Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
National Institute of Standards and Technology (NIST), (http://www.nist.gov/)
National Science Foundation (NSF), (http://www.nsf.gov/)

Components of Participating Organizations

NIH
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (
http://www.nibib.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) (
http://www.nhlbi.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (
http://www.niams.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (
http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (
http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR) (
http://www.nidcr.nih.gov/)

NIST
Chemical Science and Technology Laboratory (CSTL) (
http://www.cstl.nist.gov/)
Materials Science and Engineering Laboratory (MSEL) (
http://www.msel.nist.gov/)

NSF
Division of Bioengineering and Environmental Systems (BES) (
http://www.eng.nsf.gov/bes/bes.htm)


Title: Enabling Technologies for Tissue Engineering and Regenerative Medicine (R01)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-06-504

Catalog of Federal Domestic Assistance Number(s)
93.286, 11.609 (NIST), 47.041 (NSF ENG), 93.865, 93.173, 93.121, 93.837, 93.846

Key Dates
Release/Posted Date: August 1, 2006
Opening Date: August 20, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 21, 2006; December 20, 2006; April 23, 2007; August 21, 2007; December 21, 2007; April 21, 2008; August 21, 2008; December 21, 2008; April 21, 2009.
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): September 20, 2006; January 19, 2007; May 21, 2007; September 20, 2007; January 22, 2008 (Per NOT-EB-07-008); May 20, 2008; September 20, 2008; January 20, 2009 (Changed to January 22, 2009 per NOT-EB-08-001); May 20, 2009.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 21, 2009, unless reissued (New Expiration Date September 20, 2008 per NOT-EB-08-004).

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
   
A. Cooperative Agreement Terms and Conditions of Award
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

Tissue engineering and regenerative medicine (TE/RM) is an evolving interdisciplinary field that integrates aspects of engineering and other quantitative sciences with biology and medicine for the development of functional tissues and organs in vitro for implantation in vivo or for direct remodeling and regeneration of tissue in vivo to repair, replace, preserve or enhance tissue or organ function lost due to disease, injury, or aging. This could include reproductive as well as somatic tissues. In addition, tissue engineered products can be used as 3D tissue model system for drug development. TE/RM requires complex approaches to design and engineer tissues that combine living cells, scaffold materials, and biomolecules. Some of the challenges in TE/RM include understanding and controlling cellular responses, developing scaffold materials with key characteristics to function in their physiological environments, while maintaining relevant temporal/spatial signaling gradients, developing tools that advance the research and the translation of tissue engineered constructs to products, and establishing standard production/manufacturing protocols and preservation technologies. New measurement tools, engineering methods and design principles, and real-time assays that monitor the interaction of cells and their environment at the molecular and organelle level are essential and urgently needed to ensure the much anticipated successes in TE/RM. This FOA is issued to solicit design or hypothesis - driven research to promote development of innovative technologies, tools, methods, and devices that will enable the engineering of functional tissues. Research proposals to this FOA must focus primarily on developing enabling technologies for TE/RM. While full validation of new technologies may depend upon demonstration of effectiveness toward a specific medical challenge, the NIBIB and NSF preference will be given to approaches with potential for board applicability but a model system can be used as long as applicants explain the broader utility. The NHLBI, NIAMS, NICHD, NIDCD, NIDCR, and NIST interests in specific medical challenges are also given below. For all applications, the focus of the work must be on the development of the enabling technologies. The funding agencies particularly encourage investigators from the engineering, physical, and computational sciences working with those in the life sciences or vice versa to submit to this FOA.

The NIBIB and NSF scientific interests for this FOA include but are not limited to the following research areas:

Quantitative prediction through computational modeling can play a critical role in the engineering of 3D tissues. Utilizing advanced knowledge and tools to study molecular and cellular processes, extracellular matrices, biomaterials, and cell-material interactions, cell-cell interactions, as well as anatomic tissue structures would provide insight into designing and engineering new functional materials/constructs. To address problems of great complexity, computational models coupled with engineering principles need to be developed, validated, and tested to enable a comprehensive understanding and successful fabrication of engineered 3D tissues. These models should be developed based on well-characterized and validated experimental data that produce the rules underlying the models. The models, in turn, can be used to test experimental hypotheses and direct better experimental approaches to construct functional 3D tissues. This FOA encourages applications that integrate systems engineering to multi-level and multi-scale modeling, and combine theoretical, computational, and experimental approaches to produce models applicable to engineered functional 3D tissues.

Successful engineering of functional 3D tissues depends on advances in biomaterials as well as the effective application of developmental biology principles. However, mimicking nature does not necessarily lead to success in TE/RM as native tissue formation may take years whereas tissue regeneration in vitro or in vivo needs to occur in a much shorter time. Considerable efforts have been made to apply engineering design principles to develop 3D tissues. Tissue engineering usually involves a porous scaffold that accommodates cells, guiding their growth and differentiation in 3D. Current 3D scaffolds fabricated using conventional techniques are often less than ideal for actual applications because of deficiencies in mechanical strength, porosity, and reproducibility. This FOA encourages applications to develop novel fabrication technologies that can produce scaffolds with highly reproducible architecture and compositional variation. It is envisioned that these technologies would be computer-aided and that they would offer unique ways to precisely control matrix size, shape, interconnectivity, branching, geometry, and placement of cells and biomolecules. They should allow for various design and material compositions and also control the mechanical properties, biologic effects, and degradation kinetics. These novel technologies should facilitate a dynamic control of tissue regeneration process through temporal release of defined concentrations of growth factors, cytokines, and chemokines. Integration of the fabrication technology with imaging techniques to produce scaffolds which can be customized in overall size and shape allowing tissue-engineered grafts to be tailored to specific applications or even to individual patients is encouraged.

State-of-the-science bioreactors combine features that ensure automated feeding and monitoring, provide effective mass transfer, allow coupling to external mechanical and physical stimuli, and permit easy accessibility to the tissue or cells. Although technologies exist for developing such bioreactors and some are commercially available, bioreactors that can direct, sustain, and access the function of rapidly developing tissues are lacking. To realize the full benefits of tissue engineering, novel bioreactors are essential for the controlled fabrication of reproducible and robust tissue engineered constructs and rapid cell expansion. This FOA encourages applications for developing novel bioreactors that couple chemical, biological and mechanical signals with non-invasive monitoring systems for functional 3D tissue growth or rapid expansion of functional stem cells.

Quantitative, non-invasive tools are critical for monitoring engineered tissue growth and function or stem cell expansion in bioreactors or for assessing the functionality of implanted engineered tissues. Standard analysis methods such as biopsies are labor intensive and destructive. Although some advances have been made in developing methodologies, such as imaging, to track stem cell fate and allow the assessment of engineered constructs, in vitro and in vivo, in a non-invasive or minimally invasive manner, robust technologies to non-invasively monitor the engineered tissues both in vitro and after implantation in real-time are still lacking. This FOA specifically encourages applications for developing quantitative, non-invasive tools to monitor structure, composition, and function of engineered tissues in real time.

Much research is needed to transition from bench-scale testing of prototypes to the manufacturing of tissue engineered products. As the TE/RM field advances, cutting edge technologies for manufacturing of tissue engineered products will make “off-the-shelf” tissues and organs a reality. Currently, much of the research effort has been in cryopreservation with an attractive alternative, dry storage at ambient temperature, on the horizon. The 3D structure of tissues and organs presents a tremendous challenge for preservation. Moreover, even greater challenges exist in sterilization, packaging, and transport that have resulted in little research advances to date. This FOA encourages applications to develop feasible and cost-effective methodologies for tissue sterilization, packaging, and transport as well as methods for quantitatively evaluating cell and tissue health and phenotypic stability throughout the process.

The National Heart, Lung, and Blood Institute (NHLBI) is interested in the above listed research approaches as applied to the following mission areas of the Institute: i) engineering and regeneration of complex heart, vascular, lung, and blood systems; ii) correction of congenital and acquired heart, lung and blood defects, iii) regeneration/reconstruction of heart, lung, and blood tissue; iv) optimization of the host’s microenvironment to improve the survival and function of transplanted heart, vascular, lung, and blood tissues, and v) development and validation of imaging systems to monitor structure, composition and function of engineered HLB tissues in real time. Additionally, preemptive strategies that use physical, biochemical, and electrical forces to guide growth, differentiation, movement, and gene expression are needed for tissue repair. Hence, NHLBI has significant interest in the development of novel cell-instructive methods to overcome the unique tissue dynamics of the HLB systems that affect the delivery, implantation, and monitoring of tissue engineering approaches.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in the above listed research approaches as applied to the NIAMS mission areas: i) the engineering and regeneration of bone, cartilage, meniscus, tendon, ligament, and intervertebral disc; ii) the repair and restoration of muscle function lost due to diseases such as Muscular Dystrophies; and iii) the regeneration/reconstruction of skin tissues due to injury and diseases. Of special interest are engineering strategies enabling regeneration and total functional restoration of large defects in musculoskeletal tissues and skin, and real-time quantitative, non-invasive tools to monitor engraftment, structure, composition, and function of musculoskeletal and skin tissues in vivo.

The National Institute of Child Health and Human Development (NICHD) is interested in the above listed research approaches as applied to the NICHD mission areas, especially the development of tissue engineering technologies that incorporate the non-static developmental nature of human organ systems and tissue beds. Of particular interest are proposals that incorporate recent advances in developmental biology and differentiation, seeking to enable tissue engineering technologies to benefit persons across life and functional stages: infants, children, adolescents, pregnant women and the disabled.

The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in the above listed research approaches as applied to the seven different mission areas of voice, speech, language, smell, taste, balance/vestibular, and hearing. Fabrication of engineered functional 3-D tissues have important therapeutic potential in the areas of chemosensory and auditory/vestibular disorders, enhanced tissue interfaces with implanted prosthesis for hearing/vestibular impairment, and restoration for laryngeal damage. Additionally, the inclusion of stem cell reagents and methodologies to achieve functional engineered tissues as potential sensory restoration therapies are also of significant interest. Novel enabling fabrication technologies, as well as non-invasive monitoring tools, to assess functionality of the integrated engineered products as they pertain to these specific microenvironments are of considerable interest to the NIDCD.

The National Institute of Dental and Craniofacial Research (NIDCR) is interested in the above listed research approaches as applied to the following mission areas of the Institute: i) engineering and regeneration of the multi-tissue complexes such as, temporomandibular joint (TMJ) and periodontium; ii) correction of congenital and acquired craniofacial defects, iii) regeneration/reconstruction of salivary glands; iv) optimization of the host’s microenvironment to improve the survival and function of transplanted tissues. Additionally, the interests of the NIDCR include engineering of the biomineralized hard tissues to mimic unique mechanical properties of natural bone, teeth and cartilage. Because of their physical accessibility, the oral cavity and the craniofacial complex represent particularly attractive systems for non-invasive imaging studies to monitor structure, composition and function of engineered tissues in real time. The NIDCR is thus interested in developing and validating such imaging methodologies.

The National Institute of Standards and Technology (NIST) is interested in developing methods to quantitatively assessing of cell and tissue health following preservation, including methods that quantitatively demonstrate cell viability, metabolic activity, tumorogenicity, and other indications of cell health. Although the major focus of the proposed work should be on the development of the methods, it is anticipated that the physiological relevance of methods will be tested to determine their usefulness as reference methods for the purposes of quality assurance and quality control. Quantification in individual cells within a tissue or population of cells is of greatest interest.

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 Announcement (FOA) will use the NIH R01 research grant award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

At this time, it is not known if competing renewal (formerly “competing continuation”) applications will be accepted and/or if this FOA will be reissued.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the participating agencies provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one Project Director/Principal Investigator (PD/PI), or multiple PD/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects can be found at http://grants.nih.gov/grants/multi_pi. All PD/PIs must be registered in the 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 single investigator or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below, and the NIH review criteria for approach, investigator and environment has been modified to accommodate applications involving either a single PD/PI or multiple PD/PIs as indicated below. A weak or inappropriate PD/PI can have a negative effect on the review. Multiple principal investigators on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each principal investigator 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 all required reports.

Multiple PD/PIs may be located at the same institution or at different institutions and may request budget apportionment between the PD/PIs (see special instructions below).

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

This FOA encourages applications focusing on developing enabling technologies for tissue engineering and regenerative medicine. Areas of interests are specified in the Research Objectives.

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form, as appropriate

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Special Instructions for Applications with Multiple PD/PIs:

When multiple PD/PIs are proposed, NIH requires one PD/PI to be designated as the "contact” PI, who will be responsible for all communication between the PD/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the contact PD/PI should be entered in section 15 of the SF424(R&R) Cover component. All other PD/PIs should be listed in the Senior/Key Person component and assigned the project role of “PD/PI”. Please remember that all PD/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PD/PIs will be required to include a new section describing the leadership of the project.

Multiple Principal Investigator Leadership Plan:

For applications designating multiple PD/PIs, a new section of the research plan must be included entitled Multiple PD/PI Leadership Plan. The governance and organizational structure of the research project should be described, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD/PIs, including responsibilities for human subjects or animal studies as appropriate.   This information should be included as  “Item 14. Multiple PI Leadership Plan” of the PHS398 Research Plan component.

For Applications Involving a Single Institution: When all PD/PIs are within a single institution, follow the instructions for SF424 (R&R).

For Applications Involving Multiple Institutions: When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget form. All other institutions should have their individual budgets attached separately to the R&R Subaward Budget Attachment form. See section 4.8 of the Application Guide for further instruction regarding the use of the subaward budget form. When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget are provided in the budget justification. See section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: August 20, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 21, 2006; December 20, 2006; April 23, 2007; August 21, 2007; December 21, 2007; April 21, 2008; August 21, 2008; December 21, 2008; April 21, 2009.

Application Submission/Receipt Date(s): September 20, 2006; January 19, 2007; May 21, 2007; September 20, 2007; January 21, 2008; May 20, 2008; September 20, 2008; January 20, 2009; May 20, 2009.

Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.

Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.

Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.

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:

Christine A. Kelley, Ph.D.
Director
Division of Discovery Science & Technology
NIBIB, NIH, DHHS
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5477
Telephone: (301) 451-4778
FAX: (301) 480-4973
e-mail: kelleyc@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the NIBIB Referral Office by email GeorgeD@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH.   Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 competing renewal award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

All instructions outlined in the SF424 (R&R) application are to be followed, incorporating "Just-in-Time" concepts, and with the following additional requirements:

Specific Instructions for Modular Grant applications.

R01 applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See section 5.4 of the Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Appendix Materials

The following materials may be included in the Appendix:

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

 Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIBIB in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Additionally, the NSF staff will give careful consideration to the following in making funding decisions:

The NIST staff will consider proposals that focus on measurement science research that could lead to reference methods, reference materials and reference data. For those proposals that are selected for funding by the participating NIST Laboratories, NIST will request that applicants resubmit the research proposal directly to NIST. More information can be found in the Federal Register Vol. 70, No. 246 [Docket No.: 051202321– 5335– 02].

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important 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?

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? To what extent does the proposed activity suggest and explore creative and original concepts? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD/PI(s) and key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is there sufficient access to resources?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research:
The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.  See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations

3. Anticipated Announcement and Award Dates
Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

Awardees are encouraged to report any scientific highlights, publications, patents, and products resulted from the awards directly to the scientific program staff of the funding agency.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Christine A. Kelley, Ph.D.
Director
Division of Discovery Science & Technology
NIBIB, NIH, DHHS
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5477
Telephone: (301) 451-4778
FAX: (301) 480-4973
e-mail: kelleyc@mail.nih.gov

Frederick G. Heineken, Ph.D.
Program Director
Bioengineering and Environmental Systems Division
National Science Foundation
4201 Wilson Boulevard
Arlington, VA 22230
Telephone: (703) 292-7944
FAX: (703) 292-9098
e-mail: fheineke@nsf.gov

Anne L. Plant, Ph.D.
Leader, Cell and Tissue Measurements Group
Biochemical Science Division
National Institute of Standards and Technology
100 Bureau Drive, stop 8313
Gaithersburg MD 20899-8313
Telephone: (301) 975-8302
Fax: (301) 330-3447
e-mail: anne.plant@nist.gov

Nancy L. Freeman, Ph.D.
Scientific Program Director
National Institute on Deafness and Other Communication Disorders
NIH, DHHS
Executive Plaza South-400C
6120 Executive Boulevard MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
FAX: (301) 402-6251
e-mail: FreemanN@mail.NIH.gov

Nadya L. Lumelsky, Ph.D.
Program Director
Tissue Engineering and Regenerative Dental Medicine Research Program
Center for Biotechnology and Innovation
National Institute of Dental and Craniofacial Research
Natcher
Building, Room 4An24J
Bethesda, MD 20892-6402
Telephone: (301) 594-7703
FAX: (301) 480-8318
email:
nadyal@nidcr.nih.gov

Martha S. Lundberg, Ph.D.
Program Director, Advanced Technologies and Surgery
National Heart, Lung, and Blood Institute
Division of Cardiovascular Diseases
NIH, DHHS
6701 Rockledge Drive, Rm 9146
Bethesda, MD 20892-7940
Telephone: (301) 435-0513
Fax: (301) 480-1335
e-mail: lundberm@nhlbi.nih.gov

Louis A. Quatrano, Ph.D.
Program Director, BSRE
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
NIH, DHHS
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: 301-402-4221
FAX: 301-402-0832
e-mail: quatranl@exchange.nih.gov

Fei Wang, Ph.D.
Program Director
Musculoskeletal Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIH, DHHS
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: 301-594-5055
FAX: 301-480-4543
e-mail: wangf@mail.nih.gov

2. Peer Review Contacts:

David T. George, Ph.D.
Director, Office of Scientific Review
6707 Democracy Boulevard, Suite 920
NIBIB, NIH, DHHS
Bethesda, MD 20892-5469 (20817 for FedEx and Courier services)
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email: GeorgeD@nih.gov

3. Financial or Grants Management Contacts:

Nick Mitrano
Grants Management Specialist
6707 Democracy Blvd., Suite 900
NIBIB, NIH, DHHS
Bethesda, MD 20892-5469 (20817 for FedEx and Courier services)
Telephone: 301-451-4782
FAX: (301) 451-5735
e-mail: mitranni@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 (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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