A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2000 research grant funds. The purpose of this program is to support research projects in three Focus Areas related to: (1) Cost identification of secondary conditions; (2) determining patterns related to the onset and course of secondary conditions among persons with disabilities; and (3) the development of measures and instruments at the community level to assess those environmental factors that contribute to or mitigate the development of secondary conditions. CDC is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2010,” a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus area of Disability and Secondary Conditions. For the conference copy of “Healthy People 2010,” visit the internet site http://www.health.gov/healthypeople .
B. Eligible Applicants
Applications may be submitted by public and private non-profit organizations, including universities; university-affiliated systems, including not-for-profit medical centers; research institutions and rehabilitation hospitals; State health departments and other related State government agencies; and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.
Note:
Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.
C. Availability of Funds
Approximately $3,500,000 will be available in FY 2000 to fund 10 to 12 research grants. It is expected that the average award for projects in Focus Areas 1 and 3 will be $280,000, ranging from $240,000 to $320,000. It is expected that awards in Focus Area 2 will not exceed $350,000.
It is anticipated that awards will begin on or before September 1, 2000, for a twelve 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, monitoring conducted by the funding agency, and the availability of funds.
Applicants cannot include activities related to more than one Focus Area in the same proposal. In the event that an applicant elects to address more than one Focus Area, complete and separate applications must be submitted.
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.
CDC will sponsor annual workshops for all grantees. By virtue of accepting an award, applicants will have agreed to use grant funds to travel to and participate in these workshops. Applicants should budget travel funds for two staff members to attend one workshop in Atlanta during the first year, and also for two staff members to participate in the Disability Forum of the American Public Health Association conference in Boston in November 2000.
Funding Preferences
The precise number of awards in each of the three Focus Areas is not yet known, but CDC anticipates that no fewer than three awards will be made in each Focus Area. Scores and rankings of applications reviewed will be distinguished by individual Focus Area. Award decisions will be made according to Focus Area. The CDC review and award decision process will take into account achieving a balance of projects based on targeted population groups of persons with disabilities selected for emphasis, methodological variation, and geographical distribution considerations, such as urban/rural distinctions. CDC has an expressed interest in considering applications that address multiple diagnostic categories of persons with disabilities within the research design.
D. Programmatic Interests
The programmatic interest is centered on the following:
Focus Area 1: This Focus Area includes research on selected secondary conditions using cost identification methods (i.e., “cost analysis”, “cost itemization,” “cost inventory”), or, at the discretion of the applicant, expansion of cost identification research to incorporate methods of cost-effectiveness analysis. As a foundation, proposed research under this Focus Area must utilize cost identification methods. This research can also include fundamental cost identification augmented by cost-effectiveness analysis, or cost-utility analysis which is a specialized form of cost-effectiveness analysis.
This research can include identifying costs and outlays for: (i) The individual, care givers, or third party payers; costs for personal care assistance services; (ii) costs for adaptive equipment and technology; (iii) costs of interventions applied toward preventing or treating secondary conditions; and (iv) direct costs related to treatment of the underlying disability itself, as distinguished from direct costs associated with the identified secondary conditions.
Focus Area 2: This Focus Area is designed to measure patterns of onset and course of selected secondary conditions that undermine and adversely affect the quality of life and independence of persons with disabilities. Methods for measuring patterns of onset can rely on direct observation of a currently ongoing or newly established cohort of participants, or statistical modeling using observational data derived from a currently ongoing or newly established cohort of participants.
As an option within Focus Areas 1 and 2, applicants can target persons with disabilities as a population at large or can also select one or more demographic sub-populations (or combinations of sub-populations) such as women, men, members of ethnic minority groups, children, adolescents, older adults specified by age range, persons with limb loss, etc., as discrete populations for inclusion in the research design.
Focus Area 3: This Focus Area includes research to develop measurements of the community environment as outlined in the ICIDH-2 framework. The “ICIDH-2” refers to the revision of the “International Classification of Impairments, Disabilities, and Handicaps,” now entitled the “International Classification of Functioning and Disability.” This document states that “environmental factors make up the physical, social and attitudinal environment in which people live and conduct their lives. The factors are external to individuals and can have a positive or negative influence on a person's participation as a member of society, on performance of activities of a person, or on a person's body function or structure.”
The primary goals for research proposed and conducted within Focus Area 3 should be to develop and subsequently disseminate reliable, valid, and realizable measurement instruments that assess or quantify the various kinds of environmental factors affecting persons with disabilities in their communities.
E. Program Requirements
The Focus Areas described in the Programmatic Interests section convey the investigative characteristics of proposed research that meet the intention of this announcement. The following are program requirements: (1) Develop a work plan; (2) describe the potential collaborators and organizational structures; (3) outline the research methods and management approach; and (4) disseminate the results of the research among persons with disabilities, disability service organizations, advocacy groups, governmental agencies, non-governmental organizations, and researchers.
F. Application Content
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 are requested to identify their selected Focus Area at the beginning of the text within the space provided for the project description (abstract) on Form BB.
The main body of the application narrative should not exceed 40 double-spaced pages. For purposes of this announcement, 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) on 81/2″ by 11″ white paper with at least 1″ 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.
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)
A Letter of Intent may be submitted by prospective applicants. It must identify this announcement number, name the proposed project director, and cite the applicant's selected Focus Area of emphasis. The letter will not be used to eliminate potential applicants, but it will enable CDC to determine the level of interest in the announcement and plan the review more efficiently. Facsimile or e-mail messages will not be accepted as a Letter of Intent response.
On or before May 18, 2000, submit the Letter of Intent to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.
Application
Submit the original and five 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 for download at http://www.cdc.gov or in the application kit.
On or before June 22, 2000, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.
Deadline: Applications will be considered as meeting the deadline if they are either:
(a) Received on or before the deadline date; or
(b) Sent on or before the deadline date and received in time for submission to the objective review group. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks will not be acceptable as proof of timely mailing.)
Late Applications: Applications that do not meet the criteria in (a) or (b) above will be considered late. Late applications will not be considered in the current competition and will be returned to the applicant.
H. Evaluation Criteria (Total 100 Points)
Applications will be reviewed and evaluated individually against the following criteria by an independent review group appointed by CDC. A separate independent review group will be assigned to review applications in each of the three Focus Areas.
1. Evidence of Understanding and Protocol Planning: (10 Points)
Evaluation will be based on:
a. The applicant's description of the public health significance of secondary conditions and adherence to the purposes of this announcement, including current activities in place related to the study of secondary conditions, their prevention, and/or the disabling process.
b. The rationale for determining and addressing the selected Focus Area from among those outlined in the Programmatic Interests section.
c. As applicable, the applicant's approach to developing an inventory of necessary cost, economic, and other relevant disability data sources; the process by which study populations or community settings would be identified; and the feasibility of initiating all protocol/research development components on schedule at the outset of the project.
2. Research Resources and Organizational Capacity: (20 Points)
Evaluation will be based on:
a. The capability of the applicant to conduct the project, taking into account its institutional experience and current activities in the field proposed for this research.
b. The ability of the applicant to ensure timely and complete access to needed economic and demographic data, selected population(s), or community data related to the selected Focus Area over the entire course of the project.
c. The capacity to provide evidence of effective organizational collaborations, research linkages and formal agreements (including contractual), enabling the applicant to meet all project implementation and operational requirements.
d. Depending on the selected Focus Area, the applicant's competencies in:
(1) Concepts of cost identification;
(2) Methods for assessing the onset and course of secondary conditions;
(3) Understanding and use of the ICIDH-2; and
(4) working with the disability community and other partners to improve access and independence for persons with disabilities in the environmental aspects of the community settings chosen for investigation.
3. Research Approach: (40 Points)
Evaluation will be based on:
a. The appropriateness with which the proposed methods, sources of data, and project linkages convincingly and comprehensively meet the intention of this announcement.
b. The overall strength of the research design including:
(1) The rationale, feasibility, and appropriateness of the study protocol and methods to be employed in relation to the purpose and programmatic interests outlined in this announcement;
(2) Inclusion and discussion of case definitions, methods of enrolling and managing cohorts, and/or enlisting community input;
(3) The quality and scope of the data collection and data analysis plan, including a description of the strengths and weaknesses of each data set relative to the proposed project;
(4) Ready access to key background and foundational data sets and literature;
(5) The adequacy of the calculated statistical power and the potential capacity of the research design to generate observations of hypothesized or meaningful effects during the study period;
(6) The quality and scope of the plan to ensure that the confidentiality of all study participants would be preserved;
(7) The process by which the research will be tracked and evaluated; and
(8) the potential for effectively addressing start-up activities and specific and measurable research objectives during the first year of the proposed project.
c. The feasibility of the project related to:
(1) Prompt assembling of an effective research team with the experience and time commitments to promote full attention to implementing the study design;
(2) The potential degree of reliability and replicability of the study; and
(3) The overall plan for completing the analyses, and disseminating the findings and recommendations of the research in subsequent presentations and publications for benefit to other populations, including applications for national use.
4. Management Plan and Project Goals and Objectives: (30 Points)
Evaluation will be based on:
a. The presentation of the detailed management work plan and approach, the accounts of the project's location and functional capacity within the host organizational structure, and the process by which the applicant will meet all goals and objectives of the proposed project.
b. The degree to which approaches to meeting proposed goals and specific objectives are convincing, and the likelihood of achieving those objectives within the prescribed time frames. This includes the presentation of overarching goals for the entire three year project period with a detailed work plan denoting monthly or quarterly objectives covering the first two budget years.
c. The presentation of the specified tasks and responsibilities to be assigned for all positions proposed for financial assistance, and for other personnel contributing to the project.
d. The process for overall evaluation of the entire project including the assignment of responsibility for ongoing review of specified components.
e. 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.
f. The applicant's approach to providing opportunities for persons with disabilities to participate in project operations, activities, and administrative or research staffing.
5. Project Budget: (Not Scored)
This includes the 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 purpose of this announcement.
6. Human Subjects: (Not Scored)
This includes the degree to which the applicant proposes to comply with Department of Health and Human Services regulations (45 CFR Part 46) regarding the protection of human subjects.
I. Other Requirements
Technical Reporting Requirements
Provide CDC with an original, plus two copies of:
1. Semi-annual progress reports, due 30 days after the close of each six-month period based on the starting date of the project;
2. Financial Status Reports, due no later than 90 days after the end of each budget period; and
3. Final Financial Status Reports and performance reports, due 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.
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
J. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized by section 301(a) (42 U.S.C. 241(a)) and section 317 (42 U.S.C. 247b) of the Public Health Service Act, as amended. The Catalog of Federal Domestic Assistance number is 93.184.
K. Where To Obtain Additional Information
This and other CDC Program Announcements can be found on the CDC web site. The CDC home page address on the Internet is: http://www.cdc.gov.
To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked to leave your name, address, and telephone number and instructed to identify the announcement number of interest.
If you have questions after reviewing the contents of all the documents, business management technical assistance can be obtained from: William Paradies, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 30341-4146,Telephone (770) 488-2721, Internet address: wep2@cdc.gov
General program assistance can be obtained from: Joseph B. Smith, Disability and Health Branch, National Center for Environmental Health, CDC, 4770 Buford Highway, Building 101, Mailstop F-29, Atlanta, Georgia 30341, Telephone (770) 488-7082, Internet address: jos4@cdc.gov
Research-related technical assistance for Focus Areas 1 and 2 is available from: John F. Hough, Dr.P.H., National Center for Environmental Health, CDC, 4770 Buford Highway, Building 101, Mailstop F-29, Atlanta, Georgia 30341, Telephone (770) 488-7830, Internet Address: jph7@cdc.gov
Research-related technical assistance for Focus Area 3 is available from: Donald J. Lollar, Ed.D., National Center for Environmental Health, CDC, 4770 Buford Highway, Building 101, Mailstop F-29, Atlanta, Georgia 30341, Telephone (770) 488-7094, Internet address: dcl5@cdc.gov
Dated: April 11, 2000.
John L. Williams,
Director, Procurement and Grants Office.
[FR Doc. 00-9456 Filed 4-18-00; 8:45 am]
BILLING CODE 4163-18-P