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Notice

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

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Information about this document as published in the Federal Register.

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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 Start Printed Page 29815disorders 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 Start Printed Page 29816collaborative 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: mqw6@cdc.gov.

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: sic4@cdc.gov.

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Dated: May 25, 2001.

Henry S. Cassell, III,

Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).

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[FR Doc. 01-13734 Filed 5-31-01; 8:45 am]

BILLING CODE 4163-18-P