dd11-005 final amend ii 2.4.11.doc

Amendment II made 2.3.11

· Page 3 (Additional Overview Content, Executive Summary bullet 5) Year 3 will be 9 months therefore 75% of up to $70,000 may be awarded. The maximum awarded in Year 3 may be $52,500.

· Page 9 (Section II Award Information, 2. Funds Available) Year 3 will be 9 months therefore 75% of up to $70,000 may be awarded. The maximum awarded in Year 3 may be $52,500.

Amendment I made 1.3.11

· Executive Summary; Budget Period, Project Period, and Award Amounts, page 3

· Funds Available, page 9 Part I Overview Information

United States Department of Health and Human Services (HHS) Issuing Organization

Centers for Disease Control and Prevention at (CDC) at http://www.cdc.gov/ncbddd

Participating Organizations Centers for Disease Control and Prevention at (CDC) at http://www.cdc.gov/

Components of Participating Organizations Extramural Research Program Office (ERPO) serving, National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC) at http://www.cdc.gov/ncbddd Title: National Spina Bifida Registry Longitudinal Data Collection and Evaluation (U01)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.

Authority: This program is authorized under Sections 301, 311 and 317 (C) of the Public Health Service Act, (42 U.S.C., Sections 241, 243 and 247b-4), as amended.

Announcement Type: Renewal Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two Steps Are Required For On-Time Submission:

1) The application must be successfully submitted and validated by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-DD-11-005 Catalog of Federal Domestic Assistance Number(s): 93.283 Centers for Disease Control and Prevention Investigations and Technical Assistance

Key Dates

Release/Posted Date:

Letter of Intent Receipt Date: February 1, 2011 NOTE: On-time submission requires that applications be successfully submitted to Grants.gov and validated no later than 5:00 p.m. eastern time on the deadline date. Please see Section IV, 3.C. “Application Processing.”

Application Submission Receipt Date(s): March 14, 2011 Peer Review Date(s): June 2011 Council Review Date(s): August 2011 Earliest Anticipated Start Date(s): September 2011 Additional Information to Be Available Date: NA Expiration Date: March 15, 2011 Due Date for E.O. 12372 Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

· This FOA expands on activities funded under FOA DD08-001. This FOA solicits applications for recipients of an award that will be in the form of cooperative agreement to: 1) enhance the collection of data in the National Spina Bifida Patient Registry (NSBPR) as an approach to improving quality of care; 2) advance the understanding of patient characteristics for persons seen in spina bifida clinics; and 3) utilize registry data to determine outcomes of specific clinical interventions.

· The participating organizations intend to commit a total of $450,000-$630,000 to this FOA for payment of applications responsive to this announcement.

· Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

· Anticipated number of awards to be issued under this FOA: 9

· Budget Period, Project Period, and Award Amounts: The award ceiling for the first 12-month budget period is $450,000- $630,000 in total costs (direct and indirect). The average award amount will be $50,000 - $70,000 in total dollars (direct and indirect) for the first 12-month budget period. In years two and three the project awards are expected to range from $50,000 to $70,000 in total costs (direct and indirect). Year 3 will be 9 months therefore 75% of up to $70,000 may be awarded. The maximum awarded in Year 3 may be $52,500. The total project period for applications submitted in response to this FOA may not exceed two years, nine months. The approximate total project period funded amount is $1,552,500. Applicants should plan to fully expend grant funds during the period of performance while ensuring full transparency and accountability for all expenditures.

· Eligible Organizations: This FOA is limited to the following grantees funded under PA DD08-001: University of Alabama at Birmingham; Cincinnati Children’s Hospital; Children’s Hospital of Los Angeles; University of Colorado Denver; Connecticut Children’s Medical Center; Riley Hospital for Children, Indianapolis; Children’s Hospital of Wisconsin; Oregon Health and Science University; Seattle Children’s Hospital.

· See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc (MS Word); http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.pdf (PDF)

· For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm; General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/

· HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783.

Funding Opportunity Announcement Glossary: FOA Glossary Terminology Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Section II. Award Information

1. Mechanism(s) of Support

2. Funds Available

Section III. Eligibility Information

1. Eligible Applicants A. Eligible Institutions

2.Cost Sharing or Matching 3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information

1. Request Application Information

2. Content and Form of Application Submission

3. Submission Dates and Times A. Receipt and Review and Anticipated Start Dates

1. Letter of Intent B. Submitting an Application to CDC C. Application Processing

4. Intergovernmental Review

5. Funding Restrictions

6. Other Submission Requirements

Section V. Application Review Information

1. Criteria

2. Review and Selection Process A. Additional Review Criteria B. Additional Review Considerations C. Sharing Research Data D. Sharing Research Resources

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information

1. Award Notices

2. Administrative and National Policy Requirements A. Cooperative Agreement

1. Recipient Rights and Responsibilities

2. HHS/CDC Responsibilities

3. Collaborative Responsibilities

3. Reporting

Section VII. Agency Contact(s)

1. Scientific/Research Contact(s)

2. Peer Review Contact(s)

3. Financial/ Grants Management Contact(s)

4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations Appendices:

1. Appendix I – Initial Encounter Form

2. Appendix II – Annual Visit Form

3. Appendix III – Mortality Form

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Center on Birth Defects and Developmental Disabilities (NCBDDD) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This FOA addresses Healthy People 2020 priority area(s) of Disability and Health; Health-Related Quality of Life and Well-Being; and Maternal, Infant, and Child Health, and is in alignment with NCBDDD performance goal(s)). For more information http://www.healthypeople.gov/2020, and http://www.whitehouse.gov/omb/mgmt-gpra. In addition, this FOA addresses a number of high impact public health areas, including the CDC Health Protection Goal for Healthy People in Every Stage of Life, whereby all people, and especially those at greater risk of health disparities, will achieve their optimal lifespan with the best possible quality of health in every stage of life. For more information, see http://www.cdc.gov/osi/goals/people/index.html. This FOA is consistent with the following congressional language: “CDC is urged to support the implementation of the National Spina Bifida Patient Registry to improve the efficiency and quality of care in the nation’s spina bifida clinics” (p. 92, House Report 111-220).

Nature of the Research Opportunity

This FOA will support spina bifida clinics in the United States experienced in the collection of data in the National Spina Bifida Patient Registry (NSBPR) to participate in the NSBPR using a standardized registry tool. Clinics will: collect data on approximately 1,200 patients affected by spina bifida; submit data to a central repository; participate in the data analysis; propose improvements and additions to the registry data collection methods and process; and propose changes to clinical practice aimed to improve the quality of care of persons living with spina bifida.

Background

According to the Spina Bifida Association (SBA) more than 70,000 people in the United States are currently living with spina bifida (SB), making it the most common permanently disabling birth defect. The care of persons with spina bifida is complex, involving different organ systems and, correspondingly, multiple clinical specialties. It is estimated that approximately 50% of those affected by SB receive specialty care in one of the estimated 103 SB multidisciplinary clinics in the U.S.

In 2005 and 2006, The Delmarva Foundation and The Agency for Healthcare Research and Quality working with SBA implemented a survey of programs/clinics that serve people affected by spina bifida assessing the care that persons with spina bifida receive in the clinics. The objectives of the survey were to: 1) get a clearer overall picture of spina bifida clinics in the U.S.; 2) gain understanding of clinic operations and services; and 3) elicit information related to strengthening quality of care provided in clinics. This assessment identified variation across clinic programs and meaningful gaps between what programs felt were essential services and the services that were actually being delivered. The Professional Advisory Council of the SBA looked at this assessment, qualitative data that the survey identified, and the experience of other organizations (specifically the Cystic Fibrosis Foundation); and endorsed the concept of building a national infrastructure to support both clinical research and a systematic approach to improving quality of care. The implementation of a Spina Bifida Patient Registry was the first step towards establishing that infrastructure.

In 2008 under FOA-DD08-001 – Spina Bifida Patient Registry Demonstration Project, eight SB clinics were competitively funded to test the feasibility of using a standardized data collection tool to collect and aggregate data on spina bifida patients in the clinic setting. In 2009 a ninth SB clinic was incorporated into the group, collecting and submitting data on designated registry questions. The analysis of these longitudinal data may be used to establish standards of care which can be implemented to improve outcomes for patients with spina bifida in similar fashion to what has been done using the Cystic Fibrosis Registry.

Scientific Knowledge to be Achieved through this Funding Opportunity

This FOA will advance our understanding of the influence of population characteristics, clinical interventions, and other factors on outcomes for patients seen in spina bifida clinics. The longitudinal data collected in the NSBPR will include documentation and measurement of interventions that will help establish national standards of care for patients with spina bifida. Continued collection of these data will help determine how clinics are meeting these standards. It is also anticipated that evaluation of the data from the NSBPR will identify areas for future research whose findings will inform best clinical practices.

Research Objectives and Approach

The objective of this FOA is to continue with the collection of data started under FOA DD08-001 aimed at improving the care of individuals with spina bifida in the U.S. to establish the feasibility of longitudinal data collection in the clinic setting. The specific outcomes of this project are to collect longitudinal data on patients seen in spina bifida clinics to:

1. Describe the characteristics of the study population, its comparability to all SB patients in the clinic, and persons with SB generally;

2. Use data to establish the association between outcomes, interventions; demographic variables, and other factors;

3. Identify best practices;

4. Establish measures of quality care;

5. Compare outcomes among participating clinics by participating in a Coordinating Committee (CC); and

6. Serve as a source of information for future research or projects.

The collection of patient data will be accomplished during patient interview and assessment that are part of routine spina bifida clinic visits and by review of patient medical records for the provision of missing information when needed. Data will be obtained by the clinic staff from individuals who are seen at spina bifida clinics in the U.S. and entered into the CDC developed database. Participating clinics have been collecting data annually on a minimum of 125 patients seen in the clinics. Each clinic will collect data annually on 125 patients, preferably on those for whom data have been previously collected. New patients may be enrolled as appropriate. It is expected that the data collected will be on the same patients each year though the addition of patients not currently consented in the project is encouraged. Clinic patients who are seen in the clinic and not currently participating in the registry project will be offered the opportunity to participate and will demonstrate consent in writing. While participation by all patients seen in the clinics is desired, participation is subject to patient consent to do so. Therefore, it is anticipated that a subset of patients will be enrolled in the NSBPR. For patients who do not consent to participate in the project or are otherwise not enrolled/included in the project, aggregate data (mean age, gender, percent by race and ethnicity and other characteristics available) will be collected allowing comparison of the comparability of those on whom registry data are collected and those on whom no registry data are collected. Standardized forms containing the registry questions provided by CDC will be used by the clinic to collect patient information both during the regular clinic visit and via medical record data abstraction when necessary. The registry questions are embedded in an Electronic Medical Record (EMR) specifically designed for use in spina bifida clinics. The information that is collected on the standardized forms will be entered into the EMR and transmitted electronically to a central repository and will be in a standardized, reliable format. Applicants are encouraged to use the EMR for other than the submission of registry data though this is not a requirement. The collected data will be de-identified, edited, and combined into a uniform dataset for use by CDC and the grantees.

Electronic Medical Record:

The SBA has funded the design of a web-based EMR specific to spina bifida. The EMR will have the ability to:

1. Track patient demographics, visits, infections, diagnoses, tests, lab results, medications, allergies, and surgeries;

2. Default to spina bifida specific labs, tests, surgeries, and medications for easier access;

3. Display lab results in a spreadsheet format;

4. Enter and view medications by either brand or generic names; and

5. Display growth chart graphing.

The NSBPR-specific questions will be highlighted and embedded throughout the EMR so that the de-identified data that are transmitted electronically to CDC will be in a standardized, reliable format. Clinics who participate in this project may choose to routinely use and complete the EMR to record information for their patients’ clinic visits. If they do, they will by default answer the NSBPR questions. Clinics may also opt to use the EMR only to record the highlighted NSBPR variables. In this case, there is a requirement to complete additional fields which are inherent to the functionality of the SB EMR. CDC will receive only the NSBPR specific de-identified data electronically, after entry and submission via the EMR. Data from the participating sites will be collected, edited, and combined into a centrally stored dataset for use by the grantees. Quality Assurance/Quality Control (QA/QC) will be conducted by the CDC Spina Bifida Patient Registry Manager. The use of a shared computerized reporting and data-processing system will set data standards for completeness, timeliness, and quality among spina bifida clinics. Additionally, the EMR (a complete source for spina bifida patient data), will provide a means for comparing treatment, care, and outcomes between clinics, population groups, and geographic areas.

The Project Director/Principal Investigator from each funded institution will serve on a Coordinating Committee (CC) that will include representatives from CDC, and the Agency for Healthcare Research and Quality (AHRQ). The primary function of the CC will be to provide overall direction to the project, identify public health research priorities, and identify research opportunities. The CC will serve as a clearinghouse for proposed analytic projects by participating researchers. In this capacity, the CC will evaluate research proposals focused on data pooled across sites, minimize redundancy in research activities and ensure that appropriate analytic procedures are utilized in pooled data assessments. Registry data analyses will be guided by the CC, performed by the CDC and the principal investigators. Results from the analyses will form the basis for registry amendments and used to identify best practices. The CC will provide guidance to ensure the successful implementation of the projects. Authorship will be determined by the CC.

The primary function of the CC will be to provide overall direction to the project, identify cross-site analyses, additional projects, and research opportunities. The CC will:

1. Establish measures of performance and QA/QC checks;

2. Evaluate levels of successful implementation of the NSBPR; and

3. Develop a mechanism to evaluate outcomes from the NSBPR.

In addition, PI’s will have the opportunity to participate in a Clinical Data Quality Committee (CDQC) whose purpose is to plan for data analysis and for the identification of priority areas that will guide the addition/deletion of registry variables. The CDQC will;

1. Participate in the identification of priority areas for data collection and research;

2. Consider variables that can be collected reliably and accurately by SB clinics; and

3. Refine the SB EMR which serves as a repository of SB data variables.

Collected data will be analyzed by CDC and participating sites at the direction of the CC in order to:

1. Describe the characteristics of the study population, including its representativeness;

2. Understand the clinical data, including the variations in interventions/treatments offered to patients in participating clinics;

3. Establish measures of quality care;

4. Serve as a source of information for future research or projects;

5. Change registry methods and data collection items as needed; and

6. Identify best practices.

Interventions will be characterized by variation in responses to the Registry Questions that identify interventions/treatments. Clinical oversight to these analyses will be provided by the CDC Scientific Collaborator. Findings from the registry will be disseminated to the community of persons interested in the care and well being of those affected by spina bifida: clinicians, scientists working in the field, educators, persons with SB, and families. Based on data analysis and public health priorities, the registry variables will be expanded and or modified so that the data collected will be relevant to the purposes of improving care and establishing a foundation for future research. Special studies utilizing the collected in-depth data or data methodology may be explored and incorporated in the future.

Under FOA DD11-001 CDC expects to add 8--12 new sites to the NSPBR. It is anticipated that these new awards will be made by June of 2011, and will work collaboratively with awardees under this FOA in the successful demonstration of longitudinal data collection

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U01 activity code.

The HHS/CDC U01 is a cooperative agreement assistance instrument. Under the U01 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available The participating Centers, Institutes and Offices (CIO)(s) NCBDDD intends to commit approximately $450,000 - $630,000 in total dollars (direct and indirect) in FY2011 to fund 9 applications. The average award amount will be $50,000 - $70,000 in total dollars (direct and indirect) for the first 12-month budget period. An applicant may request a project period of up to two years, nine months. An applicant may request up to $70,000, Ceiling of Award Amount for the first 12-month budget period. Year 3 will be 9 months therefore 75% of up to $70,000 may be awarded. The maximum awarded in Year 3 may be $52,500. The approximate total project period funded amount is $1,552,500. The anticipated start date for new awards is September 30, 2011. Although the financial plans of the NCBDDD provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. 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.

These awards are going to previous applicants (continuation) how do you know they performed well on the prior award? What progress was made on the previous award? Were the goals met and addressed? How were the applicants evaluated and how do you know the prior recipients can address and the goals of the FOA better than any other entity. Did the applicants address and meet the objectives in the prior FOA?

All estimated funding amounts are subject to availability of funds.

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not be reviewed. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the CIO (s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

This FOA is limited to the nine Spina Bifida grantees currently funded under PA DD08-001: University of Alabama at Birmingham; Cincinnati Children’s Hospital; Children’s Hospital of Los Angeles; University of Colorado Denver; Connecticut Children’s Medical Center; Riley Hospital for Children, Indianapolis; Children’s Hospital of Wisconsin; Oregon Health and Science University; Seattle Children’s Hospital. These are the only sites in the United States that have experience collecting data using the Electronic Medical Record (EMR) developed for and used in the current award. They are uniquely qualified to perform the programmatic activities that will be funded under this FOA because they have the following characteristics:

1. An established Spina Bifida Registry that uses the EMR for the collection of data on patients enrolled in spina bifida clinics.

2. An identified cohort of individuals with spina bifida and their families who have and will be asked to continue to participate in these interviews. and

3. Infrastructure, experience, and personnel to conduct longitudinal data collection on over 1,200 patients seen in the nine clinics.

2. Cost Sharing or Matching

Cost sharing, matching, or cost participation are not required under this program.

The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc

3. Other-Special Eligibility Criteria

1. Demonstrate the ability to recruit patients for participation in the NSBPR as evidenced by: number of patients enrolled, and number of subsequent annual patient visits where data were obtained and submitted to CDC If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

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 an award, grant, or loan.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to Grants.gov/Apply and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at the following:

· Grants.gov Get Registered: http://www.grants.gov/applicants/get_registered.jsp

· eRA Commons Prepare to Apply: http://era.nih.gov/ElectronicReceipt/preparing.htm Note: Both the applicant organization, as well as, the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp

· Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.

· If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.

· The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.

· Direct questions regarding Grants.gov registration to:

Grants.gov Customer Support Contact Center Phone: 1-800-518-4726 Business Hours: 24 hours a day, seven days a week Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm

· To find out if an organization is already eRA Commons-registered, see the "List of Grantee Organizations Registered in eRA Commons.”

· Direct questions regarding the eRA Commons registration to:

eRA Commons Help Desk Phone: 301-402-7469 or 866-504-9552 (Toll Free)

TTY: 301-451-5939

Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time Email commons@od.nih.gov

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

· The individual designated as the PD/PI on the application must also be registered in the eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.

· The PD/PI must hold a PD/PI account in the eRA Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.

· This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the eRA Commons.

· Both the PD/PI and AOR/SO need separate accounts in the eRA Commons since both hold different roles for authorization and to view the application process.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g. sample forms, forms from another FOA); although some of the "Attachment" files may be useable for more than one FOA.

If you do not have access to the Internet, or if you have difficulty accessing the forms online, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGOTIMS) staff. For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: PGOTIM@cdc.gov.

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

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. 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 PGO TIMS 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 prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to PGO TIMS 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.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/Apply will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)

Research & Related Project/Performance Site Locations Research & Related Other Project Information Research & Related Senior/Key Person Profile

PHS398 Research & Related Budget PHS398 Cover Page Supplement PHS398 Research Plan PHS398 Checklist PHS398 Cover Letter File Research & Related Sub award Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U01 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

3. Submission Dates and Times

See Section IV.3.A for details.

3. A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: February 1, 2011 Application Submission Receipt Date(s): March 14, 2011 Peer Review Date (s): June Council Review Date (s): August

Earliest Anticipated Start Date: September 2011

3.A.1. Letter of Intent

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

· Descriptive title of proposed research

· Name, address, and telephone number of the Principal Investigator

· Names of other key personnel

· Participating institutions

· Number and title of this funding opportunity

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

The letter of intent should be sent to:

Michael A. Brown, MPH

Extramural Research Program Office

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

4770 Buford Hwy, N.E., M/S K-92

Atlanta, GA 30341

Telephone: (770) 488-5118

Fax: (770) 488-8046

Email: mab5@cdc.gov

3.B. Submitting an Application to CDC

If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should access this FOA via Grants.gov/Apply and follow steps 1-4. Applications must be submitted electronically through Grants.gov (http://www.grants.gov) where the application will be electronically time/date stamped by Grants.gov. The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application.

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission procedures, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review. You will receive notification that you did not meet the submission requirements.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received and validated by Grants.gov no later than 5:00 p.m. eastern time on the deadline date. If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

· If everything is acceptable, no further action is necessary. The application will automatically move forward for processing after two weekdays, excluding Federal holidays.

· Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to “Reject” the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The “Reject” feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.

· Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays. Warnings or errors must be addressed prior to the closing date. No changes will be accepted thereafter.

Note: The application is not complete until it has passed the Grants.gov validation process. Applicants will receive a submission receipt email followed by an email from Grants.gov confirming that the application package passed the validation process or was rejected due to errors. Validation takes two (2) calendar days; however, applicants may check the status of the application to ensure submission is complete. To guarantee that compliance with the Funding Opportunity Announcement, allocate additional time to the submission process. Applications that have not passed the validation process within 48 hours of the submission deadline may not be accepted. If no validation e-mail from Grants.gov is received within two (2) calendar days of submission, you may contact Grants.gov. Please refer to the Grants.gov email message generated at the time of application submission for instructions on how to track your application or the Application User Guide.

Upon receipt, applications will be evaluated for completeness and responsiveness by the CDC Procurements and Grants Office and the CIO. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the https://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

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 PGO TIMS 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 prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to PGO TIMS 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 TIMS to submit the original and two hard copies of the application by mail or express delivery service.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

4. Intergovernmental Review Executive Order 12372 does not apply to this program.

5. Funding Restrictions

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

Additional guidance can be found at HHS Grants Policy Statement.

All proposal costs must be necessary and reasonable in accordance with Federal guidelines. Determinations of allowable costs will be made in accordance with the applicable Federal cost principles. Disallowed costs are those charges to a grant that the grantor agency or its representative determines not to be allowed in accordance with the applicable Federal coast principles or other conditions contained in the grant.

Restrictions, which applicants must take into account while writing their budgets, are as follows:

· Funds relating to the conduct of research will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place.

· Reimbursement of pre-award costs is not allowed.

6. Other Submission Requirements

Applicants’ research plan should address activities they propose to conduct over the entire project period. The research plan should include:

1) If the spina bifida clinic is not the primary applicant, the applicant must describe their relationship with the SB clinic, and how all parties will work together to achieve FOA objectives. The application must then include a letter of support from the SB clinic Director.

2) A description of the composition of the clinic personnel. For example the SBA’s Clinical Network Guidelines could be used as markers (i.e., support services and medical specialties available).

3) A description of the clinical operations, frequency of clinic visits, etc.

4) Information on the current spina bifida data collection system being used (i.e., what type of information is being collected, who is doing it, and how is it being recorded). This may include current hospital non-spina bifida information. Include information on use of EMR, if appropriate.

5) Demographic information on current patient enrollment and any additional study participants projected (i.e., age, gender, and ethnicity).

6) A description of how participants in excess of those currently enrolled will be recruited in the study and how consent will be obtained. Grantees must collect data on those subjects currently consented to participate in the project at a minimum. The intent is to collect data each year on the patients that were consented initially, if possible. Describe what measures will be taken to retain the recruited patients for follow up each year, and how replacements for attrition will be selected.

7) A description of the method that will be used to collect patient data and strategies for obtaining complete data on each patient.

8) A description of any other research currently being done in the organization and potential for collaboration on this project.

9) Describe any relationships with local spina bifida or other parent or advocacy groups, and how they will be involved in this project. If involved, then letters of support should be provided.

10) Include in your budget if award funds will be used to pay for costs associated with attending the annual program CC meeting (held in conjunction with the SBA conference), or the Clinical Data Quality Meeting

11) Describe approaches that will be used to incorporate findings into existing clinic practice.

12) Provide a summary of site-specific accomplishments/progress from work conducted under FOA DD08-001 including:

a) A description of recruitment and retention activities,

b) Data management efforts, and

c) Collaboration activities with other participating sites.

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

The following materials may be included in the Appendix:

Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

· Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.

· Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

· Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment.

· Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.

· Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.

Please note the following restriction on appendix attachments: The Research…