Integrating Prevention Services for Persons with Bleeding and Clotting Disorders

Announcement Type: Competing Continuation-Initital.

Funding Opportunity Number: PA 04013.

Catalog of Federal Domestic Assistance Number: 93.283.

Key Dates:

Letter of Intent Deadline: March 8, 2004.

Application Deadline: April 5, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under Section 301(a) and 317(k)(2) and [42 U.S.C. 247b(k)(2)] of the Public Health Service Act, as amended.

Purpose and Research Objectives: 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.

This program addresses the “Healthy People 2010” focus area(s) of access to quality health services, disability and secondary conditions, educational and community-based programs, and public health infrastructure.

Measurable outcomes of the program will be in alignment with the following performance goal for CDC: To improve the health and quality of life of Americans with disabilities.

Information learned from this program evaluation will have immediate benefit for the program and the patients with bleeding and clotting disorders receiving prevention services.

Activities: Recipient activities for this program are as follows:

1. 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, outreach, education, support and provider training programs for persons with hemophilia, other hereditary bleeding disorders including women with bleeding disorders, and thrombophilia.

Specifically:

• 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.
• 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.
• Conduct outreach efforts to increase prevention intervention awareness and availability of comprehensive care among the affected population and referring providers and establish referral patterns.
• 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 disorders should be a preferred requirement for clinical expertise.

• Collaborate with clinical programs designed to improve the treatment of bleeding and clotting disorders.
• Develop training programs to educate physicians and other providers in management of bleeding and clotting disorders.

3. Develop education and awareness programs for affected populations to increase knowledge and assist consumers in making informed decisions.

• Establish mechanisms for consumer input and education and assist in fostering locally-based consumer organizations to assist in care evaluation.
• Develop educational materials and distribute as needed.
• Develop methods (i.e. utilizing consumers) to assist with the delivery of prevention messages through peer-led prevention education, outreach, and support.

4. Evaluate the model for feasibility and effectiveness.

• Implement 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 in their clinics.
• Establish follow-up with patients to determine the impact of multi-disciplinary care management for persons with coagulation disorders.

5. Publish and disseminate program results.

CDC Responsibilities: In this cooperative agreement, the CDC Scientist within the Division of Hereditary Blood Disorders (DHBD) in the National Center on Birth Defects and Developmental Disabilities is an equal partner with scientific and programmatic involvement during the conduct of the project through technical assistance, advice, and coordination.

This Scientist will:

1. Participate in the development of common protocols.

2. Participate in the analysis, interpretation, and reporting of findings in the scientific literature and other media to the community at large and the public policy community within the Federal government.

3. Participate in data management, analysis of data, and interpretation and dissemination of findings.

4. Provide scientific consultation and technical assistance in the design and conduct of the project, including intervention models, outcome measures, and analytical approaches in participation with the recipient organizations.

CDC Scientific Program Administrator (SPA)

CDC will appoint an SPA, apart from the DHBD Scientist, who will:

1. Serve as the Program Official for the funded research institutions.

2. Carry out continuous review of all activities to ensure objectives are being met. As such, the SPA may attend Coordination Committee meetings for purposes of assessing overall progress and for program evaluation purposes.

3. Provide scientific consultation and technical assistance in the conduct of the funded projects as requested.

4. Conduct site visits to recipient institutions to determine the adequacy of the research and to monitor performance against approved project objectives.

Collaborative Responsibilities: The planning and implementation of the cooperative aspects of the study will be effected by a Coordination Committee consisting of the Principal Investigators from each participating institution and the DHBD Scientist. This Coordinating Committee will formulate a research plan for cooperative research that will incorporate recipient research plans into uniform and compatible study designs and data collection protocols. Such support will be designed to contribute to effective program outcomes through allocation of resources among the participating cooperative agreement entities.

At periodic coordination committee meetings, the group will: (1) Make recommendations on study protocols and data collection approaches; (2) discuss the target populations that have been or will be recruited; (3) identify and recommend solutions to unexpected study problems; and (4) discuss ways to efficiently coordinate and combine common study activities and best practices.

II. Award Information

Type of Award: Cooperative Agreement.

CDC involvement in this program is listed in the Activities Section above.

Fiscal Year Funds: 2004.

Approximate Total Funding: $1,000,000.

Approximate Number of Awards: Four.

Approximate Average Award: $250,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs).

Ceiling of Award Range: $350,000 in initial budget period.

Anticipated Award Date: June 1, 2004.

Budget Period Length: 12 months.

Project Period Length: Three years. Throughout the project period, CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

III. Eligibility Information

III.1. Eligible applicants: Eligible applicants are limited to those already funded under Program Announcement 01085: Integrating Prevention Services for Persons with Bleeding and Clotting Disorders. This program was originally announcement in 2001 and was full and open competition. Funding was awarded to initiate the pilot program, however, in the first two years, only the data collection development phase was completed. Implementation and final approval from institutional review boards was in process at the end of the project period. The pilot process and these awardees have produced the background necessary for the projects to now demonstrate the effectiveness of comprehensive care models under development based on the foundations established by these institutional projects.

Therefore, the eligible applicants are:

Duke University, Durham, North Carolina

Hemophilia Foundation of Michigan, Ann Arbor, Michigan

Mountain States Regional Hemophilia and Thrombosis Center, Denver, Colorado

UMDNJ-Robert Wood Johnson University Hospital, New Brunswick, NJ.

III.2. Cost Sharing or Matching: Matching funds are not required for this program.

III.3. Other: If you request a funding amount greater than the ceiling of the award range, your application will be considered nonresponsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements. Based upon budget constraints, requests above this average award level are suject to reduction in accordance with available resources.

If your application is incomplete or non-responsive to the requirements listed below, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.

Individuals Eligible to Become Principal Investigators: Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs.

Note:

Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1 Address to Request Application Package: To apply for this funding opportunity, use application form PHS 398 (OMB number 0925-0001 rev. 5/2001). Forms and instructions are available in an interactive format on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm .

Forms and instructions are also available in an interactive format on the National Institutes of Health (NIH) Web site at the following Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.

IV.2. Content and Form of Application Submission: Letter of Intent (LOI):

The LOI must be written in the following format:

• Maximum number of pages: Two.
• Font size: 12-point unreduced.
• Paper size: 8.5 by 11 inches.
• Page margin size: One-inch margins.
• Printed only on one side of page.
• Single spaced.
• Written in English; avoid jargon. The LOI must contain the following information: Name, address, and telephone number of the proposed Principal Investigator, number and title of this program announcement, names of other key personnel, designations of collaborating institutions and entities, and an outline of the proposed work, recruitment approach, and expected outcomes.

Application: Follow the PHS 398 application instructions for content and formatting of your application. For further assistance with the PHS 398 application form, contact PGO-TIM staff at (770) 488-2700, or contact GrantsInfo, Telephone (301) 435-0714, E-mail: GrantsInfo@nih.gov

Your research plan should address activities to be conducted over the entire project period. The application should include a separate typed abstract of the proposal consisting of no more than one single-spaced page. The application should include a table of contents for the project narrative and all related attachments. Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information may include curriculum and resumes for key project staff, organizational charts, letters of support, etc.; and should be limited to those items relevant to the requirements of this announcement.

You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm .

Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”

IV.3. Submission Dates and Times:

LOI Deadline Date: March 8, 2004.

CDC requests that you send a LOI if you intend to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, and will allow CDC to plan the application review.

Application Deadline Date: April 5, 2004.

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 p.m. eastern time on the deadline date. If you send your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If CDC receives your application after closing due to: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carrier's guarantee. If the documentation verifies a carrier problem, CDC will consider the application as having been received by the deadline.

This announcement is the definitive guide on application submission address and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that your application did not meet the submission requirements.

If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait three days after the application deadline. This will allow time for applications to be processed and logged.

IV.4. Intergovernmental Review of Applications: Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions: Restrictions, which must be taken into account while writing your budget are that project funds cannot be used to supplant other available applicant or collaborating agency funds for construction or for lease or purchase of facilities or space.

If you are requesting indirect costs in oyr budget, you must include a copy of your indirect cost rate agreement. If you indirect cost rate is a provisional rate, the agreement must be less than 12 months from the application due date.

IV.6. Other Submission Requirements:

LOI Submission Address: Submit your LOI by express mail, delivery service, fax, or E-mail to: Sally Crudder, Health Scientist, CDC National Center on Birth Defects and Developmental Disabilities, CDC, 1600 Clifton Road, MS. E-64, Atlanta, GA 30333, e-mail address: scrudder@cdc.gov.

Application Submission Address: Submit the original and five copies of your application by mail or express delivery service to: Technical Information Management—PA 04013, Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.

Applications may not be submitted by fax or e-mail at this time.

V. Application Review Information

V.1. Criteria: You are required to provide measures of outcome and effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

The goals of CDC-supported research are to advance the understanding of biological systems, improve the control and prevention of disease and injury, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

Under the evaluation criteria noted below, applicants must describe how they will address the program components as they relate to the Purpose and Research Objectives, and Recipient Activities as cited in this Announcement.

Your application will be evaluated against the following criteria:

1. Methods and Activities: (30 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.

b. The extent to which the applicant describes and documents the collaborative efforts of the proposed program to (1) Assess efficacy of prevention activities and (2) develop and implement prevention programs.

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.

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.

2. Capacity: (30 points)

a. 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.

b. 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.

c. 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.

3. 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.

4. Program Management and Evaluation: (15 points)

a. The extent of management experience for recruiting and implementing large public health prevention initiatives.

b. The extent that management systems, including types, frequency, and methods of evaluation are used to ensure appropriate implementation of program activities.

5. Goals and Objectives: (10 points)

The extent that the proposed goals and project objectives meet the required activities specified under “Recipient Activities”; and are specific, measurable, time-phased, and realistic.

6. Budget: (Not Scored)

This criteria includes the degree to which the budget is reasonable, clearly justified, accurate, and consistent with the purposes of this announcement. The budget justification will not be counted in the stated page limit.

7. Human Subjects: (Not Scored)

Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects? This criteria will not be scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

V.2. Review and Selection Process: Applications will be reviewed for completeness by the Procurement and Grants Office (PGO), and for responsiveness by NCBDDD. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.

VI. Award Administration Information

VI.1. Award Notices: Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

VI.2. Administrative and National Policy Requirements: 45 CFR Parts 74 and 92.

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr_table-search.html.

The following additional requirements apply to this project:

• AR-1 Human Subjects Requirements
• AR-2 Requirement for Inclusion of Women and Racial and Ethnic Minorities in Research
• AR-9 Paperwork Reduction Act Requirements
• AR-10 Smoke-Free Workplace Requirements
• AR-11 Healthy People 2010
• AR-12 Lobbying Restrictions
• AR-25 Release and Sharing of Data

Additional information on these requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements: You must provide CDC with an original, plus two copies of the following reports:

Interim progress report, (PHS 2590, OMB Number 0925-0001, rev. 5/2001) on March 22 of each subsequent budget year. The progress report will serve as your non-competing continuation application, and must contain the following elements:

Current Budget Period Activities Objectives.

Current Budget Period Financial Progress.

New Budget Period Program Proposed Activity Objectives.

Budget.

Additional Requested Information.

Measures of Effectiveness.

Financial status report and annual report, no more than 90 days after the end of the budget period.

Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be sent to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

VII. Agency Contacts

For general questions about this announcement, contact: Technical Information Management Section (PGO-TIM), CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.

For program technical assistance, contact: Sally Crudder, Health Scientist, CDC National Center on Birth Defects and Developmental Disabilities, 1600 Clifton Road, Mailstop E-64, Atlanta, GA 30333, E-mail Address: scrudder@cdc.gov, Telephone: 404-371-5270.

For financial, grants management, or budget assistance, contact: Rick Jaeger, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2727, E-mail: rjaeger@cdc.gov.