01-11217. Prevention of the Complications of Bleeding Disorders through Hemophilia Treatment Centers; 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 for the Prevention of the Complications of Bleeding Disorders through Hemophilia Treatment Centers. This program addresses the “Healthy People 2010” focus areas of Access to Quality Health-Services, Disability and Secondary Conditions, HIV, and Immunization and Infectious Diseases. For more information on “Healthy People 2010” visit the internet site: http://www.health.gov/​healthypeople.

The purpose of the hemophilia complications prevention cooperative agreement program is to assist in: (1) Providing a regional network of comprehensive prevention services through hemophilia treatment centers to persons with hemophilia and related disorders including women with bleeding disorders to prevent complications through assessment, surveillance, outreach, education, consultation, and management; (2) maintaining a prevention evaluation network to assess the efficacy of these prevention services; (3) participating in blood safety monitoring and surveillance efforts; and (4) collaborating with lay organizations to deliver consistent prevention messages aimed at preventing complications.

B. Eligible Applicants

Assistance will be provided only to hemophilia regional core centers, defined as public or private non-profit entities that provide regional services and support to a network of comprehensive hemophilia treatment centers (HTCs) within their regional catchment area. A HTC is defined as a specialty, prevention, diagnostic and treatment program with the goal of providing family-centered, state-of-the-art medical and psycho-social evaluation and care, dental, education, genetic, research, and support services for individuals and families with bleeding disorders.

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 $6,700,000 is available in FY 2001 to fund approximately 12 awards. It is expected that the average award will be $400,000, ranging from $200,000 to $875,000. 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 five years. The funding estimates 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.

Funding Preference

One award per region will be made to support the core center and other collaborating HTC performance sites in the region. For the purposes of these awards, regional breakdowns are as follows: Region I: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont; Region II: New Jersey, New York, Puerto Rico, and the U.S. Virgin Islands; Region III: Delaware, the District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia; Region IV-North: Kentucky, North Carolina, South Carolina, and Tennessee; Region IV-South: Alabama, Florida, Georgia, and Mississippi; Region V-East: Indiana, Michigan, and Ohio; Region V-West: Illinois, Minnesota, North Dakota, South Dakota, and Wisconsin; Region VI: Arkansas, Louisiana, Oklahoma, and Texas; Region VII: Iowa, Kansas, Missouri, and Nebraska; Region VIII: Arizona, Colorado, Montana, New Mexico, Utah, and Wyoming; Region IX: California, Hawaii, Nevada, American Samoa, Northern Mariana Islands and Guam; Region X: Alaska, Idaho, Oregon, and Washington.

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. On the regional level, the regional core center should:

(1) Develop appropriate management and evaluation systems to ensure that HTCs within the region implement the activities of this program appropriately and comply with federal and other required regulations. Conduct program assessments, site visits, assist HTCs with problem solving, assess local needs and recommend support for subcontracts to a network of centers in their region, and provide technical assistance when needed;

(2) Serve as liaison with CDC to provide input and feedback regarding national programs, implementation and evaluation. Coordinate CDC consultation when necessary;

(3) Facilitate communication within the region to foster opportunities to promote the exchange of information among health care providers;

(4) Increase awareness about the prevention of complications by promoting prevention services and programs within the region among community-based organizations (CBOs) and persons with bleeding disorders to identify new patients eligible for care, and to reestablish contact with patients lost to follow-up;

(5) Facilitate collaborative program development, planning, and communication between the region's HTCs and chapter or other consumer organizations to promote referral to the centers and provide access to educational and support services;

(6) Encourage expansion of HTC populations to include services to women with bleeding disorders and develop programs to identify under served populations including minorities and women;

(7) Coordinate development of HTC program plans, goals and objectives, and progress tracking and reporting for HTCs in the region;

(8) Facilitate access to appropriate training resources and opportunities to orient new HTC personnel, and enhance the skills of current HTC personnel to increase the quality of prevention services; and

(9) Coordinate, annually or bi-annually, with CDC participation, a regional meeting for HTCs and CBOs or ad hoc consumer consultation committees to share information and plan programs. Regional meetings may be jointly sponsored with other regions that have similar needs.

b. The regional core centers should develop and coordinate a plan where HTCs within the region would:

(1) Provide comprehensive prevention services to persons with bleeding disorders directed at attaining and measuring specific outcomes to reduce complications by using a multi-disciplinary team approach. HTC services are provided by a multi-disciplinary team. The core team includes: adult or pediatric hematologist, nurse coordinator, social worker and physical therapist. HTC services include medical and psycho-social assessment and monitoring, home therapy teaching and monitoring, infectious disease management, physical therapy, dental services, rehabilitation and support services. The HTC team works closely with other specialists and local health care providers to meet specific needs of persons with bleeding disorders to increase quality of life from birth throughout life, and assist individuals with the prevention and management of complications.

(2) Assess unmet needs and under served populations, including minorities and women, participate in outreach efforts to identify patients who can benefit from prevention services, and encourage patient participation in HTCs;

(3) Develop mechanisms to deliver prevention programs, messages, and materials to persons with hemophilia and their family members;

(4) Participate in CDC surveillance efforts (including the Universal Data Collection Program, Creutz-feldt Jakob Disease (CJD) Program, investigations of sero-conversions and suspected bloodborne agents) and other data collection and surveillance efforts by complying with federal and other required regulations and offering programs to all active eligible patients;

(5) Advise CDC of any patients who have become infected with HIV or hepatitis A, B, or C viruses (HAV, HBV, or HCV), possibly as a result of contaminated clotting factor concentrates;

(6) Obtain approval from local Institutional Review Board (IRB) for all protocols. Obtain appropriate assurances as required by Office of Human Research Protections (OHRP), OPHS, DHHS. Develop and maintain strict policies on protecting the confidentiality of patients, and ensure the security of databases and other records through controlled access to areas with confidential information, database password protection, locking file cabinets, and other security features; and

(7) Establish mechanism for consumer input and involvement in planning, implementing, and assessing HTC prevention activities that include education and outreach by collaborating with local community based hemophilia consumer organizations, or ad hoc consumer consultation committee.

2. CDC Activities

a. Assist in determining priority areas and long-term goals for prevention of complications of hemophilia as a collaborative effort by encouraging regional core centers to seek input from providers, CBOs and consumer representatives.

b. Provide consultation, scientific and technical assistance in planning, implementing, and evaluating activities to prevent the complications of hemophilia by using surveillance data to develop interventions and assess their effectiveness, coordinate the development, implementation, and evaluation of prevention intervention protocols.

c. Assist in the development of research protocols for IRB review by CDC and 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.

d. Assist in the analysis and reporting of aggregate clinical outcomes data, coordinate and consolidate the transfer of tabulated data, analyses, and conclusions among participating HTCs.

e. Provide follow-up and technical assistance to HTCs implementing changes or recommendations resulting from program evaluations, assessments, or activities required to meet required federal and other regulations;

f. Provide information and feedback regularly via teleconference, email and in person meetings to regional coordinators and regional directors serving as liaisons to CDC and their respective regional HTCs.

g. Provide technical assistance and coordinate routine annual testing of patient samples for HAV, HBV, HCV, and reporting of results back to HTCs. Provide technical assistance to designated laboratory for permanent storage of blood samples.

h. Collaborate with HTCs and appropriate State or local health departments to investigate any suspected HIV, HAV, HBV, HCV seroconversions or other reported potential bloodborne agents.

i. Collaborate with Regional Coordinators, National Hemophilia Foundation, HTC personnel, consumers, and designated training centers to develop and provide training resources for providers and consumers.

j. Disseminate current information related to the development, implementation, and evaluation of these regional programs to the funded HTCs and the public as necessary and as requested.

k. Facilitate collaborative research efforts among HTCs to enhance the quality of life of persons with bleeding disorders.

E. Applications

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.

Budgetary Information

Include all major cost items for implementing the proposed program for twelve months. Submit line-item descriptive justifications for personnel, travel, supplies, and other services on Standard Form 424A, “Budget Information”, provided with PHS 5161-1 (Revised 6/99). Separate budgets should be submitted for the regional core center and each HTC performance site that is included in the regional application, plus a totaled budget request for the region.

If the regional core center also serves as an HTC performance site providing prevention services to patients, provide a separate budget for related costs. For each HTC performance site request, include the name and address of the person and organization to receive the contract, as well as a detailed line-item descriptive justification.

Each applicant must provide a brief listing of budgetary requests included in its FY 2001 HRSA HTC comprehensive care grant application, specifying personnel, service, and other costs that are anticipated to be funded by HRSA for the twelve-month period. A budget guidance and preferred format will be included in the application kit.

Supporting Materials

1. Letters of agreement from all contracting or voluntary collaborating HTCs in region detailing specific roles and responsibilities of each party.

2. Letters of support from local consumer organizations representing areas coinciding with HTCs included in application. If areas do not have existing consumer organizations, include letters of support from local consumer leaders indicating their willingness to collaborate in prevention programming.

3. Copies of policies protecting the confidentiality of persons with hemophilia and the security of patient information and records. A copy of the local IRB approval letter, copy of consent form, and assurance information (multiple project assurance number, single project assurance approval letter or signed collaborative inter-institutional amendment) for the regional core center and each participating HTC.

F. Submission and Deadline

Submit the original and three copies of PHS 5161-1 (OMB Number 0937-0189). Forms are available in the application kit and at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm. On or before June 15, 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. Background and need (20 Points Total)

a. The extent to which the applicant describes the regional hemophilia population in terms of known morbidity, demographics, sources of care, and experience in data collection and surveillance. (10 points)

b. The extent to which the applicant identifies significant problems experienced by the hemophilia community, and how this regional network of HTCs can appropriately address the issues of the target community. (10 points)

2. Goals and Objectives (20 Points)

The extent to which the applicant has included goals which are relevant to the purpose of the proposal and feasible to be accomplished during the project period, and the extent to which these are specific and measurable. The extent to which the applicant has included objectives which are feasible to be accomplished during the budget period, and which address all activities necessary to accomplish the purpose of the proposal. The extent to which the objectives are specific, time-phased, and measurable.

3. Methods and Activities (50 Points Total)

The extent to which the applicant provides:

a. A detailed description of proposed activities and methods used to accomplish each objective within the time frame indicated. (15 points)

b. A description of how proposed methods will provide valid and reliable outcomes needed to accomplish proposed objectives. (10 points)

c. A description of the limitations and anticipated implementation barriers of the principal methods, and how these problems are expected to be resolved. (15 points)

d. 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. (10 points)

4. Program Management and Evaluation (10 Points)

The extent to which the management systems and specific plans of evaluation were used to ensure sufficient progress towards achievement of proposed goals and objectives are discussed. The extent to how HTC performance sites were selected is discussed. The extent that the types, frequency, and methods of evaluation were used are described. The extent to how the above information will be used to improve or redirect program operations is explained.

5. Budget (Not Scored)

The extent to which the applicant provides a detailed budget and narrative justification consistent with stated objectives and planned program activities.

6. Human Subjects (Not Scored)

Does the application 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 original plus two copies of:

1. annual progress report, no more than 90 days after the end of the budget period;

2. financial status report, no more than 90 days after the end of the budget period; and

3. final financial report and performance report, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist with a copy to the Project Officer 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-7 Executive Order 12372 Review

AR-8 Public Health System Reporting Requirements

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 301(a)(42 U.S.C. 241 (a)) and 317(k)(2)(42 U.S.C. 247b(k)(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 obtain business management technical assistance, contact: Merlin Williams, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, Room 3000, 2920 Brandywine Road, Mailstop K-75, Atlanta, GA 30341-4146, Telephone number: 770-488-2765, E-mail: [e-mail].

For program technical assistance, contact: Sally O. Crudder, Director, Hemophilia Treatment Center Program, Hematologic Diseases Branch, National Center for Infectious Diseases, Centers for Diseases Control and Prevention, 1600 Clifton Road, Mailstop E-64, Atlanta, GA 30333, Ph: 404-371-5270 or 5903, Email: [e-mail]

Dated: April 30, 2001.

John L. Williams,

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