dd10-001 amend i 02.22.10.doc

Amendment I: Information has been added to change: the Application Submission Receipt Date and the Expiration date in the Section Key Dates; and the Application Submission Receipt Date in the Section IV. 3.A 2/17/2010.

Part I Overview Information NOTE: New versions of PHS 398 and SF424 (R&R) forms and Application Guides have been developed and are available at Grants.gov. The new forms and instructions must be used to apply for grants and cooperative agreements with receipt dates on or after January 25, 2010. Applicants should download the new application forms and instructions for this FOA through Grants.gov/Apply. Applicants should also carefully review and follow the application instructions as described specifically in this FOA, particularly with regard to page limits for the Research Plan.

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

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

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

Components of Participating Organizations National Center on Birth Defects and Developmental Disabilities (NCBDDD) at http://www.cdc.gov/ncbddd Title: Public Health Research on Craniofacial Malformations (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. 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 received 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-10-001 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: February 2, 2010 Application Submission Receipt Date(s): March 9, 2010 Peer Review Date(s): May, 2010 Council Review Date(s): June, 2010

Earliest Anticipated Start Date(s): September 30, 2010

Additional Information to Be Available Date: NA

Expiration Date: March 10, 2010 Due Date for E.O. 12372 Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

· The purpose of this funding opportunity announcement is two fold: 1) to identify risk factors for the occurrence of orofacial clefts and of craniosynostosis that could lead to future prevention strategies, and 2) to better understand adverse consequences that occur in children with orofacial clefts or with craniosynostosis, including risk factors for these adverse consequences, with the goal of identifying intervention strategies to improve the health of children with these conditions. The applicants should address one of the three identified public health research priority areas in each application submitted (see below). The research should focus on children with orofacial clefts or with craniosynostosis who have no known genetic cause (e.g. single-gene disorder or chromosomal abnormality) identified using population-based methods (e.g. using data from a birth defects surveillance system). The goal of this opportunity is to fund a new initiative, not duplicate existing efforts.

· Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

· Anticipated number of awards to be issued: 2

· Length of project period: 4 years

· A maximum of $1,800,000 is available to fund each award at an average funding level of $450,000 (includes direct and indirect cost) per year for 4 years.

· The application PHS398 Research Plan component of the SR424R&R (Items 2-5) may not exceed 25 pages.

· Eligible Organizations: Foreign institutions; 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

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The 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” focus area of Maternal, Infant, and Child Health. The measurable outcomes of this funding opportunity is in alignment with the National Center on Birth Defects and Developmental Disabilities (NCBDDD) performance goals to prevent or reduce the adverse consequences of craniofacial malformations and the Healthy People objectives addressing the health of children including those with disabilities. For more information, refer to http://www.health.gov/healthypeople and http://www.whitehouse.gov.omb/mgmt-gpra/ . In addition, this RFA addresses a number of high impact public health areas, including the following CDC Health Protection Goals: 1)Start Strong-increase the numbers of infants and toddlers that have a strong start for health and safe lives; and 2) Grow Safe and Strong-increase the number of children who grow healthy, safe, and ready to learn.

Nature of Research Opportunity

The purpose of this funding opportunity announcement is two fold: 1) to identify risk factors for the occurrence of orofacial clefts and of craniosynostosis that could lead to future prevention strategies, and 2) to better understand adverse consequences that occur in children with orofacial clefts or with craniosynostosis, including risk factors for these adverse consequences, with the goal of identifying intervention strategies to improve the health of children with these conditions. The applicants should address one of the three identified public health research priority areas for each application submitted (see below). The research should focus on children with orofacial clefts or with craniosynostosis who have no known genetic cause (e.g. single-gene disorder or chromosomal abnormality) identified using population-based methods (e.g. using data from a birth defects surveillance system). The goal of this opportunity is to fund a new initiative, not duplicate existing efforts.

Background

Craniofacial malformations (such as cleft palate, cleft lip with or without cleft palate, and craniosynostosis) have a significant public health impact. In the United States, nearly 7,000 infants are born each year with either cleft palate or cleft lip with or without cleft palate (termed orofacial clefts).[Canfield et al., 2006] Over 1,500 infants are born each year in the United States with craniosynostosis, a premature fusion of the cranial sutures.[Boulet et al., 2008] The causes of most craniofacial malformations are unknown, and limited information is available on optimal strategies for treatment of affected children and the impact on them and their families. Prior to FY04, CDC’s National Center on Birth Defects and Developmental Disabilities did not have a formal research agenda for craniofacial malformations, and did limited work on these defects. However, with the inclusion of appropriated craniofacial malformation funds beginning with FY2004, CDC has substantially increased its craniofacial malformation portfolio. Current efforts have addressed many issues including quality of life, access to services, cost, and epidemiologic research to identify risk factors.

CDC sponsored meetings of experts to review current knowledge, identify gaps, and develop priorities for future public health research related to orofacial clefts and to craniosynostosis in January and June of 2006, respectively.[Yazdy et al., 2007; Rasmussen et al., 2008] The gaps identified at those meetings were used to identify public health priorities for future research. Based on the outcome of the two CDC-funded workshops to prioritize public health research agendas for orofacial clefts and for craniosynostosis, [Yazdy et al., 2007; Rasmussen et al., 2008] CDC has identified some areas for public health research to address current critical gaps in knowledge. This FY10 funding opportunity will be directed to the public health priorities as identified in these areas.

Scientific Knowledge to be achieved through this Funding Opportunity

· To gain a better understanding of the adverse consequences that occur in children with craniofacial malformations by elucidating variables impacting outcomes that might be amenable to intervention strategies to improve the health and quality of life of children with these conditions.

· To discover new etiologic variables or better understand established risk factors for orofacial clefts and craniosynostosis, especially those that might lead to primary prevention strategies.

· To improve characterization of these craniofacial malformations to define more etiologically homogeneous groups in order to better define risk factors and outcomes.

· To better understand long-term outcomes of individuals with orofacial clefts and craniosynostosis.

· To address other gaps in knowledge identified in the two CDC-funded workshops and enumerated by Yazdy et. al. (2007) and Rasmussen et al. (2008).

Research Objectives and Experimental Approach

To accomplish the purpose of this FOA, the applicant must address one of the three following priority research areas. An applicant may apply for more than one priority area. However, the applicant must submit a separate application for each priority area applied for.

Priority Area 1:

Maternal disease or its treatment is an important risk factor for several birth defects, including craniofacial malformations. Maternal pre-gestational diabetes has been associated with an increased risk for orofacial clefts and for most other birth defects.[Correa et al., 2008]. Maternal thyroid disease or thyroid medications during pregnancy have been associated with an increased risk for craniosynostosis.[Rasmussen et al., 2007]. Maternal obesity has been associated with an increased risk of orofacial clefts in some studies, but not all.[Stothard et al., 2009].

The objective of this study is to collect and analyze data to understand the underlying mechanisms and the potential opportunities for intervention for orofacial clefts and craniosynostosis. Using population-based ascertainment data, the study should focus on:

1. Gaining a better understanding of maternal disease, its treatment and risk for craniofacial malformation;

2. Identifying maternal diseases that increase the risk for craniofacial malformations;

3. Characterizing etiologically homogenous groups of children with specific malformations in order to better define maternal risk factors;

4. Identifying specific risk factors that might be used to develop intervention strategies; and

5. Gaining a better understanding of variables impacting the risk of craniofacial malformations associated with maternal disease (i.e., level of glucose control among women with diabetes, type of treatment used, use of multivitamin supplements, nutritional factors, and type of thyroid disease).

Priority Area 2:

Diagnosis of craniosynostosis can sometimes be challenging. The diagnosis is often not apparent at birth and in some cases, diagnosis may be significantly delayed, which may result in delay in a child receiving appropriate treatment. Children with craniosynostosis who do not receive timely treatment may be at risk for adverse cognitive and visual outcomes, among others. In addition, surgical treatment approaches can vary by suture(s) involved, age at diagnosis, and surgical judgment. However, the reasons for the delay in diagnosis and appropriate treatment are unknown.

The objectives of this priority are to

1. Identify and better understand the variables that are associated with delay in diagnosis of craniosynostosis;

2. Determine the impact of demographics (e.g., maternal age, race-ethnicity, education, family socioeconomic status), and other variables (i.e., barriers to access, utilization of health care services), on delay in diagnosis and appropriate treatment of craniosynostosis.

3. Conduct outcome studies to determine optimal timing for treatment of craniosynostosis.

Priority Area 3:

The outcomes among children diagnosed with non-syndromic orofacial clefts and craniosynostosis and variables that impact these outcomes are not well understood.

The objectives of this study are to

1. Identify variables resulting in improved short-and long-term outcomes of children with orofacial clefts or craniosynostosis.

2. Study etiologically homogeneous groups of children in order to better define outcomes for specific malformations;

3. Enhance the understanding of what variables [e.g. socio-demographics, time of diagnosis, type of surgical intervention, care model (e.g., multidisciplinary team setting)] result in improved outcomes;

4. Conduct short-term (e.g. length of post operative stay, degree of blood loss, need for repeat surgery) and long-term (e.g., cognitive and neuropsychological outcomes, psychological adjustment, educational achievement, morbidity, mortality) outcome studies. A retrospective cohort of infants with these conditions should be selected such that a required minimum of 10 years of follow-up can be conducted. Standard measures of outcomes should be used when possible.

The following apply to all three priority areas:

· CDC’s intent is to fund a new initiative, not one that duplicates existing efforts. The applicant should describe their previous research experience in the selected priority area and specifically state how this proposed effort, if funded, will differ from previous work performed in this area.

· The research plan should focus on ensuring that the population studied is representative of the racial, ethnic, and socioeconomic diversity of the US population. The project must be based on population-based data (from a defined geographic area and time frame). When possible, the research should utilize data from/work with/build on existing population-based birth defects surveillance programs.

· The research should focus on persons with defects with no known genetic cause (e.g., defects caused by single-gene disorders or chromosomal abnormalities should be excluded, with a proposed or established mechanism in place to exclude these persons). The research plan should build on existing population-based ascertainment of all children with the craniofacial malformations under study (i.e., cleft palate, cleft lip with or without cleft palate, and craniosynostosis), when possible with verification of the specific diagnoses from medical record review/cytogenetic studies and not based solely on codes.

· Research cannot rely on clinic- or hospital-based selection of cases.

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. Awards are Contingent on Availability of Funding NCBDDD intends to commit approximately $900,000 (direct and indirect cost) in FY 2010 to fund 2 awards. The average award amount will be $450,000 (direct and indirect cost) for a 12-month budget period. An applicant may request a project period of up to 4 years. An applicant may request up to $450,000 for a 12-month budget period. The anticipated start date for new awards is September 30, 2010.

If an applicant requests a funding amount greater than the ceiling of the award [for any 12 month budget period ($450,000) or total project period ($1,800,000)], HHS/CDC will consider the application non-responsive, and it will not enter into the review process. 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)

· Foreign Institutions

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

Cost sharing is not required. 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. The applicant must have access to a population-based system for ascertainment of persons with craniosynostosis or orofacial clefts. The applicant must provide evidence (letter (s) of support) of existing access or commitment of ability to gain access to the population-based system.

2. The application should address one of the three priority research areas identified in the funding opportunity. An applicant may apply for more than one priority area. However, the applicant must submit a separate application for each priority area applied for. Applications addressing more than one priority area will be considered non-responsive and will not be reviewed.

3. The applicant must have experience with population-based data analyses, as demonstrated by previous funding support or publications.

Instructions:

· The evidence of eligibility should be clearly labeled and placed in the Appendix A.

· Identify the priority area the application is addressing.

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 IMPORTANT: 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.

· Applicants outside the US are required to include a NATO Commercial and Government Entity (NCAGE) number on their CCR registration. See section IV.2. Content and Form of Application Submission, for instructions.

· Direct questions regarding Grants.gov registration to:

Grants.gov Customer Support Contact Center Phone: 800-518-4726 Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time 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.

For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email: PGOTIM@cdc.gov

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

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 Research & Related Budget PHS398 Cover Page Supplement PHS398 Research Plan PHS398 Checklist Optional Components:

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 uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

· Charge back of customs and import fees is not allowed.

· Format: every effort should be made to comply with the format specifications which are based upon a standard US paper size of 8.5" x 11".

· Organizations must comply with Federal/CDC policies on human subjects, animals, and biohazards.

· Organizations must comply with Federal/CDC biosafety and biosecurity regulations. See Section VI. 2. Administrative Requirements http://oerdbdev.od.nih.gov/AGS/Admin/BoilerPlate/ShowDraftRFA.cfm, "Cooperative Agreement Terms and Conditions of Award".

· Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment exiting U.S. resources.

NATO Commercial and Governmental Entity (NCAGE) Code are required for foreign organizations only. See below for instructions:

· Registrants located outside of the U.S. are required to include an NATO Commercial and Governmental Entity (NCAGE) Code on their CCR registration, or their registration will be considered incomplete. All countries outside of the U.S. need this number, not just NATO countries.

· The Code is a five-character ID number used extensively within the federal government. It is used to support a variety of mechanized systems throughout the government and provides for a standardized method of identifying a given facility at a specific location (from CCR Handbook)

· The form and instructions can be found at http://www.dlis.dla.mil/Forms/Form_AC135.asp

· Additional instructions for completing the form can be found at http://www.dlis.dla.mil/Forms/form_ac135instr.asp

· In Block 2 of the form, select the country where your organization is located from a drop-down list. This list currently includes 30 countries; if your country does not appear on the list, choose ‘other.’

· Submit the form via the Internet by clicking the ‘Send Request/Envoyez Demande’ button at the bottom of the form.

· Once you click on the “Send Request” button, the form is automatically sent for processing to the country you selected in block 2. If you selected ‘Other’ for country, these requests will be processed by the NATO Maintenance and Supply Agency (NAMSA) in Luxembourg.

· If you cannot submit this form by Internet, you can obtain an NCAGE by contacting the National Codification Bureau of the country where your organization is located. For a list of addresses, go to http://www.dlis.dla.mil/nato_poc.asp.

For help from within the U.S., call 1-888-227-2423 for help from outside the U.S., call 1-269-961-7766 Email NCAGE@dlis.dla.mil for any problems in getting an NCAGE code

· Prior to registering in CCR, insure that your newly assigned NCAGE is listed on the Business Identification Number Cross- Reference System (BINCS) at www.bpn.gov/bincs. If the assigned NCAGE is not listed in BINCS call 269-961-4623 or send a message to NCAGE@dlis.dla.mil.

· Note to U.S. submitters: Organizations with an address containing APO, FPO, or AE do not need an NCAGE assigned by an Allied Nation and should not fill out this form. Instead, register in the Central Contractor Registration (CCR) system at www.ccr.gov and you will receive a U.S. CAGE Code.

· CAGE codes for U.S. territories like Guam, Puerto Rico, and the Virgin Islands will be assigned by the U.S by registering in CCR.

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 2, 2010

Application Submission Receipt Date(s): March 9, 2010 Peer Review Date (s): May, 2010 Council Review Date (s): June, 2010 Earliest Anticipated Start Date: September 30, 2010

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

· Priority area

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

Extramural Research Program Office

Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

4770Buford High way 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. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), 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.

All requested information must be received in the HHS/CDC Procurement and Grants Office by 11:59 p.m. Eastern Standard Time on the deadline date.

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, 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, and HHS/CDC will discard it. 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 11:59 p.m. eastern time of the closing 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.

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 Commonshttps://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.

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 and applicable grants regulations.

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.

· Specific language for international announcements is posted on the PGO intranet site: http://pgo.cdc.gov/pgo/ViewHome.do

· Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and are funded by a grant/cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB). Reduction Act.

6. Other Submission Requirements

The research plan should:

· Provide clear and measurable objectives;

· Describe the applicant’s experience with population-based systems for ascertainment of persons with craniosynostosis or orofacial clefts;

· Describe the characteristics of the study population including information on race, ethnicity and size;

· Detail the proposed study design, methods, and analytic plan;

· Describe sample size and power calculations demonstrating adequate statistical power for the proposed project;

· Provide a timeline for proposed project activities;

· Provide a detailed staffing plan;

· Document any proposed collaborative arrangements, e.g., provisions for data access, other relationships with outside institutions, or availability of clinicians for classification of records to define etiologically homogeneous groups of children;

· Describe how the proposed research is different from the previous research conducted in this area; and how the study will advance knowledge in the field;

· Demonstrate the research team’s experience in conducting similar research projects as evidenced by peer-reviewed publications;

· Provide specific details, such as citations, regarding the applicant’s or other research team members’ previous experiences with the proposed study design (s), or justification for any proposed innovative approaches;

· Describe plans for the protection of human subjects, and a timeline for obtaining institutional review board approval for the proposed research; and

· If applicable, describe the comparison population. The comparison population must be selected from the source population as the case-children and should be a representative sample of the source population, not a convenience sample.

Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information”.

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.

Required.

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.

Required.

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 ten.”

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

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

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.

Section V. Application Review Information

1. Criteria

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

2. Review and…