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Department of Health and Human Services

Part 1. Overview Information

ParticipatingOrganization(s)
/ Centers for Disease Control and Prevention (CDC)
Components of Participating Organizations
/ Delete CIOs that are not participating. List the Issuing Organization first, otherwise, do not change the order.
For other OpDivs add the relevant components (centers/offices) at the end of the list, following the same format.
National Center on Birth Defects and Developmental Disabilities (NCBDDD)
Funding Opportunity Title
/ Public Health Research for the Prevention of Complications of Bleeding Disorders
Mechanism of Support
/ Keep the relevant activity code and delete all irrelevant activity codes, so that you are left with a single line for your activity code. Do not change any of the text.
U01 Research Project Cooperative Agreements
Some activity codes may need prior approval or may have limited use, and CIO may or may not have authority for each activity code. Add the relevant activity code, if not listed above. Please see the Activity Codes, Organizational Codes, and Definitions Used in Extramural Programs for more information.
Announcement Type
/ New
Keep relevant text; enter previous FOA Number if a reissuance
Funding Opportunity Announcement (FOA) Number
/ RFA-DD-11-009
Delete the non-relevant choices (RFA/PA. Fill in Fiscal Year (FY). For a CIO RFA, insert the RFA number for NNN. Leave the FOA number as NNN and it will be assigned by PGO staff.
Catalog of Federal Domestics Assistance (CFDA) Number(s)
/ 93.073
Category of Funding Activity
/ Health
FOA Purpose
/ Please limit this field to a brief description of ¼ to ½ page in length. Brevity is appreciated.
Support will be provided for independent public health research projects on the complications of bleeding disorders. The purpose of these projects will be to produce new, generalizable information on the incidence; prevalence; risk factors for; and/or burden, consequences and prevention of complications of bleeding disorders.

Key Dates

Publication Date
/ December 9, 2010PGO will add this information when posted. This field is not available for CIO edit.
Letter of Intent Due Date
/ January 24, 2011
The Letter of Intent due date must be at leastone month (assume 30 days in one month) before application due date, and generally at least one month after posting date. If not applicable, replace “Month Day, Year” with “Not Applicable”
Application Due Date
/ March 4, 2011, by 5:00 PM Eastern Time.
On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM Eastern Time.Note:.HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).
Date is expected to be three months (minimum two months) after publication of the announcement (assume 30 days in one month).
Scientific Merit Review
/ May, 2011
SecondaryReview
/ July, 2011
Start Date
/ September, 2011

Expiration Date

/ March 5, 2011

Due Dates for E.O. 12372

/ Required. Insert the following applicable statement:
Executive Order 12372 does not apply to this program.

Required Application Instructions

It is critical that applicants follow the instructions in theSF 424 (R&R) Application Guideexcept where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance toall requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Insert as applicable and include the page limits:

Note:The Research Plan is limited to 25 pages. The Research Strategy component of the Research Plan is limited to20 pages.

Applicationsthat do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

“Apply Electronically” Text and link inserted hereby PGO.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Recommended length: 1-5 pages. Present the purpose of the funding opportunity in paragraph form, addressing all of the items below. Please keep in mind that readers will appreciate clarity and brevity. The following headers may be useful in preparing this section:

Purpose/Research objectives (describe the nature and need of the research opportunity)

Specific Areas of Research Interest (include examples of research topics. In such cases, add a statement indicating that appropriate topics “include but are not limited to those listed below.”

This section may also address scientific knowledge to be achieved through research supported by the special program and types of research and experimental approaches that are being sought to achieve the objectives.

In this section Use the following headings and add text below

The NCBDDD of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of Healthy People 2020.hp2020 This RFA addresses Healthy People 2020 focus area of Blood Disorders and Blood Safety.

Nature of the Research OpportunityThis research opportunity will support public health research projects in areas of concern to populations with bleeding disorders, primarily those due to congenital factor deficiencies such as hemophilia, Von Willebrand disease and other clotting factor deficiencies.Projects will be proposed for one of sevenpublic health research priority areas (see below).This FOA is not intended to fund clinical trials.

Background

Hemophilia and other bleeding disorders, characterized by a permanent tendency towards spontaneous or traumatic hemorrhages, are responsible for significant disease burden and negative impact on the quality of life. Hemophilia, an X-linked recessive condition resulting in a decrease or lack of clotting factor VIII or IX, is marked by bleeding into joints and muscle, but may also lead to bleeding that causes neurologic damage, damage to other organ systems, or death. Hemophilia affects all racial and ethnic groups; it is estimated there are about 20,000 males with hemophilia in the United States at this time. Von Willebrand disease (VWD) results from a deficiency or defect in the body's ability to make von Willebrand factor, a protein that helps blood clot. Although VWD occurs in men and women equally, women are more likely to notice the symptoms because of heavy or abnormal bleeding during their menstrual periods and after childbirth. Joint bleeds and muscle hematomas may occur in severe forms of the disease, but mucocutaneous bleeding is more common. VWD is thought to occur in up to 1-2% of the population. Deficiencies of other clotting factor proteins and platelet function defects may cause rarer bleeding disorders.

Since the 1990’s, the Congress has provided funding to CDC to reduce and prevent the complications of bleeding disorders, including those that are unique to women. As part of this program, since 1998 the Universal Data Collection (UDC) project, a nation-wide effort carried out in federally funded hemophilia treatment centers, has longitudinally collected medical records information, joint range of motion measurements and blood specimens for pathogen testing from persons with hemophilia, von Willebrand disease and other clotting factor deficiencies. The outcomes data collected by UDC is suitable for monitoring complications; the risk factors information is informative but is neither complete enough nor sufficiently nuanced for many research analyses that would elucidate the relationships between covariates and risk factors and the occurrence or modification of bleeding disorder complications. Additionally, the project has accumulated little data on complications specific to women with bleeding disorders.

This initiative will augment CDC’s activities by supporting expert-initiated public health research projects utilizing appropriate data and analysis strategies to produce new information on the incidence, prevalence, risk factors for, burden of and/or prevention of complications of bleeding disorders.

Scientific Knowledge to be Achieved through this Funding Opportunity

These studies will provide new information on the complications and sequealae of bleeding disorders. The goal of this research is to generate information on:

  • the incidence and prevalence of complications due to bleeding disorders;
  • risk factors for such complications, including better understanding of established risk factors and evaluation ofnew etiologic variables/risk factors;
  • the underlying mechanisms of complications and the potential opportunities for interventionto reduce the consequences or impact of complications;
  • interventions for preventing and reducing complications;
  • research findings which can be translated into interventions to prevent or mitigate the consequences of bleeding disorders and/or
  • the effectiveness of interventions which translate research into practice.

Research Objectives and Approach

To accomplish the purpose of this FOA, the applicant must address one of the seven following priority research areas. An applicant may apply for more than one priority area. However, the applicant must submit a separate application for each priority area applied for.

Priority area 1.Joint disease

Arthropathy due to bleeding into joints is the hallmark of hemophilia and is a feature of some other bleeding disorders as well. Use of clotting factor replacement products can help reduce, and, under some treatment regimens, prevent, joint damage due to bleeds. Advanced medical procedures can ameliorate the effects of severe joint disease. Nonetheless, joint disease remains an expensive, debilitating and common complication of hemophilia. Possible areas of investigationinclude but are not limited to:practices and interventions to prevent joint disease; the economic, societal and psychological costs of joint disease; disability due to joint disease; factors affecting the development and progression of joint disease.

Priority area 2.Women with Bleeding Disorders

Bleeding disorders in women commonly manifest noticeably as menorrhagia and bleeding after childbirth. However, diagnosis may be delayed due to lack of awareness on the part of health care providers and technical challenges involved in the diagnosis, especially that of the most common bleeding disorder, von Willebrand disease. Bleeding disorders have been associated with increased risk for miscarriage, bleeding during pregnancy and postpartum hemorrhage. Possible areas of investigationinclude but are not limited to: risk factors for bleeding complications among women with bleeding disorders; timely and accurate diagnosis of bleeding disorders; consequences of menorrhagia; optimum treatment strategies.

Priority area 3. Issues related to the use of prophylaxis

The regular administration of clotting factor with the intention of preventing all bleeds prior to the development of joint disease in young children (primary prophylaxis) has been demonstrated to protect joints from hemophilic arthropathy. However, the relative costs and benefits of continuing prophylaxis into adulthood or beginning secondary prophylaxis in adults have not been established. Possible areas of investigationinclude but are not limited to: research that will help develop clear guidelines on prophylaxis- optimal time of initiation, duration, frequency, termination; affects of prophylaxis on arthropathy in adults; identifying patients likely to benefit from prophylaxis; affects on complications other than joint bleeds/arthropathy; cost-effectiveness.

Priority area 4.Inhibitors

Development of an inhibitor to clotting factor replacement products is a significant complication of treatment for bleeding disorders, rendering treatment ineffective, increasing costs of care and exposing the patient to bleeding consequences. Possible areas of investigationinclude but are not limited to: modifiable risk factors for inhibitor development; interplay between genetic and non-genetic risk factors for inhibitor development; covariates and risk factors for success of immune tolerance therapy.

Priority area 5. Chronic co-morbidconditions, such as obesity, cardiovascular disease and diabetes mellitus.

Chronic medical conditions that occur in people with bleeding disorders can affect management of the bleeding disorder. As the life-span of people with hemophilia increases, conditions associated with aging that were previously insignificant to care of these patients are now of concern. Possible areas of investigationinclude but are not limited to: incidence and prevalence in populations with bleeding disorders; risk factors for development of co-morbid conditions; effect of co-morbid conditions on bleeding disorders; effects of the bleeding disorder on the course, severity, management of co-morbid conditions.

Priority area 6. Neonates, infants and toddlers.

Neonates and very young children with bleeding disorders experience complications different from those of older children and adults, often precipitated by mode of birth, iatrogenic events and frequent falls. The complications of bleeding disorders at these ages are less well characterized than in older groups, as are the optimal strategies for prevention. Possible areas of investigation include but are not limited to: ICH risk factors and prevention, line and port complications, primary vs secondary prophylaxis, alternative treatments to prevent inhibitors.

Priority area 7. Emerging issues

Projects submitted under this category should represent complications of bleeding disorders that do not fall under the categories above but which the investigator identifies as a significant or potentially significant to the population of people with bleeding disorders and that have potential impact to public health. Examples might include, but are not limited to, developmental delay ormanagement of care in the elderly with bleeding disorders.

The population of interest is persons with bleeding disorders, primarily those due to congenital factordeficiencies such as hemophilia, Von Willebrand disease and other clotting factor deficiencies. Projects related to women’s issues may also include persons with certain platelet function disorders, collagen defects and women with bleeding symptoms that may be related to an underlying bleeding disorder.

Investigationsmay utilize new data collectionor existing data sets, including administrative data sets and electronic medical records.

No one study design or approach is preferred over any other as long as it is appropriate for the research question proposed by the applicant. The study approach should be stated clearly in the application.Investigators should discuss clearly their expected sources of data, the populations represented andanalytic issues such as power calculations.In research involving existing data, it is expected that all resultant scientific publications will clearly state the post-hoc power analyses and discuss issues related to this.

Section II. Award Information

Funding Instrument

/ Delete Cooperative Agreement text unless using U activity code. In that case, delete “grant”
Cooperative Agreement:A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

/ Choose one of the following:.
New
The OER Glossaryand the SF 424 (R&R) Application Guideprovide details on these application types.

Funds Available and Anticipated Number of Awards

/ Indicate the total funds available for the entire program. Sometimes this area is complicated if multiple types of awards are awarded
A total of $3,600,000 (direct and indirect costs) will be available for up to 6 projects during the project period.
Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Ceiling and Floor of Individual Award Range

/ $200,000.00 (direct and indirect cost)
INSERT maximum $ amount; amount that you will not exceed OR INSERT "None." This ceiling is for the first 12-month budget period. Indicate if this is direct cost only or total cost, which would include indirect costs.
$75,000.00 (direct and indirect cost)
INSERT any minimum $ amount, if you will not make an award smaller than a floor amount OR INSERT "None."
Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed.

Project Period Length

/ Add Information Here (Example: Scope of the proposed project should determine the project period. The maximum period is 5 years.)
If project period is more than five years, approval is required.
The proposed project period is 3 years. Throughout the project period, CDC's commitment to continuation of awards will be conditional 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.

HHS/CDC grants policies as described in the HHS Grants Policy Statementwill apply to the applications submitted and awards made in response to this FOA.