Part 1. Overview Information
Participating Organization(s)
|
National Institutes of Health (NIH)
|
Components
of Participating Organizations
|
National Institute of Allergy and Infectious Diseases (NIAID)
|
Funding Opportunity Title
|
HIV Vaccine Research and Design (HIVRAD) Program (P01)
|
Activity Code
|
P01 Research Program Projects
|
Announcement Type
|
|
Related Notices
|
None
|
Funding Opportunity Announcement (FOA) Number
|
PAR-14-206
|
Companion Funding Opportunity
|
None
|
|
|
|
Catalog of Federal Domestic Assistance (CFDA) Number(s)
|
93.855, 93.856
|
Funding Opportunity Purpose
|
The purpose of this Funding Opportunity Announcement (FOA)
is to support multi-component, multi-disciplinary projects that address
important scientific questions relevant to AIDS prophylactic vaccine
discovery research. Extensive modeling of vaccine concepts in non-human
primates may be included.
|
Key Dates
Posted Date
|
May 5, 2014
|
Open Date (Earliest Submission Date)
|
June 29, 2014
|
Letter of Intent Due Date(s)
|
June 29, 2014
|
Application Due Date(s)
|
July 29, 2014, by 5:00 PM local time of applicant
organization.
Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.
|
AIDS Application Due Date(s)
|
July 29, 2014
|
Scientific Merit Review
|
November 2014
|
Advisory Council Review
|
January 2015
|
Earliest Start Date
|
March 2015
|
Expiration Date
|
July 30, 2014
|
Due Dates for E.O. 12372
|
Not Applicable
|
** ELECTRONIC APPLICATION SUBMISSION REQUIRED**
NIH’s new Application Submission System & Interface for
Submission Tracking (ASSIST) is available for the electronic preparation and
submission of multi-project applications through Grants.gov to NIH.
Applications to this FOA must be submitted electronically; paper applications
will not be accepted. ASSIST replaces the Grants.gov downloadable forms
currently used with most NIH opportunities and provides many features to enable
electronic multi-project application submission and improve data quality,
including: pre-population of organization and PD/PI data, pre-submission
validation of many agency business rules and the generation of data summaries
in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts) and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities.
Conformance to all
requirements (both in the Application Guide and the FOA) is required and
strictly enforced.
Applicants must read and follow all application instructions
in the Application Guide as well as any program-specific instructions noted in Section IV.
When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions.
Applications that do not comply with
these instructions may be delayed or not accepted for review.
Table of Contents
Part 2.
Full Text of Announcement
Section I. Funding Opportunity Description
Background
Rates of infection with human immunodeficiency virus (HIV),
the virus that causes Acquired Immunodeficiency Disease Syndrome (AIDS), have
not abated and another 2.8 million new infections are estimated to have
occurred worldwide in 2009.
The continuing human and economic toll of HIV/AIDS
requires a redoubled effort to develop a preventive HIV vaccine. Encouragingly,
several recent results have bolstered enthusiasm for achieving this goal.
The
RV144 trial in a low-risk heterosexual population in Thailand was reported to
show that the vaccine actually prevented infection in 31% of vaccinees during
the scheduled three-year follow-up period, and that the vaccine effect appeared
even stronger in the first year after completion of the immunization regimen.
Non-human primate (NHP) studies with repeat-exposure mucosal challenge that
transmits one or two SIV variants, just as observed for HIV in human sexual
transmission, have shown that some vaccines can likewise induce abortive infection
or prevent acquisition of virus in this analog model.
In addition, multiple
potent and broad neutralizing antibodies defining new targets on HIV gp120 have
been isolated from HIV-infected individuals.
These recent results have opened new horizons and hypotheses
that can be exploited for vaccine design and evaluation.
The partially
successful RV144 trial has introduced new ways to think about protection
against HIV.
Prior to RV144, because inducing broad neutralizing antibodies to
produce “sterilizing” immunity was such an elusive goal, an interim goal had
been to rely on T-cell immunity to suppress plasma viremia after exposure and
infection.
It now appears that vaccination can tip the balance against the
virus in the early events after exposure, so the important time frame to focus
on shifts from the weeks-long period it takes to establish and maintain
setpoint plasma viremia to the first days after exposure, when the track and
fate of the first penetrating virions are established.
The case-control
analysis of RV144 has implicated the level of IgG antibodies to a
conformational V1V2 epitope(s) as affecting infection risk, though the function
that may be performed by these antibodies to prevent infection is unclear at
present.
Since blocking the acquisition of infection is also observed in
several NHP studies, these models can effectively investigate the generation,
localization and mechanism of protective responses that operate early after
transmission.
Whether transmitted-founder viruses have properties that
differentiate them in significant ways from the chronic viruses that have been
used until now as sources of vaccine antigens is only beginning to be
investigated.
And the new epitopes described by recent antibody discoveries
enlarge the options for focusing the generation of protective antibody
responses.
These developments provide fertile new avenues of research for
improving vaccine design.
Objective:
The HIVRAD program is designed to fund projects that further
address hypotheses crucial to the design of an efficacious HIV/AIDS
prophylactic vaccine.
Applications for five years of support should include
plans that have advanced past the exploratory stage and include preliminary
data.
Less fully developed applications can request less than 5 years of
support to establish feasibility.
Applications aimed at developing or
optimizing a specific vaccine platform should lay out a research pathway with
clear decision points.
Extensive modeling of vaccine concepts in non-human
primates may be included.
Clinical studies involving human subjects or vaccine
research focused solely on therapeutic applications are not considered
appropriate and will not be funded under this FOA.
For information on programs
that support therapeutic vaccine development, please contact program staff.
Applications may address, but need not be limited to:
- Approaches to elicit durable and broadly neutralizing antibodies
against HIV and/or SIV
-
Identifying correlates of vaccine-induced immune protection to
HIV/AIDS
- HIV structural studies as they relate to designing HIV immunogens
- Improved animal model systems (and challenge viruses) to address
vaccine efficacy
- Approaches to increase the immunogenicity of HIV antigens (e.g.,
novel adjuvants)
- How vaccine design can better address the heterogeneity of HIV
- Developing or improving viral or bacterial vaccine vectors
- Determining how immune cells can be mobilized to the portal of
infection
-
Investigations into the role of glycan structures on
immunogenicity, antigenicity and infectivity
-
Investigations into innate immunity to alter the outcome of
infection
Section II. Award Information
Funding Instrument
|
Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.
|
Application Types Allowed
|
New
Renewal
Resubmission
The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.
|
Funds Available and Anticipated Number of Awards
|
NIH intends to fund an estimate of 1-3 awards,
corresponding to a total of $5M, for fiscal year 2015. Future year amounts
will depend on annual appropriations.
|
Award Budget
|
Application budgets are not limited but need to reflect the
actual needs of the proposed project.
|
Award Project Period
|
The scope of the proposed project should determine the
project period. The maximum period is 5 years.
|
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
Eligible Organizations
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:
- Hispanic-serving Institutions
-
Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
-
Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving
Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
-
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of
Higher Education)
-
Nonprofits without 501(c)(3) IRS Status (Other than Institutions
of Higher Education)
For-Profit Organizations
- Small Businesses
-
For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
-
Indian/Native American Tribal Governments (Federally Recognized)
-
Indian/Native American Tribal Governments (Other than Federally
Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally
recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible
to apply.
Required Registrations
Applicant
Organizations
Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award.
All registrations must be
completed prior to the application being submitted.
Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible.
The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.
- Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.
- NATO
Commercial and Government Entity (NCAGE) Code – Foreign organizations must
obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.
- Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.
Program
Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons.If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.
Eligible Individuals (Program Director/Principal
Investigator)
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) 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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH
Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an
Application Package
Applicants can access the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH’s ASSIST system to prepare and
submit applications through Grants.gov to NIH. Applications prepared and
submitted using applicant systems capable of submitting electronic
multi-project applications to Grants.gov will also be accepted.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities.
Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.
Letter of Intent
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.
By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:
- Descriptive title of proposed activity
-
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
-
Number and title of this funding opportunity
The letter of intent should be sent to:
Peter R. 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 (U.S. Postal Service or regular mail)
Bethesda MD 20817 (for express/courier service; non-USPS
service)
Telephone: 301-496-8426
Email: pjackson@mail.nih.gov
Page Limitations
Component
Types Available in ASSIST
|
Research
Strategy/Program Plan Page Limits
|
Overall
|
12
|
Admin Core
|
6
|
Core (use for Scientific Cores)
|
6
|
Project (use for Research Projects)
|
12
|
Additional page limits described in the SF424 Application
Guide and the Table of
Page Limits must be followed.
Instructions for the Submission of Multi-Component
Applications
The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application.
The application should consist of the following components:
- Overall: required
- Administrative Core: required
- Scientific Cores: optional
-
Research Projects: minimum of 2 required
Overall Component
When preparing your application in ASSIST, use Component
Type ‘Overall’.
All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Overall)
Complete entire form.
PHS 398 Cover Page Supplement (Overall)
Note: Human Embryonic Stem Cell lines from other
components should be repeated in cell line table in Overall component.
Research & Related Other Project
Information (Overall)
Follow standard instructions.
Project/Performance Site Location(s) (Overall)
Enter primary site only.
A
summary of Project/Performance Sites in the Overall section of the assembled
application image in eRA Commons compiled from data collected in the other
components will be generated upon submission.
Research & Related Senior/Key
Person Profile (Overall)
Include only the Project Director/Principal
Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the
entire application.
A
summary of Senior/Key Persons followed by their Biographical Sketches in the
Overall section of the assembled application image in eRA Commons will be
generated upon submission.
Budget (Overall)
The only budget information included in the Overall
component is the Estimated Project Funding section of the SF424 (R&R)
Cover.
A
budget summary in the Overall section of the assembled application image in eRA
Commons compiled from detailed budget data collected in the other components
will be generated upon submission.
PHS 398 Research Plan
(Overall)
Introduction
to Application:
For Resubmission applications, an Introduction
to Application is required in the Overall component.
Specific
Aims:
List in priority order, the broad, long-range objectives
and goals of the proposed program. Concisely and realistically describe the
hypothesis or hypotheses to be tested.
Research
Strategy:
This narrative section summarizes the overall
research plan for the multi-project application.
The multi-project
application should be viewed as a confederation of interrelated research
projects, each capable of standing on its own scientific merit, but
complementary to one another.
This is an important section for it
provides the group of investigators an opportunity to give conceptual wholeness
to the overall program – by giving a statement of the general problem area and
by laying out a broad strategy for attacking the problems.
As the
strategy develops, each project and core should be cited briefly as to its
place in the overall scheme. Summarize the special features in the
environment and/or resources that make this application strong or unique.
Resource
Sharing Plan:
Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome
Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide.
Appendix:
Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.
Administrative Core
When preparing your application in ASSIST, use Component
Type ‘Admin Core .’
All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Administrative
Core)
Complete only the following fields:
- Applicant Information
-
Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement
(Administrative Core)
Enter Human Embryonic Stem Cells in each relevant
component.
Research & Related Other Project
Information (Administrative Core)
Human
Subjects:
Answer only the ‘Are Human Subjects Involved?’ and
'Is the Project Exempt from Federal regulations?’ questions.
Vertebrate
Animals: Answer only the ‘Are Vertebrate Animals Used?’
question.
Project
Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this
attachment indicating it is required. However, eRA systems only enforce this
requirement in the Overall component and applications will not receive an error
if omitted in other components.
Project /Performance Site Location(s) (Administrative Core)
List all performance sites that apply to the specific
component.
Note: The Project Performance Site form allows up
to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key
Person Profile (Administrative Core)
- In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a
valid eRA Commons ID in the Credential field.
-
In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.
-
Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.
-
If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.
Budget (Administrative Core)
Budget forms appropriate for the specific component
will be included in the application package.
The administrative core budget should include a
description of how research-related travel and training will be budgeted.
Funding for the overall administrative efforts, including secretarial, and/or
other administrative services, publication expenses resulting from
collaborative efforts, and communication expenses, should be requested in this
core.
Budgets for the cost of travel and attendance by the
to-be-named members of the Scientific Advisory Board (SAB) should be included
in the budget for the Administrative Core.
Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.
PHS 398 Research Plan (Administrative Core)
Introduction
to Application:
For Resubmission applications, an Introduction
to Application is allowed for each component.
Specific
Aims:
List in priority order, the broad, long-range objectives
and goals of the proposed administrative core. In addition, state the core’s relationship
to the program’s goals and how it relates to the individual research projects
or other cores in the application.
Research
Strategy:
An administrative core is a resource to the
multi-project grant, providing overall management, coordination and oversight
for the program. As part of the administrative core, provide an administrative
plan that includes a description of the structure and roles of administrative
staff, including the functions to be performed; how fiscal and other resources
will be prioritized, allocated and managed; how communications will be
facilitated.
A fully developed and well-described Administrative Core plan is
required even if no additional funds for the core are requested.
In addition within the Admin Core include the following:
Scientific Advisory Board
Plans for a Scientific Advisory Board (SAB), consisting of
3-4 independent subject matter experts, should be proposed in the application.
However, for new applications the names of proposed SAB members should not be
included in the application. For a renewal application, provide the names of
current and former SAB members but do NOT contact, recruit or name potential
NEW SAB members.
It is expected that the SAB members will attend annual
meetings sponsored by the grantee to assist with interpretation of results and
planning of future studies, and to assist NIAID Program Staff with assessing
progress during the course of the project.
Annual Meetings
Plans for Annual site visits for the Program Officer, NIAID
Program Staff and SAB, should be proposed in the application. All
co-investigators should attend this meeting.
During these visits it is expected
that an update and summary of results generated from each project will be
presented by the PD/PI, co-investigators and/or all pertinent staff.
These
presentations will be expected to include summaries of all goals and milestones
achieved during the review period and a description of all problems encountered
that may have an impact on the future direction of the scientific hypotheses.
Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Administrative Core)
When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion
Enrollment Report (Administrative Core)
When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment
Report as described in the SF424 (R&R) Application Guide.
Research Project
When preparing your application in ASSIST, use Component
Type ‘Project.’
All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Research Project)
Complete only the following fields:
- Applicant Information
- Type of Applicant (optional)
-
Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Research
Project)
Enter Human Embryonic Stem Cells in each relevant
component.
Research & Related Other Project
Information (Research Project)
Human
Subjects: Answer only the ‘Are Human Subjects Involved?’ and
'Is the Project Exempt from Federal regulations?’ questions.
Vertebrate
Animals: Answer only the ‘Are Vertebrate Animals Used?’
question.
Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.
Project /Performance Site Location(s)
(Research Project)
List all performance sites that apply to the specific
component.
Note:
The Project Performance Site form allows up to 300 sites, prior to using
additional attachment for additional entries.
Research & Related Senior/Key
Person Profile (Research Project)
-
In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a
valid eRA Commons ID in the Credential field.
-
In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.
-
Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.
-
If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.
Budget (Research Project)
Budget forms appropriate for the specific component
will be included in the application package.
Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior
to using attachments for additional entries. All other SF424 (R&R)
instructions apply.
PHS 398 Research Plan (Research
Project)
Introduction
to Application:
For Resubmission applications, an Introduction
to Application is allowed for each component.
Specific
Aims: List, in priority order, the broad long-range objectives
and goals of the proposed project. Concisely and realistically describe the
hypothesis or hypotheses to be tested. In addition, state the individual
research project's relationship to the program’s goals and how it relates to
other projects or cores.
Research
Strategy:
Use this section to describe how the proposed
research will contribute to meeting the Project’s goals and objectives and
explain the rationale for selecting the methods to accomplish the specific
aims.
In addition to stating the biological significance of the research,
indicate the project's relevance to the primary theme of the application.
Organize the Research Strategy in the specified order
as stated in the SF 424 (R&R) Application Guide. Make sure to start
each section with the appropriate section heading in order, Significance,
Innovation, Approach, and include the appropriate information.
Experimental details should be cited using the Bibliography and Reference Cited
section and need not be detailed in the Research Strategy.
Preliminary
Studies for new projects or progress reports for renewals must be included as
part of the approach section, and must be contained within the page limits of
the Research Strategy section.
Describe the research design conceptual procedures,
and analyses to be used to accomplish the specific aims of the project.
Describe any new methodology and its advantage over existing methodologies.
Describe any novel concepts, approaches, tools, or technologies for the
proposed studies.
Discuss associations with clinical project(s).
Discuss the
potential difficulties and limitations of the proposed procedures and
alternative approaches to achieve the aims.
As part of this section, provide a
tentative sequence or timetable for the project.
Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Research Project)
When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion
Enrollment Report (Research Project)
When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.
Scientific Core
When preparing your application in ASSIST, use Component
Type ‘Core.’
All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Scientific
Core)
Complete only the following fields:
-
Applicant Information
-
Type of Applicant (optional)
-
Descriptive Title of Applicant’s Project
-
Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Scientific
Core)
Enter Human Embryonic Stem Cells in each relevant
component.
Research & Related Other Project
Information (Scientific Core)
Human
Subjects: Answer only the ‘Are Human Subjects Involved?’ and
'Is the Project Exempt from Federal regulations?’ questions.
Vertebrate
Animals: Answer only the ‘Are Vertebrate Animals Used?’
question.
Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components
Project /Performance Site Location(s)
(Scientific Core)
List all performance sites that apply to the specific
component.
Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key
Person Profile (Scientific Core)
-
In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a
valid eRA Commons ID in the Credential field.
-
In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.
-
If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.
Budget (Scientific Core)
Budget forms appropriate for the specific component
will be included in the application package.
Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.
PHS 398 Research Plan (Scientific
Core)
Introduction
to Application:
For Resubmission applications, an Introduction
to Application is allowed for each component.
Specific
Aims:
List in priority order, the broad, long-range objectives
and goals of the proposed core(s). Concisely and realistically describe the
hypothesis or hypotheses to be tested, if applicable. In addition, state the
core’s relationship to the program’s goals and how it relates to the individual
research projects or other cores in the application.
Research
Strategy:
Use this section to describe how the proposed core
activities will contribute to meeting the program goals and objectives and
explain the rationale for selection of the general methods and approaches
proposed to accomplish the specific aims.
In addition, this section
should indicate the relevance of the core to the primary theme of the
application. Each Core Service must support two or more projects in the
program.
Organize the Plan in the specified order as stated in
the SF 424 (R&R) Application Guide. Make sure to start each section
with the appropriate section heading in order, Significance, Innovation,
Approach, and include the appropriate information.
Experimental details should
be cited using the Bibliography and Reference Cited section and need not be
detailed in the Research Strategy.
Preliminary Studies for new cores and
progress reports for renewals must be included as part of the approach section
and must be contained within the page limits of the Scientific Core Plan
section.
Resource
Sharing Plan:
Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide.
Appendix:
Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Scientific
Core)
When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion
Enrollment Report (Scientific Core)
When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.
3. Submission Dates and
Times
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.
Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.
4. Intergovernmental Review
(E.O. 12372)
This initiative is not subject to intergovernmental
review.
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 only as described in the NIH
Grants Policy Statement.
6. Other Submission
Requirements and Information
Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be
automatically assembled for review and funding consideration after submission
go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations
before the application due date. Section
III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.
Important
reminders:
All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential field of the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.
Section V. Application Review Information
Only the review criteria described below will be considered
in the review process.
As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
Overall Impact - Overall
Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the program to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
program proposed).
Review Criteria - Overall
Is the program as a whole scientifically compelling?
Are there coordination and synergy of the individual research projects and
cores towards the achievement of the central objectives of the program?
Are the overall program goals significant and focused on studies that significantly
address hypotheses crucial to the design of an efficacious HIV/AIDS
prophylactic vaccine?
Will the integration of the individual projects
into a single program be more beneficial than pursuing each project
independently?
Does the Program Director(s)/Principal Investigator(s)
have the leadership and scientific ability to develop an integrated and focused
research program?
Will the PD(s)/PI(s) devote adequate time and effort to
the program?
Is there adequate evidence of sufficient institutional
support for the PD(s)/PI(s)?
For applications designating multiple
PD(s)/PI(s), are there adequate and appropriate coordination and communication
among the PD(s)/PI(s)?
Scored Review Criteria - Research Projects
Reviewers will consider each of the review criteria below in
the determination of scientific 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 project lead, 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-project lead , do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?
Do the project
lead(s) possess demonstrated abilities to develop a program of integrated
research projects with a well-defined central research focus?
Do the
investigators commit adequate time and effort to the program?
Do the
investigators possess the qualifications and experience necessary for the
individual research projects?
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?
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 human subjects and/or NIH-defined clinical research,
are the plans to address
1) the protection of human subjects from research
risks, and
2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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?
Overall Impact Administrative Core
Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the Administrative Core to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the core proposed).
Review Criteria – Administrative Core
Reviewers will consider each of the criteria below in the
determination of scientific and technical merit. Is the administrative
and organizational structure appropriate and adequate to the attainment of the
objective(s) of the proposed program?
Is the management plan for fiscal
accountability and communication within the program appropriate? Are the
plans for coordination, problem identification and resolution, and the
establishment of a strong collaborative environment for the program appropriate?
Are the experience, level of commitment, and availability of the Administrative
Core Leader and administrative staff adequate to manage the program?
Overall Impact - Scientific Cores (if applicable)
Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the Scientific Core to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the core proposed).
Review Criteria – Scientific Core (if applicable)
Reviewers will consider each of the criteria below in the
determination of scientific and technical merit: Is provision of resources and
core services for the individual Research Projects critical and justified?
Is the relationship of a scientific core to the central focus of the overall
program strong?
Is the quality of the relevant facilities or services
provided and criteria for prioritization and usage appropriate?
Are the
qualifications, competence, and commitment of the Core Leader and key personnel
appropriate?
Additional Review Criteria - Overall Application, Research Projects and Cores
As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.
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. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and
Children
When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed
plans for the inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of
children to determine if it is justified in terms of the scientific goals and
research strategy proposed.
For additional information on review of the
Inclusion section, please refer to the
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
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.
Resubmissions
For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.
Renewals
For Renewals, the committee will consider the
progress made in the last funding period.
Revisions
Not Applicable
Additional Review Considerations - Overall Application, Research Projects and Cores
As applicable for the project proposed, reviewers will consider
each of the following items, but will not give scores for these items, and
should not consider them in providing an overall impact score.
Applications from Foreign
Organizations
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 Agent 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:
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.
2. Review and Selection
Process
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the NIAID in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.
As part of the scientific peer review, all applications:
- May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.
- Will receive a written critique.
Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the National Advisory Allergy and Infectious Diseases Council . The
following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as
determined by scientific peer review.
-
Availability of funds.
-
Relevance of the proposed project to program priorities.
3. Anticipated Announcement
and Award Dates
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 eRA
Commons.
Information regarding the disposition of applications is
available in the NIH
Grants Policy Statement.
Section VI. Award
Administration Information
1. Award Notices
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications.
The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the
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
More information is
provided at
Cooperative Agreement Terms and Conditions of Award
Not Applicable
3. Reporting
When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH Grants
Policy Statement.
A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later.
All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.
See the NIH
Grants Policy Statement for additional information on this reporting
requirement.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Commons Help Desk (Questions regarding eRA Commons registration,
submitting and tracking an application, documenting system problems that
threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov
Scientific/Research Contact(s)
Alan Schultz, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-6169
Email: schultzam@mail.nih.gov
Peer Review Contact(s)
Peter Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-8426
Email: pjackson@mail.nih.gov
Financial/Grants Management Contact(s)
Regina Kitsoulis
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6245
Email: Kitsoulisre@mail.nih.gov
Section VIII. Other
Information
Recently issued trans-NIH policy
notices may affect your application submission.
A full list of policy
notices published by NIH is provided in the NIH
Guide for Grants and Contracts.
All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement.
Authority and Regulations
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.
