dd11-009 foa final 12.9.10.doc

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Department of Health and Human Services

Part 1. Overview Information

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)

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

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.

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.

The Letter of Intent due date must be at least one 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”

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).

Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all 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 to 20 pages.

Applications that 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 here by 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. www.healthypeople.gov/hp2020 This RFA addresses Healthy People 2020 focus area of Blood Disorders and Blood Safety.

Nature of the Research Opportunity This 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 seven public 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 of new etiologic variables/risk factors;

· the underlying mechanisms of complications and the potential opportunities for intervention to 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 investigation include 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 investigation include 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 investigation include 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 investigation include 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-morbid conditions, 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 investigation include 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 or management of care in the elderly with bleeding disorders.

The population of interest is persons with bleeding disorders, primarily those due to congenital factor deficiencies 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.

Investigations may utilize new data collection or 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 and analytic 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

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 Glossary and the SF 424 (R&R) Application Guide provide 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.

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.

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 Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligible Organizations

Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

· Hispanic-serving Institutions

· Historically Black Colleges and Universities (HBCUs)

· Tribally Controlled Colleges and Universities (TCCUs)

· Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

· Nonprofits (Other than Institutions of Higher Education) For Profit Organizations

· Small Businesses

· For-Profit Organizations (Other than Small Businesses)

Governments

· State Governments

· County Governments

· City or Township Governments

· Special District Governments

· Indian/Native American Tribal Governments (Federally Recognized)

· Indian/Native American Tribal Governments (Other than Federally Recognized)

· Eligible Agencies of the Federal Government

· U.S. Territory or Possession

Other

· Independent School Districts

· Public Housing Authorities/Indian Housing Authorities

· Native American tribal organizations (other than Federally recognized tribal governments)

· Faith-based or Community-based Organizations

· Regional Organizations

· Bona Fide Agents

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not if foreign components are not allowed, delete “not” allowed.

Add additional eligibility requirements here for institutions Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

· Central Contractor Registration (CCR) – must be renewed annually

· Grants.gov

· eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

Add additional eligibility requirements here for individuals.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

If the sentence above is not true, , CIO must insert a comment to change the sentence above to “Only one application per institution (normally identified by having a unique DUNS number) is allowed.”

HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. HHS/CDC will not accept any application that is essentially the same as one already reviewed.

Add Information Here related to eligibility and number of applications.

The application must address one of the seven priority research areas identified in the funding opportunity. An applicant may apply for more than one priority area. However, the applicant must submit a separate application for each priority area applied for.

Each application must clearly identify in the title and/or body the topic area(s) addressed. It is strongly suggested that topic areas be named in the title and the abstract.

Applicants must demonstrate active collaborations and formal agreements for data access for sources of data mentioned in the research plan. Letters of support or memoranda of understanding may be included in an appendix but must be identified in the research plan.

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

Section IV. Application and Submission Information

1. Obtaining an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent The only acceptable modifications to this section are those related to the staff contact information. Current policy does not allow any changes to the type of information requested in the Letter of Intent. If Letter of Intent is not applicable for this FOA, delete the heading above and the section below.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Donald Blackman, Ph.D.

Scientific Program Official Extramural Research Program Office 4770 Buford Highway NE MS K-92

Atlanta GA 30341

(770) 488-3023

(770) 488-8046 FAX

dblackman@cdc.gov

Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

Page Limitations

All page limitations described in this individual FOA must be followed.

For this FOA, the Research Strategy section is limited to 20 pages. , insert text for page limits for the Research Strategy section of the application. The complete Research Plan, including the Research Strategy, may be no more than 25 pages.

Use additional text to describe other exceptions to the page limits described in the Application Guide.

Research Plan Components All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Add text in the space below (before Appendix) to supply any additional instructions related to the Research Plan, but only include information that is different from application guide.

Include this information in the Significance section of the research strategy:

· Provide background and rationale for the proposed analysis;

· Provide detailed descriptions of research questions and hypotheses, and;

· Describe how the study will advance knowledge in the field and contribute to improvements in the prevention of complications of bleeding disorders.

Include this information in the Approach section of the research strategy:

· Describe the research population of interest and the study sample, including the inclusion and exclusion criteria and the sampling unit (ex.- individual, census block, etc.);

· Identify whether investigators will use existing data or collect new data and describe data sources;

· For proposals making use of existing data, provide a detailed description of the data, including, but not limited to the scope of the data (national, regional or local) and its generalizability (whether restricted on basis of sex, races, age, geographical location, etc.);

· Detail the proposed study design, methods, and analytic plan including software and any specialized equipment;

· Provide sample size and power calculations demonstrating adequate statistical power for the proposed project; a study power chart highlighting the expected power of the study under various scenarios should be provided;

· Document any proposed collaborative arrangements, e.g., provisions for data access, other relationships with outside institutions or investigators; where applicable, letters of support should specify the contributions that the partner organization is committed to making to the proposed research;

· Describe anticipated limitations of the study;

· Identify potential obstacles to implementation and possible solutions;

· Describe plans for disseminating research findings through peer-reviewed publications and presentations, and;

· Provide a timeline for proposed project activities.

In addition, the research plan must:

· Provide a detailed staffing plan describing each member’s role, expertise, and percentage of time that will be committed to this project; indicate who will provide quality oversight and supervision of the research team; if a position is yet to be filled, provide a position description in the appendix, and ;

· Demonstrate the research team’s experience in conducting similar research projects as evidenced by peer-reviewed publications.

Applicants must provide evidence that they have been approved for access to any data which has been named in this proposal. Letter of support or memoranda of understanding must explicitly indicate that investigators will have access to all data proposed for analysis.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide Delete the text block above and bullet below if not adding any changes to the Appendix instructions. If you are making changes, fill in text below.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant 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).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt and validation or rejection may take two (2) business days. Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact PGO TIMS for guidance at least 3 calendar days before the deadline date.

4. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs and construction costs are not allowable under this award.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Add information here related to responsiveness if applicable.

Add any other Submission Requirements and Information; include heading (and description. Do not include information about the CONTENT and FORM of the application, which should instead be placed above in Section IV.2. Content and Form, Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the CDC mission, all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Overall Impact is not editable.

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Additional Questions may be added.

Will this project have a significant impact, directly or indirectly, on public health approaches to bleeding disorders?

Will these results make a substantial contribution to the reduction of bleeding disorder complications or improvement in quality of life of people with bleeding disorders?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Additional Questions may be added.

Does the research team include an effective mix of public health and clinical expertise?

If the project proposes social or psychological outcome measures, are social scientists with the necessary expertise included on the research team?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Additional Questions may be added.

Does the research plan include innovative data collection or analysis methods which make an independent contribution to the field?

Do the research questions or hypotheses address issues which point to new directions that are worthy of further research?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects or clinical investigation, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Additional Questions may be added.

Does the approach reflect the current state of the art with respect to measurement and assessment of people with bleeding disorders?

Are the plans for combining data sources viable and well-reasoned?

Are the analytic approaches and statistical methods appropriate for the study of low-incidence, low-prevalence events?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Questions may be added.

If the plan involves testing of specimens, does the applicant have access to adequate and appropriate laboratory facilities?

IMPORTANT: Any reordering or rewording of the existing text above (this does not include any information you have added) should be discussed and cleared with the Scientific Review Officer, the GMO, and PGO TIMS before publication as it may require technical changes in the eRA review modules.

Additional Scored Review Criteria may be added but criterion scores for these criteria will not be captured by IAR and must instead be calculated by Review Staff..

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

· The potential for translating findings to practice.

Additional Review Criteria may be added.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Inclusion of Women and Racial and Ethnic Minorities in Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Renewals For Renewals (formerly called competing continuation applications), the committee will consider the progress made in the last funding period. If Renewals are not allowed for this FOA, replace the text with “Not Applicable”. Otherwise, do not change.

Revisions Revisions (formerly called competing supplement applications), are a request for an increase in support in a current budget period for expansion of the scope of the approved project or program or to meet an unforeseen increase in costs. The request may specify budgetary changes required for the remainder of the project period as well as for the current budget period. Supplemental applications requesting a programmatic expansion (change in scope) must undergo objective review and generally are required to compete for support; requests for administrative supplements may be awarded without objective review or competition.

Additional Review Considerations As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Additional Review Considerations may be added.

Resource Sharing Plans

HHS/CDC policy requires that recipients of grant awards make unique research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see:

http://www.cdc.gov/od/foia/policies/sharing.htm. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will: Delete first bullet if all applications will be discussed (no streamlining of applications); otherwise do not modify the bullet.

· Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.

· Receive a written critique.

Applications will be assigned to the appropriate HHS/CDC Center, Institute, or Office. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review. The following will be considered in making funding decisions:

· Scientific and technical merit of the proposed project as determined by scientific peer review.

· Availability of funds.

· Relevance of the proposed project to program priorities.

· Diversity of FOA priority research areas.

For any additional considerations in funding decisions, add a bullet and enter text such as “Compliance with resource sharing policies.”

Indicate if this award will include special terms and conditions that differ from the agency’s usual terms and conditions. Include Programmatic Priorities and Other Cost Limitations (e.g., excluding Facilities & Administrative costs for R13s). See also Section IV.5. “Funding Restrictions.”

3. Anticipated Announcement and Award Dates After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs specified in the FOA document.

2. Administrative and National Policy Requirements

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award, Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants. Additional requirements are available at the following internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Cooperative Agreement Terms and Conditions of Award Indicate if this FOA is not for a cooperative agreement and this section (from here to Reporting) can be removed.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.

Recipient Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for:

· all management, administrative and scientific aspects of the project. The grantee is strongly encouraged to review the HHS grant policy statement, for aid with post award administration, at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

· coordinating project activities, technically, scientifically, and administratively at the awarded institution and at other sites that may be supported by sub-contracts to this award. The applicant will have primary authority and responsibility to define objectives and approaches; collect and analyze data; and to publish results, interpretations, and conclusions of studies under the terms and conditions of the program project award.

· obtaining and documenting appropriate institutional human subjects protection (IRB) review and approvals throughout the study.

· Participating in conference calls and face-to-face meetings with CDC.

· Maintaining the…