an application after that date, we will return it to the applicant without review.  Upon receipt, HHS/CDC will evaluate applications for completeness and responsiveness.  HHS/CDC will not review incomplete and non-responsive applications.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS/PHS Grants Policy Statement.

Additional guidance can be found at NIH Grants Policy Statement.

Restrictions, which applicants must take into account while writing their budgets, are as follows:

6. Other Submission Requirements

Applicants should follow the general instructions in the HHS/PHS 398; however, the following other submission requirements apply to both components and applicants should include them in the application: 

For Component 1, the U.S.-MXBDPCP, the following other submission requirements apply and applicants should include them in the application:

For Component 2, CAMDI, the following other submission requirements apply and should be included in the application: 

Applicants’ research plans should address activities they will conduct over the entire project period.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.  "Award Administration Information.”

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement.  If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. 

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data collected and how the investigator is planning to share the data.  Applicants should describe briefly the expected schedule for data-sharing, the format of the final dataset, the documentation they will provide, whether or not they will provide any analytic tools, whether or not a data-sharing agreement will be required, and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data-sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing could also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application.  The HHS/CDC data-sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how they will share final research data.

Reviewers will assess t he reasonableness of the data-sharing plan; however, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

HHS/ PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (HHS/PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a plan for sharing research resources.

HHS/CDC program staff will consider the adequacy of the resources-sharing plan and any related data sharing plans when making recommendations about funding applications. The effectiveness of the resource sharing will form part of the evaluation of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://www.cdc.gov/od/pgo/forminfo.htm ).  See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

HHS/CDC will consider only the review criteria described below in the review process, as well as the following in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by HHS/CDC/NCCDPHP, in accordance with the review criteria stated below.  The peer review group will include representatives from other HHS agencies, including the National Institutes of Health, the Health Resources and Services Administration, the Office of Health Promotion and Disease Prevention within the Office of Public Health and Science, and the U.S. Agency for International Development.

As part of the initial merit review, the application will:

The goals of the HHS/CDC-supported research are to advance the understanding of health promotion; prevent disease, injury, and disability; and enhance preparedness.  In the written comments, reviewers will evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. 

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, care, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

For Component 1, the U.S.-MXBDPCP:  Does the application adequately describe a) the population source (including size, age, ethnicity, medical insurance status, socio-economic status, and geographic distribution); b) the partnership/network(s) which will provide access to information to access the adult type 2 cases of diabetes within this population source; c) a plan for recruiting adults with type 2 diabetes in the region and family members at high risk for developing type 2 diabetes, and retaining them for long-term follow-up; d) data sources (community/municipal health centers); e) how the study will ascertain the population size (denominator) for evaluation of the family-based intervention over the three years of the study; and f) strategies for the follow-up regional household survey to evaluate the natural history of type 2 diabetes and the long-term impact of quality of diabetes care?

For Component 2, CAMDI:  Does the applicant adequately describe: a) the approach for establishing and expanding sustainable surveillance systems and programs for epidemiologic and cost investigations; b) the organizational structure to be maintained and a communication plan that ensures participation among the Central American investigators and institutions and HHS; c) regionally appropriate surveillance approaches and study designs; d) the procedure for establishing regional coordinating centers; and e) the procedure for soliciting, selecting, and administering the activities of the coordinating centers within the Central America region (e.g. multi-center studies, implementing workshops/training courses, and soliciting, evaluating, and administering pilot surveillance and epidemiological research approaches)?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Does the project employ methods that are appropriate for the region and utilize resources that are available to the region?

Investigators: Are the investigators appropriately trained and well-suited to carry out this work? Are they bilingual in English and Spanish?  Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

For Component 1, the U.S.-MXBDPCP:  Does the Principal Investigator (PI) or co-PI have a history of conducting competitively funded, peer reviewed research on the epidemiology of type 2 diabetes with adults?  Is there evidence of prior experience in working collaboratively to carry out a population-based, multi-site study or standard protocol?  Does the project team include significant expertise in diabetes type 2, access to health care, community intervention research, and with the Community Health Workers/Promotores de Salud model?

For Component 2, CAMDI:  Is the PI an experienced biostatistician, epidemiologist, physician, or other professional with experience in directing a coordinating center for a collaborative, population-based, large-scale epidemiological research project?  Does the project team involve investigators who are working or have worked in the Central American region in key roles?  Does the project team include epidemiologic and statistical staff from the Central American region that will devote substantial time to designing new studies, conducting surveillance activities and conducting data analysis methods for use in the study?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

For Component 1, the U.S.-MXBDPCP:  Is there an institutional research infrastructure to carry out large, complex, population-based projects, as well as facilities to perform in-person visits, and handle and process biological samples?

For Component 2, CAMDIAre there physical facilities, data-management and computer resources, and facilities for data retrieval identified in the region for this study?  Are letters of support provided by potential collaborating investigators and institutions from the region, including national Governments?

2.A. Additional Review Criteria:

In addition to the above criteria, HHS/CDC will consider the following items in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: HHS/CDC will assess involvement of human subjects and protections from research risk relating to their participation in the proposed research (see the Research Plan, Section E on Human Subjects in the HHS/PHS Form 398). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The evaluation of the budget should not affect the priority score.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers; however, the proposed data-sharing plan will not be factored into the determination of scientific merit or the priority score.  The presence of a data-sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

HHS/ PHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication.  Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.  Investigators responding to this funding opportunity should include a plan on sharing research resources.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

Program staff will consider the adequacy of the resources-sharing plan when making recommendations about funding applications.  Program staff can negotiate modifications of the data- and resource-sharing plans with the awardee before recommending funding of an application.  The final version of the data- and resource-sharing plans negotiated by both will become a condition of the award of the grant.  HHS/CDC will evaluate the effectiveness of the resource sharing as part of the administrative review of each non-competing Grant Progress Report (HHS/PHS 2590 http://www.cdc.gov/od/pgo/forminfo.htm). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

HHS/CDC expects to make this award on or about August 31, 2006.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will receive a written critique called a Summary Statement.

HHS/CDC will contact those applicants under consideration for funding for additional information.

HHS/CDC will provide a formal notification in the form of a Notice of Award (NoA) to the applicant organization.  The NoA signed by the Grants Management Officer (GMO) is the authorizing document.  HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application. 

Selection of the application for award is not an authorization to begin performance.  Any cost incurred before receipt of the NoA is at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about policy requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.  Additional requirements are available in Section VIII. Other Information of this document, or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
 

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, HHS/PHS, and HHS/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement CDC U01 an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although the awardees and the HHS/CDC may share specific tasks and activities, as defined above.

2.A.1. Rights and Responsibilities of the Principal Investigator

The Principal Investigator (PI) of both Component 1 and 2 will have the primary responsibility for the following:

1. Promoting and facilitating a multi-site and collaborative environment among the project site participants;

2. Establishing and maintaining networks or partnerships with community-based organizations, health-care providers, and the diabetes health-care systems that have access to information on adults with type 2 diabetes;

3. Developing the methodology and protocol of the study; coordinating and conducting on-going data collection and follow up, quality control, data analysis and interpretation; and preparing peer-reviewed publications in English and Spanish for presentation of findings.   The PI will develop study protocol(s) and manuals of operation in collaboration with other study investigators;   

4. Based on input from the Steering Committee (SC), the PI will prepare and update the protocols and manuals of operation, provide materials to aid in patient recruitment and retention, and ensure the training and certification of staff at the study sites as outlined in the study protocol;

5. Ensuring the submissions of the standard protocol in English and Spanish through each cooperating institution’s approval processes, and/or Ethical Boards of Ministries of Health, and the HHS/CDC Institutional Review Board (IRB).  The CDC IRB will review and approve the protocol initially, and on at least an annual basis, until the research project is completed;

6. Obtaining an annual, updated local IRB approval;

7. Assuring and maintaining the confidentiality of all study data;

8. Establishing a database to accommodate data generated by each study site, developing a data-transmission system, and assessing the quality and completeness of data throughout the study; 

9. Providing statistical reports on the progress of the study at SC meetings and facilitating communication among investigators, including scheduling meetings and conference calls, developing agendas and documenting minutes, and maintaining membership rosters and committee lists; and

10.  Performing joint analysis with aggregate data, and communicating scientifically (via publications, abstracts, and presentations) the main and secondary findings pertaining to the goals of the study.

For Component 1, the U.S.-MXBDPCP, the PI will also have the primary responsibility for the following:

1.  Facilitating the formation of the Intervention and Scientific Standing Committees that include representatives from each of the ten state’s diabetes program, non-governmental agencies, and foundations;

2.  Facilitating the formation of the Steering Committee (SC) that consists of the members of the Intervention and Scientific Standing Committees; 

3. Managing the project as the National/Binational Director, treating the region as an epidemiological unit, and maintaining a collaborative binational framework;

4. Maintaining an effective and adequate management and staffing plan that includes a U.S. Coordinator, a Mexican Coordinator, and two field team leads;

5. Maintaining and managing data of the project, including previous diabetes-related data from the region;

6. Establishing, through subcontracts, a medical home for the study participants; and

7. Maintaining a participatory approach between clinics and participant communities.

For Component 2, CAMDI, the PI will also have the primary responsibility for the following:

1. Facilitating the formation of a Steering Committee that consists of representatives from each regional coordinating center and the Chairs of the Scientific and Intervention Standing Committees.  The Scientific and Intervention Standing Committees will be comprised of a representative from each national Government’s diabetes program;

2. Maintaining an effective and adequate management and staffing plan that is representative of the region; and

3. Maintaining a communication plan in English and Spanish that ensures participation among the Central American investigators, institutions, and HHS/CDC.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to U.S. Federal Government rights of access, consistent with current HHS, HHS/PHS, and HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities

An HHS/CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

1.  Support the grantees’ activities by collaborating and providing scientific and public health consultation and assistance in the development of activities related to the cooperative agreement;

2.  Assist in facilitating communication among study investigators in the development of common multi-site protocol(s); quality control; interim data-monitoring; and data analysis, interpretation, reporting, and coordination;

3.  Ensure adherence of human subjects requirements, and approval of study protocol by appropriate local IRBs, for all cooperating institutions that are participating in the research project;

4.  Facilitate movement of the initial research protocol through the CDC IRB, including by keeping the CDC IRB abreast of protocol amendments and facilitating annual reviews, if applicable;

5.  Serve as a consultant to the SC and the Intervention and Scientific Standing Committees, and provide written critiques of the protocol and recommendations to the SC and HHS/CDC; 

6.  Facilitate the process for obtaining Certificates of Confidentiality, in the form of 301(d), as appropriate; and

7.  Collaborate to produce technical reports or manuscripts for peer-reviewed publications in English and Spanish, as appropriate.  Provide assistance for joint analysis with aggregate data.

HHS/CDC reserves the right to terminate or curtail the study in the event of substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol.  HHS/CDC may also terminate or curtail the study if human subjects safety or ethical issues dictate a premature termination.  HHS/CDC may also terminate the project if there is failure to develop or implement a mutually agreeable collaborative protocol.

Additionally, an HHS/CDC agency program official or CIO program director, named in the award notice, will be responsible for the normal scientific and programmatic stewardship of the award.

2.A.3. Collaborative Responsibilities

Components will each have a Steering Committee (SC) that will have primary responsibility for developing common research designs, protocols and manuals of operation, for facilitating the conduct and monitoring of studies, and for reporting study results for their region.  The SC must approve the protocol, changes to protocols, and manuals of operation.  It will also develop policies related to access to patient data and specimens and ancillary studies.  The PI of each component will be responsible for the execution of the protocol and will provide progress reports to the SC.  The SC of each component will also establish guidelines for presentations at scientific meetings and for writing and publishing manuscripts on the findings of the study. 

The SC will have a minimum of two meetings each year and monthly teleconferences throughout the year, and will approve/disapprove recommendations through a consensus process. 

For Component 1, the U.S.-MXBDPCP, the SC will be comprised of the PI, representatives from the ten State Departments of Health, non-governmental agencies, and foundations.   The Executive Leadership Board (ELB) of the SC will function as the main governing board of the study.  The ELB will be comprised of the Principal Investigator/Binational Director, the Mexican and U.S. Coordinators, the Scientific Standing Committee Chair, the Intervention Standing Committee Chair, and the HHS/CDC Project Officers.  The ELB will meet initially to review and update IRB protocols and throughout the year to discuss the progress of the study.

For Component 2, CAMDI, the SC will be comprised of the Principal Investigator/National Director, Coordinators from each regional collaborative center, the Scientific Standing Committee Chair, the Intervention Standing Committee Chair, and the HHS/CDC Project Officers.  The SC will meet initially to develop the protocol and throughout the year to discuss the progress of the study. 

3. Reporting

Awardees must provide HHS/CDC with an original, plus two hard copies of the following reports:

1.  Interim/Grant Progress Report, (use form PHS 2590, OMB Number 0925-0001, rev. 9/04 as posted on the HHS/CDC website), no less than 120 days prior to the end of the current budget period.  The progress report will serve as the non-competing continuation application.

2.  Annual Progress Report, due 90 days after the end of the budget period.

3.  Financial status report, due 90 days after the end of each budget period.

4.  Final financial and performance reports, due 90 days after the end of the project period.

Awardees must forward these reports by the U.S. Postal Service or express delivery to the HHS/CDC Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal Government.

Section VII. Agency Contacts


HHS/CDC encourages your inquiries concerning this funding opportunity and welcomes the opportunity to answer questions from potential applicants.  Inquiries can fall into three areas,  scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-6295
Email:  bjc4@cdc.gov

2. Peer Review Contacts:

Scientific Review Administrator
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-8390
Email:  oer@cdc.gov

3. Financial or Grants Management Contacts:

Steward Nichols, Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
Koger Center-Colgate Building, MS K-75
2920 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-2788
Email: shn8@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341
Telephone:  770-488-2700
Email:  PGOTIM@cdc.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection 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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).  Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) within HHS to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

HHS/Public Health System Reporting Requirements
This program is subject to the HHS Public Health System Reporting Requirements. Under these requirements, all community-based, non-governmental organizations that submit health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A.  A copy of the face page of the application (SF 424).

B.  A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

1.  A description of the population to be served.

2.  A summary of the services to be provided.

3.  A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by OMB.

Smoke-Free Workplace Requirements
HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

Healthy People 2010
The HHS/Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at the following Internet address:   http://www.health.gov/healthypeople.


Lobbying Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition, no part of HHS/CDC appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself.  No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying."  That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited.  As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health.  Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health.  However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent HHS/CDC funds from being used to influence or promote pending legislation.  With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-HHS/CDC funds.  HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel.  These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment
It might be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in an HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardee employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC, must undergo a security-clearance process.

Research Integrity
The signature of the institution official on the face page of the application submitted under this Program Announcement is certifying compliance with the DHHS regulations in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science."

The regulation places several requirements on institutions receiving or applying for funds under the PHS Act, monitored by the HHS Office of Research Integrity's (ORI) Assurance Program.

For example:

Section 50.103(a) of the regulation states: "Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research must have an assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has established an administrative process, that meets the requirements of this subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS-sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant; and (2) Will comply with its own administrative process and the requirements of this Subpart."

Section 50.103(b) of the regulation states that: "an applicant or recipient institution shall make an annual submission to the [ORI] as follows: (1) The institution's assurance shall be submitted to the [ORI], on a form prescribed by the Secretary,...and updated annually thereafter...(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe."

An additional policy is added in the year 2000 that "requires research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with HHS/PHS funds.

Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  HHS/CDC considers this project a public health activity, consistent with the Standards for Privacy of Individually Identifiable Health Information, and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data
The Data Release Plan is the grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:

a. In a timely manner.

b. Completely, and as accurately as possible.

c. To facilitate the broader community.

d. Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www4.law.cornell.edu/uscode/html/uscode05/usc_sec_05_00000552----000-.html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 


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