EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health, (http://www.nih.gov)
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www3.niaid.nih.gov/)
Title: Phased Innovation Awards in AIDS Vaccine Research (R21/R33)
Announcement Type
This Program Announcement is a reissue of PA-06-109 which was published on December
23, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-06-519
Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856
Key Dates
Release/Posted Date: August 9, 2006
Opening Date: August 15, 2006 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable.
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).
AIDS Application Submission/Receipt Date(s): Standard dates beginning with September 1, 2006 apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation
Date): Not Applicable
Expiration Date: May 2, 2009 (now May 8, 2009 per NOT-OD-07-093)
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated
Start Dates
1. Letter of Intent
B. Submitting an Application Electronically
to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
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
BACKGROUND
Every year approximately five million people worldwide are infected with the human immunodeficiency virus (HIV), the virus that causes the Acquired Immunodeficiency Disease Syndrome (AIDS). Almost 14,000 people become newly infected each day and 45 million additional infections are projected to occur by 2010 unless more effective measures are taken to prevent new infections. The human and economic toll of HIV/AIDS has made the development of a safe and effective prophylactic vaccine against HIV/AIDS one of the highest priorities of the National Institutes of Health (NIH). Within NIH, the NIAID has a lead role in this endeavor and supports a number of research programs using multiple grant and contract funding mechanisms. The Innovation Grant Program for AIDS Vaccine Research is one among several such programs, and since 1997 has served as the main entry point and solicitation source of applications for exploring as yet untested novel approaches. More research is needed to understand the immune parameters required for vaccine-elicited protection, AIDS vaccine design, and development of adjuvants that focus on inducting persistent mucosal and systemic immune responses against this virus.
PURPOSE OF THIS FOA
This program will support prophylactic vaccine research projects that are innovative, novel, may be high risk/high impact, and that exhibit the potential to advance AIDS prophylactic vaccine design or evaluation. This FOA uses the NIH Phased Innovation Award mechanism (R21/R33). Awarded projects will first be tested in milestone-driven exploratory/feasibility proof of concept studies (R21 phase); and then, if eligible, will be reviewed for the expanded development (R33 phase) award without the need of submitting an additional grant application. The phased R21/R33 mechanism offers the potentially successful Project Directors/Principal Investigators (PDs/PIs) the opportunity to devote full attention to the research project without the burden of additional grant writing for continued support, and will permit promising research to continue with no lapse in funding. Only applications for the combined mechanism (R21/R33) will be deemed responsive to this FOA.
Applications targeting any scientific area(s) related to HIV/AIDS prophylactic vaccine research are encouraged. Applications for therapeutic vaccine research are excluded. Before application receipt dates, scientific areas of particular programmatic interest may be posted on the NIAID website http://www.niaid.nih.gov/daids/vaccine/innovation.htm. Periodically, highly focused scientific areas are posted upon the recommendation of the AIDS Vaccine Research Working Group (AVRWG), or may emerge from meetings, workshops, and discussions with program staff. Applicants are strongly encouraged to contact program staff (see Agency Contacts: Scientific/Research) and visit the website before submitting an application.
RESEARCH OBJECTIVES
All relevant areas of investigation contributing to the development of an efficacious prophylactic HIV/AIDS vaccine are welcome. These may include but are not limited to: structural studies of HIV envelope proteins to aid immunogen design; strategies to induce broadly reactive neutralizing antibodies to primary isolates; approaches to enhance HIV vaccine-induced immunologic memory; vaccine approaches that induce mucosal immunity; improving HIV vaccines by harnessing innate immunity and regulatory T cell responses; methods to enhance antigen presentation/processing; vaccine approaches that use adjuvants or immunomodulators to increase or improve immunogenicity of HIV vaccines; mobilizing antigen presenting cells to vaccination sites; novel approaches in nucleic acid vaccination; recombinant vectors; and pseudovirion approaches. Within the R21 phase, successful applicants are expected to generate proof of concept feasibility data that meet well-defined measurable goals (quantitative milestones). Research on therapeutic vaccine approaches is not within the scope of this FOA.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This FOA will use the NIH Phased Innovation
(R21/R33) Exploratory/ Developmental Research Grant Mechanism that couples
the Phase I (R21) and Phase II (R33) award mechanisms.
Transition of the R21 to the R33 phase will be expedited and is dependent
on the completion of negotiated milestones.
This FOA uses just-in-time concepts. It uses the non-modular, detailed budget format for both the R21 (Phase I) and the R33 (Phase II) components of the solicited grant applications; in other words, it does not allow use of the NIH modular budget format for either component of the application.
The combined R21/R33 application offers two advantages: (1) single submission and evaluation of both the R21 and the R33 in one application, and (2) expedited transition and minimal or no funding gap between the R21 feasibility and R33 development phases for successful applicants.
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 based on successful completion of scientific milestones, program priorities, and availability of funds. For the R21/R33 Phased Innovation Award, the R21 phase must include one to three clear, well-defined measurable goals (quantifiable milestones) that can be used to judge the success of the proposed research, as well as a credible developmental research plan for the R33 phase.
Under this FOA applicants may only submit for the combined R21/R33 (Phased Innovation Award). Applications for R21 support alone are not accepted under this FOA. Investigators seeking support solely through the R21 mechanism are encouraged to apply for the NIH-wide R21 exploratory program (see http://grants2.nih.gov/grants/guide/pa-files/PA-06-181.html), or other announcements. Similarly, applications for R33 support alone are not permitted.
Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
2. Funds Available
For this phased R21/R33 FOA, funding for the R21 phase cannot extend beyond
2 years, and funding for the R33 phase cannot extend beyond 3 years.
Thus, funding for the total project period for an application submitted in
response to this FOA may not exceed 5 years.
Applicants may request up to two years of support for the R21 feasibility phase limited to $275,000 direct costs over the two year award period. Budgetary support for the R33 phase will be limited to $300,000 per annum in direct costs.
NIAID anticipates a maximum of fifty percent (50%) of the initially funded applications will eventually progress to the R33 phase.
Funding of the R33 phase will be based on program priorities, on the availability of funds, and successful completion of negotiated scientific milestones within the R21 phase, as determined by program staff in the context of peer review recommendations.
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
You may submit an application(s) if your institution/organization
has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills,
knowledge, and resources necessary to carry out the proposed research as the
Project Director/Principal Investigator (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.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application,
provided each application is scientifically distinct.
Clinical trials or first-time-in human studies will not be supported under this FOA. (See . http://grants.nih.gov/grants/guide/notice-files/NOT-AI-05-021.html). Clinical research, including research that uses clinical specimens, is within the scope of this announcement.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424
(R&R) Application Guide for completing the SF424 (R&R) forms for this
FOA, link to http://www.grants.gov/Apply/
and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants must download the SF424 (R&R) application
forms and 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 (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations
Several special provisions apply to applications submitted
by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: August 15, 2006 (Earliest date an application may
be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
AIDS Application Submission/Receipt Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
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/Apply
and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov no
later than 5:00 p.m. local time (of the applicant
institution/organization) on the application
submission/receipt date(s). (See Section IV.3.A.
for all dates.) If an application is not submitted by the receipt date(s)
and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete
applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the assignment
of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental
Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.
Prior to funding an application, the NIAID Program Director will contact
the applicant to discuss the proposed milestones and any changes suggested
by the review panel as indicated in the Summary Statement. The Program Director
and the applicant will negotiate and agree on a final set of milestones. These
will be the basis for judging the success of the R21 work. At least one interim
progress report will be required during the R21 phase.
For funded applications, completion of the R21 milestones
will elicit an expedited review by the NIAID that will determine whether or
not the R33 grant should be awarded. The release of R33 funds will be based
on successful completion of negotiated scientific milestones, program priorities,
and on the availability of funds. The expedited transitional review may result
in additional negotiations of award.
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: are necessary to conduct the project,
and would be allowable under the grant, if awarded, without NIH prior approval.
If specific expenditures would otherwise require prior approval, the grantee
must obtain NIH approval before incurring the cost. NIH prior approval is
required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new 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.
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.
6. Other Submission Requirements
The NIH requires the PD/PI 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. The applicant organization must include its DUNS number
in its Organization Profile in the eRA Commons. This DUNS number must match
the DUNS number provided at CCR registration with Grants.gov. For additional
information, see Registration FAQs Important Tips -- Electronic Submission
of Grant Applications.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21/R33 applications:
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Note: While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected schedule
for data sharing, the format of the final dataset, the documentation to be
provided, whether or not any analytic tools also will be provided, whether
or not a data-sharing agreement will be required and, if so, a brief description
of such an agreement (including the criteria for deciding who can receive
the data and whether or not any conditions will be placed on their use), and
the mode of data sharing (e.g., under their own auspices by mailing a disk
or posting data on their institutional or personal website, through a data
archive or enclave). Investigators choosing to share under their own auspices
may wish to enter into a data-sharing agreement. References to data sharing
may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research data in their application.
The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that grant
awardee recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after publication
(See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established Public Health Service
(PHS) referral guidelines.
Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not
need to be strong in all categories to be judged likely to have major scientific
impact and thus deserve a high priority score. For example, an investigator
may propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.
Significance: Does this study address an important scientific health problem?
If the aims of the application are achieved, how will scientific knowledge
or clinical practice be advanced? What will be the effect of these studies
on the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the proposed milestones appropriate and specific? Do the milestones have specific 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?
Innovation: Is the project original and innovative? For example: Does the
project challenge existing paradigms or clinical practice; address an innovative
hypothesis or critical barrier to progress in the field? Does the project
develop or employ novel concepts, approaches, methodologies, tools, or technologies
for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and
the priority score:
Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed. See item
6 of the Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals
of the research will be assessed. Plans for the recruitment and retention
of subjects will also be evaluated. See item 7 of the Research Plan component
of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under item 11 of the Research Plan component of the SF424 (R&R) will be
assessed.
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the proposed
protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to
the proposed research may be assessed by the reviewers. Is the number of person
months listed for the effort of the PD/PI appropriate for the work proposed?
Is each budget category realistic and justified in terms of the aims and methods?
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be assessed
by the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms
and conditions of the award. The funding organization will be responsible
for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
2.D. Sharing Research Resources
NIH policy requires that grant
awardee recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after publication
(See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative
review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.
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/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.
3.
Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required
in the NIH
Grants Policy Statement.
Section VII. Agency Contacts
We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Jon Warren, Ph.D.
Director, Innovation Grant Program for AIDS Vaccine
Research
Division of AIDS (DAIDS)
National Institute of Allergy and Infectious Diseases, NIH
6700B Rockledge Drive, Room 5124
Bethesda, MD 20892-7628
Telephone: (301) 402-0633
FAX: (301) 402-3684
Email: [email protected]
2. Peer Review Contacts:
Not Applicable.
3. Financial or Grants Management
Contacts:
Mary Ledford
Grants Management Branch
DEA, NIAID, NIH
6700B Rockledge Drive, Room 2129
Bethesda, MD 20892-7614
Telephone: (301) 402-6446
FAX: (301) 493-0597
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use
of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
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 IRB rules, as well as
local, State and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan
into the determination of the scientific merit or the priority score.
Access to Research Data through
the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement). Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include
in the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to
a cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators
proposing clinical research should read the "NIH Guidelines for Inclusion
of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description
of plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical research, conducted
or supported by the NIH, unless there are scientific and ethical reasons not
to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly
accessible on-line journal articles. Unless otherwise specified in this
solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution reviewers
that their anonymity may be compromised when they directly access an Internet
site.
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 PA
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 and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under the authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations
42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms
and conditions, cost principles, and other considerations described in the
NIH Grants Policy
Statement.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the American
people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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