and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National
Institute of Allergy and Infectious Diseases (NIAID), (http://www3.niaid.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), http://www.ninds.nih.gov)
Title: HLA
Region Genomics in Immune-Mediated Diseases (U01, U19)
Announcement
Type
This is a reissue of RFA-AI-04-039
Update: The following updates relating to this announcement have been issued:
Key Dates
Release Date: July 31, 2009
Letters of Intent Receipt Date: October 19, 2009
Application Receipt Date: November 19,
2009
Peer Review Date: March 2010
Council Review Date: May 2010
Earliest Anticipated Start
Date: July 2010
Additional Information To Be Available Date
(Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: November 20, 2009
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(s) 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, Review and Anticipated Start Dates
1. Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
D. Application
Assignment
4.
Intergovernmental Review
5. Funding
Restrictions
6.
Other Submission Requirements
Section V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Resource Sharing Plan(s)
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. Arbitration 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
Purpose:
The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Neurological Disorders and Stroke (NINDS) invite new and renewal applications from institutions to participate in the HLA Region Genomics in Immune-Mediated Diseases Consortium (HLAGC), a cooperative research group whose goals are to define the association between variations in human leukocyte antigen (HLA) and natural killer cell immunoglobulin-like receptor (KIR) genetic regions and immune-mediated diseases, including risk and severity of disease, and organ, tissue, and cell transplantation outcomes. The purpose of this FOA, through renewal of the HLAGC program, is to continue to generate high quality HLA- and/or KIR- disease association data that will be submitted to and maintained by dbMHC (http://www.ncbi.nlm.nih.gov/gv/mhc/main.fcgi?cmd=init ) and dbGaP (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=gap ), the publicly accessible databases of MHC genetics and of genotypes and phenotypes, respectively, which are housed and maintained by the National Center for Biomedical Information (NCBI) at the National Institutes of Health National Library of Medicine (NLM).
The NIAID Bioinformatics Information Support Contract (BISC) program (http://www3.niaid.nih.gov/about/organization/dait/bisc.htm ) will provide information technology support, software development, and statistical analysis for all HLAGC awardees. In addition, BISC will facilitate data submission to dbMHC and dbGaP. For an overview of BISC’s Immunology Database and Analysis Portal (ImmPort), please see (https://www.immport.org/immportWeb/home/home.do ). BISC was developed to provide access for all NIAID-supported investigators to high-quality bioinformatics technology support. BISC is also charged with developing standards for data collection and exchange that can be adapted by NIAID-supported research programs. For more details concerning the involvement and responsibilities of BISC, please see Cooperative Agreement Terms and Conditions of Award located in Section VI.2.2.A. NIAID staff contact information for questions regarding BISC can be found under Section VII, Agency Contacts.
Background:
Immune-mediated diseases affect approximately 10% of the world’s population. Risk and severity of these diseases have been shown to correlate with genetic variations in the human major histocompatibility complex (MHC) region genes also known as human leukocyte antigens (HLA) genes. The HLA gene complex is the most polymorphic region of the human genome, displaying an extraordinary degree of sequence variation between individuals, racial groups and ethnic populations. It covers a 4-megabase span of chromosome 6 and includes HLA Class I, II and III genes. HLA Class I and II-encoded molecules present endogenously and exogenously derived peptides to T cells, while HLA Class III-encoded molecules include a variety of immune response genes such as complement components and inflammatory mediators. HLA Class I molecules also serve as identification ligands for KIR on natural killer cells. Although the KIR genetic region is less polymorphic and smaller than the HLA region, it extends over 150kb of DNA and includes 17 genes, which show a high degree of diversity. Each gene is represented by 2-12 alleles, with the various allele combinations accounting for at least 42 different KIR haplotypes.
In fiscal year 2005, the NIAID began support of the HLAGC with co-sponsorship from NINDS. To reflect the genomic nature of the studies conducted by the HLAGC, the name has changed with the current FOA to HLA Region Genomics in Immune-Mediated Diseases Consortium. The scope of this program is to define and catalog the associations between HLA and KIR gene sequence variations and susceptibility to immune-mediated diseases, including autoimmune diseases, primary immunodeficiencies and outcomes of cell, tissue and organ transplantation. Genome-wide scans of individuals with these diseases consistently reveal the highest association with genes in the HLA region. Identification and definition of the role of specific HLA-region and KIR-region gene variations in disease susceptibility or protection, progression, and severity will allow clinicians to predict disease risk and to develop targeted treatments and/or preemptive strategies. The studies currently carried out by the HLAGC focus on seven autoimmune diseases (Multiple Sclerosis, Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Myasthenia Gravis, Systemic Lupus Erythematosus, Crohn’s Disease and Ulcerative Colitis), two primary immunodeficiencies (IgA deficiency and Common Variable Deficiency), and outcomes of hematopoietic stem cell transplantation. This research has proven valuable in establishing inter-disease and inter-disciplinary research collaborations in which researchers share discoveries, technologies, and standardized reagents, as well as data from valuable control populations. The NIAID intends to renew the HLAGC program to continue progress in studying HLA and KIR region genomics; continue efforts to identify, map, and associate genetic variants with various immune-mediated diseases, with an emphasis on population diversity; and populate dbMHC and dbGAP with high-quality, high-resolution HLA and KIR genomics data.
Objective and Scope:
This FOA will support prospective and/or retrospective studies to investigate the role of the HLA and KIR genomic regions in susceptibility to or protection from immune-mediated diseases, including autoimmune diseases and primary immunodeficiency diseases, graft versus host disease (GVHD), and graft rejection or survival in solid organ, tissue and cell transplantation. The primary focus of the application must be on the correlation between HLA and/or KIR genomic regions and immune-mediated diseases, including transplantation outcomes. Especially encouraged are studies examining the association between race- or ethnically-specific HLA region diversity and disease susceptibility or transplant outcomes. Studies may examine polymorphisms in the coding and/or non-coding regions within the HLA and KIR regions.
Research projects may address, but are not limited to the following research areas:
Applicants proposing multi-institutional projects are encouraged to provide the breadth and depth of expertise and research tools necessary to carry out the objectives of this FOA. The applicant will be responsible for all aspects of data collection, determination of optimal sample size for statistical power/validity, and, in collaboration with BISC, statistical analysis of study results. For a complete description of awardee scope responsibilities, see Section VI.2.2.A., Cooperative Agreement Terms and Conditions of Award.
Immune-mediated diseases to be studied may include, but are not limited to, the following:
This FOA will NOT support:
Applicants are encouraged to contact NIAID program staff well in advance of the application submission date to discuss the proposed research program. This will allow staff to assess responsiveness to this FOA and provide appropriate guidance as needed with regard to this initiative. Discussion with program staff does not guarantee funding of an application.
Steering Committee: PD(s)/PI(s) funded under this program will form a Steering Committee after award. This Steering Committee will: serve as the main governing board; identify scientific opportunities, emerging needs, and impediments; ensure the timely release of data through publication and/or release of data to dbMHC and/or other public databases; develop guidelines for publication of collaborative project results; prepare HLAGC cumulative progress reports, when requested by the NIAID Project Scientist; establish policies for data handling in collaboration with BISC and NCBI staff; and establish definitions and data collection standards in collaboration with BISC that will allow pooling of data across studies and disease areas. The Steering Committee will be comprised of one U01/U19 PD/PI from each U01 and U19 award, and one additional U19 project leader from each U19 award, to be selected by the U19 PD(s)/PI(s). The Steering Committee will meet at least annually. Unless agreed to by the NIAID Project Scientist, annual meetings will be held in Bethesda, MD. Budget requests should include travel funds to attend Steering Committee meetings for the PD(s)/PI(s) and for one project leader for U19 projects. Statistical liaisons are required to attend Steering Committee meetings if statistical issues are to be specifically discussed. For more detailed information on the Steering Committee and related guidelines, see Section VI.2.2.A Cooperative Agreement Terms and Conditions of Award: NIH Staff Responsibilities.
Additional Information for Multi-Project (U19) Applications
Research Project: If submitting a multi project (U19) application, at least two research projects must be proposed for the application to be considered responsive.
Administrative Core (required): Each application should provide an Administrative Core headed by the contact PD/PI of the application who is responsible for the overall management, communication, coordination and supervision of the Program. This core may provide infrastructure support for program personnel to work closely with other investigators. The application should include 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, communication expenses, attend steering committee meetings, etc., should be requested here.
Scientific Core(s) (optional): A scientific core is a resource to the multi-project grant as a whole and, if included, must support at least two of the proposed research projects. The application must indicate the specific projects to be served by the Scientific Core(s). 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 described.
See Section VIII, Other
Information - Required Federal Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity will use the U01 and U19 cooperative agreement award mechanisms. The Project Director/Principal Investigator (PD/PI) 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 funding opportunity will use 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".
At this time, NIAID has not determined whether this solicitation will be continued beyond the present FOA.
2. Funds Available
The estimated amount of funds available for support of 4-5 projects awarded as a result of this announcement is $3.525 million in total costs for fiscal year 2010. Future year amounts will depend on annual appropriations.
As a guideline, the approximate amount of funding in direct costs per award in the current funding year is $1.2 million for U19 awards and $0.25 to $0.40 million for U01 awards. An applicant may request a project period of up to 5 years.
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 plan of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The
following organizations/institutions are eligible to apply:
Foreign institutions are not eligible to apply as the primary applicant; however, applications from domestic institutions may include foreign research components or collaborative sites.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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 support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, 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 with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering 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 project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Investigators may only be a PD/PI, or a PD/PI as part of a multiple PD/PI team, on one application submitted in response to this FOA. A PD/PI on a U01 or U19 application or a Project or Core Leader on a U19 application may serve as a collaborator or as a Project or Core Leader on another application submitted in response to this FOA provided there is no scientific overlap with the application submitted by the PD/PI or with the project proposed by the U19 Project or Core Leader. Although more than one PD/PI may be designated on the application, for U19 applications only one Project Leader or Core Leader may be designated for each U19 Project or Core.
PD(s)/PI(s) are expected to commit substantial time and effort to ensure success of the program and should commit, at a minimum, 1.8 calendar months. Project Leaders on U19 applications should commit 1.2 calendar months.
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. An institution may submit more than one application as the applicant institution, provided they are scientifically distinct.
Resubmissions. Resubmission applications are not permitted
in response to this FOA.
Renewals. Renewal applications are permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to Request
Application Information
The
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
Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. 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.
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 .
SPECIAL INSTRUCTIONS
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 such as SO or IAR 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, a new 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.
3.
Submission Dates and Times
Applications
must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt
Date: October
19, 2009
Application Receipt Date: November 19,
2009
Peer Review Date: March, 2010
Council Review Date: May 2010
Earliest Anticipated Start
Date: July 2010
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The
letter of intent is to be sent by the date listed in Section
IV.3.A.
The
letter of intent should be sent to:
B. Duane Price, Ph.D.
Division of Extramural
Activities
National Institute of
Allergy and Infectious Diseases
Room 3139, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or
regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-2592
FAX: (301) 480-2408
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications
must be prepared using the 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 material must be sent to:
B. Duane Price, Ph.D.
Division of Extramural
Activities
National Institute of
Allergy and Infectious Diseases
Room 3139, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular
mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-2592
FAX: (301) 480-2408
Email: [email protected]
3.C. Application
Processing
Applications
must be received on or before the application
receipt date described above (Section IV.3.A.). If an application is received after
that date, the application may be delayed in the review process or not
reviewed. Upon receipt, applications will be evaluated for completeness
by the CSR and for responsiveness by the reviewing Institute Incomplete and/or
non-responsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
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. The Grants Policy Statement can be found at 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 or renewal 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 or renewal award.
The
incurrence of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other
Submission Requirements
Supplemental Instruction for the Preparation of Multi-Project Applications (U19 applicants only)
The following section supplements the instructions found in Form PHS 398 for preparing 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. Applicants preparing single project applications (U01) should follow the PHS Form 398.
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 Principal Investigator of the
multi-project application, followed by the Project 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).
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 Principal Investigator 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 25 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.
If the application is a renewal, this section should also highlight past performance and the major accomplishments from the prior funding period as described in the PHS 398 Instructions. In addition to discussing results from individual projects, describe the synergy and collaborations that occurred within the Program. For individual research projects in a renewal application that will be continued, additional details should be provided in the Progress Report section of the Research Plan within each research project and core.
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.
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
Resources Format Page
Items 2-5 of the Research Plan as defined in the PHS 398 instructions
Items 6-17 of the Research Plan, as appropriate
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 Federalwide 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. 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).
6. Resources Format Page
Provide information on resources available for the project.
7. Research Plan (Items 2-5 cannot exceed 25 pages)
Item 2 -- Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the project's relationship to the multi-project program goals and how it relates to other projects or cores. This section is typically one page.
Item 3 -- Background and Significance: 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.
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
Resources Format Page
Items 2-5 of the Research Plan as defined in the PHS 398 instructions
Items 6-17 of the Research Plan, as appropriate
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 Federalwide 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. Biographical Sketches
Do not repeat the biographical sketches of participating investigators since this information will be located at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
6. Resources Format Page
Provide information on resources available for the core.
7. Core Research Plan (Items 2-5 cannot exceed 10 pages for the Administrative Core and 15 pages for each Scientific Core)
Item 2 - Specific Aims: List in priority order the broad, long-range objectives of the proposed core. 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.
Item 3 - Background and Significance: Use this section to describe how the proposed core activities will contribute to meeting the goals and objectives and explain the rationale for the 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 grant.
Special Requirements for all U01 Applications and Individual Research Projects in U19 Applications
1) Following items 2-5 of the Research Plan and within the 25 page Research Plan page limit of single project (U01) applications, and individual research projects in a multi-project (U19) application, applicants should include the following:
a) A section titled Timelines and Milestones with clearly stated interim and long-term objectives and milestones (e.g., subject recruitment and data deposition into BISC) to be achieved during the project, identify impediments or critical decision points that could require a revision in the work plan, and provide a detailed timeline for the attainment of each goal for each proposed research project.
b) A section titled Experience and Qualifications with a detailed description of demonstrated scientific and technical expertise related to the design, conduct, analysis and interpretation of work as related to the proposed specific aims, and in a research program of similar size and scope.
c) A section titled Statistical Plan with: (1) a detailed description of the statistical considerations to be utilized in determining the sample size and statistical power/validity for the proposed studies and a justification for the required sample size for each proposed research project; (2) a statistician named to serve as the: project’s statistical expert with direct responsibility for statistical analysis; as liaison to BISC throughout the data submission, data cleaning and analysis phases; and as the point of contact between BISC and the PD/PI, multi-PDs/PIs, and/or Project Leaders for issues related to the design and implementation of statistical methods utilized by BISC for analysis of study results, and a clear plan for these interactions with BISC through the statistical liaison; and (3) an outline of the process and format proposed for data submission to ImmPort (for an overview of BISC and ImmPort, please see https://www.immport.org/immportWeb/home/home.do ). Development of any necessary analytical tools will be the responsibility of BISC with input from the PD/PI, statistical liaison, and the Steering Committee (see Section VI.2.2.A, Cooperative Agreement Terms and Conditions of Award: Data Handling and Statistical Analysis ). BISC will also assist as needed with statistical analysis.
d) A section titled Study Population(s) with a description of study populations and, for prospective studies, demonstrated capacity to recruit human subjects. Human samples may be derived from ongoing, completed, or prospective clinical trials or studies in which samples were maintained for the expressed purpose of future genomic research or in which individuals are re-consented to allow use of specimens for this research. Support for clinical procedures to obtain samples that are not part of an associated clinical trial or study (e.g., additional biopsies) should be clearly described and strongly justified. In addition, applications should include documentation of the ability to acquire human samples and clinical data for the proposed studies.
If the studies are to be conducted on samples from an ongoing clinical trial or not currently in the possession of the PD/PI, the application should include as an attachment a letter of support from the person or institution who controls the samples indicating that the samples will be made available to the applicant. The NIH brochure entitled "Research on Human Specimens: Are You Conducting Research Using Human Subjects?" may be useful to applicants (http://www.cancerdiagnosis.nci.nih.gov/specimens/brochure.htm). OHRP guidance on Repositories, Tissue Storage Activities and Data Banks should also be considered (http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm).
Please note: IRB approval of the consent form(s) is not required at the time of submission of the application. However, at a minimum, a draft of the consent form to be used for the studies, as well as the consent form for any associated clinical trial or study, if applicable, should be included after Items 2-5 of the Research Plan. These pages will not be counted as part of the 25 page Research Plan page limit.
B. Special Requirement for Multi-project U19 Applications:
As part of the Program Overview section in multi-project U19 applications, applicants should provide: a clear and concise plan that depicts the interrelationships among the research groups, their relevant experience/expertise, and the contribution of each to fulfillment of the objectives of this FOA; and an organizational chart of the U19 cooperative group showing the name, organization, and scientific discipline of the PD/PI 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. If the application is from a consortium of institutions, the applicant should provide a plan to ensure the maintenance of close cooperation and effective communication among members of the U19 cooperative group.
For cooperative agreements, awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.2.A.
Research Plan Page Limitations
See Section IV.2, Content and Form of Application Submission for Research Plan page limitations associated with single project applications and see text above for page limitations associated with multi-project applications.
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 of the Research Plan component. 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/.
Section V. Application Review Information
1. Criteria
Only the review criteria described below
will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by 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 following will be considered in making funding decisions:
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 U01 Applications and Individual Projects within Multi-Project (U19) Applications
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 core review criteria, and additional review criteria (as applicable for the project proposed).
Core 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, 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? Is the level of effort of the PD/PI, multi-PD(s)/PI(s) or Project Leader(s) sufficient to ensure success of the program? Is there adequate scientific and technical experience within the team for the work proposed, including involvement in a program of similar size and scope?
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? Are there sufficient preliminary data to support the proposed research projects? Does the applicant provide compelling evidence that the genetic material and clinical data necessary for the proposed project will be available within an acceptable timeframe? Are milestones and timelines reasonable and appropriate? If applicable, is the study adequately powered? Are the statistical plan and interactions with BISC adequately described and appropriate?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria for U19 Multi-Project Applications:
Overall Impact of the U19 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 U19? Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently? Does/Do the PD(s)/PI(s) have the leadership and scientific ability to develop an integrated and focused research program? Will the PD(s)/PI(s) 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? For applications designated 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?
Administrative Core: Reviewers will consider each of the criteria below in the determination of 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? Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate?
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?
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.
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.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
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.
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.
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.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 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).
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.
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 (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award
costs. See Also Section IV.5. Funding Restrictions.
2. Administrative
and National Policy Requirements
All
NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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. Principal Investigator Rights and
Responsibilities
The Principal Investigator (PD/PI) will have the primary responsibility for: defining the research objectives, approaches and details of the projects within the guidelines of the FOA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below.
The Principal Investigator will: determine and coordinate the scientific and administrative activities of the approved projects; set project goals and timelines; accept and implement common guidelines approved by the Steering Committee; collect, validate and assure the quality of the data; interact with BISC staff through the statistical liaison; submit data to ImmPort, BISC s Immunology Database and Analysis Portal, and agree to the subsequent submission of these data to dbMHC and dbGaP by BISC in accordance with policies established by NIAID and NCBI and the NIH data sharing policy available at: http://grants.nih.gov/grants/policy/data_sharing/. In addition, each PD/PI will attend Steering Committee meetings, serve as a voting member of the Steering Committee (one PD/PI if multiple PDs/PIs); and participate in HLAGC activities. The awardee will be responsible for the study design and preliminary statistical analysis necessary to ensure adequate sample size for study validity.
NIAID intends to support the peer-reviewed studies proposed in the awarded grant applications. However, under special circumstances (e.g., duplicative or overlapping specific aims among awardees), the Steering Committee will establish guidelines and review procedures, and will evaluate and recommend to the NIAID opportunities for collaboration, redirection or modification of the peer-reviewed or new projects when applicable and necessary. This policy is in keeping with the terms and conditions of the cooperative agreement mechanism. Any recommendations that result in a change in the research projects must be approved by the NIAID Program Official.
The PD/PI, or contact PD/PI in the case of a multi-PI application, will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Agreement. All publications and presentation abstracts resulting from work done in this consortium will be submitted to the Program Officer at least one week prior to journal submission for review, and within two weeks of acceptance for publication so that an up-to-date summary of the cooperative program accomplishment can be maintained and NIAID press releases can be prepared and coordinated. Publications or oral presentations of work performed under this Agreement are the responsibility of the PD(s)/PI(s) and appropriate Project Leaders and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.
Prior to award, the PD/PI (multiple PDs/PIs) agrees to
document commitment to the collaborative group, signed by the PD/PI (multiple
PDs/PIs) and the applicant institution, to participate in the cooperative
research program, including serving on the Steering Committee, adhering to
Steering Committee polices and decisions, and accepting the participation and
assistance of NIH staff.
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 non-cooperative agreement awards, as described below.
The NIH/NIAID Project Scientist, with assistance from the NINDS Project Scientist and other scientific program staff, will support the HLAGC activities through technical assistance, advice and coordination, including providing assistance with the design of the Steering Committee technical and management activities; serve as facilitator of activities, such as the selection of resources and identification of potential collaborations to further the goals of the Program. In addition, the NIAID Project Scientist will coordinate NIH staff assistance, including interactions with BISC. The role of the NIAID Project Scientific will be to facilitate, not direct, the activities.
The NIH/NIAID Project Scientist will serve as a non-voting member of the Steering Committee and will assist with scheduling meetings and teleconferences of the Steering Committee and subcommittees, provide assistance to the Steering Committee in the development of procedures for evaluating the performance of research studies, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies. It is anticipated that the majority of Steering Committee decisions will be reached by consensus and that NIAID staff will be given the opportunity to offer input into this process. However, the manner of reaching this consensus and the primary decision-making responsibility will rest with the Steering Committee, except where stated in this FOA.
Additionally, an NIH program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Program Officer may also serve as the Project Scientist. The Government, via the NIAID Program Official, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.
Release of each annual funding increment by NIAID will be
based on an NIAID review of progress towards achieving the previously agreed
upon research goals, interim objectives and milestones. It is recognized
that project goals may require revision and re-negotiation during the course of
the project period. The NIAID reserves the right to terminate or curtail
a study (or any individual award) in the event of a substantial shortfall in
participant recruitment, follow-up, data reporting, quality control, or other
major breach of the approved project.
2.A.3. Collaborative Responsibilities
Steering
Committee
A Steering Committee will serve as the governing board of the HLAGC. Each voting member of the Steering Committee will have one vote. Voting membership of the Steering Committee will include one U01/U19 PD/PI and one additional individual U19 project leader from each U19 award, to be selected by the U19 PD(s)/PI(s). Therefore, each U01 has one vote and each U19 has two votes on the Steering Committee. In the case of U01/U19 awards with multiple PDs/PIs, only one PD/PI will be a voting member of the Steering Committee, to be determined by the U01/U19 PDs/PIs. Voting membership may be rotated between PD/PIs and Project Leaders at the discretion of each U01/U19 PDs/PIs. The non-voting PD/PIs and Project Leaders will serve as non-voting Steering Committee members.
The Steering Committee will appoint additional non-voting members by majority vote. In addition, the NIAID may appoint two external scientists to an Advisory Working Group (acting in a scientific advisory capacity to NIAID) and a representative from BISC and a member of the NCBI dbMHC and dbGAP development staff to the Steering Committee as non-voting members. The NIAID and NINDS Project Scientists will also serve as non-voting members. A Chairperson will be selected by the Steering Committee from among the voting Committee members. Subcommittees of the Steering Committee may be established as necessary. Each Steering Committee and subcommittee member will participate in all meetings, teleconferences, and activities of those committees. Statistical liaisons are required to attend Steering Committee meetings if statistical issues are to be specifically discussed. All consortium investigators will be required to accept and implement common guidelines and procedures approved by the Steering Committee. The Steering Committee will meet at least annually. Unless agreed to by the NIAID Project Scientist, annual meetings will be held in Bethesda, MD. Budget requests should include travel funds to attend Steering Committee meetings for the PD(s)/PI(s) and for one project leader for U19 projects.
The Steering Committee or a designated subcommittee will prepare a cumulative group progress report, when requested by the NIAID Program Official, generally at the completion of the second year of funding and either annually or biannually after the first report. This cumulative group progress report will, at a minimum, contain the following information: project overviews, progress of ongoing and newly-initiated projects; manuscripts published, in press, and in preparation; presentations at regional, national, and international meetings; ongoing and planned interactions with other NIH-supported research programs; other activities of the group; data submitted to dbMHC and other databases, as applicable; and future plans. The first such report will be submitted to the NIAID Program Official no later than four months after the NIAID Program Official requests a report, or a time agreed upon by the Chairperson of the Steering Committee and the NIAID Program Official.
The NIAID Project Scientist will schedule the meetings of the Steering Committee and actively assist the Chairperson in developing the meeting agendas. The Project Scientist will ensure coordination of the Steering Committee’s activities and implementation of its recommendations.
The Steering Committee will:
Subcommittees of the Steering Committee may be established as needed to make recommendations on shared aspects of the cooperative research group, including:
In order to most efficiently utilize research resources and rapidly exchange scientific information to promote HLA genetics research and NIAID objectives, it is anticipated that cooperation or opportunities to collaborate with other NIH funded programs will be initiated in future years and will be coordinated and facilitated by the NIAID Project Scientist.
Data Handling and Statistical Analysis
The data generated by the HLAGC will be submitted to the BISC database, ImmPort. ImmPort is designed to manage data integration and statistical analysis, and will serve as a central data repository for NIAID-supported research in immune-mediated diseases, including linkages with high resolution HLA genomic information. Each awardee will collect and ensure the consistency and quality of their data, with assistance from BISC, as needed. . For an overview of BISC’s Immunology Database and Analysis Portal (ImmPort), please see (https://www.immport.org/immportWeb/home/home.do ).
BISC Responsibilities
BISC will be responsible for data receipt, deposition, curation, archive and backup, recovery (as necessary), statistical analysis, and subsequent data deposition into and interface with dbMHC, dbGaP and other appropriate public databases (e.g., dbSNP, GenBank). BISC will develop and disseminate software for data submission and analysis as needed. BISC will also provide statistical software tools for local interim analysis (as needed), and assist with technical support in the collection, submission, and exchange of data primarily through the statistical liaison of each U01/U19 project. BISC will provide feedback to the statistical liaison regarding the quality of data submitted, and will accept data from the project(s) in a variety of formats (such as XML or tab-delimited text files), which will be determined in consultation with the Steering Committee and project statistical liaisons. NIAID staff contact information for questions regarding BISC can be found under Section VII, Agency Contacts .
Data Sharing and Submission to dbMHC and dbGaP
Timely release of data to NIH-supported
and/or public databases is expected in accordance with the guidelines
established by the NIAID, NCBI, and NIH data sharing policy available at: http://grants.nih.gov/grants/policy/data_sharing/.
One of the goals of the HLAGC is to enter data generated from these studies
into the NCBI-maintained dbMHC and dbGaP databases. Both are
open, publicly accessible platforms: dbMHC contains DNA and clinical data
related to the human major histocompatibility complex, dbGaP, human DNA and
phenotypic data, derived from genome-wide association studies, molecular
diagnosis assays, and medical sequencing. Data generated or analyzed
through the HLAGC will be submitted to dbMHC and dbGaP through BISC. Data
submitted to dbMHC and dbGaP will be released to the public on a schedule
determined by the NIAID and the NCBI in consultation with the individual
investigators.
2.A.4. Dispute Resolution
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
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning this
funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Jeffrey Rice, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 6221, MSC-6601
6610
Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-5598
FAX: (301) 496-0693
Email: [email protected]
Ursula
Utz, Ph.D., MBA
Neural Environment
National
Institute of Neurological Disorders and Stroke
Room
2134, MSC-9521
6001 Executive Boulevard
Bethesda, MD 20892-9521
Telephone: (301) 496-1431
FAX: (301) 480-2424
Email: [email protected]
Direct questions related to BISC to:
Cheryl Kraft, M.S.
Division
of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room
3005, MSC-6601
6610
Rockledge Drive
Bethesda, MD 20892-6601
Telephone:
(301) 755-4029
FAX:
(301) 480-2381
Email: [email protected]
2. Peer Review Contacts:
B.
Duane Price, Ph.D.
Division of Extramural
Activities
National Institute of
Allergy and Infectious Diseases
Room 3139, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or
regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-2592
FAX: (301) 480-2408
Email: [email protected]
3. Financial or Grants Management Contacts:
Julie Waugh
Division of Extramural Activities
National
Institute of Allergy and Infectious Diseases
Room 2239, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
FEDEX
ZIP: 20817-7616
Telephone:
(301) 451-7381
FAX:
(301) 493-0597
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients
of PHS support for activities involving live, vertebrate animals must comply
with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human
Subjects Protection:
Federal
regulations (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. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
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/.
Access to Research Data through the Freedom
of Information Act:
The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the distribution
for an indefinite period of time. If so, the application should include a
description of the archiving plan in the study design and include information
about this in the budget justification section of the application. In addition,
applicants should think about how to structure informed consent statements and
other human subjects procedures given the potential for wider use of data
collected under this award.
Sharing
of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement 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.
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-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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