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/vaccine/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 Diseases (NCIRD/CDC), at http://www.cdc.gov/vaccine/default.htm
Title: Annual Estimates of Influenza Vaccine Effectiveness for Preventing Laboratory-confirmed Medically Attended Outcomes in the United States (U18)
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:
42 U.S.C. 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 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 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-IP08-001
Catalog
of Federal Domestic Assistance Number(s):
93.185 Microbiology and
Infectious Disease Research
Key
Dates
Release/Posted
Date:
December 7, 2007
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 RFA addresses “Healthy People 2010” priority area(s) of Immunization and Infectious Diseases and is in alignment with NCIRD’s performance goal(s) to protect Americans from infectious disease. For more information, www.healthypeople.gov. and http://intra-apps.cdc.gov/fmo/
Estimates of the effectiveness of influenza vaccines are needed to assess the protection against influenza infection and its associated complications provided by annual, nationwide vaccination programs. Vaccine effectiveness can vary by the age and underlying health status of vaccine recipients and by influenza season, because the match between circulating and vaccine influenza strain changes over time. Due to the changing nature of influenza viruses and vaccine composition, annual estimates of the effectiveness of the influenza vaccine are needed to assess the effects of the U.S. influenza vaccination program and to help guide influenza vaccination policy. In addition, results of annual vaccine effectiveness studies may provide valuable data for future influenza vaccine strain selection decisions and provide a methodological basis for conducting vaccine effectiveness evaluations during an influenza pandemic.
The purpose of this FOA is to enable several research institutions to conduct annual assessments of the effectiveness of licensed influenza vaccines against laboratory-confirmed medically attended influenza infections diagnosed by viral culture and RT-PCR. Results of these assessments must be available for public health use by the September following the conclusion of the influenza season. The populations to be studied should include those for whom CDC’s Advisory Committee on Immunization Practices (ACIP) recommends receipt of trivalent inactivated influenza vaccine or live attenuated influenza vaccine. Influenza-related complications are greatest among those aged 65 years and older. Each applicant must demonstrate the ability to enroll sufficient numbers of laboratory-confirmed cases of influenza among persons aged 65 years and older to estimate vaccine effectiveness, based on conservative estimates of annual attack rates, vaccine coverage, and medical care utilization.
Observational studies of the effectiveness of licensed vaccines (as compared with randomized clinical trials) can suffer from several types of bias, including selection bias and confounding bias. Confounding by propensity to seek health care (e.g., subjects who receive recommended annual vaccinations may be more likely to seek care for acute illnesses) is a concern in observational studies of vaccine effectiveness against medically attended outcomes. The funded sites and CDC will develop methods to address this source of bias. Severe outcomes of influenza infection are relatively rare, and many past single-site studies of influenza vaccine effectiveness have been underpowered to assess vaccine effectiveness against more severe outcomes, including influenza-related hospitalizations. Thus, CDC’s Influenza Division will work with each of the funded sites to develop common methods for measuring vaccine effectiveness against laboratory-confirmed influenza hospitalizations; it is expected that an anonymized dataset containing selected variables from the data collected at each of the funded sites will be made available for this aspect of the funded work. Because the predominant circulating influenza strains during a particular influenza season may vary by geographic location, preference will be given to funding study sites in different U.S. Census regions (Northeast, South, Midwest, and West). It is anticipated that influenza vaccines will be administered according to usual clinical practice; no funding will be made available to applicants for purchase of influenza vaccines.
RFA Objectives
Applicants must address all four of the required objectives described below in the research plan section of their application:
1. Assess the effectiveness of influenza vaccines against laboratory-confirmed influenza infections among children and adults who present for inpatient care in hospitals and in either outpatient or emergency department settings, or both. Make available to CDC sufficient data so that vaccine effectiveness against hospitalizations across all funded sites can be estimated by using methods developed by the funded sites and CDC.
a. Applicants must propose a case-control approach that uses as controls those who seek care for respiratory illness, but test negative for influenza virus infection.
b. Applicants may also propose a variety of observational study methods to assess vaccine effectiveness (e.g., cohort, case-cohort, or case-control methods), and must describe plans to minimize confounding and selection biases in each proposed analysis
2. Diagnose influenza cases by using both viral culture and RT-PCR methods (with probes, primers and reagents approved by CDC). The application must describe in detail the viral culture, RT-PCR, and other laboratory methods to be used and provide evidence of competency in the use of these methods, and a system to demonstrate the quality of the laboratory methods and results. Proposals will not be funded unless applicant’s state in their applications that influenza isolates obtained in this work will be submitted to CDC for antigenic characterization and for other WHO Influenza Collaborating Center surveillance purposes.
3. Describe methods to provide an interim estimate of vaccine effectiveness during the influenza season, to provide more detailed results by the September following the conclusion of the influenza season, and to summarize final results for publication.
4. Describe how vaccination data will be obtained and validated:
a. Describe the use of a real-time, electronic vaccine registry that captures vaccination data for enrolled persons to determine fact and date of receipt of influenza vaccinations.
b. If a real-time electronic vaccine registry is not available for tracking receipt of influenza vaccines, describe how the applicant will rapidly assess and verify influenza vaccine status during an influenza season among enrolled persons, and conduct a validation study of the method(s) used.
Optional Objective 5. Applicants may choose to address this optional objective in the research plan; only 1 or 2 applicants will be funded to perform this work.
Collect, process, store, and ship to a reference laboratory designated by CDC paired serum specimens so that the serologic responses to influenza vaccines can be studied among older adults. Describe a process to enroll patients for collection of serum specimens on or before the date of vaccination, and several weeks after receipt of vaccine. Paired sera will be tested by hemagglutination-inhibition assay methods by a single reference laboratory by using standard, validated procedures. For a subset of persons enrolled to provide pre- and post-vaccination blood specimens, additional blood will be collected for the isolation of peripheral blood mononuclear cells (PBMC). PBMC’s will be separated, processed and stored, and shipped once a year to a designated reference lab for testing. The numbers of paired serum and PBMC specimens to be collected each season would be approximately 300-450 and 100-150, respectively, among all awardees combined.
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 U18 activity code.
The HHS/CDC U18 is a cooperative agreement assistance instrument. Under the U18 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
NCIRD intends to commit approximately $3,000,000 in direct and indirect costs in FY2008 to fund 3 to 5 applications. The average award amount will range from $500,000 to $750,000, including both direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to 3 years. An applicant may request up to $1,000,000 for the first 12-month budget period, if the applicant addresses optional objective 5, which requires the collection, processing, storage and shipping of paired sera and PBMCs. Only 1 or 2 applications will be funded for work related to optional objective 5. All other applications will be limited to maximum request of $750,000 for each 12-month period. The approximate total project period funded amount is $11,000,000. The anticipated start date for new awards is July 1, 2008. Applicants should budget for travel to annual investigator meetings.
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, matching, or cost participation is not required.
3. Other-Special Eligibility Criteria
Each applicant may submit only one application.
Only studies proposed for conduct in the United States are eligible for consideration
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.
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.htmIMPORTANT: 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
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.
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.
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
U18
(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:
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:
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.
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
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 human subject’s research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place. · Reimbursement of pre-award costs is not allowed. · Awardees may not enroll human subjects until they receive a revised Notice of Award from the Procurement and Grants Office lifting the human subject’s restriction.
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”.
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.
Applicants’ research plan(s) should address activities they will conduct over the entire project period.
The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.
Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.
The following materials may be included in the Appendix:
Up to 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.
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.
Section V. Application Review Information
1.
Criteria
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·
Funding preferences 1. Applications that do not address all four required objectives listed in Part II, Section 1 Research Objectives will not be funded even if they rank higher than other applications that address all required objectives. 2. Because the circulation of influenza viruses may differ across the United States, funding decisions will attempt to achieve geographic diversity among the research sites selected. Applications will be stratified by the U.S. Census regions and an attempt will be made to fund the highest ranking award in each of the four U.S. Census regions (Northeast, South, Midwest, and West) prior to funding additional awards in the same Census region 3. The three highest