dd11-001r 09 02 10 final 09 03 10.doc

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 Patient Registry - Clinic Demonstration Project (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: New Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be 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-DD11-001 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: November 8, 2010 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): December 7, 2010 Peer Review Date(s): February 2011 Council Review Date(s): March 2011

Earliest Anticipated Start Date(s): June 1, 2011 CDC will conduct two conference calls to assist prospective applicants in the development of research projects submitted in response to this FOA.

First conference call details:

Date: September 29, 2010 at 3:00 p.m. (EST)

Call-in Number: 1-866-453-4956

Pass Code: 4859507# Content: To discuss utilization of the Spina Bifida Electronic Medical Record for the submission of registry data to CDC.

Second conference call details:

Date: October 13, 2010 at 3:00 p.m. (EST)

Call-in Number: 1-866-453-4956

Pass Code: 4859507# Expiration Date: December 8, 2010 Due Date for E.O. 12372 Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

· This FOA solicits applications in the form of cooperative agreements to: 1) establish the National Spina Bifida Patient Registry (NSBPR) as an approach to improving quality of care; 2) expand the use of the standardized spina bifida registry tool; 3) advance the understanding of patient characteristics for persons seen in spina bifida clinics; and 4) utilize registry data to determine outcomes of specific clinical interventions. This FOA expands on activities funded under RFA DD08-001.

· The participating organizations intend to commit a total of $320,000 - $480,000 in FY2011 to this FOA for payment of applications responsive to this announcement statement regarding the total amount to be awarded.

· 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: 8-12

· Budget Period, Project Period, and Award Amounts: The award ceiling for the first 12-month budget period is $40,000 in total costs (direct and indirect). It is expected that the first year of the project will include the completion of the local IRB process, followed by initiation of subject recruitment. In years two and three the project awards are expected to range from $50,000 to $70,000 in total costs (direct and indirect). The total project period for applications submitted in response to this FOA may not exceed three years. The approximate total project period funded amount is $1,260,000.

· Eligible Organizations: Public nonprofit organizations; private nonprofit organizations; 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); and political subdivisions of states (in consultation with states.) A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide required documentation 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.

· 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 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses “Healthy People 2010” priority area(s) of Disability and Secondary Conditions; Maternal, Infant, and Child Health; and to Prevent Birth Defects and Developmental Disabilities, and is in alignment with NCBDDD performance goal(s): Disability and Secondary Conditions; Maternal, Infant, and Child Health; and to Prevent Birth Defects and Developmental Disabilities. For more information, www.healthypeople.gov. and http://www.whitehouse.gov/omb/mgmt-gpra/.

Nature of the Research Opportunity

This FOA will support spina bifida clinics in the United States to participate in the National Spina Bifida Patient Registry (NSBPR) using a standardized registry tool. Clinics will: collect data on 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, different clinical specialists. It is estimated that approximately 50% of those affected by SB receive specialty care in one of the estimated 150 SB multidisciplinary clinics in the U.S. Many of these clinics care for patients only until the age of 21 years; therefore, some persons with SB do not have the opportunity to seek care in a SB clinic.

In 2005-2006, a number of organizations working with SBA undertook a survey of current care in the programs/clinics that serve persons with spina bifida. The objectives of the survey were to: 1) get a clearer overall picture of spina bifida clinics in the U.S.; 2) gain a better understanding of clinic operations and services; and 3) elicit information related to strengthening clinic quality.

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 assessment process 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 RFA-DD08-001 – Spina Bifida Patient Registry Demonstration Project, eight SB clinics were funded to test the feasibility of using a standardized data collection tool to collect and combine data on spina bifida patients in the clinic setting. In 2009 a ninth SB clinic was incorporated into the group. The project included a Coordinating Committee (CC) comprised of: the Principal Investigators; the CDC Scientific Collaborator; and representatives from the SBA, and the Agency for Healthcare Research and Quality (AHRQ).

Based on this test of feasibility of a registry being created from standardized clinic data, there is evidence that SB clinics can work together to collect and to share clinical processes and outcomes. It is anticipated that this collection of clinical data can be used to improve the care of persons affected by spina bifida in similar ways to those demonstrated by the Cystic Fibrosis Foundation using the Cystic Fibrosis Registry.

Scientific Knowledge to be Achieved through this Funding Opportunity

This FOA will advance our understanding of the influence of demographic factors and clinical interventions on outcomes for patients seen in spina bifida clinics by the development and use of the NSBPR within a larger number of clinics with more diverse populations. Findings from the data collected for the NSBPR will be used to identify measures that will aid in the development of national standards of care for patients with spina bifida, and assess progress toward those standards. It is also anticipated that evaluation of the data from the NSBPR will identify areas for future research that will inform best clinical practices and improve the lives of persons living with spina bifida.

Research Objectives and Approach

The objective of this FOA is to establish a standardized collection of spina bifida patient data via the NSBPR. The NSBPR is an expansion of the pilot data collection from a limited number of sites under DD08-001, and established for the purpose of improving the care of individuals with spina bifida in the U.S. The activities of this FOA are:

1. Implementing standardized data collection process in the NSBPR,

2. Conducting data collection,

3. Implementing an analytical plan,

4. Participating in a Coordinating Committee (CC) with other awardees, and

5. Developing a plan for integrating data findings into clinical practice.

This FOA will support spina bifida clinics to collect patient data into a central repository. The NSBPR is defined as a system for the collection and maintenance of longitudinal data in a structured record including demographics, interventions, and outcomes for persons with spina bifida. The registry variables to be used in the research projects funded through this announcement have been developed by an expert panel, and are being tested and amended by the Spina Bifida Patient Registry Demonstration Project CC (appendices I, II, & III) funded under RFA-DD08-001. It is anticipated that some changes will be made to the registry tools, thus these appendices should be considered as drafts. (See Section IX. Appendix I. Spina Bifida National Patient Registry - Initial Encounter Form; Appendix II. Spina Bifida National Patient Registry - Annual Visit Form; and Appendix III – Spina Bifida National Patient Registry – Mortality Form).

Data should be obtained from individuals who are seen at spina bifida clinics in the U.S. and entered into the NSBPR database using an Electronic Medical Record (EMR) specifically designed for use in spina bifida clinics. Data on a minimum of 125 of the spina bifida patients enrolled in each clinic will be submitted in each of the three year project periods, using the standardized forms developed for this multi-site project. The intent is to collect data each year on the patients initially consented, although others can be added to the registry.

Electronic Medical Record

The SBA has funded the design of the 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, 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 PD/PI from each funded institution will serve on a CC that will include representatives from CDC and AHRQ. The CC from this FOA will work with the CC that was created under DD08-001 to provide oversight to ensure the successful implementation of the project. 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. Incorporate the clinic demonstration project data into ongoing data collection and analysis;

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

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

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

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

1. Describe the characteristics of the study population;

2. Understand the clinical data, including the effectiveness of clinical interventions;

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.

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, and families. Based on data analysis, 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.

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

Section II. Award Information

1. Mechanism(s) of Support

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 NCBDDD intends to commit approximately $320,000 - $480,000 in total dollars (direct and indirect) in FY2011 to fund 8-12 awards for year one. The average award amount will be $40,000, which includes direct and indirect costs. An applicant may request a project period of up to three years. An applicant may request up to $40,000, Ceiling of Award Amount, for the first 12 month budget. The approximate total project period funded amount is $1,260,000. The anticipated start date for new awards is June 1, 2011. 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.

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:

· Public nonprofit organizations

· Private nonprofit organizations

· 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 as eligible to submit an application under the state eligibility in lieu of a state 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.

2. Cost Sharing or Matching

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

Eligible applicants must meet the following criteria, or have an established partnership with an institute that meets the criteria:

1. Document that in 2009 you had a clinic census of at least 250 spina bifida patients.

2. Letter of support or e-mail response from SBA, or designee, acknowledging participation in the 2008 National Spina Bifida Clinic Survey, or a description of involvement with SBA during 2008-2010.

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/day, seven days/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.

For specific steps in the application process and additional guidance and resources, please review the following websites:

http://era.nih.gov/ElectronicReceipt/files/PI_Advice.pdf http://era.nih.gov/ElectronicReceipt/ http://era.nih.gov/ElectronicReceipt/faq.htm http://era.nih.gov/ElectronicReceipt/support.htm

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 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. 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: November 8, 2010 Application Submission Receipt Date(s): December 7, 2010 Peer Review Date (s): February 2011 Council Review Date (s): March 2011

Earliest Anticipated Start Date: June 1, 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 Commons

HYPERLINK "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.

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 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. A brief history of the spina bifida clinic, including location, organizational structure, and funding sources.

2. 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.

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

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

5. 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.

6. Demographic information on current patient enrollment and on the anticipated study participants (i.e., age, gender, and ethnicity).

7. A description of how participants will be enrolled in the study and how consent will be obtained. Grantees must enroll a minimum of 125 of the spina bifida patients seen in the clinic in 2009. 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.

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

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

10. 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.

11. 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), those costs must be included in the budget.

12. Describe how the clinic would approach using or incorporating registry findings into their clinic practice.

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.

Applicants’ research plan(s) should address activities they will conduct over the entire project period.

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 ten 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 Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.”

Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

HHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.) Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by the HHS/CDC Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590,http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by Extramural Research Program Office (ERPO) and in accordance with HHS peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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

· Receive a written critique; and

· Receive a second level of review by ERPO.

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

·…