dd12-1207 foa final 4.5.12.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: Surveillance of Congenital Heart Defects (CHDs) Focusing on Adolescents and Adults Announcement Type: New – Type 1

Agency Funding Opportunity Number: CDC-RFA-DD12-1207 Catalog of Federal Domestic Assistance Number: 93.073; Birth Defects and Developmental Disabilities - Prevention and Surveillance Key Dates:

To receive notification of any changes to FOA # DD12-1207, 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: May 1, 2012 Application Deadline Date: June 6, 2012, 11:59pm U.S. Eastern Standard Time Executive Summary:

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center on Birth Defects and Developmental Disabilities (NCBDDD): 1) Enhance the quality and utility of birth defects surveillance systems; and 2) Increase the evidence base on effective interventions to decrease the prevalence of modifiable risk factors for major birth defects.

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 317C and 399V-2 of the Public Health Service Act [42 U.S.C. 247b-4 and 280g-13], as amended.

Background The National Center on Birth Defects and Developmental Disabilities, Division of Birth Defects and Developmental Disabilities, seeks to fund collaborative pilot projects to develop and implement innovative approaches for conducting population-based surveillance of structural, congenital heart defects (CHDs) focusing on adolescents and adults and examining healthcare utilization and referral to timely and appropriate services.

CHDs are one of the most prevalent birth defects in the United States affecting about one percent of all births and are a leading cause of birth defect-associated infant mortality, morbidity, and healthcare costs.1-6 However, most current efforts to conduct population-based surveillance of CHDs have focused on monitoring newborns, and little data exist on the prevalence of CHDs beyond early childhood in the United States. Improvements in treatment of CHDs and consequently in survival have resulted in many individuals, even those affected by very severe CHDs, living into adolescence and adulthood.7-10 There are an estimated 2 million people living with a CHD in the United States, including over one million adults and about 12% of these affected individuals have a severe CHD. Despite the public health burden, the lack of population-based surveillance for CHDs among individuals of all ages in the United States precludes reliable data on the actual prevalence, the type and number of health services required to address the health needs of these individuals, costs of such health services, and longer term outcomes including comorbidities and survival of individuals living with CHDs.

The federal Patient Protection and Affordable Care Act (PL 111-148, Section 10411) amended the Public Health Service Act to add Section 399V-2 which authorized CDC to “enhance and expand infrastructure to track the epidemiology of congenital heart disease and to organize such information into a nationally-representative, population-based surveillance system” for the purpose of facilitating “further research into the types of health services patients use and to identify possible areas for educational outreach and prevention”.

Language from the Joint Statement of Managers states: “Congenital Heart Disease.- The conferees are concerned that there is a lack of rigorous epidemiological and longitudinal data on individuals of all ages with congenital heart disease and has included funding to begin to compile this information. The conferees are particularly interested in information on prevalence, barriers to effective care, survival outcomes and neurocognitive outcomes.”

The proposed surveillance systems for CHDs would utilize standardized data elements to provide centralized, uniform reporting by demographic and clinical characteristics of all individuals with confirmed CHDs in a defined source population (population-based surveillance) by using multiple and existing data sources. Potential data sources to be utilized could include electronic medical records and other health records, hospital discharge data, vital records, inpatient and outpatient medical records, CHD specialty clinic records (adult and pediatric), administrative and healthcare claims data, and existing birth defects surveillance systems. High-quality, collaborative data on CHDs among adolescents and adults will improve the understanding of the epidemiology and public health significance of these disorders. Surveillance data will also allow monitoring of special populations (e.g., pregnant women with CHDs), and identification of risk and prognostic factors. These data will provide a foundation for identifying opportunities and developing effective secondary prevention strategies directed at reducing the personal and public health impact of congenital heart defects. In addition, collection of outcome information would allow for assessment of factors contributing to disparities in outcomes such as the racial/ethnic disparities in mortality for persons with CHDs that were identified in a study using vital records.11

Currently, there are no U.S. data systems that can be used to accurately estimate the prevalence of CHDs among individuals of all ages, nor to describe the affected population. Existing birth defects surveillance systems in 42 states can estimate the birth prevalence of at least some types of CHDs, but there are no existing population-based systems to estimate the prevalence beyond early childhood or to assess the health care utilization or longer term outcomes among adolescents and adults with CHDs.

Purpose

The purpose of this program is to provide support through CDC cooperative agreements for non-research activities to develop robust, population-based estimates of the prevalence of CHDs focusing on adolescents and adults, and better understand the survival, healthcare utilization, and longer term outcomes of adolescents and adults affected by CHDs. The program is a pilot and designed as a learning collaborative effort between CDC and grantees with potentially unique and innovative approaches to monitoring CHDs among adolescents and adults. One of the funded sites or the CDC will serve as a data repository so that data can be pooled for more robust estimates. Successful grantees will share individual level, de-identified data with CDC and the other grantees under this agreement. Linked data files may contain both cross-sectional and longitudinal data.

The activities will be used to help:

1. Determine the prevalence of CHDs among a population-based sample of adolescents and adults in the U.S.;

2. Describe the health care utilization and direct medical care costs for adolescents and adults with CHDs;

3. Describe the distribution of disease severity, co-morbidities, and longer term outcomes of adolescents and adults with CHDs;

4. Describe any racial/ethnic or socioeconomic disparities in healthcare use or long-term outcomes;

5. Monitor the health outcomes in special populations such as pregnant women with CHDs;

6. Calculate the survival and life expectancy for persons with specific types of CHDs;

7. Describe the availability of specialty care and referral patterns that are currently in place;

8. 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 CHDs.

Program Implementation

Recipient Activities In conducting activities to achieve the purpose of this program, the recipient will be responsible for the following activities:

1. Data collection

a. Define the source population for the surveillance for a one year time period, with the same calendar year period agreed upon by all grantees. Data should be population-based or information should be provided on how the data will provide estimates that approximate population-based estimates with respect to racial/ethnic and socioeconomic diversity.

b. To ensure the identification of a sufficient number of CHD cases, the applicant should have a minimum source population of at least 500,000 could include subgroups of i) adolescents only, ii) adolescents and adults, or iii) adults only. Adolescents are defined as aged 11-20 years and adults are defined as aged 21 years and over. If an applicant focuses on only one subgroup (adolescents only, adolescents and adults, adults only), the population size for that subgroup should be at least 500,000. The applicant should indicate the data source (2010 Census, etc.) and geographic area (census tract, city, county, etc.) used to obtain the minimum 500,000 population. When possible, the source population should include racial/ethnic and socioeconomic diversity.

c. Follow CDC’s definition for CHDs that are major, structural birth defects.12 http://www.cdc.gov/ncbddd/birthdefects/documents/MACDPcode0807.pdf

d. Develop a list of limited key data elements (e.g., medical diagnosis of the CHDs, other significant medical conditions, age (date of birth), race/ethnicity, health insurance status, education, census code of residence, date of death, etc.) to be collected.

e. Identify existing data sources that allow determination of adolescents and adults in the source population meeting the CHDs case definition at any age. Demonstrate capacity to access, and use data from clinics, health providers, payers, and other sources.

f. Utilize strengths of electronic health record systems when possible to facilitate identification of adolescents and adults with CHDs.

g. Develop the capacity to link data from multiple sources (i.e. vital records, hospital discharge records, administrative databases and others) to facilitate data collection and improve the sensitivity of the surveillance system.

h. Develop new data collection capacity to enhance the surveillance of CHDs among adolescents and adults.

i. Propose an appropriate method of data validation.

2. Data reporting & Project management

a. Collect and store data in a standardized manner with limited, common data elements that are agreed upon by CDC and all grantees such that de-identified data can be pooled.

b. Electronically submit de-identified, individual level data including standardized data elements in a secure manner to data repository for all study sites at least quarterly.

c. Develop a management and staffing implementation plan for of this program.

d. If applicable, prepare an OMB package and obtain OMB approval before collecting data.

3. Collaboration

a. Collaborate and coordinate across state agencies and clinical settings for data collection. Involve appropriate state and regional partners such as health care providers, community based organizations, academic medical centers and/or outpatient centers specializing in CHDs care, and other organizations to assist with data collection.

b. Work with CDC and other awardees to agree on standardized processes, methods, standardization of data collection, and other project activities.

c. Identify and engage appropriate state and regional partners to develop, implement, and expand activities to improve the access to quality, specialized care.

4. Dissemination of information

a. Disseminate data on enhanced population-based surveillance for CHDs among adolescents and adults.

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

c. Share information with CDC and other awardees in a timely manner such that it can be used to refine innovative methods tested as part of this pilot effort.

d. Participate in publications using pooled data from all sites.

5. Evaluation

a. Prepare a written assessment of the challenges and opportunities of the pilot CHDs surveillance project including a description of the problems encountered, lessons learned, potential improvements, etc.

b. With assistance of CDC, develop and conduct an evaluation of the surveillance pilot project. This plan will include action steps for evaluating the:

i. surveillance methodology used and its impact on accuracy and completeness of the surveillance data for specific age groups and CHD phenotypes;

ii. referral to appropriate services including timeliness and any gaps that exist;

iii. progress on improving access to services, effectiveness of referral activities, and impact on affected individuals (e.g., identification of individuals eligible for services.

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

1. Provide advisory technical assistance such as in defining the minimum data elements.

2. Provide the case definition for major, structural CHDs and technical assistance for implementing this case definition.

3. Assist with the development of an algorithm for identifying adolescents and adults with CHDs.

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

5. Convene awardees regularly by conference call and in-person to support collaboration and shared learning.

6. If needed, provide on-line webinars and in-person training.

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

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

9. Assist with submission of data from each awardee to a central repository at least on a quarterly basis.

10. Develop and maintain the centralized database of de-identified, individual level data. Compile, perform quality reviews of data, and disseminate data. Only de-identified data will be submitted, and the grantees will sign a form provided attesting they will not ever provide the names to CDC.

11. Prepare and submit the OMB package for OMB approval. Assist the grantees in the preparation of their OMB package.

12. Assist with evaluation of the pilot project.

13. Serve as a resource for sharing data, templates, and linking to other 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 – Special Cooperative Health Investigations and Assessments of Control and Prevention Methods

Fiscal Year Funds: 2012 Approximate Current Fiscal Year Funding: Up to $1,425,000

Approximate Total Project Period Funding: Up to $4,275,000 (This amount is an estimate of the total direct and indirect cost, and is subject to availability of funds.)

Approximate Number of Awards: 3-4 Approximate Average Award: Up to $475,000 (This amount is for the first 12-month budget period and includes both direct and indirect costs.)

Floor of Individual Award Range: Up to $300,000 Ceiling of Individual Award Range: Up to $550,000 (This amount is for the first 12-month budget period and includes both direct and indirect costs.)

Anticipated Award Date: 9/1/2012 Budget Period Length: 1 year; 9/1/2012 – 8/31/2013

Project Period Length: 3 years; 9/1/2012 – 8/31/2015 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:

· Nonprofit with 501C3 IRS status (other than institution of higher education)

· Nonprofit without 501C3 IRS status (other than institution of higher education)

· For profit organizations

· Small, minority, and women owned businesses

· Universities

· Colleges

· Research institutions

· Hospitals

· Community-based organizations

· Faith-based organizations

· Federally recognized or state-recognized American Indian/Alaska Native tribal governments

· American Indian/Alaska Native tribally designated organizations

· Alaska Native health corporations

· Urban Indian health organizations

· Tribal epidemiology centers

· State and local governments or 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

· Political subdivisions of States (in consultation with States) A Bona Fide Agent is an agency/organization identified by the state or local government as eligible to submit an application in lieu of a state or local government application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as "Other Documents" and label as appropriate.

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.

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

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.

Special Requirements:

1. Provide evidence of legal authority to share de-identified, individual-level data with CDC and other awardees; and to access datasets critical to accomplish the activities in this FOA and their application, including HIPAA and IRB requirements.

2. Population Area: Population-based coverage area for the defined geographic area of the city, region, or state area should have at least 500,000 people could include subgroups of i) adolescents only, ii) adolescents and adults, or iii) adults only. Adolescents are defined as aged 11-20 years and adults are defined as aged 21 years and over. If an applicant focuses on only one subgroup (adolescents only, adolescents and adults, adults only), the population size for that subgroup should be at least 500,000. The applicant should indicate the data source (2010 Census, etc.) and geographic area (census tract, city, county, etc.) used to obtain the minimum 500,000 population.

Additional documentation submitted via www.Grants.gov should be uploaded in a PDF file format under “Other Attachment Forms,” and should be labeled: Documentation of Population, Evidence of Legal Authority, etc.

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. Application and Submission Information” for more information on deadlines.

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: May 1, 2012 Application Deadline Date: June 6, 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 LOI. Although a LOI 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 the potential review workload and plan the review. Requested LOIs should be provided no later than by the date indicated in Part 1 entitled “Overview Information” and also listed below. The LOI does not need to be signed and should include the following information:

· This FOA title and number.

· The applicant’s name and address; principal investigator’s name, phone number, and e-mail address.

· A brief description of the planned statement of work. 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.

Letter of Intent (LOI) Submission Address: Submit the LOI by fax or e-mail to:

Tineka Yowe-Conley

CDC, NCBDDD

Telephone: 404-498-3941

Fax: 404-498-3040

E-mail address: TYoweConley@cdc.gov 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

· Single spaced

· Page margin size: One inch

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

· Printed only on one side of page.

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

1. Plan

a. Plan to carry out the proposed objectives

b. Complete and comprehensive plan for the entire project period (3 years)

c. Quantitative process and outcome measures

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

e. Description of ability to begin immediate implementation of the activities

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

2. Methods

a. Methods that are specific and feasible within the project timeframe

b. Ability to accomplish the program goals

c. Description of methods for evaluation of the methodology of the pilot project

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

e. Description of established or proposed mechanisms for data collection

3. Organizational and Personnel Capability and Collaborations

a. Appropriate expertise and skills

b. Staff roles defined and sufficient to accomplish program goals

c. Appropriate and meaningful partners documented with specific letters of support

4. Understanding of the Public Health Burden and Impact of CHDs Across the Lifespan

a. Description of public health burden that the program will address

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

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

d. Description of diverse race/ethnic population included in the surveillance population

e. Description of the estimated current number of individuals with CHD in the planned population for surveillance

5. Objectives

a. Objectives are specific, measurable, attainable, realistic, and timely (SMART) to address the need and activities of this FOA

b. Description of the proposed intent to enhance current monitoring activities for CHDs by collecting data from multiple existing sources, linking data, and collecting longitudinal data to ascertain longer term outcomes Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

1. 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

2. Curricula Vitae/Resumes

3. Bona fide agent letter from government, if applicable

4. Timeline clearly identifying all key milestones

5. Letters of Support

6. Organizational Charts

7. Indirect Cost Rate Agreement

8. Memorandum of Understanding/Agreement (MOU/MOA)

Additional information submitted via www.Grants.gov should be uploaded in a PDF file format, and would be named: Appendix 1 - Budget and Budget Narrative; Appendix 2 - Curricula Vitae/Resumes; Appendix 3 - Bona fide agent letter government, if applicable, etc.

No more than 20 appendices should be uploaded per application.

Additional requirements for additional documentation with the application are listed in Section VI. “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.

· Project funds may not be used to supplant State funds available for birth defects surveillance or prevention, health care services, patient care, nor construction.

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

Executive Order 12372 does not apply to this program.

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 Funding Opportunity Announcement CDC-RFA-DD12-1207. 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.

V.1. Evaluation Criteria

Eligible applications will be evaluated against the following criteria:

1. 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 individual-level, identifiable data on the population under surveillance with a population size of at least 500,000 of the age group under study [please note the “age group under study” can be adolescents 10-21 years, adults 22 years and up, or adolescents and adults combined aged 10 years and up], including access to multiple data sources that can be linked to increase sensitivity and eliminate duplicates. Did the applicant describe their planned collaboration with appropriate partners both internal to the state health department as well as external?

2. Methods (25 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 key partners to maximize the number of data sources that can be used? Did applicant describe the ability to obtain data that is population based?

3. Organizational and Personnel Capability and Established Collaborations (20 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? Are the collaborations well established and documented by letters of support?

a. Demonstrate ability to identify and hire needed staff and consultants in a timely manner.

b. Demonstrate ability to identify and hire subawardees

c. Demonstrate ability to begin immediate implementation of the activities

d. Demonstrate relationships and 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).

4. 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 sufficient population size with diversity in terms of both race/ethnicity and socioeconomic status included in the surveillance population? Did the applicant provide a description of the estimated number of adolescents and/or adults with CHDs in the population in which surveillance will be conducted?

5. 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 conduct comprehensive surveillance adolescents and/or adults with CHDs? Do the objectives include the ascertainment of longer term outcomes including health outcomes? Did applicant characterize current efforts to serve adolescents and adults with CHDs including specialty clinics that exist and might facilitate case-findings activities?

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. Award recipients agree to use cooperative agreement funds for travel by project staff agreed-upon by CDC to participate in CDC-sponsored workshops, or other called meetings such as regional or annual meetings.

If the applicant requests 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 applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:

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

V.2. Review and Selection Process

All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness 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 eligibility and/or published submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in Section V. “Application Review Information”, subsection entitled “Evaluation Criteria”. The objective review panel will consist of CDC employees from outside the funding division who will evaluate the technical merit of the application for the purpose of advising the awarding official. The panel shall numerically score each application using only the criteria listed in the announcement.

Selection

Applications will be funded in order by score and rank determined by the review panel. In addition, the following factors may affect the funding decision:

1. Race/ethnicity, socioeconomic status, population size and geographic region

2. Subgroups (adolescents only, adolescents and adults, adults only) on which the activities are focused.

CDC will provide justification for any decision to fund out of rank order.

VI. AWARD ADMINISTRATION INFORMATION

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 e-mailed to the program director. A hard copy of the NoA will be mailed to the recipient fiscal officer identified in the application.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration and Transparency Act requirements.

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

Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. The following additional requirements apply to this project:

· AR-8

Public Health System Reporting Requirements

· AR-9

Paperwork Reduction Act Requirements

· AR-10

Smoke-Free Workplace Requirements

· AR-11

Healthy People 2020

· 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

(Public Law 89-665, 80 Stat. 915)

· AR-27

Conference Disclaimer and Use of Logos

· AR-29

Compliance with E.O. 13513 Federal Leadership on Reducing

Text Messaging While Driving, October 1, 2009.

· AR-30

Information Letter 10-006. – Compliance with Section 508 of the

Rehabilitation Act of 1973

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.

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 Reporting

Federal Funding Accountability And Transparency Act Of 2006 (FFATA): Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, www.USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:

1. The name of the entity receiving the award

2. The amount of the award

3. Information on the award including transaction type, funding agency, etc.

4. The location of the entity receiving the award

5. A unique identifier of the entity receiving the award; and

6. Names and compensation of highly-compensated officers (as applicable)

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the Federal Funding Accountability and Transparency Act of 2006, please review the following website:

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf.

Each funded applicant must provide CDC with an annual Interim Progress Report submitted via www.grants.gov:

1. The interim progress report is due no less than 120 days before the end of the budget period. The Interim Progress Report will serve as the non-competing continuation application, and must contain the following elements:

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

b. Budget Narrative

c. Indirect Cost Rate Agreement

d. Project Narrative

e. Current Budget Period Activities Objectives

f. Current Budget Period Financial Progress

g. 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.

h. New Budget Period Program Proposed Activity Objectives

i. Budget

j. Measures of Effectiveness

k. Additional Requested Information Additionally, funded applicants must provide CDC with an original, plus two hard copies of the following reports:

1. Federal Financial Report* (SF 425) and annual progress report, no more than 120 days after the end of the budget period.

2. Final performance and Federal Financial Reports*, no more than 120days after the end of the project period.

*Disclaimer: As of February 1, 2011, current Financial Status Report (FSR) requirements will be obsolete. Existing practices will be updated to reflect changes for implementation of the new Federal Financial Reporting (FFR) requirements.

These reports must be submitted to the attention of the Grants Management Specialist listed in the Section VII below entitled “Agency Contacts”.

VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For programmatic technical assistance, contact:

Tineka…