Part I Overview Information

 

United States Department of Health and Human Services (HHS)

 

Issuing Organization

 

Centers for Disease Control and Prevention (NCIRD/CDC), at http://www.cdc.gov/vaccines/about/default.htm

 

Participating Organizations

 

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


 Components of Participating Organizations

 

National Center for Immunization and Respiratory Disease (NCIRD/CDC), at http://www.cdc.gov/vaccines/about/default.htm

 

Title Influenza Vaccine Efficacy in Tropical and Developing Countries (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  Sections 307 and  317(k)(1) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)(1)), 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 May 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 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-IP08-002

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: Not applicable
 Application Submission Receipt Date(s): February 4, 2008
Peer Review Date(s): March-April 2008
 Council Review Date(s): April -May 2008

Earliest Anticipated Start Date(s): July 1, 2008

Additional Information to Be Available Date: Not applicable

Expiration Date: February 5, 2008

 

Due Date for E.O. 12372

 

Due no later than 60 days after the application receipt date.

 

Additional Overview Content

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 National Center for Immunization and Respiratory Diseases (NCIRD) 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 FOA addresses “Healthy People 2010” priority area(s) of Immunization and Infectious Diseases and is in alignment with the performance goal(s) to Protect Americans from Infectious Diseases. For more information, www.healthypeople.gov. and

http://intra-apps.cdc.gov/fmo/

 

 

The NCIRD Influenza Division (ID) is seeking a cooperative agreement for studies to evaluate the efficacy or effectiveness of influenza vaccine among children and the indirect protective effects for unvaccinated persons in the same community in one or more tropical and developing countries.  Funding preference will be given to proposals for studies to be conducted in tropical, developing countries over non-tropical, developing countries.  Proposals to conduct studies in developed countries will not be considered for funding. 

 

A limited number of studies have suggested that influenza vaccination of select groups in a population provides protection to both vaccinated and unvaccinated persons, including those who respond poorly to vaccination, by decreasing transmission within a community to susceptible persons.  Studies that have been conducted to assess the indirect effects of influenza vaccination have generally focused on the indirect effects among household members when children are vaccinated or on the effects of nursing home residents when health-care workers are vaccinated.  Apart from an observational study that was conducted from a community perspective during the 1968 pandemic, few data are available to evaluate the effects of influenza vaccination on rates of illness in a community among non-vaccinated persons.  Furthermore, no information is available from tropical, developing countries, where influenza vaccine use remains limited.  In these countries, differences in social interactions, population density, household composition, and school attendance could alter the transmission characteristics of influenza compared to those in the United States and other developed countries in temperate climates.   

 

As the next influenza pandemic could arise in a tropical, developing country, such information is critical to effective planning and preparedness, but will also add to the general understanding of the dynamic interplay between influenza transmission, social structure, and population immunity.  Information obtained from such studies will also provide important data on strategies for the use of influenza vaccine during a pandemic, when the supply of vaccine will likely be limited.  Results from these studies will also provide important information on the epidemiology and disease burden of influenza in tropical regions, and on the potential benefits of seasonal vaccination programs in developing countries.

 

This research will assess the effectiveness of influenza vaccine against laboratory-confirmed influenza among children and the indirect effects of influenza vaccination among unvaccinated persons in the same community.  The study should compare rates of the relevant outcomes among children selected to receive influenza vaccine compared with those selected not to receive vaccine.  Persons not selected to receive an influenza vaccine should receive some benefit from participation, such as an alternate vaccine with similar dose schedule.  In addition, the proposed studies should determine the effects of vaccination in reducing laboratory-confirmed influenza among unvaccinated persons in the community, other household members, and persons who are living in households without children. Selection of vaccinees will be at the community level, not the individual level, so that all members of the target age group in each community should be offered either influenza vaccine or a control vaccine. The populations chosen for the studies should be sufficiently large and separate that the study can demonstrate indirect protection of influenza vaccination of children and sufficiently distinct such that mixing of populations between intervention and non-intervention areas is limited. The treatment and control communities should also be expected to have similar rates of ILI and of health outcomes associated with ILI based on demographic characteristics, geographic proximity and health utilization patterns.  The researchers should enumerate each area such that they can make population-based estimates of influenza disease outcomes. 

Influenza vaccination of all groups in the study populations should be consistent with the countries’ National Government vaccination policies and practices.

 

Studies should begin with the 2008-2009 influenza season, based on the timing of funding.  The study should take place during three consecutive influenza seasons, and vaccination should occur before each season.

 

All of the following objectives must be addressed in the research plan of the application: 

 

•          Determine the efficacy or the effectiveness of influenza vaccination in children six months of age through primary school (age about 10 years) on decreasing the incidence of laboratory-confirmed influenza in the children; and

Determine the indirect effects of influenza vaccination on laboratory-confirmed influenza among unvaccinated individuals who are living in the same community (i.e., whether incidence of influenza is decreased among these individuals) using an appropriate study design (e.g. an observer-blinded, randomized, placebo-controlled study). Applications should include a non-vaccine comparison group, and children who do not receive vaccine must receive a direct benefit from being in the study (such as an alternative vaccine).  Observers who collect clinical outcome data should be blinded as to whether the participant is in the placebo or intervention arm of the study.  

•          Proposals should demonstrate the ability to enroll and monitor sufficient numbers of persons in intervention and non-intervention communities in order to have adequate power to detect 25% indirect protection in unvaccinated members of the vaccinated community.

•          Define the rates and epidemiological characteristics of influenza disease outcomes in persons of all ages who are living in the study communities, including the incidence of severe disease, such as hospitalization;

•          Conduct laboratory testing for influenza using viral culture and/or reverse transcriptase polymerase chain reaction (RT-PCR) testing among persons in intervention and non-intervention communities who meet pre-determined criteria for testing based on symptoms.

•          Describe the clinical presentations of influenza disease, including co-morbid conditions and influenza-related complications, in the study population.

•          Describe the impact of vaccination on non-laboratory-confirmed syndromic outcomes, such as influenza-like illness, febrile respiratory illness, and pneumonia.

•          Detect in a timely and sensitive manner any adverse events related to vaccine implementation in the population.d Purpose Information Here

 

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

Section II. Award Information

 

1. Mechanism(s) of Support

 

This funding opportunity will use the U01 activity code.

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

2. Funds Available

The participating Centers, Institutes and Offices (CIO)(s) of  NCIRD intends to commit approximately $2,500,000 in direct and indirect costs in fiscal year (FY)2008 to fund 1 - 2 applications. The total project period is 3 years and funding may vary by year being more or less than the year one award.  Each applicant may request up to $1,250,000 in total costs including direct and indirect for the first 12 months.    The estimated total project funding for each grantee is approximately $4,000,000 for the 3 year project period.  Funding the cost of vaccine is the responsibility of the awardee (s). HHS/CDC will not entertain proposals over the funding limit with the expectation that applicants will propose to make-up any additional cost with in kind donations, such as donated vaccine.  Funding may vary by year and be more or less than the year 1 budget.  The anticipated start date for new awards is July 1, 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:

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 or matching 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


 Applications for studies must include letters of support from authorized representatives of partners whose cooperation and/or approval will be important. These include, but are not limited to, letters of endorsement from the Ministry of Health of the country concerned. However, applications must demonstrate collaboration with National public-health and medical institutions and the WHO National Influenza Laboratory.  The PD/PI must have prior experience in conducting large community, epidemiologic studies in tropical and/or developing countries and have published study findings in peer-reviewed scientific journals.  PI’s with experience in conducting studies on vaccine effectiveness and/or viral respiratory illness would be preferred.

 

Funding preference will be given to proposals with studies to be conducted in tropical developing countries over non-tropical developing countries. 

 

Proposals to conduct studies in developed countries will not be considered for funding. 

 

Applicants must agree to share influenza isolates derived from the study with HHS/CDC and the WHO.  

 

Applicants must indicate knowledge of influenza-related projects currently underway or planned for the country in which the studies are planned and show linkages with and avoid duplication of other, HHS-funded, influenza-related research projects in the same country.

 

Studies must be conducted in country with a WHO National Influenza Center Laboratory that has submitted influenza viruses to WHO Collaborating Centers during each of the past two years, and should demonstrate evidence of this in the proposal.  Applicants must include collaboration with National public-health and the relevant WHO National Influenza Center in their study plans and evidence of such collaboration must accompany the application package in the form of letters from National Government health official(s).

 

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

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 (activity code) 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: N/A
 Application Submission Receipt Date(s): February 4, 2008
Peer Review Date(s): March-April 2008
 Council Review Date(s): April-May 2008

Earliest Anticipated Start Date(s): July 1, 2008


 3.A.1. Letter of Intent

 

A letter of intent is not applicable to this funding opportunity announcement.

 

3.B. Submitting an Application to CDC

 

If the instructions in this announcement differ in any way from the SF424 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 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 SF424 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 – IP08-002

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 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 the Coordinating Center for Infectious Diseases (CCID) 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. 

4. Intergovernmental Review

Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

 

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.

 

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 and a Notice of Award is issued lifting the restriction.  Thus, it is in the best interest of applicants to have a fully developed study protocol, consent forms, and data collection instruments in hand so that a the protocol can be rapidly reviewed by the IRB of the awardee’s institution and HHS/CDC’s IRB in order to begin the study prior to the 2008-09 influenza season. 

·          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   


6. Other Submission Requirements

 

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 Five 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

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.