[Federal Register Volume 65, Number 76 (Wednesday, April 19, 2000)]
[Notices]
[Pages 20985-20988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9456]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00073]


Research Grants for Investigating the Cost, Onset, and 
Development of Community Measurements of Secondary Conditions in 
Persons With Disabilities; Notice of Availability of Funds

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-

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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 8\1/2\" 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.

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    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

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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: [email protected]
    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: [email protected]
    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: [email protected]
    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: [email protected]

    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