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 Disease (NIAID), (http://www.niaid.nih.gov)
National Institute of Mental Health (NIMH),
(http://www.nimh.nih.gov)
Office of Research on Women’s Health (ORWH), (http://orwh.od.nih.gov/)
Title: Microbicide Innovation Program (MIP VI)
(R21/R33)
Announcement Type
This is a reissue of RFA-AI-09-021.
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-AI-10-011
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 (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856, 93.242
Key Dates
Release/Posted
Date: April 20, 2010
Opening Date: May 10, 2010 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): June 9, 2010
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
Due Date(s): July 9, 2010
Peer
Review Date(s): November 2010
Council Review Date(s) January 2011
Earliest Anticipated Start
Date(s): March
2011
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: July
10, 2010
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. Receipt, 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. Resource Sharing Plan
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 purpose of the Microbicide Innovation
Program is to support novel, high-risk and under-explored strategies in the
field of topical microbicides to facilitate the advancement of the field as a
whole. A safe, effective, acceptable topical microbicide that prevents the
sexual transmission of HIV could play a major role in world-wide reduction of
the over 7,000 new HIV infections per day, potentially saving millions of
lives. Topical microbicides are agents which when applied vaginally, rectally,
and/or on the penis can result in inhibition of the transmission of HIV and/or
other sexually transmitted infections (STI) that may be co-factors in HIV
transmission and acquisition.
The discovery, development and testing of microbicide candidates, targets and supporting technologies are complex processes that require multi-disciplinary resources and expertise to support the discovery and development identification of potential candidates that are safe, effective and acceptable. The MIP program is designed to assist in this effort by supporting the advancement of novel scientific ideas, models, tools, agents, targets, and technologies with the potential to iteratively and substantially advance microbicide science in five general areas.
(1) Support basic and preclinical research leading to the identification of new agents, strategies and targets for microbicide discovery and development.
(2) Support discovery and preclinical characterization of microbicides (singly or in combination) directed against HIV and/or STIs that are thought to play a role positively or negatively in HIV transmission and acquisition. All microbicides and targets proposed for study or development must have demonstrable antiviral activity to HIV included in either preliminary data or as a milestone for demonstration in the R21 phase. Applications developing solely anti-STI microbicides or targets may not be considered for review.
(3) Support emerging or new technologies or models that could contribute to new and/or more efficient mechanisms for (i) understanding the interaction of microbicide candidates with vaginal, rectal and penile mucosa, (ii) assessing microbicide safety, efficacy and acceptability, (iii) discovery and characterization of new microbicide candidates, (iv) formulation and delivery of microbicide products, and (v) validation of surrogate markers for safety and/or efficacy.
(4) Proof-of-concept for combination biomedical prevention strategies incorporating vaginal, rectal and/or penile microbicides with other biomedical prevention modalities
(5) Development of behavioral and social tools that are integrated with drug-discovery-based iterative preclinical microbicide development that bring product acceptability, initiation, and potential for sustained use into the preclinical development path as part of the optimization and selection of lead candidates
Examples of the types of studies that are considered responsive to this FOA and could be supported under this program include, but are not limited to:
Applications proposing research in the following areas will NOT be considered responsive to this FOA and will not be reviewed:
Applicants are cautioned that product/candidate safety data from mucosal tissues other than the female reproductive tract and gastrointestinal tract do not necessarily equate to safety in these compartments. Likewise, human exposure and experience with products or formulary components as vaginal and/or rectal medicants, or for health purposes, does not necessarily equate to safety for use as a microbicide to prevent HIV transmission.
See Section
VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section
II. Award Information
1. Mechanism
of Support
This FOA will use the R21/R33 award mechanism. The Project
Director/Principal Investigator (PD/PI) will be solely
responsible for planning, directing, and executing the proposed project.
Transition of the R21 to the R33 phase will be expedited and is dependent on the completion of negotiated milestones. Milestones will be evaluated in the peer review process and negotiated with NIAID Program staff prior to award of the R21 phase. Once milestones are achieved, advancement to the R33 phase will be considered. The SOP for the R21/R33 mechanism can be found at: http://www.niaid.nih.gov/ncn/sop/r21r33.htm.
Although applicants are solely responsible for planning, directing, and executing the proposed project, the transition from the R21 feasibility phase, and eligibility for award of the R33 development phase, will be determined by NIAID Program staff and based on successful completion of negotiated scientific milestones, program priorities, and availability of funds.
The R21 phase provides up to two years of funding for innovative hypothesis-driven projects supported by limited or no preliminary data to allow investigators to demonstrate feasibility of the proposed microbicide-related innovation or technology. Applicant-proposed milestones, acceptable to both Program and the applicant will be used to measure progress. Although preliminary data are not required, applicants are urged to supply preliminary data when possible, and in lieu of preliminary supporting data are urged to provide sufficient information to allow assessment of the proposed hypothesis or concept. The R33 award provides a second phase for the support of the innovative exploratory research initiated under the R21 mechanism for a period of up to three years, for a total period of support of five years.
Under this FOA applicants may only submit for the combined R21/R33 (Phased Innovation Award).
Applications for R21 or R33 support alone ARE NOT accepted under this FOA and will not be reviewed.
Investigators seeking support solely through the R21 mechanism are encouraged to apply for the NIH-wide R21 Exploratory/Developmental Research Grant Program (see http://grants.nih.gov/grants/guide/pa-files/PA-09-164.html)http://grants2.nih.gov/grants/guide/pa-files/PA-06-181.html, or other announcements).
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2. Funds Available
The NIH intends to commit approximately $2.5M in FY 2011 to make 7 to 10 awards. Funding will be based on scientific and technical merit, program priorities, and availability of funds.
Funding for the total project period for an application submitted in response to this FOA cannot exceed five years. Support for the R21 feasibility phase cannot exceed two years and is limited to $275,000 direct costs over the two year award period with no more than $200,000 in direct costs allowed in any single year. Budgetary support for the R33 phase is limited to $300,000 per annum in direct costs and cannot exceed three years.
The NIH funding components anticipate that a maximum of fifty percent (50%) of the funded R21 applications will progress to the R33 phase. Funding of the R33 phase will be based on program priorities, the availability of funds, and successful completion of negotiated scientific milestones within the R21 phase, as determined by NIAID staff in the context of peer review recommendations.
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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The
following organizations/institutions are eligible to apply:
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.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do 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 electronic Research Administration (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 grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, 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 PDs/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
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA
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, use the Apply for Grant Electronically button
in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
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 NIH eRA Commons.
Several additional separate actions are required before an applicant 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 PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
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. Some fields within the SF424 (R&R) application components, 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
PHS398 Research & Related Budget (See Section
IV.6., Special Instructions, regarding
appropriate required budget component
Optional Components:
PHS398
Cover Letter File
Research
& Related Subaward Budget Attachment(s) Form
Foreign Organizations (Non-Domestic
[non-U.S.] Entities)
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 (U.S.) 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 on 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
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan , 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, and should include 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 (NoA).
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: May 10, 2010 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent
Receipt Date(s): June 9, 2010
Application Due Date(s): July 9, 2010
Peer Review Date(s): November 2010
Council Review Date(s) January 2011
Earliest Anticipated Start
Date(s): March 2011
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:
Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda,
MD 20892-7616 (Express mail zip:
20817-7616)
Telephone: (301) 496-8426
FAX: (301) 480-2408
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. 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.
3.C.
Application Processing
3.C.1
Submitting On-Time
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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
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.
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 award if such costs: 1) are necessary to conduct
the project, and 2) 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 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(s)/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
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:
Budget Component
U.S. and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
Appendix Materials
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. An application that does not comply with the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
Foreign Applications (Non-Domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing health science in the United States.
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
Review Process
Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The NIH Phased Innovation Award (R21/R33) mechanism supports novel scientific ideas, new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. An exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in a Research Project Grant (R01) application. Accordingly, reviewers will be asked to focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance knowledge or understanding. For applications that may include iterative drug development methodologies and previously described methods and technologies, it is possible nonetheless for innovation to be realized through the potential for overall advancement of the microbicide or the field.
Reviewers will be asked to place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Is the application innovative in addressing discovery and/or development of a microbicide candidate and/or microbicide-associated technology to prevent HIV transmission?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Milestones. Given the critical nature of the milestones for the potential R21 to R33 transition, are the proposed Milestones well-defined with quantifiable measures that are appropriate for assessing the success of the R21 phase of the application? Do the Milestones have specific quantifiable criteria that will enable clear decisions about their attainment? Is it clear how the R33 phase of the study will develop and expand once the R21 Milestones are achieved? Given the potential benefits of the proposed research, do the milestones support the potential for transition and will the overall project advance the compound, target, technology or strategy?
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed
Resubmission Applications. Not applicable to this FOA.
Renewal Applications. Not applicable to this FOA.
Revision Applications. Not applicable to this FOA.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations. As applicable for the FOA or submitted application, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
In addition, decisions for funding the R33 portion of award for years 3 to 5 will be based on:
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
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.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
Investigators responding to this FOA ARE STRONGLY ENCOURAGED TO DISCUSS the development of their application with Program staff PRIOR TO SUBMISSION for the purpose of clarifying responsive and nonresponsive criteria.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Jim A.
Turpin, Ph.D
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5118, MSC-7620
6700B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 451-2732
Fax:(301) 496-8530
Email: [email protected]
Fulvia
Veronese, Ph.D
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5122, MSC-7620
6700B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 451-2732
Fax:(301) 402-4148
Email: [email protected]
Andrew Forsyth, Ph.D.
Chief, Primary Prevention/HIV
National Institute of Mental Health
Rm NSC-6204, MSC-9619
6001 Executive Blvd
Bethesda, MD 20892-9619
Telephone: (301) 443.8403
Fax: (301) 443-9719
Email: [email protected]
2. Peer Review Contact(s):
Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda,
MD 20892-7616 (Express mail zip:
20817-7616)
Telephone: (301) 496-8426
FAX: (301) 480-2408
Email: [email protected]
3. Financial/Grants Management Contact(s):
Devon R. Bumbray-Quarles
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2253, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-6213
Fax: (301)
493-0597
E-mail: [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).
Data
and Safety Monitoring Plan:
Data and
safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (Phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants ( NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and
Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local institutional review board (IRB) rules, as
well as local, State and Federal laws and regulations, including the Privacy
Rule.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in
advancing genome-wide association studies (GWAS) to identify common genetic
factors that influence health and disease through a centralized GWAS data
repository. For the purposes of this policy, a genome-wide association study is
defined as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such as
blood pressure or weight), or the presence or absence of a disease or
condition. All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data repository
management (submission and access) is governed by the Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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.
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.
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-09-116.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.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National Library
of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.
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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. 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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