[Federal Register Volume 68, Number 46 (Monday, March 10, 2003)]
[Notices]
[Pages 11395-11399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03029]


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

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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

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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 8\1/2\ 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

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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: 
(770) 488-2700.
    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: (770)

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488-2723. E-mail address: [email protected].
    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: 770-488-2632. E-
mail address: [email protected].
    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: (404) 498-3021. E-mail address: [email protected].

    Dated: March 3, 2003.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-5581 Filed 3-7-03; 8:45 am]
BILLING CODE 4163-18-P