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 Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
Title: The
FaceBase Consortium: Functional Genomics of Craniofacial Development and
Disease (U01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-DE-09-003
Catalog of Federal Domestic Assistance Number(s)
93.121
Key Dates
Release Date: October 30, 2008
Letters of
Intent Receipt Date: January
2, 2009
Application Receipt Date: January 30, 2009
Peer Review
Date(s): May/June 2009
Council Review
Date: August 2009
Earliest
Anticipated Start Date: September 2009
Additional Information To Be Available Date (Url
Activation Date): Not applicable
Expiration Date: January 31, 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 and Information
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
OBJECTIVE
This comprehensive research initiative is focused on understanding the genetic basis of craniofacial development and the etiological spectrum for the manifestation of craniofacial diseases and disorders. Central to this initiative is the creation of the FaceBase Consortium to coordinate research efforts, to facilitate synergy, to accomplish targeted milestones and to accelerate progress. The accumulated knowledge will be housed in a database termed FaceBase for coordination, management, integration and mining. This initiative embraces the elements of experimental data collection and annotation, data coordination and integration, systems level analyses, and clinical application. The long-term program goal is to accelerate development of molecular medicine for improved risk assessment, effective prevention, screening and treatment strategies, as well as functional restoration in oral, dental and craniofacial disorders.
BACKGROUND
More than half of all birth defects are associated with some form of craniofacial malformation. Orofacial clefts alone occur in approximately one in 700 live births, and affect more than 6,800 infants every year in the United States. The lifetime cost of treating the children born each year with cleft lip or cleft palate is estimated to be almost $700 million. Although surgery can correct these structural defects, patients still face a lifetime of functional, social, and aesthetic challenges. Many other syndromes are associated with oral, dental and craniofacial defects, and although less common than clefts, these syndromes exert a tremendous financial, social and psychological burden on affected families. One of the key missions articulated in the NIDCR Strategic Plan is to strive through research, to build a broader knowledge base for the development of methods to prevent craniofacial birth defects, and to improve prenatal diagnosis and treatment. In addition, one of our top research priorities in the Implementation Plan for the Strategic Plan is to advance the understanding of the normal and abnormal processes underlying oral, dental and craniofacial diseases and disorders by supporting research to understand the molecular mechanisms underlying gene-disease associations, genes, and gene products in normal craniofacial development, and gene-environment interactions in oral, dental and craniofacial diseases and disorders.
While there have been successes in identifying and characterizing the genetic etiology of many craniofacial disorders with ‘simple’ Mendelian inheritance, much less is known regarding the genetics of complex disease traits and the extent of environmental perturbation. It is increasingly evident that cumulative small effects of numerous alleles and variations in gene dosage may confer predisposition to diseases. Differences in penetrance and expressivity of genetic variants highlight the importance of genetic background and environmental exposures in determining complex disease phenotypes. Moreover, it is becoming apparent even for Mendelian traits, that much research is needed to achieve a molecular and cellular understanding of the mechanisms by which genes and gene products interact to generate complex phenotypes.
In recent years developmental biologists have made tremendous progress in revealing conserved gene regulatory modules that are crucial for patterning the cranial neural crest and signaling pathways that regulate tissue interactions during craniofacial development. Human geneticists have also achieved remarkable recent success in identifying genes involved in craniofacial defects, including genes recently shown to play a role in human cleft lip and palate. These genes have largely been revealed in genome-wide linkage scans and SNP analysis of candidate genes run on global populations. These successes have positioned us to tackle the next challenge, that of achieving a comprehensive systems biology understanding of how collections of genes interact at the cellular level, to generate normal or defective complex craniofacial phenotypes. This craniofacial construction research theme seeks to approach this goal by establishing multidisciplinary research consortia that merge expertise and integrate information on genetic, cellular, and systems levels to achieve mechanistic insights that will support the design of efficient interventions.
Armed with the human genome and high-resolution information on sequence variations, coupled with increasingly powerful technologies to analyze genomic information and gene expression profiles, we are at the next frontier of using molecular information to understand human craniofacial development and diseases at a systems level. We have the opportunity to build upon this foundation of high-density genomic data to unravel, at a systems biology level, the genetic and environmental factors that produce complex diseases. The FaceBase Consortium will provide our research communities with the tools to achieve a comprehensive understanding of craniofacial construction and enhance our ability to investigate, diagnose and ameliorate human craniofacial diseases and disorders. By understanding the complex regulatory networks that govern normal craniofacial morphogenesis and the variations that contribute to diseases and disorders, we can begin to face the future with predictive, preemptive and personalized medicine.
CONSORTIUM STRUCTURE
The FaceBase Consortium will comprise the data coordination and management hub, research projects and technology development projects, all of which will collaborate and interact scientifically and operationally. Research projects will target their studies at specific aspects of craniofacial development (e.g., cranial neural crest migration, formation of lip and palate, cranial sutures, tooth, salivary gland or temporomandibular joint) and associated clinical conditions. It is envisioned that the Consortium will include new research projects that are funded in response to this FOA. After the Consortium is launched, additional investigator-initiated funded projects that are consistent with the FaceBase theme may be invited to join. The data coordination and management hub will manage FaceBase, the database that houses collected data and protocols and accessible through a web interface, and facilitate data mining. Technology development projects will provide cutting edge technologies to enable enhanced visualization, manipulation and analysis of the craniofacial complex.
Because of the complexity in large scale data management and establishing collaborative and interactive projects, the Consortium will be built by staged implementation over several years, and will be launched by a collection of projects funded in response to this FOA. The initial phase of implementing the FaceBase Consortium, as solicited through this FOA, will focus on creating the data coordination and management hub, identifying enabling technologies, and incorporating only research projects that address mid-face development and orofacial clefting. Applications must be identified in the title by the type of application: data hub, research project or technology project. Applications should be submitted independently, however, it is expected that the principal investigators formulate how their project contributes to an integral component of the FaceBase Consortium by crafting the required Collaboration and Interaction Plan (see Other Submission Requirements and Information section). In addition to scientific merits, potential synergies will be considered for the selection of the complement of projects to launch the Consortium. The FaceBase Consortium relies on collegial and robust collaboration and interaction among the constituent projects to achieve scientific cohesion and operational coordination. Integration of these projects within the FaceBase Consortium will foster high-throughput, genome-wide research strategies as well as the application of new technologies for identifying key genes and regulatory pathways controlling craniofacial development.
The Consortium will be anchored by a single data coordination and management hub that will serve as a centralized data repository and provide data management, and integration for the Consortium and craniofacial community at large. It will import data from Consortium studies, integrate with existing datasets, implement standardized data format and, importantly, develop, host, manage and regularly update FaceBase, a publicly accessible web-based user-minable resource for the deposition of verified data. This database will be accessible and interpretable for multi-scale analysis of craniofacial data derived from biochemical, molecular, genetic and morphological studies, ranging from single genes to networks. This includes temporal and spatial patterning information underlying craniofacial morphogenesis and dysmorphogenesis in humans and model systems. The hub will work with other projects to identify, gather, organize, and curate information. The hub will facilitate data sharing, data dissemination and the development of informatics tools that evolve with time as the data become more complex. In particular, the FaceBase will provide a portal and a platform to provide access to large datasets, facilitating analysis, dissemination of experimental results, fostering interactions and collaborations within the research consortia and the research community at large.
The research projects will be tasked with the efficient and rapid generation of new data resources and the execution of research strategies to test hypotheses. Projects could include the development of structural and molecular atlases of development, detailed comparative analyses across model organisms or between wild type and genetic or environmental mutants, genome-wide association and linkage studies, polymorphism mapping, synthesis of gene regulatory networks, or modeling of cellular processes across stages of development. Data from research projects will be deposited into FaceBase and be updated periodically. This FOA will only accept research projects that focus on mid-face development and orofacial clefting. Research project applications that address other parts of the craniofacial complex and other craniofacial disorders will be non-responsive to this FOA and returned.
The technology development projects will pursue innovative technologies essential for understanding craniofacial construction. Examples include but are not limited to, high resolution imaging of developmental processes in vivo, development of markers and probes to track normal and abnormal developmental processes at the single cell level, high-throughput screening methods for structural and functional alterations, algorithms for 4-D expression and co-expression pattern analysis, and computational modeling of gene regulatory networks. These projects are expected to benefit not only mid-face development and orofacial clefting research as solicited by this FOA, but also to demonstrate feasibility to address other aspects of craniofacial development and disorders. Protocols and information on research tools from technology development projects will be deposited into FaceBase and be updated periodically.
All PI’s in the Consortium are expected to function collaboratively and interactively, to participate in Steering Committee activities and to cooperate with NIDCR-appointed Project Scientist and Program Director as described in the Terms and Conditions of the cooperative agreements. Consortium PI’s will meet annually with the Scientific Advisory Panel and with NIDCR staff to showcase accomplishments and to negotiate milestones. Taken together, these collaborative and interactive projects will provide a comprehensive knowledge base for a systems-level understanding of normal and abnormal craniofacial development. This is critical for tackling the challenge of treatment and prevention of complex disorders affecting craniofacial and dental tissues. The FaceBase Consortium will also serve to attract and nurture the next generation of craniofacial scientists.
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 NIH Research
Project Cooperative Agreement (U01) award
mechanism(s).
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".
The NIDCR has not determined if this particular FOA will be reissued. Plans beyond the current funding opportunity are indefinite. However, since The Consortium will be built by staged implementation over several years, we intend to solicit for research projects that will address additional aspects of craniofacial development and associated diseases and disorders.
2. Funds Available
The
estimated amount of funds available for support of 8-10
collaborative and interactive projects, including
a single data coordination and management hub awarded
as a result of this announcement is $6.0 million in total cost for
fiscal year 2009. Future year amounts will depend on annual appropriations.
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. The expected
direct cost for the data coordination and management hub is $1.0 - $1.2
million. The expected direct cost for each research or technology
development project is $150,000 - $300,000. The cost for genotyping may
be included in the requested budget for those projects involving genome-wide
studies. However, it is strongly recommended that these projects explore
services provided by the Center for Inherited Diseases Research (http://www.cidr.jhmi.edu/index.html)
to reduce costs. The total project period for an application submitted in
response to this funding opportunity may not exceed five years. Funding
decisions will be made based on review panel recommendations, programmatic
balance and potential synergies among complementary projects. Although the financial plans
of the IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds 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:
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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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.
Because of the multidisciplinary, collaborative and interactive nature of projects within The FaceBase Consortium, and the leverage of complementary expertise in each project, the use of multiple PD/PI format is strongly encouraged.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants are not
permitted to submit a resubmission application in response to this FOA.
Renewal applications are not permitted in response to this FOA.
Applicants may submit more than one application, provided each application is scientifically distinct.
This FOA will only accept research projects that focus on mid-face development and orofacial clefting. Research project applications that address other parts of the craniofacial complex and other craniofacial disorders will be non-responsive to this FOA and not reviewed.
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: GrantsInfo@nih.gov.
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.
Foreign
Organizations (Non-domestic
(non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
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
Letter
of Intent Receipt Date: January
2, 2009
Application Receipt Date: January
30, 2009
Peer Review Date(s): May/June 2009
Council Review Date: August 2009
Earliest
Anticipated Start Date: September 2009
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:
Lynn
Mertens King, Ph.D.
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
1DEM, Room 662, MSC 4878
6701 Democracy Boulevard
Bethesda, MD 20892-4878
Telephone: (301) 594-5006
E-mail: lynn.king@nih.gov
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:
Lynn Mertens King,
Ph.D.
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
1DEM, Room 662, MSC 4878
6701 Democracy Boulevard
Bethesda, MD 20892-4878
Telephone: (301) 594-5006
E-mail: lynn.king@nih.gov
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 award if such costs: 1) are necessary to conduct the project,
and 2) would be allowable under the grant, if awarded, without NIH prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain NIH approval before incurring the cost. NIH prior approval
is required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
All applications must provide a detailed budget for all years. Provide narrative justification for each project personnel based on his/her role on the project and proposed level of effort, and any major budget categories and items listed in the budget request. Applications should include the cost for travel for the principal investigator(s) to participate in the planning meeting in year 1 and annual Steering Committee meeting for all years.
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
This particular FOA solicits for three types of applications: i) data coordination and management hub, ii) research projects that will focus on mid-face development and orofacial clefting, and iii) technology development projects. Applications must be identified in the title by the type of application; data hub, research project or technology project. Applicants may submit applications for support of all three types of projects/hub but must submit a separate application for each type.
Following the Research Plan sections (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods), each application must also contain additional sections on:
Milestones and Timeline
Each application must include a timeline as well as PI determined milestones for each proposed year of funding. These milestones should be concrete and provide quantitative project specific criteria, and not simply be a restatement of the specific aims. Describe specific outcomes to be achieved and the metrics by which the accomplishment of the milestones will be assessed.
Collaboration and Interaction Plan
The FaceBase Consortium relies on collegial, robust and productive collaboration and interaction among the constituent projects to achieve scientific cohesion and operational coordination. All applications are expected to collaborate and interact to develop or provide input to develop FaceBase, the database that houses the collected data as well as the web-interface that will be accessible by the research community at large. Applications should provide a plan for data acquisition or data submission and updates, including a description of the type of data and the level of details to be provided. Describe how exchange of data and resources will be achieved and coordinated through FaceBase. Each application must describe how the project may present unique opportunities or resources that are likely to be integral for the initial development of the FaceBase Consortium, and how the project will remain as a contributing component to future expansion of the Consortium as additional craniofacial elements are incorporated. For example, for the data hub, how growth capacity can accommodate additional datasets; for technology development projects, how the evolving technology can be applied and/or adapted to garner data from other parts of the craniofacial complex, or other model organisms; and for research projects, how mid-face development and orofacial clefting may influence or be influenced by the development of other aspects of the craniofacial complex. Describe how the project will be enhanced by the Consortium structure that would otherwise not be afforded. Applicants should describe prior or existing experience in working as part of a research consortium or other collaborative activities to meet individual study and collaborative goals.
Research Plan Page Limitations
In the application, the Research Plan including items 2-5 (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed 25 pages. The two additional sections, Milestones and Timeline and Collaboration and Interaction Plan are limited to a total of three pages.
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/.
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria
described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review
group convened by the NIDCR 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
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a meritorious priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? For applications
designating multiple PDs/PIs, is the leadership approach, including the
designated roles and responsibilities, governance, and organizational
structure, consistent with and justified by the aims of the project and the
expertise of each of the PDs/PIs?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the
PD/PI(s) and other key personnel appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to the experience level of the
principal investigator and other researchers? Does the PD/PI(s) and
investigative team bring complementary and integrated expertise to the project
(if applicable)?
Environment: Do(es) the scientific environment(s) in which
the work will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence of
institutional support?
Milestones and Timeline: Are the milestones and timelines quantitative, reasonable and appropriate?
Collaboration and Interaction: Does the team demonstrate its willingness and capability to work with other members of the FaceBase Consortium to enhance the project's productivity? Are the plans for sharing research findings, tools, and methods among Consortium members adequate? Is the plan for, or evidence of, the ability of the team of investigators to collaborate and interact with other teams in the FaceBase Consortium likely to meet the individual study and collaborative goals? Does the project present (or identify) unique opportunities or resources that are likely to be integral for the initial development of the FaceBase Consortium?
2.A. Additional Review Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:
Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed (see the Research Plan section on Human
Subjects in the PHS 398 instructions).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan section on Human Subjects in the
PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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 Notice of Award 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).
Grantee institutions must comply with the NIDCR Clinical
Terms of Award that will be incorporated into the Notices of Grant Award.
Potential applicants are encouraged to contact appropriate NIDCR Program
Officials or Office of Clinical Trial Operations and Management staff concerning
this policy. NIH policy requires certain information regarding research
that involves human subjects. The NIDCR Clinical Terms of Award are in addition
to and not in lieu of other NIH policies. The NIDCR Clinical Terms of
Award policy requires that all clinical research and clinical trials conducted
under grants and cooperative agreements supported by NIDCR are well designed,
conducted with rigor, monitored commensurate with risk and complexity, and that
the Institute is kept informed of study progress through reporting. For
these terms of award, see - http://www.nidcr.nih.gov/GrantsAndFunding/PoliciesandGuidance/ClinicalResearch/NIDCRClinicalTermsofAward
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 will have the primary responsibility for defining the
details for the project within the guidelines of RFA-DE-09-003 and for
performing the scientific activities. The PIs will agree to accept close
coordination, cooperation, and participation of NIH staff in those aspects of
scientific and technical management of the project as described under "NIH
Program Staff Responsibilities". The PIs will:
Additionally, the PI’s of the
2. A.2. NIH Responsibilities
An NIH Project
Scientist will have substantial programmatic involvement that is above and
beyond the normal stewardship role in awards, as described below. However,
the role of the Project Scientists will be to facilitate and not to direct the
activities. It is anticipated that decisions in all activities will be reached
by consensus of the Steering Committee and that the NIH Project Scientists will
be given the opportunity to offer input to this process. Other NIDCR staff may
assist and advise the Consortium on relevant programmatic and scientific issues
through the NIDCR Project Scientist. The Project Scientists will:
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIDCR Program Director will:
2.A.3. Collaborative Responsibilities
Steering Committee
The Steering Committee will serve as the main governing board of the FaceBase Consortium and will be responsible for coordinating the activities being conducted by the Consortium. The Steering Committee membership will include the NIDCR Project Scientist and the Consortium PIs of each awarded cooperative agreement. The Steering Committee Chair will be one of the Consortium PI and will not be an NIH staff member. The PI or contact PI of multiple PI’s projects from each project will have one vote and the NIDCR Project Scientist will have one vote. The Steering Committee may, as it deems necessary, invite additional, non-voting scientific advisors to meetings. Other government staff may attend the Steering Committee meetings if their expertise is required for specific discussions. There will be two meetings of the Steering Committee in the first year, the first of which will be a planning meeting, and one meeting per year in the following years. Additional meetings by teleconference may be held as needed. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. The Steering Committee will:
Scientific Advisory Panel
The Scientific Advisory Panel will be responsible for
reviewing and evaluating the progress of the awardees toward meeting their
individual milestones and collective goals. Annually, the Panel will provide
recommendations to the Director of the NIDCR, about progress, scientific
direction and continued support of the individual projects of the FaceBase
Consortium. The Panel will also advise on any changes that could enhance
synergies and accelerate progress. The Panel will be composed of four
senior scientists with relevant expertise who are not PIs of a cooperative
agreement involved in the FaceBase Consortium. The membership of the Panel may
be enlarged permanently, or on an ad hoc basis, as needed. The Scientific
Advisory Panel will meet once a year and in a joint meeting with the Steering
Committee to allow the Scientific Advisory Panel members to interact directly
with the awardees. Additional meetings by teleconference may be held as needed.
2.A.4.
Arbitration Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration 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
arbitration 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:
Lillian Shum, PhD
Chief, Integrative Biology and Infectious Diseases Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Room 624
Bethesda, MD 20892-4878
Voice: (301) 594-0618
Fax: (301) 480-8319
Email: ShumL@nidcr.nih.gov
2. Peer Review Contacts:
Lynn Mertens King, PhD
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Room 662
Bethesda, MD 20892-4878
Voice: (301) 594-5006
Fax: (301) 480-8303
Email: Lyking@nidcr.nih.gov
3. Financial or Grants Management Contacts:
Mary Daley
Chief, Grants Management Branch
National Institute of Dental and Craniofacial Research
6701
Democracy Blvd., Room 658
Bethesda, MD 20892-4878
Voice: (301)
594-4808
Fax: (301) 480-3562
Email: Daleym@mail.nih.gov
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 public
access to research data through the Freedom of Information Act (FOIA) under
some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
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. Applications that do not provide this
information will be returned without review.
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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