[Federal Register Volume 66, Number 106 (Friday, June 1, 2001)]
[Notices]
[Pages 29814-29816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01085]


Integrating Prevention Services for Persons With Bleeding and 
Clotting Disorders; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program to demonstrate the effectiveness of the comprehensive care 
model in preventing or reducing bleeding and clotting disorder related 
complications through hemostasis and thrombosis centers. This program 
addresses the ``Healthy People 2010'' focus areas of access to quality 
health services, disability and secondary conditions, educational and 
community-based programs, and public health infrastructure.
    The purpose of the program is to (1) determine the efficacy of 
integrated multi-disciplinary care and prevention services for persons 
with hemophilia, other hereditary bleeding disorders including women 
with bleeding disorders, and thrombophilia to reduce morbidity and 
mortality associated with bleeding and clotting diseases; (2) assess 
unmet needs for service delivery and identify outreach strategies 
designed to improve access to care; (3) develop effective messages 
aimed at disease management and prevention; and (4) foster the 
development of training programs to enhance provider skills for the 
delivery of hemostasis and thrombosis care.

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: Title 2 of the United States Code, Chapter 26, section 
1611 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 $1,000,000 is available in FY 2001 to fund 
approximately four awards. It is expected that the average award will 
be $250,000, ranging from $200,000 to $300,000. It is expected that the 
awards will begin on or about September 30, 2001, and will be made for 
a 12-month budget period within a project period of up to two years. 
The 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 
and the availability of funds.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under 2. (CDC Activities).

1. Recipient Activities

    a. Using the principles of the multi-disciplinary comprehensive 
care model utilized in hemophilia treatment center prevention programs, 
implement the model in a health care setting that features strong 
clinical, research, outreach, education, support and provider training 
programs for persons with hemophilia, other hereditary bleeding 
disorders including women with bleeding disorders, and thrombophilia.
    Specifically:
    (1) Identify unmet needs of target populations and establish 
outreach mechanisms to improve access to care for persons with bleeding 
and clotting disorders for the purpose of evaluating prevention 
interventions.
    (a) Determine strategies that will address unmet needs, assess the 
efficacy of prevention activities and improve access to under-served 
populations such as women with bleeding disorders and individuals with 
thrombophilia.
    (b) Conduct outreach efforts to increase prevention intervention 
awareness and availability of comprehensive care among the affected 
population and referring providers and establish referral patterns.
    (c) Facilitate communication with other sub-specialties concerning 
awareness and prevention of the complications of bleeding and clotting 
disorders.
    (2) Develop and implement a plan that will provide clinical 
expertise for diagnosing underlying causes of coagulation disorders and 
provide management and prevention services. Experience with bleeding 
and clotting

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disorders should be a preferred requirement for clinical expertise.
    (3) Collaborate with clinical research programs designed to improve 
the treatment of bleeding and clotting disorders.
    (4) Develop training programs to educate physicians and other 
providers in management of bleeding and clotting disorders.
    b. Develop education and awareness programs for affected 
populations to increase knowledge and assist consumers in making 
informed decisions.
    (1) Establish mechanisms for consumer input and education and 
assist in fostering locally based consumer organizations to assist in 
care evaluation.
    (2) Develop educational materials and distribute as needed.
    (3) Develop methods (i.e. utilizing consumers) to assist with the 
delivery of prevention messages through peer-led prevention education, 
outreach, and support.
    c. Evaluate the model for feasibility and effectiveness.
    (1) Develop appropriate data collection and evaluation systems to 
document unmet needs for integrated diagnostic, management and 
prevention services for persons with hemophilia, other hereditary 
bleeding disorders including women with bleeding disorders, and 
thrombophilia.
    (2) Establish longitudinal studies to determine outcomes related to 
multi-disciplinary care management for persons with coagulation 
disorders.
    (3) Devise consent and protocol for collection of DNA samples for 
analysis.
    (4) Publish and disseminate program results.

2. CDC Activities

    a. Provide consultation, scientific and technical assistance in the 
design and conduct of the project, including intervention methods, 
outcome measures, and analytic approach, as requested;
    b. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.
    c. Perform selected laboratory testing as needed including DNA 
analysis of blood samples.
    d. Assist in data management, the analysis of research data, 
interpretation and dissemination of research findings, as requested.

E. Content

Letter of Intent (LOI)

    An LOI is required for this program. The narrative should be no 
more than 3 single-spaced pages, printed on one side, with one inch 
margins, and unreduced font. Your letter of intent will be used to 
enable CDC to plan for the review, and should include the following 
information (1) the program announcement number 01085, (2) name and 
address of institution, and (3) name, address, and telephone number of 
contact person. Notification can be provided by facsimile, postal mail, 
or electronic mail (E-mail).

Application

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 20 double-spaced pages, 
printed on one side, with one inch margins, and unreduced font.

F. Submission and Deadline

Letter of Intent (LOI)

    On or before June 29, 2001, submit the LOI 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 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are available in the application kit and at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm
    On or before July 20, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall 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 independent review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    Late Applications: Applications which do not meet the criteria in 
(a) or (b) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

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

1. Capacity (25 Points Total)

    The extent that the applicant provides multi-disciplinary, 
integrated, clinical and research-based prevention activities, 
outreach, education, support and provider training programs to persons 
with hemophilia, other hereditary bleeding disorders including women 
with bleeding disorders, and thrombophilia.
    a. The extent that the applicant documents and explains the scope 
and magnitude of previous experiences in providing a comprehensive, 
prevention program for hemophilia, thrombophilia, and women's bleeding 
disorders including diagnosis, management, outreach, education, and 
data collection utilizing the multi-disciplinary, comprehensive care 
model. The extent to which these services are prevention oriented. (15 
points)
    b. The extent that the applicant demonstrates a collaborative 
relationship with well-established basic science and clinical research 
programs to provide the environment for broad based training and 
translation research. (10 points)

2. Background and Need (15 Points)

    The extent that the target populations and catchment area are 
described in terms of known morbidity, demographics, sources of care, 
and existing data collection and surveillance. The extent the applicant 
identifies unmet needs and how they can appropriately address the 
issues of the target communities.

3. Goals and Objectives (10 Points)

    The extent that the applicant's proposed goals and objectives meet 
the required activities specified under ``Recipients Activities'' and 
are specific, measurable, time-phased, and realistic.

4. Methods and Activities (35 Points)

    a. The extent that the applicant's plan explains how the program 
activities are to be conducted and the extent that prevention methods 
proposed are: (1) appropriate to accomplish stated goals and objectives 
and (2) feasible within programmatic and fiscal restrictions. (15 
points)
    b. The extent to which the applicant describes and documents the

[[Page 29816]]

collaborative efforts of it's program to (1) assess efficacy of 
prevention activities and (2) develop and implement prevention 
programs. (15 points)
    c. The extent that the applicant incorporates gathering and using 
input from persons with bleeding disorders and thrombophilia and their 
family members, and local consumer and community based organizations, 
and the applicant's willingness to cooperate with consumers in the 
development and implementation of prevention services. (5 points)

5. Program management and evaluation (15 Points)

    a. The extent that management systems, including types, frequency, 
and methods of evaluation are used to ensure appropriate implementation 
of program activities. (5 points)
    b. The extent of management experience for recruiting and 
implementing large public health prevention initiatives. (5 points)
    c. The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes (1) the proposed plan 
for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation; (2) the proposed 
justification when representation is limited or absent; (3) a statement 
as to whether the design of the study is adequate to measure 
differences when warranted; and (4) 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. (5 points)

6. Budget (Not Scored)

    The extent that the budget is reasonable and consistent with the 
intended use of the cooperative agreement funds.

7. Human Subjects (Not Scored)

    Application must adequately address the requirements of Title 45 
CFR Part 46 for the protection of human subjects.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original plus two copies of--
    1. Annual progress reports;
    2. Financial status report (FSR), no more than 90 days after the 
end of the budget period; and
    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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I 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-15  Proof of Non-Profit Status
    AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 301(a)[42 U.S.C. 241(a)] 
and 317(k)(2)[42 U.S.C. 247b9k)(2)] of the Public Health Service Act, 
as amended. The Catalog of Federal Domestic Assistance number is 
93.283.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov Click on ``Funding'' then ``Grants 
and Cooperative Agreements.''
    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 
Program Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Merlin Williams, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Road, Room 3000, MS-K75, Atlanta, GA 30341-
4146, Telephone number: 770-488-2765, Email: [email protected].
    For program technical assistance, contact: Sally Crudder, 
Hemophilia Treatment Center Program, National Center for Infectious 
Diseases, Centers for Diseases Control and Prevention, 1600 Clifton 
Road NE, MS-E64, Atlanta, GA 30333, Telephone Number: 404-371-5270, 
Email: [email protected].

    Dated: May 25, 2001.
Henry S. Cassell, III,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 01-13734 Filed 5-31-01; 8:45 am]
BILLING CODE 4163-18-P