cdc-rfa-dd10-1017 foa final 5 12 10.doc

An amendment is issued on this FOA, May 12, 1010 to extend the application deadline 30 days. The changes are indicated in red on this page and

Section IV.3 Submission Dates and Times.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC) State-based Surveillance for Hemoglobinopathies

Announcement Type: New – Type 1 Funding Opportunity Number: CDC-RFA-DD10-1017 Catalog of Federal Domestic Assistance Number: 93.184 Key Dates:

Letter of Intent Deadline: April 30, 2010 after Publication on www.Grants.gov Application Deadline Date: June 14, 2010 on Grants.gov, 11:59pm Eastern Standard Time I. Funding Opportunity Description

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: The National Center on Birth Defects and Developmental Disabilities, Division of Blood Disorders in collaboration with the National Institutes of Health, National Heart Lung and Blood Institute (NIH/NHLBI), seeks to develop and implement a collaborative pilot project with population-based surveillance of confirmed hemoglobinopathies of both pediatric and non-pediatric populations using the established newborn screening program and other data sources. This type of collaboration would utilize the strengths of population-based data collection infrastructure with data linkage and lay the foundation for future hemoglobinopathy registries. The proposed surveillance programs would utilize standardized data elements in order to provide centralized, uniform reporting by demographic and clinical characteristics of confirmed hemoglobinopathy cases identified from newborn screening and other data sources. High-quality, collaborative data collection systems are needed to better understand the epidemiology of hemoglobinopathies. In addition, short-term outcome information would allow for the monitoring and quality improvement of referral patterns to health care providers.

Currently, there are no 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 hemoglobinopathies. However, NBS statistics most likely underestimate the populations due to missing information about immigrants and people who were born before newborn screening, and hemoglobin disorders that are not tested by NBS (e.g. many of the thalassemias). No data system or health survey, based on sound sampling algorithms, exists to capture data on immigrants or pre-NBS adults with hemoglobinopathies. Data from the new surveillance system will fill the need for statistically sound estimates of prevalence and for much needed information on medical care utilization and complication rates in sickle cell disease and thalassemia patient populations by ascertaining pediatric and non-pediatric cases from several sources including, but not limited to NBS, vital records, blood banks, laboratories, and/or hospitals as authorized by current individual state public health policy.

CDC and NIH seek to develop a pilot program for a comprehensive population-based data system for sickle cell disease and thalassemia. Data from the system will fill the need for statistically sound estimates of prevalence and for much needed information on medical care utilization and complication rates in sickle cell disease and thalassemia patient populations. Biospecimens are needed for use in genetic and genomic analyses designed to increase knowledge about disease phenotypes and possible genetic influences on heath outcomes and response to therapy. This pilot program will be implemented in phases. This current announcement is for surveillance phase of this program only, but there will be plans to link clinical information that will be collected by the state awardees. Thus, a core activity for awardees of this announcement will be to assist in planning subsequent phases of this program including planning the development of a registry and biospecimen repository.

Purpose: The purpose of this program is to provide support through CDC cooperative agreements for non-research activities to collect and link data on selected samples of patients for population-based estimates. The program is a pilot and designed as a learning collaborative effort between states with a mixture of characteristics. Both cross-sectional and longitudinal data that is linkable will be collected, depending on the health indicator to be measured.

This announcement is comprised of multiple funding Modules: (1) Module A: Surveillance of Hemoglobinopathies in States; (2) Module B: Capacity Building and Surveillance of Hemoglobinopathies in States with a High Historically Underserved Population. The programs in Module A and B are a pilot and designed as a learning collaborative effort between states with a mixture of characteristics. Module B will be targeted to states requiring additional capacity building and that have a higher proportion of historically underserved populations (e.g., states with high percentage of low-to-moderate income individuals and a high proportion racial/ethnic minorities). The programs in Modules A and B will collect both cross-sectional and longitudinal data that is linkable depending on the health indicator to be measured. The activities in Module A and B will be used to:

1) determine prevalence of hemoglobinopathies across the lifespan in the US;

2) determine annual incidence of hemoglobinopathies utilizing newborn screening data as well as identifying new cases due to immigration;

3) describe the demographics of the various hemoglobinopathies patient populations;

4) describe the distribution of disease severity, co-morbidities, and chronic disease complications among people with hemoglobinopathies;

5) monitor patterns of disease and treatment-related infections;

6) describe the reproductive and pregnancy outcomes of the hemoglobinopathy patient populations;

7) calculate mortality rates, including case fatality rates for hemoglobinopathies and complications;

8) track health care utilization, costs of care, and the availability of specific services;

9) describe community-level resources;

10) assist with public health planning CDC’s mission is “to promote health and quality of life by preventing and controlling disease, injury, and disability.” One of the many strategies that CDC employs to accomplish this goal includes “monitoring health” through the use of public health surveillance. Disease specific surveillance systems are critical for the accomplishment of this and other objectives that support CDC’s mission. Consistent with CDC’s mission, CDC has identified four overarching Health Protection Goals. This program is most closely aligned with CDC’s Health Protection Goal of “Healthy People in Every Stage of Life.” Surveillance such as this will help CDC determine ways to achieve optimal lifespan and best possible quality of life across the lifespan for individuals with hemoglobinopathies. This program addresses the “Healthy People 2010” focus area(s) of Access to Quality Health Services and Disability and Secondary Conditions.

Measurable outcomes of the program will be in alignment with one or more of the following performance goals for the National Center on Birth Defects and Developmental Disabilities, Division of Blood Disorders: 1) Prevent and Reduce Complications Experienced by Persons with Certain Blood Disorders, and 2) Improve the Health and Development of All People with Disabilities or Potentially Disabling Conditions.

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/regs/hrpp/researchDefinition.htm Applicants may only apply to ONE module.

Awardee activities for this program are as follows:

Module A: Surveillance of Hemoglobinopathies in States

· Data collection and reporting

a. Report sickle cell disease and thalassemia data from NBS and other data sources for surveillance.

b. Produce timely data with well-defined, standardized data elements such as demographic information and genotypes when applicable for hemoglobinopathies.

c. Generate new data collection capacity for effective surveillance of adults with hemoglobinopathies.

d. Contribute data at least semiannually to a centralized dataset with de-identified, individual level data including standardized data elements. Awardees can contribute data more frequently at their discretion.

· Collaboration

e. Collaborate and coordinate across state agencies for data collection.

f. Involve appropriate within-state partners, such as health care providers, community based organizations, academic medical center and/or treatment center specializing in hemoglobinopathies, and other organizations to assist with the collection of data.

g. As part of CDC project learning collaborative, discuss process, methods, standardization of data collection, and other project experiences with other state awardees.

· Data integration

h. Enhance collaboration between the newborn screening program and other existing data systems to integrate the collection and reporting of data captured by newborn screening with hemoglobinopathies.

i. Demonstrate capacity to link and use data from laboratories, health providers, payers, and other sources

· Dissemination of information

j. Disseminate data on enhanced population-based surveillance for hemoglobinopathies.

k. Communicate information on project activities and results to partners and other state programs.

l. Share information among states in CDC project learning collaborative

· Evaluation and progress reports

m. Assess the challenges and opportunities of the pilot project including a description of the problems encountered, lessons learned, potential improvements, etc.

n. With assistance of CDC, conduct an evaluation of the surveillance pilot project.

· Potential to continue above activities in years of future funding including the expansion of birth cohort years, enhancement of linkages and databases, contribution of data to centralized database, dissemination of data, and other activities.

o. Develop a plan to create hemoglobinopathy registries.

Module B: Capacity Building and Surveillance of Hemoglobinopathies in States with a High Historically Underserved Population. In order to ensure that during the pilot phase of this project the program assesses and develops best practices for serving economically distressed and medically underserved populations as well as best practices for multiracial and multiethnic populations, applicants may seek funding for Module B if they have a substantial socioeconomically and historically underserved population. For this module, states with substantial socioeconomically and historically underserved population are states with high rates of low-income individuals and a high proportion racial/ethnic minorities. For module B, this would include those states with 14% or more of the total state population consisting of individuals below U.S. poverty level based in 2005-2007 data, at least 20% or more racial/ethnic minorities, and with 14% or more of the total state population who are black or African American based on data from U.S. census bureau (Source: U.S. Census Bureau, 2006-2008 American Community Survey: http://www.census.gov/acs/www/index.html)

· Data collection and reporting

a. Report sickle cell disease and thalassemia data from NBS and other data sources for surveillance.

b. Produce timely data with well-defined, standardized data elements such as demographic information and genotypes when applicable for hemoglobinopathies.

c. Generate new data collection capacity for effective surveillance of adults with hemoglobinopathies.

d. Contribute data at least semiannually to a centralized dataset with de-identified, individual level data including standardized data elements. Awardees can contribute data more frequently at their discretion.

Collaboration

e. Collaborate and coordinate across state agencies for data collection.

f. Involve appropriate within-state partners, such as health care providers, community based organizations, academic medical center and/or treatment center specializing in hemoglobinopathies, and other organizations to assist with the collection of data.

g. As part of CDC project learning collaborative, discuss process, methods, standardization of data collection, and other project experiences with other state awardees.

Data integration

h. Enhance collaboration between the newborn screening program and other existing data systems to integrate the collection and reporting of data captured by newborn screening with hemoglobinopathies.

i. Demonstrate capacity to link and use data from laboratories, health providers, payers, and other sources

Dissemination of information

j. Disseminate data on enhanced population-based surveillance for hemoglobinopathies.

k. Communicate information on project activities and results to partners and other state programs.

l. Share information among states in CDC project learning collaborative

Evaluation and progress reports

m. Assess the challenges and opportunities of the pilot project including a description of the problems encountered, lessons learned, potential improvements, etc.

n. With assistance of CDC, conduct an evaluation of the surveillance pilot project.

· Potential to continue above activities in years of future funding including the expansion of birth cohort years, enhancement of linkages and databases, contribution of data to centralized database, dissemination of data, and other activities.

o. Develop a plan to create hemoglobinopathy registries.

In order to achieve the intended purpose of this program, applicants for modules A and B must fully describe and document in their application:

· Characteristics of their proposed study population (e.g. size of annual birth cohort (minimum of 125,000 annual birth population for applicants to module A and a minimum of 40,000 annual birth population for applicants to module B), access to Thalassemia population, racial and ethnic distribution of whole state population, and socioeconomic status of state population (poverty).

· Access to newborn screening data, specifically for hemoglobinopathy population, and capacity to link to other data sources (i.e. vital records, hospital discharge records, administrative databases and others).

· Capabilities of surveillance of non-pediatric populations

· Data sources for case finding including blood banks, laboratories, hospitals, payers, etc.

· Evidence of legal authority to access data needed to accomplish the activities in this FOA and their application, including HIPAA and IRB requirements. Evidence of legal authority to share de-identified data with CDC and other awardees of this Cooperative agreement.

· Established relationships and demonstration of cooperation with appropriate partners (i.e. state officials, cross-department personnel-including informatics personnel within state health department, community based organizations, academic medical center and/or treatment center specializing in these conditions).

· Management and staffing plan already in place or proposed for implementation of this program.

· Characterization of current efforts to serve people with hemoglobinopathies, including long term follow-up, and short term outcomes.

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

CDC activities for this program are as follows:

a. Provide advisory technical assistance such as defining minimum data elements

b. Facilitating the communication/coordination among awardees regarding standardization of procedures and tools to improve the efficiency of activities.

c. Convene awardees to support collaboration and shared learning

d. In collaboration with state awardees, develop and provide a template for the central reporting of de-identified, individual-level data sets.

e. Assist in performing data analysis and/or quality assurance verification.

f. Maintain the centralized database and assist with data dissemination.

g. Assist with evaluation of the pilot project.

h. Serve as a resource for sharing data, templates, and linking to other newborn screening programs.

II. Award Information

Type of Award: Cooperative Agreement. CDC’s involvement in this program is listed in the Activities Section above.

Award Mechanism: U50 Fiscal Year Funds: 2010 Approximate Current Fiscal Year Funding: $1,500,000 Approximate Total Project Period Funding: $3,000,000 (This amount is an estimate of the total direct and indirect cost, and is subject to availability of funds.)

Module A: Surveillance of Hemoglobinopathies in States Maximum Number of Awards: 2

Funding Ceiling: $600,000

Floor of Individual Award Range: $300,000

Approximate Average Award: $500,000 (This amount is for the first 12-month budget period and includes both direct and indirect costs.)

Module B: Capacity Building and Surveillance of Hemoglobinopathies in States with a High Historically Underserved Population Maximum Number of Awards: 2

Funding Ceiling for Individual Award: $600,000

Floor of Individual Award Range: $300,000

Approximate Average Award: $500,000 (This amount is for the first 12-month budget period and includes both direct and indirect costs.)

Anticipated Award Date: 9/1/2010 Budget Period Length: 12 months; 9/1/2010 – 8/31/2011 Project Period Length: 2 years; 9/1/2010 – 8/31/2012 Throughout the project period for both Modules A and B, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

III. Eligibility Information

III.1. Eligible Applicants Eligible applicants that can apply for this funding opportunity are listed below:

· State governments, their Bona Fide Agents (this includes 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), or New York City government.

The entities listed above are uniquely qualified for the activities under this FOA. They have the public health authority and/or legislative mandate to conduct activities which gives them unique and specific access to datasets from multiple data sources that are required to implement the activities outlined in this FOA. The activities outlined are a pilot project to collect and link data on selected samples of patients for population-based estimates.

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 letter from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

III.2. Cost Sharing or Matching

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

III.3. Other

CDC will accept and review applications with budgets greater than the ceiling of the award range.

Special Requirements:

If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the application did not meet submission requirements.

· Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.

· 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 documentation into www.Grants.gov and include as Appendix 3 of your application. Applications that fail to submit the evidence requested above will be considered non-responsive.

· 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.

· Applicants may not currently be receiving funds through CDC-RFA-DD09-909, Population-based Surveillance for Hemoglobinopathies

· If applicant applies to both Module A and Module B, only one application will be eligible for review. The CDC will decide which application will be reviewed.

IV. Application and Submission Information

IV.1. Address to Request Application Package

To apply for this funding opportunity use the application forms package posted in www.Grants.gov .

Electronic Submission:

The applicant must submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide E-grant Web site. Registering your organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Registered” screen of www.Grants.gov.

Please visit www.Grants.gov at least 30 days prior to filing your application to familiarize yourself with the registration and submission processes. Under “Get Registered,” the one-time registration process will take three to five days to complete; however, as part of the Grants.gov registration process, registering your organization with the Central Contractor Registry (CCR) annually, could take an additional one to two days to complete. CDC suggest submitting electronic applications prior to the closing date so if difficulties are encountered, you can submit a hard copy of the application prior to the deadline.

IV.2. Content and Form of Submission

Letter of Intent (LOI):

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

· 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.

· Descriptive title of proposed project.

· A brief description of the most current annual number of state-wide births with hemoglobinopathies, current newborn screening system, access and linkage capabilities to other data sources.

· A brief description of the planned activities. The narrative should be no more than two, double-spaced pages, printed on one side, with one-inch margins and 12-point unreduced, Times New Roman font.

Application:

A Project Abstract must be submitted with the application forms. All electronic project abstracts must be uploaded in a PDF file format when submitting via Grants.gov. The abstract must be submitted in the following format, if submitting a paper application:

· Maximum of 2-3 paragraphs.

· Font size: 12 point unreduced, Times New Roman

· Single spaced

· Paper size: 8.5 by 11 inches

· Page margin size: One inch

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. All electronic narratives must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format, if submitting a paper application:

· 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

· Paper size: 8.5 by 11 inches

· Page margin size: One inch

· Printed only on one side of page.

· 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:

1. Understanding of the Public Health Burden and Impact

· Description of public health burden that the program will address

· Understanding of the need for this program and the planned activities within the target community

· Clear, concise descriptions and understanding of the requirements, objectives, and purpose of this FOA

· Description of diverse race/ethnic population included in the surveillance population

· Description of the current number of individuals with Sickle Cell Disease and Thalassemia Understanding of need for planned activities.

2. Objectives

· Objectives clear and measurable to address the need and activities of this FOA

· Description of the proposed intent to enhance current monitoring activities for confirmed newborn screening cases, linked data sets, data collection from pediatric and non-pediatric populations, long term follow up, and collection of short-term outcome data

3. Plan

· Plan to carry out the proposed objectives

· Complete and comprehensive plan for the entire project period

· Quantitative process and outcome measures

· Reasonable and achievable timeline to complete the activities in the specified project period

· Description of ability to begin immediate implementation of the activities

· Document their legal authority to access population-based surveillance data of confirmed newborn screening cases, linked data sets, data collection from pediatric and non-pediatric populations, long term follow up, and short-term outcome data and have access to an annual birth population of at least 40,000 births for module B and 125,000 births for module A.

· Description of planned collaboration with appropriate partners both internal to the state health department as well as external

4. Methods

· Methods that are specific and feasible within the project timeframe

· Ability to accomplish the program goals

· Description of methods for evaluation of the methodology of the pilot project

· Methods to address the procedures for generation of the standardized data elements and process for the dissemination of quality data

· Description of established or proposed mechanisms for collaboration between the newborn screening program and other existing data sources

5. Organizational and Personnel Capability

· Appropriate expertise and skills.

· Ability to identify and timely hire needed staff and consultants.

· Staff roles defined and sufficient to accomplish program goals.

6. Collaborations

· Appropriate and meaningful partners

· Ability to identify meaningful contractual agents or agencies

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

· Budget (SF 424A) and Budget Narrative (Reviewed, but not scored): 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.

· Curricula Vitae/Resumes

· Letters of Support

· Organizational Charts

· Indirect Cost Rate Agreement

Additional information submitted via www.Grants.gov should be uploaded in a PDF file format, and should be named:

· Appendix 1 - Curricula Vitae/Resumes

· Appendix 2 - Letters of Support, etc.

· Appendix 3 - Bona fide agent letter from state, if applicable

· Appendix 4 -.Memorandum of Understanding (MOU) for subawards, consultants, partnering agreements, etc.

No more than 20 should be uploaded per application.

The agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access the Dun and Bradstreet website or call 1-866-705-5711.

Additional requirements that may request submission of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”

IV.3. Submission Dates and Times

Letter of Intent (LOI) Deadline Date: April 30, 2010, after Publication on www.Grants.gov Application Deadline Date: June 14, 2010 on Grants.gov, 11:59pm Eastern Standard Time

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date.

Applications must be submitted electronically at www.Grants.gov. Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Organization Representative (AOR) electronically submits the application to www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully submitted electronically by the applicant organization’s AOR to Grants.gov on or before the deadline date and time.

When submission of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped and a tracking number will be assigned, which will serve as receipt of submission. The AOR will receive an e-mail notice of receipt when HHS/CDC receives the application.

This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline above, it will not be eligible for review. The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance. The applicant will be notified the application did not meet the submission requirements.

IV.4. Intergovernmental Review of Applications

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.html.

IV.5. 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.

If requesting indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

The recommended guidance for completing a detailed justified budget can be found on the CDC Web site, at the following Internet address:

http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

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

Althea Grant, Project Officer

OR

Melissa Creary, co-Project Officer

Telephone: 404-498-6719

Telephone: 404-498-6694

E-mail: agrant@cdc.gov

E-mail: mcreary@cdc.gov

Department of Health and Human Services

Centers for Disease Control and Prevention

National Center on Birth Defects and Developmental Disabilities

Division of Blood Disorders

1825 Century Boulevard

Atlanta, GA 30345

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

Applicants must submit applications electronically at www.Grants.gov. The application package can be downloaded from www.Grants.gov. Applicants are able to complete it off-line, and then upload and submit the application via the Grants.gov Web site. E-mail submissions will not be accepted. If the applicant has technical difficulties in Grants.gov, customer service can be reached by E-mail at support@grants.gov or by phone at 1-800-518-4726 (1-800-518-GRANTS). The Customer Support Center is open from 7:00a.m. to 9:00p.m. Eastern Time, Monday through Friday.

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.

V. Application Review Information

V.1. Criteria

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

Each applicant within each module will be evaluated against the following criteria:

1. Understanding of the Public Health Burden and Impact (10 Points)

Did the applicant explain the public health burden that the program will address? To what extent does the applicant demonstrate understanding of the need for this program and the planned activities within the target community? Did the applicant adequately describe a clear, concise understanding of the requirements, objectives, and purpose of this FOA? Does the applicant have a diverse race/ethnic population included in the surveillance population? Did the applicant provide a description of the current number of individuals with Sickle Cell Disease and Thalassemia?

2. Objectives (10 Points)

Are the objectives clear and measurable to address the need and activities of this FOA? Do the objectives describe the proposed intent to enhance current monitoring activities for confirmed newborn screening cases, linked data sets, data collection from pediatric and non-pediatric populations, long term follow up, and collection of short-term outcome data?

3. Plan (35 points)

Is the plan adequate to carry out the proposed objectives? How complete and comprehensive is the plan for the entire project period? Does the plan include quantitative process and outcome measures? Does the applicant include a reasonable and achievable timeline to complete the activities in the specified project period? Does the applicant describe their ability to begin immediate implementation of the activities? Does the applicant document their legal authority to access population-based surveillance data of confirmed newborn screening cases, linked data sets, data collection from pediatric and non-pediatric populations, long term follow up, and short-term outcome data and have access to an annual birth population of at least 125,000 births. Did the applicant describe their planned collaboration with appropriate partners both internal to the state health department as well as external?

4. Methods (30 Points)

Are the proposed methods specific and feasible within the project timeframe? To what extent will they accomplish the program goals? Do the methods describe the evaluation of the methodology of the pilot project? Do the methods address the procedures for generation of the standardized data elements and process for the dissemination of quality data? Does the applicant describe established or proposed mechanisms for collaboration between the newborn screening program and other existing data sources?

5. Organizational and Personnel Capability (15 Points)

Do the staff members have appropriate expertise and skills necessary to complete the planned activities? If additional staff or consultants are needed, does the applicant have the capacity to identify additional staff and consultants in a timely manner? Are the staff roles clearly defined? As described, will the staff be sufficient to accomplish the program goals?

6. Budget (SF 424A) and Budget Narrative (Reviewed, but not scored)

The budget will be evaluated for the extent to which it is reasonable, clearly justified, and consistent with the intended use of the cooperative agreement funds. The applicant shall describe and indicate the availability of facilities and equipment necessary to carry out this project.

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness jointly by the National Center on Birth Defects and Developmental Disabilities and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified the application did not meet submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above. CDC will provide justification for any decision to fund out of rank order. In addition, the following factors may affect the funding decision:

1. Diverse race/ethnic population included in the surveillance population to provide representation in data analyses.

2. Hemoglobinopathy population

3. Historical deficiencies in public health infrastructure

4. Geographical diversity V.3. Anticipated Announcement Award Dates

The anticipated award date is September 1, 2010.

VI. Award Administration Information

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

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

VI.2. Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92, as appropriate. The following additional requirements apply to this project:

· AR-7

Executive Order 12372

· AR-9

Paperwork Reduction Act

· AR-10

Smoke-Free Workplace

· AR-11

Healthy People 2010

· AR-12

Lobbying Restrictions

· AR-13

Prohibition on Use of CDC Funds for Certain Gun Control

Activities

· AR-14

Accounting System Requirements

· AR-15

Proof of Non-Profit Status

· AR-21

Small, Minority, and Women-owned Business

· AR-23

States and Faith-Based Organizations

· AR-24

Health Insurance Portability and Accountability Act Requirements

· AR-25

Release and Sharing of Data

· AR-26

National Historic Preservation Act of 1966

· AR-27

Conference Disclaimer and Use of Logos

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

CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html VI.3. Reporting Requirements

The applicant must provide CDC with an annual interim progress report via www.grants.gov:

1. The interim progress report is due no less than 90 days before the end of the budget period. The progress report will serve as the non-competing continuation application, and must contain the following elements:

a. Standard Form (“SF”) 424S Form

b. SF-424A Budget Information-Non-Construction Programs

c. Budget Narrative

d. Indirect Cost Rate Agreement

e. Project Narrative

f. Identify Estimated Unobligated Funds in the current budget period by component separately on the 424A Forms and provide detail actions to be taken to obligate the funds.

Additionally, the applicant must provide CDC with an original, plus two hard copies of the following reports:

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

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

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

VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For general questions, contact:

Technical Information Management Section

CDC Procurement and Grants Office

2920 Brandywine Road, MS K-98

Atlanta, GA 30341

Telephone: 770-488-2700

For program technical assistance, contact:

Althea Grant, Project Officer Melissa Creary, Proj Officer

Telephone: 404-498-6719

Telephone: 404-498-6694

E-mail: agrant@cdc.gov

E-mail: mcreary@cdc.gov

Centers for Disease Control and Prevention

National Center on Birth Defects and Developmental Disabilities

Division of Blood Disorders

1825 Century Boulevard

Atlanta, GA 30345

For financial, grants management, or budget assistance, contact:

Sheila Edwards, Grants Management Specialist

CDC Procurement and Grants Office

2920 Brandywine Road, M/S E-09

Atlanta, GA 30341

Telephone: 770.488.1644

E-mail: gmf2@cdc.gov CDC Telecommunications for the hearing impaired or disabled is available at: TTY 770-488-2783.

VIII. Other Information

Other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: http://www.cdc.gov/od/pgo/funding/FOAs.htm.

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