[Federal Register Volume 63, Number 217 (Tuesday, November 10, 1998)]
[Notices]
[Pages 63057-63059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30058]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99009]


Notice of Availability of Funds; Cooperative Agreement for Limb 
Loss Research and the Prevention of Secondary Conditions

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program for limb loss research and the prevention of secondary 
conditions. The purpose of the program is to advance the field of limb 
loss epidemiology, surveillance, data analysis, and intervention design 
including health promotion programs for persons with limb loss and the 
prevention of secondary conditions. This program addresses the 
``Healthy People 2000'' priority area of Preventive Services.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations, and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, 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

    It is anticipated that a maximum of $500,000 will be available in 
FY 1999 to fund one award, including direct and indirect costs. It is 
expected that the project period will begin on April 1, 1999 and the 
award will be made for a 12-month budget period within a project period 
of up to four years. This funding estimate may change. Continuation 
awards within an approved project period will be made on the basis of 
satisfactory progress as evidenced by required reports, CDC site 
visits, and the availability of funds.

Use of Funds

    Project funds may be used to support personnel services, supplies, 
equipment, travel, subcontracts, and other services consistent with the 
approved scope of work.
    Project funds may not be used to supplant other available applicant 
or collaborating agency funds, for construction, or purchase of 
facilities or space, or for patient care. Project funds may not be used 
for individualized preventive measures (direct patient support) such as 
wheelchairs, assistive technology, and medical appliances including 
prosthetic devices unless specifically approved by the funding agency. 
Travel funds should be requested for at least three project staff to 
participate in a CDC Office on Disability and Health workshop in 
Atlanta, GA during the first budget year.

D. Program Requirements

    The applicant should: (1) propose and utilize a six month planning 
period at the beginning of the project in order to structure key 
staffing and organizational activities; (2) establish formal 
collaborations with identified outside entities, and solicit diverse 
input for use in project design, objective setting, and operations; and 
(3) appoint a full-time manager/coordinator with the authority and 
responsibility to conduct and manage all components of the project.

Cooperative Activities

    In conducting activities to achieve the purposes of this program, 
the Recipient shall be responsible for activities listed under 
Recipient Activities, item A; and CDC shall be responsible for 
activities listed under CDC Activities, item B.

A. Recipient Activities

    1. Develop an epidemiologic capacity to understand and characterize 
secondary conditions in persons with limb loss including analyses of 
differential secondary conditions and their associations with co-
morbidities.
    2. Collect, compile, and analyze information relevant to the 
incidence and prevalence of limb loss and amputations on a national, 
regional, and state/local basis.
    3. Develop cost-effectiveness measures and models as optimal 
approaches for intervention design and efficacy, and provide guidance 
for their implementation.
    4. Characterize the population of persons with limb loss by 
determined incidence, etiology/causality, functional effects, co-
morbidities, and affected limb site variables.
    5. Develop and maintain research literature and resources on the 
prevention of secondary conditions and health promotion strategies 
regarding limb loss, and establish a communication process to 
disseminate prevention information to research entities including 
collaboration with the National Limb Loss Information Center.
    6. Provide technical assistance on health promotion and community-
directed interventions that has as its purpose the prevention of 
secondary conditions in targeted populations.
    7. Develop a model limb loss and amputation reporting system that 
could be piloted in a geographic or health jurisdiction.
    8. Collaborate with other organizations for the design and/or 
implementation of programs meriting replication in other settings, 
recognizing appropriate cultural sensitivity and controlled by a formal 
program evaluation protocol.
    9. Establish relationships and client access linkage with public/
community/advocacy/voluntary agencies and provider organizations that 
serve persons with limb loss for the purpose of addressing and 
understanding secondary conditions and promoting best practices from 
the health promotion and personal perspective of persons who have 
experienced limb loss.
    10. Collect and report information on community programs related to 
limb loss including complications from surgery, comparisons of clinical 
and community programs geared toward preventing secondary conditions, 
vocational and educational outcomes in persons with limb loss, gaps in 
services and data, and provider training needs.

B. CDC Activities

    1. Provide consultation in the development of data collection 
instruments, methods, procedures, and outcome determinations.
    2. Provide technical consultation, assistance, and referrals on 
existing epidemiological information regarding limb loss and 
amputations in the United States.
    3. Serve as a reference for accessing other data sets that will be 
of value to the surveillance and epidemiologic activities of the 
recipient.
    4. Provide consultation on the development of cost-effectiveness 
and cost-utility models, and in designing minimal data sets for 
developing pilot reporting systems for limb loss and amputations.
    5. Assist the project in the planning and organizing of conferences 
and

[[Page 63058]]

workshops regarding surveillance activities, developing partnerships, 
and in the characterization of limb loss nationally and in population 
sub-groups.
    6. Assist in the transfer of information and methods developed in 
the project to other disability-related entities and programs.

E. Application Content

    Use the information in the Program Requirements, Cooperative 
Activities, and Evaluation Criteria sections to develop the application 
content. The application will be evaluated on the criteria listed, so 
it is important to follow them in laying out the program plan. The 
narrative addressing the scored criteria should be no more than 40 
single-spaced pages, printed on one side, with one inch margins, and 
unreduced font.

F. Submission and Deadline

Letter of Intent (LOI)

    A non-binding letter of intent to apply is requested from potential 
applicants. The LOI should identify the Announcement number, name the 
proposed project director, and describe the scope of the proposed 
project in not more than three pages. The letter will not influence 
review or funding decisions, but it will enable CDC to plan the review 
more efficiently, and ensure that each applicant receives timely and 
relevant information prior to the application review.
    The LOI should be submitted on or before December 22, 1998 to 
Victoria Sepe, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), Room 300, 255 East Paces Ferry Road, NE, Mailstop E-
13, Atlanta, Georgia 30305-2209.

Application

    Applicants must submit a separate typed abstract/summary of their 
proposal as a cover to their applications, consisting of no more than 
two single-spaced pages. Applicants should also include a table of 
contents for the project narrative and related attachments. It is 
strongly suggested that applications be organized to be compatible with 
the evaluation scoring criteria, as that is the process by which the 
review committee will assess the quality of the proposals.
    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001). Adhere to the instructions on the Errata Instruction Sheet for 
PHS 398. Budget and other required forms are in the application kit. 
Applications are due on or before Wednesday, January 20, 1999.
    Submit the application to Victoria Sepe, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), Room 300, 255 East 
Paces Ferry Road, NE, Mailstop E-13, Atlanta, Georgia 30305-2209. 
Please list the Announcement Number 99009 on the covering address 
label. If your application does not arrive in time for submission to 
the independent review group, it will not be considered in the current 
competition unless you can provide proof that you mailed it on or 
before the deadline (i.e., receipt from U.S. Postal Service or a 
commercial carrier; private metered postmarks are not acceptable).

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

A. Problem Statement and Evidence of Need--15 Points

    This includes: 1. the extent to which the applicant understands the 
purpose and requirements of the program.
    2. The presentation of the magnitude and impact of limb loss as a 
public health issue with cited references.
    3. The understanding of unmet needs as they affect the occurrence 
and documentation of secondary conditions, and the information gaps 
associated with the epidemiology of secondary conditions related to 
limb loss.
    4. The presentation of the full range of surveillance activities 
required and inventory of data sets to be developed and accessed.
    5. The description of research needs in the development of models 
for intervention design, and the problems (and opportunities) inherent 
in developing uniform reporting systems for limb loss and amputations.

B. Research Resources and Organizational Capacity--20 Points

    This includes: 1. the capability of the applicant to conduct the 
project, taking into account its institutional experience and its 
current activities in the field for all required activities.
    2. The ability of the applicant to ensure timely access to 
necessary population-based data related to the surveillance and 
epidemiology of secondary conditions associated with limb loss.
    3. The understanding demonstrated and the resources available to 
address the development of cost-effectiveness models for the design and 
conduct of health promotion interventions.
    4. The capacity of the applicant to provide evidence of effective 
collaborations and linkages to meet the research requirements of the 
project including documented letters of support and commitments from 
collaborating entities.
    5. The capacity of the applicant to include and effectively work 
with community organizations and service providers in order to develop 
and sustain an outreach capacity to assess the needs of persons with 
limb loss, and to provide guidance and consultation regarding health 
promotion interventions to prevent secondary conditions.
    6. The capacity of the applicant to collect and secure confidential 
information, and to protect study participants through rigorous human 
subjects clearance procedures.

C. Research Approach--35 Points

    This includes: 1. the methods to be employed to gather necessary 
etiological/causality, demographic, and functional data, including the 
kinds and resources of data to be accessed, collected, analyzed, and 
used.
    2. The quality and scope of the data collection and data analysis 
plan, and the description of the staff and organizations charged with 
its control.
    3. The approach proposed to use extant or emerging epidemiologic 
data to assess the frequency and significance of secondary conditions, 
including risk and protective factors.
    4. The approach to translate epidemiological/ surveillance data 
into outreach intervention protocols designed to prevent secondary 
conditions in persons with limb loss through the provision of guidance 
and technical assistance to community groups and service providers.
    5. The approach to gather information on the experiences, 
perceptions, and concerns/needs of persons with limb loss (and their 
families), and translate that information into intervention protocols 
designed to provide knowledge to prevent secondary conditions. This 
approach should consider both healthy living practices (e.g., tobacco 
use cessation, nutrition, weight management, physical activity and 
exercise), as well as secondary medical/clinical conditions directly 
related to an amputation/limb loss (e.g., infections, fall-related 
injury, pain, depression, prosthetic adaptability, etc).
    6. The capacity of the applicant to describe their approach and 
later develop a prototype uniform reporting system for limb loss and 
amputations

[[Page 63059]]

that could be piloted in a selected jurisdiction to demonstrate 
feasibility and reasonableness.
    7. The quality and comprehensiveness of the overall research plan 
that includes innovative approaches to best address the epidemiologic/
surveillance, demographic characterization, health promotion 
interventions, and collaborative opportunities.
    8. The degree to which the applicant has met CDC policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in proposed research. This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits.

D. Management Plan and Project Goals and Objectives--30 Points

    This includes: 1. how the applicant will use the six month planning 
period to gather diverse input and engage all collaborating partners 
and constituencies in meeting the full range of activities required 
under this announcement.
    2. The management work plan for conducting the project including 
the advantage defined by its placement within the applicant 
organization (include an organization chart and denote the relationship 
of this project within the applicant organization).
    3. The presentation of the approach, methods, and goals, objectives 
and timelines for the first year by calendar month or quarter; and a 
work plan outline for the second, third, and fourth years of the 
project.
    4. The description of the specified tasks and responsibilities for 
all positions proposed for financial assistance, including both 
applicant organization staff and contractual/consultant personnel.
    5. The manner in which the project will seek out, utilize, and 
benefit from other research and provider organizations in developing 
limb loss project priorities and objectives.
    6. The proposed plan to maintain and disseminate appropriate limb 
loss information through defined communications technology processes 
and systems.
    7. The process for how the applicant will evaluate the management 
work plan and all research and outreach activities of the project.

E. Budget Justification--Not Scored

    This criteria includes the adequacy of the budget justification and 
its relationship to program operations, collaborations, and services. 
Each line item of the budget must be well justified in a brief 
narrative with special attention given to contractual requests 
including the responsibilities of consultants, percentage time 
equivalents, hourly or daily rates, etc. This section will also be 
evaluated on the adequacy of facilities to conduct the project. The 
relevance of this section to the other evaluation criteria will be 
measured on the extent to which the budget narrative is reasonable, 
clearly documented, accurate, and consistent with the purpose of this 
announcement.

F. Human Subjects--Not Scored

    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 project involves research on human 
participants, assurance and evidence must be provided to demonstrate 
that the project will be subject to initial and continuing reviews by 
an appropriate institutional review board. Does the project adequately 
address the requirements of 45 CFR 46 for the protection of human 
subjects?

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. semi-annual progress reports; due dates to be denoted in the 
notice of grant award;
    2. financial status report, due no more than 90 days after the end 
of each budget period; and
    3. final financial and performance reports, due no more than 90 
days after the end of the project period.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Addendum I.

AR98-1  Human Subjects Requirements
AR98-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR98-9  Paperwork Reduction Act Requirements
AR98-10  Smoke-Free Workplace Requirements
AR98-11  Healthy People 2000
AR98-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act [42 
U.S.C. section 241 (a)], as amended. The Catalog of Federal Domestic 
Assistance number is 93.184.

J. Where To Obtain Additional Information

    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 and address and will be instructed to identify the 
Announcement number of interest. Also, the CDC Home Page on the 
Internet: http://www.cdc.gov is available for copies of this 
Announcement, application forms, and funding information.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from Victoria Sepe, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Announcement 99009, Centers for 
Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry 
Road, NE, Mailstop E-13, Atlanta, GA, 30305-2209, telephone (404) 842-
6804. E-mail address: [email protected]
    For program technical assistance, contact Jack Stubbs, Office on 
Disability and Health, Centers for Disease Control and Prevention, 
National Center for Environmental Health (NCEH) 4770 Buford Highway, 
Mailstop F-29, Atlanta, GA, telephone (770) 488-7096. E-mail address: 
[email protected]

    Dated: November 4, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 98-30058 Filed 11-9-98; 8:45 am]
BILLING CODE 4163-18-P