Part I Overview Information

United States Department of Health and Human Services (HHS)

Issuing Organization  

National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, (NCBDDD/CDC) at http://www.cdc.gov/ncbddd

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/CDC) at http://www.cdc.gov/ncbddd 

Title: Reducing Prenatal Exposure to Alcohol and other Co-Occurring Risk Behaviors in the Preconception Period (U84)

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 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-08-003

Catalog of Federal Domestic Assistance Number(s): 93.283 Centers for Disease Control and Prevention Investigations and Technical Assistance

Key Dates

Release/Posted Date: March 6, 2008
Letter of Intent Receipt Date:  April 7, 2008
 Application Submission Receipt Date(s): May 7, 2008
Peer Review Date(s):  June/July 2008
 Council Review Date(s): August 2008

Earliest Anticipated Start Date(s):  September 30, 2008

Additional Information to Be Available Date: N/A

Expiration Date: May 8, 2008

Due Date for E.O. 12372  

Executive Order 12372 does not apply to this program.

 

Additional Overview Content


 Executive Summary 

·          This funding opportunity announcement (FOA) solicits Cooperative Agreements (U84) proposals to reduce both alcohol and smoking among women (18-44) at high risk for an alcohol and tobacco-exposed pregnancy.

·          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:  Up to three

·          Budget Period, Project Period, and Award Amounts: The total project period will be four (4) years.  It is expected that the average yearly award will be $375,000, ranging from $350,000 to $400,000 per year including direct and indirect costs.

·          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


 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” priority area(s) of Substance Abuse:  Alcohol, Tobacco, and Other Drugs, and Maternal, Infant, and Child Health and is in alignment with NCBDDD performance goal(s) to prevent birth defects and developmental disabilities. For more information, www.healthypeople.gov. and

http://intra-apps.cdc.gov/fmo/ 

Prenatal alcohol exposure can lead to a spectrum of adverse consequences for the fetus defined as Fetal Alcohol Spectrum Disorders (FASD) with Fetal Alcohol Syndrome (FAS) representing the most commonly recognized condition.  Children with FAS have facial abnormalities, pronounced neuro-developmental disorders and growth deficits.  Prevalence estimates of FAS range from 0.3 to 2 per 1,000 live births.  Prevalence estimates of children affected by conditions along the full spectrum (FASD) are as high as 1 in 10.  Centers for Disease Control and Prevention (CDC) studies find that approximately 1 in 2 childbearing-aged women report past-month alcohol use, with 1 in 8 reporting binge drinking. Many of these women who are sexually active but not using contraception will become pregnant and are at risk for having an alcohol-exposed pregnancy (AEP).  CDC estimates that 1-2% of childbearing aged women overall are at risk for an AEP.  Identifying and intervening with these women before they become pregnant is an important strategy for reducing FASDs.  In 2007, CDC published the results of an efficacious preconception intervention targeting this group of high risk women consisting of motivational counseling sessions and a family planning consultation and services visit (Project CHOICES). See http://www.cdc.gov/ncbdd/fas/default.htm for more information on project CHOICES.  This study was supported by Public Law 105-392, Fetal Alcohol Syndrome and Fetal Alcohol Effect Services and Prevention, that charged CDC to “coordinate, support, and conduct prevention and intervention studies as well as epidemiologic research concerning Fetal Alcohol Syndrome and Fetal Alcohol Effects”.  Based on the demonstrated efficacy of this intervention, CDC seeks to conduct translation studies of the Project CHOICES intervention model in additional community-based healthcare settings serving women at high-risk for an AEP.  In addition to being at risk for AEP, more than 70% of women in the Project CHOICES efficacy study reported they were smokers.  Given the risks of smoking to both the woman and her fetus, this translation study will also investigate the value of a facilitated referral to an evidence-based smoking cessation program such as a CDC-funded telephone quit line or a nicotine treatment program for assistance in achieving cessation for women who are current smokers.  For more information on best practices for smoking cessation please see http://www.cdc.gov/tobacco. 

The primary objectives of this project are to: 

(1)   Increase the number of preconception women (18-44 years) who reduce their use of alcohol and tobacco using the Project CHOICES intervention model. 

(2)   Demonstrate the feasibility and impact of integrating the CHOICES intervention and data collection components of the study into the existing electronic medical records (EMR) of the healthcare system.

(3)   Estimate the cost of implementing the intervention.

(4)   Determine the feasibility and impact of combining a smoking cessation referral and intervention with the Project CHOICES intervention.  

Potential applicants will be required to identify a population of women in the preconception period who are at increased risk for an alcohol-exposed pregnancy and who receive ambulatory women’s healthcare within a designated publicly or privately managed healthcare system.  The applicant must develop a protocol for the intervention and provide supporting evidence of their capacity to: 

·         Estimate the required sample size for the study, including power calculations.

·         Randomly assign clinics within the health care system to intervention and control groups.

·         Provide a plan for integrating the study into the EMR system including screening, intervention, and follow-up of study participants.

·         Recruit and train qualified health professionals to provide the intervention which will include a referral for smoking cessation.

·         Recruit and follow study participants to assess the impact of the intervention on pregnancy outcomes; a follow-up rate equal to or greater than 70% is desirable.

·         Analyze study data to determine the efficacy of the intervention using appropriate statistical methods. 

·         Collect cost-analysis data as part of the study and perform appropriate analyses. 

Applicants may consider adaptations to the CHOICES intervention based on population characteristics, clinical settings, and methods for implementing the facilitated smoking cessation referral.  Such adaptations may include fewer than 4 counseling sessions and/or shorter sessions. Providers of the intervention must be designated by the applicant along with evidence that these individuals possess or will be adequately trained to possess the interviewing and counseling skills necessary for delivering the intervention.  

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

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 U84 activity code.

The HHS/CDC U84 is a cooperative agreement assistance instrument. Under the U84 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The participating Centers, Institutes and Offices (CIO)(s) NCBDDD intends to commit approximately $1,200,000 direct and indirect  dollars in FY2008 to fund up to 3 applications. The average award amount will be $375,000 for a 12-month budget period.   An applicant may request a project period of up to four years. An applicant may request up to $400,000 for the 12-month budget period.   The anticipated start date for new awards is September 30, 2008.

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 enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements. 

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

 

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

  • 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

Cost sharing is not required under this announcement.


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

 

3. Other-Special Eligibility Criteria

To be eligible, applicants must:
  • Document a source population of at least 300,000 childbearing aged women (18-44) to ensure adequate sample sizes for the intervention study.
  • Designate a geographical area or service population for the study in which 20% or more of childbearing aged women report binge drinking (4 or more drinks on one occasion); 30% report smoking; and 10% or more are estimated to be at risk for and alcohol-exposed pregnancy AEP (i.e. binge drinking, sexually active, and not actively taking steps to avoid pregnancy).

All estimates must be substantiated using vital records, surveys (i.e. Behavioral Risk Factor Surveillance System (BRFSS), National Survey on Drug Use and Health (NSDUH), and other available clinical and epidemiological data. 
  • Provide childbearing aged women in the designated geographic area ambulatory women’s health care services using a designated publicly or privately managed health care system.  
  • Have in place an Electronic Medical Records system (EMR) that is used throughout the designated managed health care system. 

A letter of commitment/support from the managed care organization indicating: (1) their ability to provide health care services to the target population, and (2) conformation that the health care organization providing these services has a fully functioning EMR system.  

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process. 

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.
  • 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

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

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 U84 (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: April 7, 2008

Application Submission Receipt Date(s):  May 7, 2008

Peer Review Date (s): June/July 2008

Council Review Date (s): August 2008

Earliest Anticipated Start Date: September 30, 2008

 

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 April 7, 2008. 

The letter of intent should be sent to: 

JoAnn M. Thierry, Ph.D.
CDC/NCBDDD
1600 Clifton Road, MS-E88

Executive Park, Building 12
Atlanta, GA 30333
Telephone: (404) 498-3022
Fax:  (404) 498-3060
Email: jthierry@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 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.   

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. 

Otherwise, HHS/CDC will not notify you upon receipt of your paper submission.  If you have a question about the receipt of your application, first contact your courier.  If you still have a question, contact the PGO-TIMS staff at: 770-488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for HHS/CDC to process and log submissions.
  

If submitting a paper application, it must be prepared using the 424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:

 

Technical Information Management Section – RFA-DD-08-003

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Phone:  770-488-2700 EST


 3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date 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 business days to view the application image.

·          If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.

·          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 the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken.  Please remember that some warnings may not be applicable or may need to be addressed after application submission.

·          If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

·          If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.

·          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 days.

Upon receipt, applications will be evaluated for completeness and responsiveness by NCBDDD and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.  

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons. 

The HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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 involving human subjects will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.


 6. Other Submission Requirements

A description of the study population and risk behaviors such as alcohol use, binge drinking, smoking, sexual activity, and ineffective use of contraception, including no contraception, must be provided.   

A thorough description of the managed health care system should be provided including but not limited to: the number of clinics serving childbearing aged women, types of services provided, and number of annual visits.  

Applicants must also provide a thorough description of their EMR system platform including capacity for data entry, alert triggers, recommendations, and follow-up actions.

 

Applicants will be required to participate in monthly conference calls and an initial training session sponsored by CDC to review the CHOICES protocol.  Meetings of the key investigators and appropriate staff will be convened annually. Applicants should include the cost for one annual trip to Atlanta in their budget.

 

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”. 

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.

Scientific merit of the proposed project as determined by peer review

·         Availability of funds

·         Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services

·         Geographical diversity is desirable and may be considered in making final selection decisions

 

2. Review and Selection Process


Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCBDDD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will: 

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

·          Receive a written critique; and

·          Receive a second level of review by HHS/CDC NCBDDD

·          Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions. 

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness.  In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals.  Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each applications. 

·          Significance

·          Approach

·          Innovation

·          Investigators

·          Environment 

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: