03-5581. Intervention Research Grants To Promote the Health of People With Disabilities; Notice of Availability of Funds

Application Deadline: May 13, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301 and 317(C) of the Public Health Service Act, (42 U.S.C. 241 and 247b-4, as amended). The Catalog of Federal Domestic Assistance number is 93.184.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 research grant funds for intervention research directed to implementing health promotion programs for people with disabilities. This announcement is related to the “Healthy People 2010” focus area of Disability and Secondary Conditions.

The purpose of this program is to support research to develop, implement and measure the effectiveness of interventions that promote the health and wellness of people with disabilities and prevent secondary conditions. For the purpose of this announcement, disability is defined as a physical or cognitive limitation in a major life activity(ies). For the purpose of this announcement, health promotion will be defined as the process of enabling people to increase control over, and to improve their health.

Measurable outcomes of the program must be in alignment with the following performance goal of the National Center on Birth Defects and Developmental Disabilities: Monitor, characterize, and improve the health status of Americans with disabilities.

C. Eligible Applicants

Applications may be submitted by public and private non-profit organizations and by governments and their agencies; that is, universities, colleges, technical schools, research institutions, hospitals, other public and private nonprofit organizations, community-based organizations, faith-based organizations, state and local governments or their bona fide agents, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

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.

D. Funding

Availability of Funds: Approximately $2,275,000 will be available in FY 2003 to fund an estimated seven awards. It is expected that the average award will be $325,000, ranging from $310,000 to $340,000. The maximum funding level per year will not exceed $340,000, including both direct and indirect costs. Applications that exceed the funding cap of $340,000 will be excluded from the competition and returned to the applicant without review.

In addition to the above, one award will be made to an applicant whose intervention targets populations with limb loss or limb absence. This award will have a budget ceiling of $450,000, including both direct and indirect costs. Applications for limb loss intervention research that exceed the funding cap of $450,000 will be excluded from the competition and returned to the applicant without review.

It is anticipated that awards will begin on or before September 1, 2003, for a 12-month budget period within a project period of up to three years. Funding estimates are subject to change. Continuation awards within an approved project period will be based on satisfactory progress as evidenced by required reports and the availability of funds.

Applicants may submit more than one application under the selections available for intervention research targeting populations of people with disabilities. However, given the limited funds available under this announcement, no applicant nor an applicant's parent organization will receive more than one award.

Use of Funds: Grant funds may be used to support personnel services, supplies, equipment, travel, subcontracts, and other services directly related to project activities consistent with the approved scope of work. Project funds cannot be used to supplant other available applicant or collaborating agency funds, for construction, for lease or purchase of facilities or space, or for patient care. Project funds cannot be used for individualized preventive measures (direct patient support) such as for wheelchairs, medical appliances, or assistive technology unless specifically approved by the funding agency.

Each year, applicants should budget travel funds for two staff members to attend a three day workshop in Atlanta to review the collective performance of funded projects; and for two staff members to participate in a four day national conference/meeting of relevance to the project.

Given the availability of other Federal resources for that purpose, grant funds under this announcement cannot be used for intervention research directed at people with a “Diagnostic and Statistical Manual of Mental Disorders” (DSM IV) primary diagnosis of mental illness, although such impairments (e.g., depression, adjustment reaction, anxiety) can be considered as secondary conditions as part of the intervention research.

Funding Preferences: As determined by the quality and ranking of the applications received, CDC plans to support research projects based on: (a) The programmatic interest areas listed in the announcement; (b) race, age, gender and ethnic diversity of the populations to be included within the study groups; (c) geographical distribution; and (d) urban/rural distinctions.

Recipient Financial Participation: Although matching funds are not a requirement under this announcement, applicants are encouraged to seek additional funds to support project activities. Applicants should document the source and amount of financial support, including in-kind contributions. Such letters of financial commitment as well as additional correspondence citing specific areas of project collaborations should be included in the application Appendix.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the grantee will be responsible for the following activities:

1. Confirm the basis for study participant selection and the mechanisms in place to access this group(s); finalize the location/sites of the study; and engage and impact the target population selected for interventions over the full course of the project.

2. Implement the proposed research methods including study instruments, questionnaires, protocols, and expected outcome measures; and address the expected applicability of research findings to the intended population.

3. Institute the work plan based on the major actions (measurable goals and objectives) required to conduct and complete the project with specific timelines and action steps for attaining all work plan and performance outcomes.

4. Undertake major activities as identified to be performed by key staff, sustain management oversight for all components of the project, and sustain a viable organizational structure to assure optimal performance.

5. Measure the effects of the proposed collaborations and outline the project's relationship to other programs underway or recently completed.

6. Account for the expected outcomes of the intervention and how the overall effectiveness of the project will be measured; including methods for detecting meaningful changes in outcomes of interest such as improved health, reductions in health disparities, and fewer or less severe secondary conditions among the targeted populations.

7. Catalog effective communication channels and announce best formats for disseminating results to specific and general audiences including; persons with disabilities, caregivers, disability service organizations, advocacy groups, public health organizations, governmental agencies, non-governmental organizations, researchers, and the general public.

Programmatic Interests: The CDC is interested in funding interventions that address the health of people with disabilities across the lifespan. CDC encourages the development of interventions and/or the modification of existing programs shown to be effective in the general population. Research should include interventions that address objectives identified in “Healthy People 2010,” for which people with disabilities demonstrate disparities in health. The leading health indicators reflect the major public health concerns in the United States and were chosen based on their ability to motivate action, the availability of data to measure their progress, and their relevance as broad public health issues. Within the descriptions of the leading health indicators contained in “Healthy People 2010,” CDC is interested in projects that address physical activity, overweight and obesity, depression, violence, and access to quality health care services.

Specific populations of people with disabilities targeted for health promotion interventions should be appropriately justified. Interventions may be targeted at the individual, group or system level. Applicants may focus on multiple and/or common functional categories such as people with mobility limitations, sensory, communication, or developmental disabilities. Applicants must focus on at least two or more underlying etiologies within the population of people with disabilities selected for intervention.

Applicants are encouraged to collaborate with existing programs that have experience conducting effective interventions in the areas of interest. In addition, applicants are strongly encouraged to include people with disabilities in all phases of research planning and implementation.

Applicants should pilot, implement, and evaluate innovative health promotion interventions that have the potential for application and/or replication in other settings (e.g., local and state health departments, disability and voluntary organizations) beyond what is developed within the controlled research environment.

F. Content

Letter of Intent: A letter of intent (LOI) is requested for this program. The LOI should identify the program announcement number and the proposed project director. The LOI should be no more than three pages, double spaced, printed on one side, with one inch margins, and unreduced 12-point font. It should describe the intent of the proposed intervention, the target population, and describe those activities and collaborations already in place to fully meet the requirements of the announcement. The LOI will be used to determine the level of interest in the announcement, and assist CDC in the planning for the conduct of the application review process.

Applications: The PHS 398 grant application form requires the applicant to enter the project title on page 1 (Form AA, “face page”) and the project description (abstract) on page 2 (Form BB). Applicants must also submit a separate typed summary of their proposal consisting of no more than two single-spaced pages. Applicants must include a table of contents for the project narrative and related attachments.

The main body of the application narrative should not exceed 35 double-spaced pages. Please note that this maximum number of pages allowed exceeds the maximum number of pages (25 pages) indicated in the PHS 398 grant application form (Form CC, “Research Grant Table of Contents”.) The budget justification and biographical sketch sections do not count toward the maximum page limit. Pages must be numbered and printed on only one side of the page.

All material must be typewritten, with 10 characters per inch type (12-point font) on 81/2 inch by 11 inch white paper with one inch margins, headers and footers (except for applicant-produced forms such as organizational charts, graphs and tables, etc.) Applications must be held together only by rubber bands or metal clips, and not bound together in any other way. Attachments to the application should be held to a minimum in keeping to those items required or referenced by this announcement.

Within the application narrative, present the rationale for the proposed research, and explain the public health and scientific importance of the study. In the context of previous studies, describe the contribution this research will make and how the conduct of this intervention research will achieve the stated purpose of this Announcement. In addition, address and defend the choice of the leading health indicator of interest and the proposed intervention, including a statement of the main purpose/goal of the intervention.

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated according to the criteria listed in those sections of this announcement, so it is important to follow them in laying out your program plan.

G. Submission and Deadline

Letter of Intent (LOI) Submission: On or before April 10, 2003, submit the LOI to the Senior Project Officer identified in the “Where to Obtain Additional Information” section of this Announcement.

Application Forms: Submit the signed original and two copies of PHS-398 NIH Form (OMB Number 0925-0001) and adhere to the instructions on the Errata Instruction Sheet for PHS-398. Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address: The application must be received by 4 p.m. eastern time on May 13, 2003. Submit the application to: Technical Information Management—PA# 03029, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Atlanta, Georgia 30341-4146.

Forms may not be submitted electronically.

CDC Acknowledgment of Application Receipt: A postcard will be mailed by PGO-TIM notifying you that CDC has received your application.

Deadline: Letters of intent and applications will be considered as meeting the deadline if they are received before 4 p.m. eastern time on the deadline date. Applicants sending applications by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received 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, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Applications which do not meet the above criteria will not be eligible for competition and will be returned. Applicants will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Applicants are required to provide measures that will demonstrate the effectiveness of the proposed intervention. Measures of effectiveness must relate to the performance goal stated in section “B. Purpose” of this announcement. Measures must also be objective and quantitative and must measure the intended outcome. These measures of effectiveness shall be submitted with the application and shall be an element of evaluation.

Applications will be reviewed by CDC staff for completeness and responsiveness as outlined under the previous heading, Program Requirements. Incomplete applications and applications that are non-responsive will be returned to the applicant without further consideration.

Applications which are complete and responsive will be subjected to a preliminary evaluation (triage) by a Special Emphasis Panel (SEP) to determine if the application is of sufficient technical and scientific merit to warrant further review by the SEP. Applications that are determined to be non-competitive will not be considered, and the SEP will promptly notify the investigator/program director and the official signing for the applicant organization. Applications then determined to be competitive will be evaluated by a dual review process.

Awards will be made based on priority scores assigned to applications by the SEP, programmatic priorities, needs as determined by a secondary review committee, and the availability of funds.

Each application will be evaluated individually against the following criteria. It is suggested that applications be organized to be compatible with the evaluation criteria, as that is the process by which the review committee will assess the quality of the applications.

All criteria (Background/Understanding of Need, Research Approach, Investigators/Collaborators/Management Plans, and Evaluation) are of equal importance, however an application does not need to be strong in all categories to be judged likely to have a major scientific impact.

1. Background/Understanding of Need

Evaluation will be based on:

a. Identification of the problem and justification for the study, including the “Healthy People 2010” objective(s) to be addressed.

b. Review of the relevant literature and discussion of the research foundation being utilized in determining the proposed intervention.

c. Description of the theoretical framework underlying the intervention.

d. Description of the study goals, objectives and/or hypotheses.

e. Intended use and applicability of study findings

2. Research Approach

Evaluation will be based on:

a. The overall strength and feasibility of the research design.

b. Description and justification of the study population, including case definitions, number of participants, selection criteria, and methods for recruiting, enrolling, and sustaining participation.

c. Description of the consent process, including procedures for informing participants about the study and methods for obtaining consent.

d. A detailed description of the intervention.

e. Description of all study instruments, including survey questionnaires, and a discussion of their reliability and validity.

f. Data handling and analysis plans, including statistical methodology, data entry, storage, and disposition.

g. Plans for disseminating and reporting results to multiple target audiences.

3. Investigators/Collaborators/and Management Plans Evaluation Will Be Based on:

a. A description of the major collaborators and their explicit contributions to project objectives.

b. A description of investigator(s) qualifications, roles, tasks, time commitments, and responsibilities.

c. A detailed work plan with specific time frames for implementation of the project. This includes the presentation of overarching goals for the full three year project period with a detailed work plan outlining monthly or quarterly objectives covering the first two budget years.

d. Evidence that people with disabilities will participate in all phases of the research.

4. Evaluation

Evaluation will be based on:

a. A description of how progress will be monitored and evaluated over the course of the intervention.

b. The extent to which project goals are attained and specific objectives accomplished.

c. A description of expected outcomes and the overall effectiveness of the intervention. This includes methods for detecting meaningful changes in outcomes of interest such as improved health, reductions in health disparities, and fewer or less severe secondary conditions among the targeted populations.

d. A description of the expected cost/benefit of the intervention.

5. Budget

This includes the comprehensiveness and adequacy of the applicant's proposed budget in relation to program operations, collaborations, and services; the degree of cost-sharing; and the extent to which the budget is reasonable, clearly justified, accurate, and consistent with the purposes of this announcement.

6. Human Subjects

This includes the extent to which the application adequately addresses the requirements of title 45 CFR part 46 for the protection of human subjects. If the proposed project involves research on human participants, assurance and evidence must be provided that the project will be subject to initial and continuous reviews by an appropriate institutional review board. Does the applicant adequately address the requirements of 45 CFR part 46 for the protection of human subjects?

7. The Degree to Which the Applicant Has Met the CDC Policy Requirements Regarding the Inclusion of Women, Ethnic Minorities, and Racial Groups in the Proposed Research

This includes: The proposed plan for the inclusion of racial ethnic minority populations and both sexes for appropriate representation; the proposed justification when representation is limited or absent; a statement as to whether the design of the study is adequate to measure differences when warranted; and a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with communities and recognition of mutual benefits.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Progress Report for a PHS Research Grant (form PHS-2590 found on the CDC Web site), no less than 90 days before the end of the budget period (date to be determined at time of award).

A. The progress report should represent the accomplishments of the project during the reporting period. You do not need to limit the progress report to two pages as specified in the standard PHS-2590 form instructions (page 2, item A).

B. The report should describe the work which has been accomplished to date, please describe accomplishments in terms of the specific aims/timetable.

C. List each specific aim separately and elaborate on the progress that has been made and where you are in terms of the time schedule.

D. Include a detailed budget with justification.

E. Include a copy of your most current IRB approval.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see the Attachment in the application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-14 Accounting System Requirements

AR-15 Proof of Non-Profit Status

AR-22 Research Integrity

Executive Order 12372 does not apply to this program.

J. Where to Obtain Additional Information

For this and other announcements, the necessary applications and associated forms can be found on the CDC home page Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Room 3000, Atlanta, Georgia 30341-4146. Telephone: [phone].

For business management and budget assistance in the states, contact: Sheryl Heard, Grants Management Specialist, Procurement and Grants Office Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Atlanta, Georgia 30341-4146. Telephone: [phone]. E-mail address: [e-mail].

For business management and budget assistance in the territories, contact: Charlotte Flitcraft, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146. Telephone: [phone]. E-mail address: [e-mail].

For program technical assistance, contact: Joseph B. Smith, Senior Project Officer, National Center on Birth Defects and Developmental Disabilities, Disability and Health Team, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road (Mailstop F-35). Atlanta, Georgia 30333. Telephone: [phone]. E-mail address: [e-mail].

Dated: March 3, 2003.

Sandra R. Manning,

CGFM, Director, Procurement and Grants Office, Centers for Disease Control and Prevention.