and Human Services (HHS)
EXPIRED
Department of Health and Human
Services
Participating Organizations
National
Institutes of Health (NIH) ( http://www.nih.gov)
Components of
Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov/)
Title: NIAID
International Research in Infectious Diseases (IRID) Program (R01)
Announcement Type
This is a reissue with modifications of RFA-AI-06-041,
which was previously released June 15, 2006.NEW
Update: The following update relating to this announcement has been issued:
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
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-07-376
Catalog of Federal Domestic Assistance Number(s)
93.855,
93.856
Key Dates
Release/Posted Date: June 8, 2007
Opening Date: August 26, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters of
Intent Receipt Date(s): August 26, 2007
NOTE: On time submission requires that applications be
successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization).
Application Submission/Receipt
Date(s): September 26,
2007 and September 26, 2008
Peer Review
Date(s): January/February 2008 and January/February, 2009
Council Review
Date(s): May 2008 and May 2009
Earliest
Anticipated Start Date(s): July 1, 2008 and July 1, 2009
Additional
Information To Be Available Date (Activation Date): Not
Applicable
Expiration
Date: September 27, 2008 (Expired March 31, 2008 per PAR-08-130)
Due Dates for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
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 of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A.
Eligible Institutions
B.
Eligible Individuals
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. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
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
3. Reporting
Section
VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review
Contact(s)
3. Financial/Grants
Management 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 Institute of Allergy and Infectious Diseases (NIAID) encourages the
submission of R01 applications from institutions in eligible foreign countries
to conduct studies and establish collaborative infectious diseases research
among investigators and institutions at international sites where NIAID has
significant investment in research and/or infrastructure (see below for list of
NIAID programs). These grants will serve to build independent research capacity
by providing direct funding to investigators who do not currently have NIAID
funded grant awards for research projects. The intent of these activities is to
advance the development of local scientific expertise, build local research
infrastructure and to increase collaborative research partnerships at NIAID
international sites.
Collaborative projects involving investigators and institutions from international sites and the U.S. are particularly encouraged; a US partner is not required. NIAID has a long-standing interest in and commitment to global health and international research. Topics of interest for this program are limited to research on infectious diseases, including emerging infections that are of the greatest public health significance within the applicant country (e.g. tuberculosis; malaria; HIV/AIDS; sexually transmitted diseases; diarrheal, respiratory, and enteric diseases; viral hemorrhagic fevers; viral encephalitides; parasitic diseases; and vector-borne diseases). Development of immunological, microbiological, biostatistical, epidemiological, and clinical research capacity is encouraged. Studies may be proposed on any aspect of infectious diseases (except clinical trials), including but not limited to: the epidemiology, pathogenesis, immunopathogenesis of infectious diseases; epidemiologic studies to define the incidence, clinical presentations, and outcomes of diseases; identification of resistance patterns; characterization of susceptible cohorts for a particular pathogen; pilot and feasibility studies in preparation for larger studies.
NIAID supports a number of international research programs on infectious diseases, including HIV/AIDS. These include the International Centers of Excellence in Research (ICERs), International Collaborations for Infectious Disease Research (ICIDRs), the Tropical Medicine Research Centers (TMRCs), the Tuberculosis Research Program, the HIV Vaccine Trials Network (HVTN), and the HIV Prevention Trials Network (HPTN).
This International Research in Infectious Diseases (IRID) Program (R01) is intended to extend these programs by expanding the breadth of research supported at international sites and by providing support to new researchers. Applications from institutions in eligible countries where NIAID has significant investments through extramural research grants, cooperative agreements or contracts or through programs of the NIAID Division of Intramural Research are particularly encouraged. However, current NIH or NIAID funding is not a requirement.
Clinical trials will not be supported. When non-interventional clinical studies are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).
See Section VIII, Other Information - Required Federal
Citations, for
policies related to this announcement.
Section
II. Award Information
1.
Mechanism of Support
This
Funding Opportunity Announcement (FOA) will use the NIH Research Project Grant (R01) award
mechanism.
The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). All foreign applicants must complete and submit non-modular budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
At this time, it is not known if competing renewal (formerly competing continuation ) applications will be accepted and/or if this FOA will be reissued.
2.
Funds Available
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 NIAID provide support for this program, awards pursuant
to this funding opportunity are contingent upon the availability of funds and
the submission of a sufficient number of meritorious applications.
The participating organization NIAID intends to commit approximately $800,000 dollars in fiscal year 2008 to fund 8 10 applications. A project period of up to four years and a budget for annual direct costs of up to $75,000 per year may be requested (i.e., a maximum of $300,000 over four years). At least 80% of the requested must be spent in the applicant country or through subcontracts/collaborations with another eligible country; no more than 20% of the requested budget may be spent in high-economy countries.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Indirect cost for foreign grantees are limited to 8%.
F&A costs requested by consortium
participants are not included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
Applications may be submitted by institutions or organizations that are located in foreign (non-U.S.) resource-constrained countries ((i.e. low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank definition: http://www.worldbank.org/data/countrydata/countrydata.html.) U.S. Institutions (located in the U.S. or in a foreign country) are not eligible to apply; foreign laboratories associated with organizations based in other high-economy countries are also not eligible to apply. Applications from organizations that are not eligible will be returned without review.
You may submit an application(s) if your foreign (non-US) institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Foreign investigators who currently serve as Principal Investigators on R01/P01 or U01/U19 grants funded by NIH are not eligible to apply. US investigators are not eligible to apply.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each application is scientifically distinct.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH 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 Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1.
Request Application Information
Applicants
must download the SF424 (R&R) application forms and the 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 GrantsInfo: Telephone 301-710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
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 for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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
Research & Related Budget (required
for foreign applications)
Optional Components:
PHS398
Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Required for Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.)
organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
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 existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: August 26, 2007 (Earliest date an
application may be submitted to Grants.gov)
Letters of
Intent Receipt Date(s): Letters of Intent Receipt Date(s): August 26, 2007
NOTE: On time submission
requires that applications be successfully submitted to Grants.gov no later
than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): September 26, 2007 and September
Peer Review
Date(s): January/February 2008 and January/February 2009
Council Review
Date(s): May 2008 and May 2009
Earliest
Anticipated Start Date(s): July 1, 2008 and July 1, 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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 IC staff to estimate the potential review
workload and plan the review.
The
letter of intent is to be sent by the date listed in Section
IV.3.A.
The
letter of intent should be sent to:
Polly R. Sager, Ph.D.
Division
of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious
Diseases
Room
6005, MSC-6603
6610
Rockledge Drive
Bethesda, MD 20892-6603
Telephone:
(301) 496-1884
FAX:
(301) 480-4528
Email: [email protected]
3.B. Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application
submission/receipt date(s). (See Section IV.3.A. for
all dates.) If
an application is not submitted by the receipt date(s) and time, the
application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy
Statement.
When clinical studies are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).
Pre-award costs are allowable. A grantee may, at its own
risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new or competing renewal (formerly competing continuation ) award
if such costs: are necessary to conduct the project, and would be allowable
under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs
to be incurred more than 90 days before the beginning date of the initial
budget period of a new or competing renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase the
amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred. NIH
expects the grantee to be fully aware that pre-award costs result in borrowing
against future support and that such borrowing must not impair the grantee's
ability to accomplish the project objectives in the approved time frame or in
any way adversely affect the conduct of the project. See the NIH Grants
Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. 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 NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Instructions for Modular Grant applications
Foreign organizations may not submit modular budgets. See NOT-OD-06-096.
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 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 monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
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 who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, 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 any conditions will be placed 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). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. 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 data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. 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.
NIAID recognizes that pre-publication DNA sequence information is a unique research resource for scientists and that rapid and unrestricted sharing of microbial genome sequence data is essential for advancing research on infectious agents responsible for human disease. Therefore, it is anticipated that genome sequence data generated with NIAID funds will be made freely and publicly available via deposition to Gen Bank, a publicly searchable, international database, as rapidly as possible.
Data release plans for NIAID-funded sequencing projects should be based on the guiding principle that pre-publication genome sequence data should be released to the scientific community as rapidly as possible into a searchable, public international database. This principle is based on the expectation that users of the data will act responsibly to promote the highest standards of respect for the quality and the priority of the scientific contribution of others and that normal standards of scientific etiquette and fair use will be respected within the broad scientific community using the pre-publication data.
A data release plan for each NIAID-funded sequencing project is required and final details will be negotiated between NIAID and the sequencing group. Final approval for the data release plan will be given by NIAID.
Sharing Research Resources
NIH policy expects that grant recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan 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
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). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Applications that are
complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by CSR in accordance with the review criteria stated
below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
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: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Is the scientific
question of importance to the country in which the research will be conducted?
Approach: Are the conceptual or clinical framework, design,
methods, and analyses adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics? For applications
designating multiple PDs/PIs, is the leadership approach, including the
designated roles and responsibilities, governance, and organizational structure,
consistent with and justified by the aims of the project and the expertise of
each of the PDs/PIs?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the
PD/PI(s) and other key personnel appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to the experience level of the
principal investigator and other researchers? Does the PD/PI(s) and
investigative team bring complementary and integrated expertise to the project
(if applicable)?
Environment: Do(es) the scientific environment(s) in which the
work will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support? Will the proposed research
contribute to the overall research environment?
2.A.
Additional Review Criteria
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Protection of Human Subjects from Research Risk: The
involvement of human subjects and protections from research risk relating to
their participation in the proposed research will be assessed. See the
Human Subjects Sections of the PHS398 Research Plan component of the SF424
(R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398
Research Plan component of the SF424 (R&R)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the Other Research Plan Sections of the PHS398 Research Plan
component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by the
reviewers. The priority score should not be affected by the evaluation of the
budget.
Applications from Foreign Organizations: Whether the project presents 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 existing U.S. resources will be assessed.
2.C.
Sharing Research Data
Data Sharing Plan: 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. The
presence of a data sharing plan will be part of the terms and conditions of the
award. The funding organization will be responsible for monitoring the data
sharing policy.
Applicants that are proposing genomic sequencing projects are expected to share the pre-publication sequencing data by deposition to GenBank as rapidly as possible.
A data release plan for each NIAID-funded sequencing
project is required and final details will be negotiated between NIAID and the
sequencing group. Program staff will be responsible for the administrative
review of the plan for data release. Final approval for the data release plan
will be given by NIAID.
2.D. Sharing
Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will
be responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the resources sharing plan and any related
data sharing plans will be considered by 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), See Section VI.3.,
Reporting.
Model Organism Sharing Plan: Reviewers are
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis, taking
into consideration the organism, the timeline, the applicant's decision to
distribute the resource or deposit it in a repository, and other relevant
considerations.
3. Anticipated Announcement and
Award Dates
Not
Applicable.
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.
2. Administrative and
National Policy Requirements
When clinical studies are a component of the
research proposed, NIAID policy requires that studies be monitored commensurate
with the degree of potential risk to study subjects and the complexity of the
study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html.
The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years
are involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
For non-AIDS research:
Polly
R. Sager,
Ph.D.
Division
of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room
6005, MSC-6603
6610
Rockledge Drive
Bethesda, MD 20892-6603
Telephone:
(301) 496-1884
FAX:
(301) 480-4528
Email: [email protected]
For AIDS research:
Opendra
Sharma, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious
Diseases
Room
4151, MSC-7626
6700
B Rockledge Drive
Bethesda, MD 20892-7626
Telephone:
(301) 496-9041
FAX:
(301) 402-3211
Email: [email protected]
2. Peer Review Contact(s):
Dan Gerendasy, Ph.D.
Center for Scientific Review
6701 Rockledge Drive, RM 3212 (MSC 7808)
Bethesda, MD 20892-7843 (use 20817 for overnight mail)
Telephone: (301) 594-6830
Fax: (301) 594-6363
Email: [email protected]
3. Financial/Grants Management Contact(s):
Quadira
Huff
Division of
Extramural Activities
National Institute of
Allergy and Infectious Diseases
Room 2231, MSC-7614
6700 B Rockledge
Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-2696
Fax: (301) 493-0597
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients
of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal
regulations (45 CFR 46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Access to Research Data through the Freedom of Information Act:
The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit
other researchers to benefit from the resources developed with public funding.
The inclusion of a model organism sharing plan is not subject to a cost threshold
in any year and is expected to be included in all applications where the
development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It
is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The
NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All
investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria
for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov/) at
PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part
with direct costs from NIH. The author's final manuscript is defined as the
final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH
is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For
more information about the Policy or the submission process, please visit the
NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable Health Information:
The
Department of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability
and Accountability Act (HIPAA) of 1996 that governs the protection of
individually identifiable health information, and is administered and enforced
by the HHS Office for Civil Rights (OCR).
Decisions
about applicability and implementation of the Privacy Rule reside with the
researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission
identification numbers must be used for publicly accessible on-line journal
articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the
full reference in either the Bibliography & References Cited section, the
Progress Report Publication List section, or the Biographical Sketch section of
the NIH grant application. A URL or PMC submission identification number
citation may be repeated in each of these sections as appropriate. There is no
limit to the number of URLs or PMC submission identification numbers that can
be cited.
Healthy People 2010:
The
Public Health Service (PHS) is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This FOA is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal
Domestic Assistance in the following citations: No. 93.855, Allergy, Immunology
and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research, and is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review. Awards are made under
the authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy Statement.
The
PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law
103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities
(or in some cases, any portion of a facility) in which regular or routine
education, library, day care, health care, or early childhood development
services are provided to children. This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH
encourages applications for educational loan repayment from qualified health
professionals who have made a commitment to pursue a research career involving
clinical, pediatric, contraception, infertility, and health disparities related
areas. The LRP is an important component of NIH's efforts to recruit and retain
the next generation of researchers by providing the means for developing a
research career unfettered by the burden of student loan debt. Note that an NIH
grant is not required for eligibility and concurrent career award and LRP
applications are encouraged. The periods of career award and LRP award may
overlap providing the LRP recipient with the required commitment of time and
effort, as LRP awardees must commit at least 50% of their time (at least 20
hours per week based on a 40 hour week) for two years to the research. For
further information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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