dd12-1206 foa final 3.30.12.doc

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 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Agency Name: Federal Centers for Disease Control and Prevention (CDC) Funding Opportunity Title: Hemoglobinopathies Surveillance, Health Promotion, and Laboratory Capacity Demonstration Project Announcement Type: New – Type 1

Agency Funding Opportunity Number: CDC-RFA-DD12-1206 Catalog of Federal Domestic Assistance Number: 93.184 Key Dates:

To receive notification of any changes to DD12-1206, return to the synopsis page of this announcement at: www.grants.gov and click on the “Send Me Change Notification Emails” link. An email address is needed for this service.

Letter of Intent Deadline Date: April 30, 2012 Application Deadline Date: May 30, 2012, 11:59pm U.S. Eastern Standard Time Executive Summary:

The purpose of this cooperative agreement is to expand upon the work of the Registry and Surveillance for Hemoglobinopathies (RuSH) project so as to address the new Healthy People 2020 topic, Blood Disorders and Blood Safety. This will be a demonstration project addressing three areas of Public Health: surveillance, health promotion and prevention awareness, and laboratory capacity building. Applicants are encouraged to assemble strategies that both strengthen their current capacities and develop innovative approaches to accomplish the objectives of this program. Applicants may apply for one or more of the following modules: (A): Surveillance and health promotion for sickle cell disease, (B): Surveillance and health promotion for thalassemia, and (C): Laboratory enhancement for hemoglobinopathy screening and diagnosis.

A separate application is required for each module.

Applicants must complete each separate application in grants.gov and identify the application by the Module in the “Descriptive Title of Applicant’s Project” field #15 on the “SF-424” form. i.e. Module A "org project title", Module B "org project title", etc.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center on Birth Defects and Developmental Disabilities:

· Prevent and control complications resulting from hemoglobinopathies, with a focus on sickle cell disease and thalassemia.

The program will also address three of the focus areas under the Healthy People 2020 (HP2020) topic of Blood Disorders and Blood Safety:

· BDBS-1 Increase the proportion of persons with hemoglobinopathies who receive recommended vaccinations.

· BDBS-4 Increase the proportion of persons with hemoglobinopathies who receive early and continuous screening for complications.

· BDBS-5 Increase the proportion of persons with hemoglobinopathies who receive disease-modifying therapies.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address:

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

PART 2. FULL TEXT

I..FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

This program is authorized under Sections 311, 317 (k)(2) and 317 (C) of the

Public Health Service Act [42 U.S.C. Sections 243, 247b(k)(2) and 247b-4] as amended.

Background Currently, there are no national data systems that can be used to calculate the prevalence of hemoglobinopathies such as sickle cell disease (SCD) and thalassemia in the United States, nor to describe the patient population. Newborn screening (NBS), which has recently been adopted by all states, can yield incidence figures for SCD. However, NBS statistics most likely underestimate the total population numbers due to missing information about immigrants, people who were born before newborn screening, and hemoglobin disorders that are not tested by NBS (e.g. many of the thalassemias).

In 2010, the Centers for Disease Control and Prevention, National Center on Birth Defects and Developmental Disabilities, Division of Blood Disorders (CDC/NCBDDD/DBD) in collaboration with the National Institutes of Health, National Heart Lung and Blood Institute (NIH/NHLBI) developed and implemented a collaborative pilot project for population-based surveillance of both pediatric and non-pediatric hemoglobinopathy populations. The Registry and Surveillance of Hemoglobinopathies (RuSH) pilot project was a two-year cooperative agreement designed to create a data system with information about the incidence and prevalence, demographic trends, pregnancy outcomes, causes of mortality and mortality rates, and health care utilization of persons with hemoglobinopathies. However, due to a short time frame (two years) and limited financial resources, the pilot project did not allow for evaluation and validation of the project’s methods and activities. Furthermore, longitudinal data is necessary to provide accurate information on the impact of these conditions throughout the patients’ life course and to monitor the health impact.

Healthy People 2020 includes a new topic, Blood Disorders and Blood Safety. Baseline estimates for three of the objectives for this topic were collected through the RuSH pilot project: 1) Increase the proportion of persons with hemoglobinopathies who receive recommended vaccinations; 2) Increase the proportion of persons with a diagnosis of hemoglobinopathies who receive early and continuous screening for complications; and 3) Increase the proportion of people with hemoglobinopathies who receive disease-modifying therapies. The baseline estimates for these three areas need to be validated, data collection methods need to be evaluated, plans for longitudinal data collection need to be made, and strategies for health promotion and prevention awareness need to be developed and disseminated to increase the proportion of patients with hemoglobinopathies receiving recommended vaccinations, early and continuous screening for complications, and receiving disease-modifying therapies.

Finally, the only method currently available for universal identification of persons with hemoglobinopathies is newborn screening. In most states, this does not include comprehensive thalassemia screening. Efforts to support laboratory screening and diagnosis for non-newborns are needed to assure appropriate patient follow-up and management.

Purpose

The purpose of the program is to create a framework that will address three HP2020 objectives listed above through:

· Public health surveillance – Evaluate and refine the methods employed in the RuSH project to establish valid baseline estimates for the HP2020 objectives, and apply these methods in a longitudinal fashion to determine if the health promotion and prevention awareness activities (see below) are successful;

· Health promotion and prevention awareness - Conduct prevention research activities focused on the HP2020 objectives, and design, implement, and evaluate corresponding educational tools for patients and providers; and

· Laboratory capacity building – Determine the best practices for analyzing all relevant hemoglobin variants throughout the lifespan, including training and proficiency testing, in order to help correctly identify and diagnose persons with hemoglobinopathies. A comprehensive model for the complex analysis of hemoglobin variants throughout the lifespan should be established. The model should include a training program for implementing laboratory techniques, a plan for proficiency testing, and quality assurance to evaluate testing methodologies.

The information learned from all components of this project will serve as a model for all states and non-US countries.

The primary objectives of this project are:

· To demonstrate the feasibility of a hemoglobinopathy surveillance program within a geographically defined area that provides public health professionals with credible, accurate information about the burden of the disease in their jurisdiction, especially in the areas of the three HP2020 topics defined above;

· To implement health promotion and prevention awareness strategies designed to improve patient care quality, especially concerning vaccination status among persons with hemoglobinopathies, early and continuous screening, and use of appropriate disease modifying therapies for secondary, disease-associated complications; and

· To develop a strategy for state and/or regional laboratories to perform accurate hemoglobinopathy laboratory testing (including molecular) for all hemoglobinopathies, to correctly identify patients for whom the HP2020 objectives are applicable.

Outcomes for this project include:

· A validated case definition and methodologies for collection of surveillance data on persons with hemoglobinopathies;

· Baseline estimates of the demographics and health service utilization of persons with hemoglobinopathies, especially in the areas of vaccinations, screening for complications, and disease-modifying therapies;

· Development, dissemination, and evaluation of key messages for population-targeted health education materials, including persons with hemoglobinopathies, their families, and health care providers;

· Increased awareness and knowledge by persons with hemoglobinopathies and their health care providers about the preventative measures proven to reduce secondary complications due to hemoglobinopathies;

· Increased utilization of preventative measures related to secondary complications due to hemoglobinopathies; and

· Development of a comprehensive model for the laboratory identification of persons with hemoglobin variants, to include a training program for implementing the laboratory technology in regional and/or state facilities and a plan for proficiency testing and quality assurance.

Program Implementation

Recipient Activities There are three funding modules for this program:

1) Module A: Surveillance and health promotion for sickle cell disease;

2) Module B: Surveillance and health promotion for thalassemias; and

3) Module C: Laboratory enhancement for hemoglobinopathy screening and diagnosis.

The target population for the project is people of all ages with hemoglobinopathies, primarily sickle cell disease and thalassemia.

Module A Activities: Surveillance and health promotion for sickle cell disease

1. Through an existing, population-based, state-wide surveillance system, identify all patients, both pediatric and non-pediatric, in the state with sickle cell disease, and collect data on specified demographic and healthcare-related topics.

2. Collaborate with appropriate partners, such as other health department divisions, health care providers, community based organizations, academic medical centers and/or hemoglobinopathy treatment centers to assist with the collection of data.

3. Evaluate and refine the applicant’s current case definition and surveillance methods for sickle cell disease, using methods to include medical record abstraction and laboratory confirmation.

4. Conduct a needs assessment that identifies gaps in knowledge and educational and informational resources for SCD patients, families, and health care providers. This assessment should include the following:

a. Identification of health education materials, related to the three HP2020 objectives, that are currently available for SCD patients, families, and providers, and their dissemination methods;

b. Identification of gaps in knowledge and reported needs of providers, including non-hematologists, about SCD and related issues; and

c. Assessment of the applicant’s capacity to develop and/or adapt tools/resources to enhance and increase the number of materials available for SCD patients, families, and providers.

5. Develop 3-5 strategies to fill the gaps identified in the needs assessment.

6. Develop or adapt existing health education materials and/or self-care tools for SCD patients, families, and/or health care professionals to address SCD related issues.

7. Conduct a process and outcomes evaluation of developed or adapted health education materials for SCD patients, families, and/ or health care professionals.

8. Engage academic, public health, and community based organizations, including non-traditional partners, to increase the reach and impact of SCD messages, including policy related materials and advocacy tools.

9. Participate in conference calls and annual face-to-face meetings with CDC, and host annual site visits.

10. Contribute de-identified collected surveillance, evaluation, and health promotion-related data to CDC.

11. Define performance measures to evaluate the effectiveness of both surveillance and education activities.

12. Maintain the confidentiality of the study data in accordance with all applicable laws and regulations.

13. Work with CDC to disseminate findings, including oral and poster presentations, manuscripts, and learning collaboratives.

Module B Activities: Surveillance and health promotion for thalassemia

1. Through an existing, population-based, state-wide surveillance system, identify all patients, both pediatric and non-pediatric, in the state with thalassemia, and collect data on specified demographic and healthcare-related topics.

2. Collaborate with appropriate partners, such as other health department divisions, health care providers, community based organizations, academic medical centers and/or hemoglobinopathy treatment centers to assist with collection of data.

3. Evaluate and refine the applicant’s current case definition and surveillance methods for thalassemia, using methods to include medical record abstraction and laboratory confirmation.

4. Conduct a needs assessment that identifies gaps in knowledge and educational and informational resources for thalassemia patients, families, and health care providers. This assessment should include the following:

a. Identification of health education materials, related to the three HP2020 objectives, that are currently available for thalassemia patients, families, and providers, and their dissemination methods;

b. Identification of gaps in knowledge and reported needs of providers, including non-hematologists, about thalassemia and related issues; and

c. Assessment of the applicant’s capacity to develop and/or adapt tools/resources to enhance and increase the number of materials available for thalassemia patients, families, and providers.

5. Develop 3-5 strategies to fill the gaps identified in the needs assessment.

6. Develop or adapt existing health education materials and/or self-care tools for thalassemia patients, families, and/or health care professionals to address thalassemia related issues.

7. Conduct a process and outcomes evaluation of developed or adapted health education materials for thalassemia patients, families, and/ or health care professionals.

8. Engage academic, public health, and community based organizations, including non-traditional partners, to increase the reach and impact of thalassemia messages, including policy related materials and advocacy tools.

9. Participate in conference calls and annual face-to-face meetings with CDC, and host annual site visits.

10. Contribute de-identified collected surveillance, evaluation, and health promotion-related data to CDC.

11. Define performance measures to evaluate the effectiveness of both surveillance and education activities.

12. Maintain the confidentiality of the study data in accordance with all applicable laws and regulations.

13. Work with CDC to disseminate findings, including oral and poster presentations, manuscripts, and learning collaboratives.

Module C Activities: Laboratory enhancement for hemoglobinopathy screening and diagnosis

1. Create a bio specimen repository containing complex hemoglobin variant specimens, both protein and DNA, to be used for assay development, testing, and quality assurance.

2. Develop standardized, molecular-based methods for detecting hemoglobin variants and algorithms for further, molecular testing, when indicated.

3. Work with CDC and other relevant groups to identify training standards and competency outcomes.

4. Work with CDC and other relevant groups to develop quality assurance and proficiency testing for proposed methods.

5. Participate in conference calls and annual face-to-face meetings with CDC, and host annual site visits.

6. Work with CDC to disseminate findings, including oral and poster presentations, manuscripts, and learning collaboratives.

CDC Activities In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

Module A & B:

1. Specify minimal data elements to be collected through surveillance activities.

2. Provide technical support for collection ofsurveillance data, including a secure interface for data submission.

3. Provide technical assistance for surveillance evaluation activities.

4. Serve as host and steward of de-identified surveillance data from awardee(s).

5. Lead the cleaning and analysis of data sent to CDC and provide technical assistance to awardee(s) for analysis of their data as requested.

6. Provide technical assistance with development and adaptation of health education tools to be disseminated to patients, family members, and providers.

7. Work with awardee(s) to evaluate the effectiveness of both surveillance and education activities.

8. Convene and participate in project site visits, conference calls, and face-to-face meetings.

9. Convene external partners and experts for steering committees and/or working groups.

10. Work with awardees to disseminate findings, materials, and tools.

Module C:

1. Convene external partners and experts to evaluate current methodologies and capacities and identify best practices for public health laboratory training.

2. Work with awardee(s) and other relevant groups to identify training standards and competency outcomes.

3. Provide technical assistance for molecular-level screening of complex hemoglobin variants.

4. Work with awardee(s) and other relevant groups to develop quality assurance and proficiency testing for proposed methods.

II. AWARD INFORMATION

Type of Award: Cooperative Agreement - CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism: U50 Fiscal Year Funds: 2012 Approximate Current Fiscal Year Funding: $ 600,000 Approximate Total Project Period Funding: $ 1,200,000 (This amount is an estimate of the total direct and indirect costs, and is subject to availability of funds.)

Approximate Number of Awards: 3 Approximate Average Award: $ 200,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Module A: Surveillance and health promotion for sickle cell disease Maximum number of Awards: 1

Floor of Individual Award Range: None Ceiling of Individual Award Range: $250,000

Module B: Surveillance and health promotion for thalassemia Maximum number of Awards: 1

Floor of Individual Award Range: None Ceiling of Individual Award Range: $250,000

Module C: Laboratory enhancement for hemoglobinopathy screening and diagnosis Maximum number of Awards: 1

Floor of Individual Award Range: None Ceiling of Individual Award Range: $250,000

Floor of Individual Award Range: None Ceiling of Individual Award Range: $250,000 (This ceiling is for the total cost for the first 12-month budget period.)

Anticipated Award Date: 09/01/2012 Budget Period Length: 12 months Project Period Length: 2 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

Eligible Applicants Eligible applicants that can apply for this funding opportunity are listed below:

· A state governmental agency, its bona fide agent or its equivalent, as designated by the Governor, Health Office, or other state executive as the official applicant for this program. For this announcement, the term “State” includes the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

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.

State governmental agencies, their bona fide agent, or their equivalent, as designated by the Governor, Health Officer, or other state executive as the official applicant for this program (hereafter referred to as “State) are uniquely positioned to address the public health needs of their respective states. The activities necessary to meet the objectives of this FOA are the inherent responsibility of the state.

Required Registrations

Registering your organization through www.Grants.gov, the official agency-wide E-grant website, is the first step in submitting an application online. Registration information is located on the “Get Registered” screen of www.Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, the Grants.gov registration process also requires that you register your organization with the Central Contractor Registry (CCR) and DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) which will require up to at least 4 weeks to complete registration in its entirety. The CCR registration can require an additional two weeks to complete. You are required to maintain a current registration in CCR. CCR registration must be renewed annually.

Other

If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the eligibility requirements.

Central Contractor Registration and Universal Identifier Requirements All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An Authorized Organization Representative (AOR) should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the Central Contractor Registry (CCR) and maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. CCR is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the CCR internet site at www.ccr.gov.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

Other Special Requirements:

Applicants may apply for one or more Modules. A separate application must be submitted for each module, with the title of the Module clearly stated.

Applicants must complete each separate application in grants.gov and identify the application by the Module in the “Descriptive Title of Applicant’s Project” field #15 on the “SF-424” form. i.e. Module A "org project title", Module B "org project title", etc.

Modules A and B:

· Applicants must submit letters of support from any subcontracting sites or partners indicating that those sites are able and willing to participate in the recipient activities. Upload letters of support under “Other Attachment Forms” and label them “Appendix 3 – Letters of Support.”

· Applicants must have legal authority to access all datasets needed for determining the prevalence of SCD/thalassemia in their state. Upload proof of authority under “Other Attachment Forms” and label them “Appendix 8 – Legal Authority to Data.”

· If you are applying as a bona fide agent of a state government, you must provide a letter from the state as documentation of your status. Upload this bona fide state agent letter under “Other Attachment Forms” and label it “Appendix 4 – Bona Fide Agent Letter.”

· Applicants must show that they have previously conducted population-based, state-wide surveillance of SCD/thalassemia in their state. This can be documented in the Project Narrative.

Module C:

· Applicants must submit letters of support from any subcontracting sites or partners indicating that those sites are able and willing to participate in the recipient activities. Upload letters of support under “Other Attachment Forms” and label them “Appendix 3 – Letters of Support.”

· If you are applying as a bona fide agent of a state government, you must provide a letter from the state as documentation of your status. Upload this bona fide state agent letter under “Other Attachment Forms” and label it “Appendix 4 – Bona Fide Agent Letter.”

· Applicants must have legal authority to receive and screen specimens from external groups (academic centers, community based organizations, clinical practices, etc.)

· Applicants must show that they have the capability to perform molecular level screening for hemoglobinopathies, both sickle cell disease and thalassemia, in both pediatric and non-pediatric populations. This can be documented in the Project Narrative.

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 a grant, loan, or an award.

Maintenance of Effort

Maintenance of Effort is not required for this program IV. Application and Submission Information Submission Dates and Times This announcement is the definitive guide on LOI and application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the applicant will be notified the application did not meet the submission requirements.

Letter of Intent (LOI) Deadline Date: April 30, 2012 Application Deadline Date: May 30, 2012, 11:59pm U.S. Eastern Standard time

Applicants must download the SF424 application package associated with this funding opportunity from Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 email:pgotim@cdc.gov Monday-Friday 7:00am – 4:30pm U.S. Eastern Standard Time for further instruction. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

Content and Form of Application Submission

All applicants are required to sign and submit CDC Assurances and Certifications that can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm Print, scan and upload as an additional attachment into the application package.

Letter of Intent (LOI):

Prospective applicants are requested to submit a letter of intent that includes the following information:

· Descriptive title of proposed project, including the Module(s) being applied for.

· Name, address, and telephone number of the Principal Investigator/Project Director.

· Names of other key personnel.

· Participating institutions.

· Number and title of this funding opportunity.

LOI Submission Address: Submit the LOI by express mail, delivery service, fax, or E-mail to:

Mary Hulihan

CDC, NCBDDD, DBD

1600 Clifton Road, MS E-64 Atlanta, GA 30333 404-498-6724 404-498-6799 ibx5@cdc.gov 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 CDC Program staff to estimate and plan the review of submitted applications.

Requested LOIs should be provided not later than May 4, 2012.

Note: (Limit file names to 50 characters and do not use special characters (example: &, -,*,%,/,#) including periods (.), blank spaces and accent marks, within application form fields and file attachment names. An underscore (_) may be used to separate a file name. Also, do not attach multiple documents with the same file name.) Please do not Cut&paste information into any fields within the application package all information must be typed.

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:

· Maximum number of pages: 25 If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

· Font size: 12 point unreduced, Times New Roman

· Double spaced

· Page margin size: One inch

· Number all narrative pages; not to exceed the maximum number of pages.

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed for each module requested:

1. Understanding of the Public Health Need and Impact

Modules A, B, and C:

· State the name of the Module for which the application is being made.

· Demonstrate understanding of the need for the program, the public health burden that the program will address, and the planned activities for the targeted population.

· Demonstrate comprehension of the requirements, objectives, and purpose of this FOA by describing them clearly and concisely.

Modules A and B:

· Describe the characteristics of the state’s SCD/thalassemia population: prevalence of condition, basic demographics, baseline estimates for the 3 HP2020 objectives, sources of this information, and methods used to determine these statistics.

· Describe previous successes engaging the SCD/thalassemia community in identifying disease-related interventions.

2. Methods

Modules A and B:

· Describe the applicant’s legal authority to access data sources needed to accomplish activities and goals.

· Describe the applicant’s legal authority to share data with CDC; describe any limitation to sharing data with CDC or other awardees of this Cooperative Agreement.

· Describe methods previously used to conduct population-based, state-wide surveillance of SCD/thalassemia in their state.

· Describe existing and potential collaborative working partnerships with academic institutions, providers, community groups, various agencies, or others who serve and represent the population and have established relationships in the population.

· Provide evidence of intent to collaborate with other entities, including letters of support, memoranda of understanding, etc.

· Describe plan for evaluation and validation of current surveillance data and case definitions.

· Describe plan for a needs assessment to identify gaps in knowledge and resources for SCD/thalassemia patients, families, and provider within a stated amount of time from the beginning of the project.

· Identify the 3-5 priorities obtained from the needs assessment and the strategies that are planned to address these areas.

· Provide a detailed plan that describes strategies to assess and enhance current partnerships and establish new partnerships with entities that have experience enhancing and extending existing support services or developing and disseminating previously developed and tested tools and resources.

· Describe the dissemination plan for materials, project lessons learned, and other information resulting from this project, both surveillance and health education.

· Describe the evaluation plan for educational tool development, adaptation, and dissemination.

· Describe the establishment of milestones to monitor program progress and to support program management decisions.

Module C:

· Describe plan for creating a bio specimen repository and collecting complex hemoglobin variant specimens, both DNA and protein.

· Describe the applicant’s legal authority to receive and screen samples from a variety of sources, including clinical settings, community based organizations, academic institutions, and other state-based laboratories.

· Describe existing and potential collaborative working partnerships with academic institutions, providers, various agencies or groups (CDC, APHL, ACMG, etc), or others.

· Describe the applicant’s current methodology.

· Provide evidence of intent to collaborate with other entities, including letters of support, memoranda of understanding, etc.

· Describe the dissemination plan for materials, project lessons learned, and other information resulting from this project.

· Describe the establishment of milestones to monitor program progress and to support program management decisions.

3. Objectives

Modules A, B, and C:

· Present clear and measurable objectives to address the need and activities of this FOA.

· Submit measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of this FOA. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement and must be objective, quantitative, and measure the intended outcome of the proposed project.

· Provide clearly defined performance measures to evaluate the effectiveness of both surveillance and education activities and a plan for carrying out this evaluation.

· Describe how the program’s priorities will be further articulated as goals and objectives within the program plan.

4. Plan and Timeline

Modules A, B, and C:

· Provide a complete and comprehensive plan to carry out the proposed objectives for the entire project period with a timeline for activities.

· Describe ability to begin immediate implementation of the proposed activities.

5. Organizational and Personnel Capacity

Modules A, B, and C:

· Define the roles of project staff.

· Describe the expertise, experience, and skills of the project personnel as it relates to project activities, including previous experience with similar data collection efforts.

· If applicable, describe how quickly staff and consultants can be identified and hired.

Modules A and B:

· Describe the personnel available with specific expertise in surveillance and epidemiology, data collection, medical record abstraction, public health evaluation, and health education.

Module C:

· Describe the personnel available with specific expertise in molecular-based laboratory methods of screening for hemoglobinopathies.

· Describe current capacity for molecular-level screening for hemoglobinopathies, including laboratory equipment, processing of specimen from receipt to result, number of samples screened annually, reporting of results, and ability to expand current levels to include entire patient population, both newborns and non-newborns. If applicable, describe the extent to which screening results are utilized by those in the clinical setting.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

· Curriculum Vitae/Resumes

· Letters of Support, if applicable

· Budget (SF 424A) and Budget Narrative: provide a detailed budget which identifies and describes the basis for the anticipated costs for personnel, fringe benefits, travel, supplies, equipment, contractual, consultants, indirect, and other items.

· Bona fide agent letter from state, if applicable

· Memorandum of Understanding (MOU) for subawards, consultants, partnering agreements, etc., if applicable

· Indirect Cost Rate agreement

· Organizational Chart

· Legal authority to patient data sources Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:

· Appendix 1 – Curriculum Vitae/Resumes

· Appendix 2 – Budget (SF 424A) and Budget Narrative

· Appendix 3 – Letter(s) of Support

· Appendix 4 – Bona fide agent letter

· Appendix 5 – MOUs

· Appendix 6 – Indirect Cost Rate Agreement

· Appendix 7 – Organizational Chart

· Appendix 8 – Legal Authority to data No more than 20 electronic attachments should be uploaded per application.

Additional requirements for additional documentation with the application are listed in Section VII. Award Administration Information, subsection entitled “Administrative and National Policy Requirements.”

Funding Restrictions Restrictions, which must be taken into account while writing the budget, are as follows:

· Recipients may not use funds for research.

· Recipients may not use funds for clinical care.

· Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

· Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

· The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

· Reimbursement of pre-award costs is not allowed.

Additional Submission Requirements Electronic Submission Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC, Procurement and Grant Office, Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 Email:pgotim@cdc.gov Monday-Friday 7:30am -4:30pm for further instruction.

Note: Application submission is not concluded until successful completion of the validation process. After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. Applicants are strongly encouraged to check the status of their application to ensure submission of their application package is complete and no submission errors exists. To guarantee that you comply with the application deadline published in the Funding Opportunity Announcement, applicants are also strongly encouraged to allocate additional days prior to the published deadline to file their application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a “validation” email within two (2) business days of application submission, please contact Grants.gov. Refer to the email message generated at the time of application submission for instructions on how to track your application or the Application User Guide, Version 3.0 page 57.

Applications must be submitted electronically at www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully made available to CDC for processing from Grants.gov on the deadline date. The application package can be downloaded from www.Grants.gov. Applicants can complete the application package off-line, and then upload and submit the application via the Grants.gov Web site. The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.

Applications submitted through Grants.gov (http://www.grants.gov), are electronically time/date stamped and assigned a tracking number. The AOR will receive an e-mail notice of receipt when Grants.gov receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

Organizations that encounter technical difficulties in using www.Grants.gov to submit their application must attempt to overcome those difficulties by contacting the Grants.gov Support Center (1-800-518-4726, support@grants.gov). After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to the GMO/GMS [See Section VII “Agency Contacts”], for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevented electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the GMO/GMS at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered.

If a paper application is authorized, the applicant will receive instructions from PGO TIMS to submit the original and two hard copies of the application by mail or express delivery service.

Intergovernmental Review The application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contact the state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State’s process. Visit the following Web address to get the current SPOC list: http://www.whitehouse.gov/omb/grants_spoc/.

V. Application Review Information Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the DD12-1206. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

Criteria Eligible applications will be evaluated against the following criteria:

1. Methods (40 points)

Modules A and B:

· Does the applicant describe their legal authority to access data sources needed for their proposed activities and to share collected data with CDC? Were limitations to data sharing, if any, discussed?

· Does the applicant describe methods previously used to conduct population-based, state-wide surveillance of SCD/thalassemia in their state and the effectiveness of those methods?

· Are existing and potential working collaboratives with various entities discussed? Are letters of support or memoranda of understanding, etc. provided?

· Is the plan for evaluation and validation of current surveillance data, data collection methods, and case definitions outlined?

· Does the applicant describe a plan for a needs assessment to identify gaps in knowledge and resources and strategies to address these areas?

· Is there a clear plan to assess and enhance current partnerships and establish new partnerships in order to develop and disseminate tools and resources?

· Is a dissemination plan for both surveillance and health education information provided?

· Is a detailed evaluation plan for educational tool development, adaptation, and dissemination included?

· Does the applicant provide milestones for monitoring program progress?

· Are the proposed methods feasible? To what extent will they accomplish the program goals?

Module C:

· Is there a plan for creating and housing a bio specimen repository?

· Does the applicant describe their legal authority to receive and screen samples? Are the potential sources for these samples outlined?

· Does the applicant describe their legal authority to share collected data with CDC?

· Are existing and potential working collaboratives with various entities discussed? Are letters or support or memoranda of understanding, etc. provided?

· Is a dissemination plan for both materials and project lessons learned provided?

· Does the applicant provide milestones for monitoring program progress?

2. Plan and Timeline (20 points) Modules A, B, and C:

· Does the applicant provide a plan to carry out all of the proposed objectives?

· Is the plan adequate to carry out the proposed objectives?

· Does the plan cover the entire project period?

· Is a timeline provided for activities that will accomplish the objectives?

· Is the timeline reasonable?

· Will the applicant be able to implement project activities immediately?

· Will the timeline allow the applicant to accomplish the goals of the program?

3. Organizational and Personnel Capacity (20 points)

Modules A, B, and C:

· Are the roles of project staff well defined?

· Are the expertise, experience, and skills of project personnel appropriate to their roles on the project?

· Are the personnel sufficient given the nature and scope of the project?

· If applicable, can staff and consultants be identified and hired in a timely manner?

Modules A and B:

· Are personnel with expertise in surveillance and epidemiology, data collection, public health evaluation, medical record abstraction, and health education included?

Module C:

· Are personnel with expertise in molecular-based laboratory screening methods included?

· Does the applicant describe their current capacity for molecular-based hemoglobinopathy screening? Do they have the ability to increase this capacity to include specimens from patients of all ages?

4. Objectives (10 points)

Modules A, B, and C:

· Does the applicant present objectives to address the need and activities of this FOA? Are they clear? Are they measurable?

· Does the applicant suggest measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of this FOA? Are they objective? Are they quantitative? Do they measure the intended outcome of the program?

· Does the applicant provide clearly defined performance measures to evaluate the effectiveness of both surveillance and education activities and a plan for carrying out this evaluation?

· Does the applicant further describe the program’s priorities as goals and objectives within the program plan?

5. Understanding of the Public Health Burden and Impact (10 points)

Modules A, B, and C:

· Did the applicant explain the public health burden…