EXPIRED
Department of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Allergy and
Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
Title: Integrated Preclinical/Clinical AIDS
Vaccine Development Program (IPCAVD) (U19)
Announcement
Type
This is a reissue PAR-06-286,
which was released on March 28, 2006.
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Program Announcement (PA) Number: PAR-10-161
Catalog of Federal Domestic
Assistance Number(s)
93.855, 93.856
Key Dates
Release Date: March 30, 2010
Letters of Intent Receipt Date: October 8, 2010; October 7, 2011; October 9, 2012
Receipt
of Applications: November 8, 2010; November 8, 2011; November 8, 2012
Peer Review Date(s): March, 2011, 2012, 2013
Council Review Date(s): May, 2011, 2012, 2013
Earliest
Anticipated Start Date: July, 2011, 2012, 2013
Additional
Information to Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: (New Date November 9, 2011
per NOT-AI-11-043), Original Date: November 9, 2012
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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
Terms and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3.
Collaborative Responsibilities
4. Dispute
Resolution Process
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:
The development of a safe and effective prophylactic
vaccine against HIV/AIDS is one of the highest priorities of the National
Institute of Allergy and Infectious Diseases, part of the National Institutes
of Health (NIH).
Numerous experimental prophylactic HIV vaccines have been tested in human clinical trials, and several of these trials received funding through NIAID’s Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD). Only three large-scale HIV vaccine efficacy trials have been completed to date: two provided no evidence of efficacy despite the fact that the vaccines induced an immune response in many trial participants, then most recently, products tested in a third trial in Thailand demonstrated modest efficacy at preventing HIV infection. The significant results from this latest trial have recharged the HIV vaccine field and highlight the importance of testing promising HIV vaccine concepts in carefully planned clinical research studies. In response to the HIV vaccine research field’s evolving priorities, the NIAID Division of AIDS has refocused the traditionally product development-oriented IPCAVD program to emphasize the development of experimental HIV vaccine clinical trial materials/reagents that can be used to address specific vaccine and immunological questions.
Objective and Scope:
The objective of the IPCAVD program is to facilitate the translation of innovative and promising basic science-derived vaccine concepts for prophylactic HIV vaccines to initial clinical trials by providing the critical resources necessary for achieving this goal. An IPCAVD award will provide support in the following 3 areas: (1) support for basic hypothesis-driven science development of the vaccine concept through facilitation of NHP proof-of concept studies and down-selection to the best lead candidate; (2) access to resources for determining whether the new concept is clinically feasible by determining whether a candidate vaccine successfully addresses FDA requirements for performing clinical testing, by determining the feasibility of whether cGMP lots of the vaccine can be manufactured and by determining whether the vaccine is safe by conducting the required toxicology and pharmacology safety studies; and (3) support for the initial human clinical study central to determining whether future development is feasible and warranted via achievement of the original basic science-generated hypothesis. Applicants will be expected to articulate what scientific question(s) or concepts their experimental vaccine concept is designed to answer. Applicants must also provide clear and convincing preclinical data supporting the ability to answer questions with the proposed HIV vaccine concept.
Research Projects: The multi project (U19) application must propose a minimum of two research projects and one project must perform product manufacture as described below. This Program will support the funding of a multidisciplinary consortium of experts in animal models, molecular biology, immunology, manufacturing and clinical testing. Specific activities in the application may include: basic HIV vaccine research, preclinical testing and vaccine optimization, product development and cGMP manufacturing (only as necessary for the generation of clinical materials for use in clinical studies) and parallel NHP studies that will further help calibrate the utility of the NHP model, and early stage human clinical testing. In addition each individual research project must include a clear delineation of goals with measurable milestones including detailed quantitative and qualitative criteria to be used to decide when to proceed to the next phase and a timeline for the attainment of each goal and milestone.
Product Manufacturing Project (required). Product development will be required for generating materials for a clinical study to answer the specific questions and vaccine concepts being proposed. The applicant must include a Product Manufacturing Project as one of the projects in the multi-project (U19) application; the relegation of cGMP manufacturing to a Core is not appropriate. The Product Manufacturing Project should contain a Product Development Plan describing the clinical materials to be generated for the clinical studies. This should include: (1) a detailed description of the conceptual framework, design, and iterative evaluation of the vaccine concept, (2) a description of the proposed vaccine candidate and its stage of development, (3) data resulting from research conducted to date with respect to the potential for the proposed vaccine candidate to elicit the desired responses, (4) a clear delineation of the proposed product development activities to be undertaken, (5) a discussion of potential limitations/obstacles in achieving project objectives, and proposed alternative methods to deal with anticipated limitations/obstacles, and (6) proposed steps for the maintenance of quality oversight throughout the implementation and operation of the project. In addition the applicant should include a thorough description of the infrastructure, facilities, and resources for both production of the vaccine under cGMP (Good Manufacturing Practices as defined in the US Code of Federal Regulations 21 CFR Part 211) conditions and GLP (Good Laboratory Practices 21 CFR Part 58) performance of IND-enabling preclinical animal studies.
Core Facilities:
Administrative Core (required): An administrative core is a resource to the multi-project grant, providing overall management, coordination and supervision of the Program. As part of the administrative core, provide an administrative plan that includes a discussion of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research related travel and training will be budgeted. Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses, should be requested in this core.
The administrative core should also include a description of the functions of the External Advisory Committee (EAC). It is strongly recommended that a 3-4 member EAC consisting of independent experts in the areas of research that the program project addresses, be identified soon after award. EAC members will be requested to attend annual meetings sponsored by the grantee to assist the grantee with interpretation of results and planning of future studies, and to assist Program Staff with assessing progress during the course of the award. Applicants must NOT include names of proposed EAC members in their applications.
Scientific Core(s) (optional): A scientific core may be proposed if it supports the multi-project grant as a whole and must directly support at least two of the proposed research projects. The application must indicate which specific projects the Scientific Core(s) will support. This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide and describe the role of the Scientific Core Leader and each of the key participants. The apportionment of dollars or percentage of dollars that will be required to support each component research project that will utilize each scientific core should also be included in the budget.
Applications including only preclinical research alone will not be considered appropriate for this announcement.
Additional Information for Multi-Project Applications
Program Overview
The Program Overview of the multi-project application MUST include:
1. A Communication Plan for each research project that is clear and concise and depicts the interrelationships between the research groups, their relevant experience and expertise, organization , communication, and the contribution of each component to the fulfillment of the objectives of this PAR.
2. An organizational chart of the U19 cooperative group showing the name, institution, and scientific discipline of the Principal Investigator and of all key scientific and technical personnel, as well as a discussion of lines of authority and plans for the coordination of research projects.
3. Scientific and Technical Expertise: documentation of the scientific and technical expertise required to design, conduct and analyze the proposed studies and development activities, including GMP vaccine production.
4. Clinical Trial Synopsis: a description of the plans for the management and implementation of a clinical trial in support of the proposed research including a timeline for protocol development and implementation.
5. Milestones and Timeline: A clear delineation of goals with measurable milestones for the entire application including detailed quantitative and qualitative criteria to be used to decide when to proceed to the next phase of product development toward a testable vaccine in humans, and a timeline for the attainment of each goal and milestone.
Please see Section IV.6. Other Submission Requirements for additional information on application requirements.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding opportunity announcement (FOA) will utilize the NIH multi-project Cooperative Agreement (U19) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
The following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution 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 programs.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for a cooperative agreement that requires a team science approach and therefore clearly does not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant/cooperative agreement with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the cooperative agreement. Applications with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a cooperative agreement share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the, cooperative agreement including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Applications may include investigators from more than one institution if such arrangements enhance the scientific strength of the proposed research program. In addition, a Principal Investigator may serve as a Project Leader in another multi-project application if there is no scientific overlap with the application submitted by the Principal Investigator.
2. Cost Sharing or Matching
This program
does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to
Request Application Information
The current
PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently
approved version of the PHS 398.
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 PHS 398 application forms and in accordance with the PHS
398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Applications
must have a D&B Data Universal Numbering System (DUNS) number as the
universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the
face page of the PHS 398 form.
The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page
of the application form and the YES box must be checked.
Foreign Organizations [Non-domestic
(non-U.S.) Entity]
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from 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.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
The exceptions from the PHS 398 instructions and detailed information on the application structure and components are provided in Section IV.6 Other Submission Requirements . All applicants must follow the specific instructions in that section.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: October 8, 2010; October 7, 2011; October 9, 2012
Receipt
of Applications: November 8, 2010; November 8, 2011; November 8, 2012
Peer Review Date(s): March, 2011, 2012, 2013
Council Review Date(s): May, 2011, 2012, 2013
Earliest
Anticipated Start Date: July, 2011, 2012, 2013
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD, 20892-7616
(FedEx zip: 20817-7616)
Telephone: 301-402-1464
FAX:
301-480-2408
Email: [email protected]
3.B.
Sending an Application to the NIH
Applications
must be prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three
signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to:
Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD, 20892-7616
(FedEx zip: 20817-7616)
Telephone: 301-402-1464
FAX: 301-480-2408
Email: [email protected]
Applications must be received on or before the application receipt/date(s) described above (Section
IV.3.A.). If an application is received after that
date, it will be
returned to the applicant without review.
Upon receipt applications will be evaluated for
completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to
this funding opportunity 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. However, the NIH will accept a resubmission application, but
such application must include an Introduction addressing the critique from the
previous review.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: 1) are necessary to conduct the project,
and 2) would be allowable under the grant, if awarded, without NIH prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain NIH approval before incurring the cost. NIH prior approval
is required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission
Requirements and Information
Supplemental Instruction for the Preparation of Multi-Project Applications
The following section supplements the instructions found in Form PHS 398 for preparing a multi-project grant application U19. Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.
The supplemental instructions for multi-project applications below are divided as follows:
A. General Instructions addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.
B. Specific Instructions for Individual Projects describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.
C. Specific Instructions for Core Units Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.
A. General Instructions
All applications must be submitted on Form PHS 398. The multi-project grant
application should be assembled and paginated as one complete document.
1. Form Page 1 - Face Page
Items
1 - 14: complete these items as instructed. This should be the first page of
the entire application and all succeeding pages should be numbered
consecutively.
When multiple PDs/PIs are proposed, use the Face
Page-Continued page to provide items 3a-3h for all PDs/PIs. The Contact
PI should be listed on block 3 of Form Page 1-Face Page, with additional
PDs/PIs listed on the Face Page-Continued.
2. Form Page 2
Using Page 2 of Form 398; provide a succinct but accurate description
(abstract) of the OVERALL multi-project application addressing the major,
common theme of the program. Do not exceed the space provided.
List the performance sites
where the research will be conducted.
Under "Key Personnel", list the PD(s)/PI(s) of the multi-project
application, followed by the Project and Core Leaders of the component research
projects and cores, and other key personnel and then other significant
contributors.
3. Form Page 3 - Table of Contents
Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents
is needed for a multi-project application.
Bearing in mind that the application will be scientifically reviewed project by
project and core by core; prepare a detailed Table of Contents that will enable
reviewers to readily locate specific information pertinent to the overall
application as well as to each component research project and core. A page
reference should be included for the budget for each project and each core.
Further, each research project should be identified by number (e.g. Project 1),
title, and responsible Project Leader, and each Core should be identified by
letter (e.g. Core A), title, and responsible Core Leader. The page location of
a COMPOSITE BUDGET should be indicated in the "Table of Contents."
4. Composite Budget
Do not use Form Page 4 of PHS Form 398. Instead, using the suggested format
presented below, prepare a Composite Budget for All Proposed Years of Support.
(Justification for budget elements should not be presented here but in the
individual budgets of the projects and cores.)
SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support
Component |
Year 1 |
Year 2 |
Year 3 |
Year 4 |
Year 5 |
All Years |
Project 1. Invest. |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
677,040 |
Project 2. Study |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
677,040 |
Project 3. Develop. |
100,000 |
104,000 |
108,160 |
112,486 |
116,985 |
541,631 |
Core A. Admin. Core. |
50,000 |
52,000 |
54,080 |
56,243 |
58,493 |
270,816 |
Core B. DNA |
25,000 |
50,000 |
52,000 |
54,080 |
56,243 |
237,323 |
Totals |
425,000 |
466,000 |
484,640 |
504,025 |
524,185 |
2,403,850 |
5. Form Page 5
Complete the Total Direct Cost line entries for all requested budget periods
(years) and the Total Direct Cost for Entire Period of Support entry. Detailed
budgets are required within the descriptions of each project and core (see
below). If the FOA allows for budget requests beyond 5 years, use a second
Form Page 5 to reflect the additional budget years requested.
6. Biographical Sketch Format Page
Biographical sketches of all professional personnel for all components should
be placed at the end of the application with the PI(s)/PD(s) first, followed by
those of other key personnel in alphabetical order.
7. Resources Format Page
Do not complete. Essential
information is to be presented in the individual research project and core
sections of the application.
8. Program Overview (Research Objectives and Strategic Plan)
This narrative section summarizes the overall research plan for the
multi-project application and is limited to (12) pages. 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.
As part of the overall Program Overview (included within the 12 page limit) the application must include 1) a Communication Plan; 2) an organizational chart of the U19 cooperative group; 3) Scientific and Technical Expertise; 4) a Clinical Trial Synopsis; and 5) Milestones and Timelines. See Section I.1 Objectives and Scope for details.
9. Leadership Plan for Multiple PDs/PIs (required if applicable)
Applications designating multiple PDs/PIs for the overall Program must include a new section, entitled Multiple PD/PI Leadership Plan , as part of the Program Overview. This Plan must describe: a rationale for choosing a multiple PD/PI approach; the governance and organizational structure of the leadership team and the research projects and cores; communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts; the administrative, technical, and scientific roles and responsibilities for the PDs/PIs and other collaborators. If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should also be delineated. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Please note: A separate leadership plan is not required within individual project(s) and core(s) that designate multiple Project/Core Leaders.
10. Checklist
One
Checklist, placed at the end of the application, is to be submitted for the
entire application.
11. Appendix Materials
Refer to Section
IV.6. Appendix Materials below,
for instructions on submitting appendix materials.
For each project or core in the multi-project application, 3 publications plus other approved material are allowed.
B. Specific Instructions for Individual Research Projects
Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.
For each individual Research Project, include:
Cover page (see special instructions, below)
Description & Key personnel (PHS 398 Form Page 2)
Table of Contents (PHS 398 Form Page 3)
Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications
Research Plan
Resources
1. Cover Page
The Face Page of the 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):
Project Number and Title: (e.g., 1. Preclinical Evaluation of HIV Microbicides)
Name of Project Leader: (e.g., Jones, Roberta A.)
Human Subjects: (Yes or No)
If Yes:
Exemption number, -or-
IRB Approval Date (e.g., 12/13/2006, or "Pending"), and Federal wide Assurance (FWA) number
Vertebrate Animals: (Yes or No)
If Yes:
IACUC Approval Date (e.g., 11/17/2006, or Pending) and Animal welfare assurance number:
Proposed Period of Support:
From: (mmddyy - e.g., 07/01/2007)
To: (mmddyy - e.g., 06/30/2112)
Costs Requested for Initial Budget Period: (e.g. 07/01/2007-06/30/2008)
Direct Costs: (e.g., $ 150,000)
Total Costs: (e.g., $162,000)
Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2112)
Direct Costs: (e.g., $700,000)
Applicant Organization (full address)
2. Form Page 2
Provide a Description (abstract) of the research proposed in the project
according to the instructions on Form Page 2 of PHS Form 398. In addition, the
abstract should contain a brief description of how the research project will
contribute towards attainment of the multi-project program objectives.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.
3. Form Page 3
Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.
4. Budget Pages (PHS 398 Form Pages 4 and 5)
Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.
5. Research Plan
Introduction (For Resubmission or Revision Projects within a Resubmission or Revision Application Only. Limited to 1 page.)
See specific instructions in 2.7 Resubmission Applications and 2.8 Revision Applications on the content of the Introduction. New applications and projects should not include an Introduction.
Specific Aims (Limited to 1 page.)
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 project's relationship to the multi-project program goals and how it relates to other projects or cores.
Research Strategy (Limited to12pages.)
Use this section to describe how the proposed research will contribute to meeting the program'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 PHS 398 Instructions, Section 5.5. 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 and progress reports for renewal and revision projects as part of a renewal or revision application must be included as part of the approach section.
As part of the required Product Development Project (included within the 12 page limit) the application must include a Product Development Plan. See Section I.1 Research Objectives for details.
As part of the requirement for each individual Research Project (included within the 12 page limit) the application must include Milestone and Timelines. See Section I.1 Research Objectives for details.
6. Resources
Provide information on resources available for the project. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
7. Biographical Sketches
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
8. Select Agent Research (if applicable)
As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used in the project. Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s). Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Describe the biocontainment resources available at all performance sites.
C. Specific Instructions for Core(s)
Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.
For each individual Core, include:
Cover page (see special instructions, below)
Description & Key personnel (PHS 398 Form Page 2)
Table of Contents (PHS 398 Form Page 3)
Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications
Research Plan
Resources Format Page
1. Cover Page.
The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):
Core Letter and Core Title: (e.g., A. Monoclonal Antibody Production Core)
Name of Core Leader: (e.g., Smith, Robert A.)
Human Subjects (Yes or No)
If Yes,
Exemption Number, -or-
IRB Approval Date (e.g., 5/14/06, or Pending), and Federal wide Assurance (FWA) number
Vertebrate Animals (Yes or No)
If Yes,
IACUC Approval Date (e.g., 4/15/07, or Pending), and Animal welfare assurance number
Proposed Period of Support
From: (mmddyy, e.g., 07/01/2007)
To: (mmddyy, e.g., 06/30/2012)
Costs Requested for Initial Budget Period
Direct Costs (e.g. $50,000)
Total Costs (e.g. $70,000)
Costs Requested for the Entire Budget Period
Direct Costs (e.g. $212,323)
Total Costs (e.g. $297,252)
Applicant Organization (ABC University; 111 Main Street; Anywhere, Else 99999)
The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual. For all other items in the core application, follow the usual PHS 398 instructions.
2. Form Page 2.
Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.
List the performance sites where the core activities and services will be conducted.
Under "Key Personnel", list the Core Leader,
followed by other key core personnel, and then other significant contributors.
3. Form Page 3.
Prepare a Table of Contents for the core using page 3 of Form PHS 398.
4. Budget Pages (PHS 398 Form Pages 4 and 5)
Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.
5. Research Plan
Introduction (For Resubmission or Revision Projects within a Resubmission or Revision Application Only, Limited to 1 page.)
See specific instructions in 2.7 Resubmission Applications and 2.8 Revision Applications on the content of the Introduction. New applications and cores should not include an Introduction.
Specific Aims (Limited to 1 page.)
List in priority order, the broad, long-range objectives and goals of the proposed core. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the core’s relationship to the multi-project program goals and how it relates to the research projects or other cores in the application.
Core Research Strategy (Limited to 6 pages.)
Use this section to describe how the proposed core activities will contribute to meeting the program's 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 multi-project application..
Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5. 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 cores in a revision application must be included as part of the approach section.
6. Resources
Provide information on resources available for the core. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
7. Biographical Sketches
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
8. Select Agent Research (if applicable)
As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used with respect to the core. Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s). Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Describe the biocontainment resources available at all performance sites.
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
See Section IV.2, Content and Form of Application Submission and additional text above for page limitations associated with multi-project applications.
PHS398 Research Plan Component Sections
All application instructions outlined in the PHS 398 Application Guide are to be followed, with the following additional requirements:
Budget Component
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.
Specific Instructions for Applications
Requesting $500,000 (direct costs) or More per Year
Applicants requesting $500,000 or more in direct costs
for any year (excluding consortium F&A costs) must carry out the following
steps:
1) Contact the IC program staff at least 6 weeks
before submitting the application, i.e., as plans are being developed for the
study;
2) Obtain agreement
from the IC staff that the IC will accept the application for consideration for
award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Section V. Application Review Information
1.
Criteria
Only the review criteria described below will
be considered in the review process.
2. Review and Selection Process
Review Process
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Review Criteria for Individual Research Projects
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are all the necessary skill sets of the PD/PIs and key personnel sufficient to accomplish the goals of the application?
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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the candidate vaccine feasible for further preclinical and clinical development? Are the milestones and timelines appropriate for the proposed approach?
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? What is the adequacy of the facilities for cGMP manufacturing?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.
Review Criteria for a Multi-Project Application (U19)
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Overall Impact of the Multi-Project Application: The following items will be considered in the determination of the overall scientific and technical merit and impact/priority score for the entire multi-project application: 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 meet the objectives of the FOA? Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently? Does the Principle Investigator have the leadership and scientific ability to develop an integrated and focused research program? Will the PI and other Project/Core Leaders devote adequate time and effort to the program? For renewal applications, what are the accomplishments and progress achieved during the prior funding period? Is there adequate evidence of sufficient institutional support for the PI in terms of laboratory space, equipment and other resources? For applications designating multiple PDs/PIs, is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PDs/PIs? Is there an adequate Clinical Trial Synopsis? Does the overall Product Development and Clinical Trial Plan have realistic timelines with measurable Go/No Go milestones? Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate?
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?
Scientific Cores (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?
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.
Renewal Applications. Renewal applications are not allowed for this FOA.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award
Dates
Not Applicable
Section VI. Award Administration Information
1. Award Notices
After the peer
review of the application is completed, the PD/PI will be able to access his or
her Summary Statement (written critique) via the 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.
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 Also Section IV.5. Funding Restrictions.
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.
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards,
Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and
Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official at the time of award.
2.A. Cooperative
Agreement Terms and Conditions of Award
The following
special terms of award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant administration regulations
at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local
Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement, an "assistance"
mechanism (rather than an "acquisition" mechanism), in which
substantial NIH programmatic involvement with the awardees is anticipated
during the performance of the activities. Under the cooperative agreement, the
NIH purpose is to support and stimulate the recipients' activities by
involvement in and otherwise working jointly with the award recipients in a
partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the dominant
role and prime responsibility resides with the awardees for the project as a
whole, although specific tasks and activities may be shared among the awardees
and the NIH as defined below.
2.A.1. Project
Director/Principal Investigator (PD/PI) Rights and Responsibilities
The Principal Investigator will have the primary responsibility for: defining the research objectives, approaches, and details of the projects within the guidelines of the PAR and for performing the scientific activities.
Annual Site Visit Review
All awardees are required to host for the NIAID/DAIDS Program Officer and NIAID Program Staff, an annual site visit review. The PI, all co-Investigators, and the External Advisory Committee (see below under Collaborative Responsibilities) members shall attend this meeting. An update and summary of the results generated on each project shall be presented by the PI, Co- Investigators, and/or pertinent staff. These presentations should include summaries of all goals or milestones (refer to Other Submission Requirements section of the PAR) and a description of all problems encountered that may have an impact on the achievement of future goals and milestones.
Review at 2.5 years. At the mid-point of the grant (2.5 years), the NIAID Program Officials with assistance from other NIAID staff will assess the accomplishment of the milestones as a measure of progress, the immunologic parameters of the vaccine candidate as an efficacious prophylactic HIV/AIDS vaccine, and whether the feasibility of manufacture as reported will allow, with high probability, initiation of a clinical study within the duration of the grant. The assessment will be based on the first two annual reports and any additional information that the PI elects to submit at the 2.5 year period (Refer to Section Mid-Point Progress Report above and Reporting below for specifics on the mid-point review process).
Intellectual Property
The successful development of tools for the evaluation of a prophylactic HIV/AIDS vaccine will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet this critical public health need. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees understand and acknowledge the following:
The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for applicant to perform the project;
Before, during, and subsequent to the award, the U.S. Government is not required to obtain for awardee any proprietary rights, including intellectual property rights, or any materials needed by awardee to perform the project;
Awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified at 35 U.S.C. Sect. 202 (Bayh-Dole Act) ). In addition, awardees are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goal of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and report to the NIAID or other mechanisms consistent with laws, regulations, and NIH policies.
Data
Awardees will retain custody of and have primary
rights to the data and software developed under these awards, subject to
Government rights of access consistent with current HHS, PHS, and NIH policies.
2.A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.
NIAID program staff will provide technical assistance, advice, and coordination, and interact with the PI on a regular basis to monitor study progress, regulatory compliance, adherence to clinical protocol, and quality assurance in order to ensure the production of high-quality, unbiased results. Monitoring may include: (1) regular communication with the PI and staff, (2) periodic site visits for discussions with awardees research teams, and (3) observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters, as well as, (4) attendance at and participation in annual site visit meetings and/or External Advisory Committee meetings. The NIAID retains as an option, periodic review of progress. NIAID retains the right to independently monitor any clinical trial to ensure adherence to regulatory requirements. Such review and monitoring may be conducted through organizations contracted by and acting on behalf of NIAID.
NIAID program staff will serve as a resource with respect to concurrent NIAID research and research support activities that may be relevant to the IPCAVD project, to facilitate compatibility, avoid unnecessary duplication, and potentially forge collaborations that may enhance the quality and breadth of the study.
NIAID program staff will provide substantial assistance in design and coordination of preclinical research activities and clinical testing for awardees, including: (1) advice on the planning, management, and technical performance of the investigators, (2) access to and use of reagents and assays, and other resources available through NIAID contractors and grantees, including the independent non-clinical evaluation of the candidate vaccine , (3) technical advice and assistance for meeting Food and Drug Administration requirements for investigational drugs, (4) serving as the point of contact between the PI and NIAID for initiating the NIAID review process of all clinical protocols (per the NIAID Clinical Terms and Conditions of Award), (5) providing guidance (e.g., submission of the required documentation etc.) for the NIAID clinical protocol review process, and (6) providing guidance and oversight throughout the clinical trial to ensure that the awardee is in full compliance with all human subjects research as delineated in the NIAID Clinical Terms and Conditions of Award.
At the mid-point of the cooperative agreement (2.5 years), NIAID Program Officials, will assess the accomplishment of the milestones as a measure of progress, the immunologic parameters of the vaccine candidate as an efficacious prophylactic HIV/AIDS vaccine, and whether the feasibility of manufacture as reported will allow, with high probability, initiation of a clinical study within the duration of the grant. The assessment will be based on the first two annual reports and any additional information that the PI elects to submit at the 2.5 year period (Refer to Section Mid-Point Progress Report above and Reporting below for specifics on the mid-point review process). Based on comments from the peer reviewers, the Program Official may wish to revise the milestones included in the application through negotiation with the awardee. The revised milestones will be included in the Terms of Award.
Funding for the final 2 years of the cooperative agreement will be contingent on the successful completion of the negotiated milestones delineated in the Terms of Award and the feasibility of clinical testing within the funding period, as determined by this mid-point review.
The decision to release funds for initiation of the Project Development Project will be contingent upon the successful completion of a DAIDS-contracted GMP audit of the manufacturing facility.
Additionally, an NIAID program official or NIAID program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
External Advisory Committee
In addition to the
interactions defined above, awardees and NIAID staff shall share responsibility
for the organization of an External Advisory Committee (EAC). The composition
and membership of the EAC shall be determined by consensus between the PI and
the NIAID Program Officials. The EAC will consist of a minimum of 3 members not
directly affiliated with the research being conducted by the awardee. The
EAC, together with the PI, will be responsible for determining progress of the
PI/co-investigators during the annual site visit. The EAC will provide
input into the mid-point review.
Each EAC member will have one vote. Awardees will be required to accept and
implement policies approved by the External Advisory Committee.
2.A.4. Dispute Resolution Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to dispute resolution. A
Dispute Resolution Panel composed of three members will be convened. It will
have three members: a designee of the Steering Committee chosen without NIH
staff voting, one NIH designee, and a third designee with expertise in the
relevant area who is chosen by the other two; in the case of individual
disagreement, the first member may be chosen by the individual awardee. This
special dispute resolution procedure in no way affects the awardee's right to
appeal an adverse action that is otherwise appealable in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
Mid-Point Progress Report
In addition to the annual site visits, the PI will be required to submit a written mid-point progress report delineating progress on each of the stated milestones, the immunologic parameters of the vaccine candidate as an efficacious HIV/AIDS prophylactic vaccine, the feasibility for GMP manufacture, and a clear plan for the initiation of a clinical study. All information must be provided no later than 1 month before the 2.5 year stage of the award.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into the following three areas: scientific/research, peer review, and financial or grants management issues.
Applicants are encouraged to contact NIAID program staff well in advance of the application submission date to discuss the proposed research with program. Discussion with program staff does not guarantee funding of an application.
1. Program/Scientific/Research
Contact:
Michael Pensiero, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5136, MSC-7628
6700B Rockledge Drive
Bethesda, MD 20892-7628
Bethesda, MD 20817 (for express mail)
Telephone: 301-435-3749
FAX: 301-402-3684
Email: [email protected]
2. Peer Review Contacts:
Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD, 20892-7616
(FedEx zip: 20817-7616)
Telephone:
301-402-1464
FAX:
301-480-2408
Email: [email protected]
3.
Financial or Grants Management Contacts:
Chanee Williams
Division of Extramural Activities
National Institute of Allergy and Infectious
Diseases
Room 2248, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614 (20817 express)
Telephone: 301-496-7075
FAX: 301-480-3780
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 (45CFR46) 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.
Policy for Genome-Wide Association Studies
(GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of
grantees and contractors to elect and retain title to subject inventions
developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or
contract proposal, beginning with the October 1, 2004 receipt date, are
expected to include in the application/proposal a description of a specific
plan for sharing and distributing unique model organism research resources
generated using NIH funding or state why such sharing is restricted or not
possible. This will permit other researchers to benefit from the resources
developed with public funding. The inclusion of a model organism sharing plan
is not subject to a cost threshold in any year and is expected to be included
in all applications where the development of model organisms is anticipated.
Access
to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide public access to research data through the
Freedom of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with Federal
funds and (2) cited publicly and officially by a Federal agency in support of
an action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this
funding opportunity in a public archive, which can provide protections for the
data and manage the distribution for an indefinite period of time. If so, the
application should include a description of the archiving plan in the study
design and include information about this in the budget justification section
of the application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH
definition of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language governing
NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and
updated roles and responsibilities of NIH staff and the extramural community.
The policy continues to require for all NIH-defined Phase III clinical trials
that: a) all applications or proposals and/or protocols must provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including subgroups if
applicable; and b) investigators must report annual accrual and progress in
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be
found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the
NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with
the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must
submit or have submitted for them their final, peer-reviewed manuscripts that
arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS)
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 DHHS 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 FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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 NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
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.
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NIH Funding Opportunities and Notices
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