Part I Overview Information

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: Planning Grants (P20) for U54 Specialized Center-Cooperative Agreement

Announcement Type:
New

Request For Applications (RFA) Number: RFA-DE-06-002

Catalog of Federal Domestic Assistance Number(s)
93.121

Key Dates
Release Date: March 7, 2005
Letters of Intent Receipt Date(s): May 20 2005
Application Receipt Date(s): June 21, 2005
Peer Review Date(s): August 2005
Council Review Date(s) : October 2005
Earliest Anticipated Start Date: December 1, 2005
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: June 22, 2005

Due Dates for E.O. 12372
Not applicable

Additional Overview Content

Executive Summary

The long-term goal of this initiative is to move from isolated discoveries and the non-systematic accumulation of data to integrated, quantitative analyses such that each tooth structure and surrounding tissues can be fully understood as a unified system. The endpoint of this activity will be the complete characterization of teeth and their supporting tissues as an integrated biological and biomechanical system that can provide the engineering specifications and design principles required to create blueprints for the design of new teeth and their associated structures. The broad scope of this initiative requires the efforts of well-integrated, interdisciplinary teams of investigators with significant expertise in cell and developmental biology, genomics and proteomics, chemistry, material sciences, biophysics, and engineering as well as biocomputational sciences. Such groups do not spontaneously self-assemble, but can successfully coalesce around a common challenge. In recognition of the difficulty of establishing interdisciplinary research efforts, this Request for Applications (RFA) solicits applications for P20 planning grants that will support planning activities for groups of researchers to develop interdisciplinary research strategies for the development of a U54 ( Specialized Center-Cooperative Agreement). Planning activities are intended to lay the foundation and prepare investigators for submitting a subsequent application for U54. Therefore, only applicant teams who have awarded a P20 and have written a Concept Development Plan (CDP) will be eligible to apply for funding for a U54 in FY 2007.

Applicants will be expected to demonstrate a fundamental understanding and adequate expertise in all relevant areas of engineering, tooth biology, and computational science.

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

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 and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  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
        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

This RFA invites applications for planning grants using the P20 mechanism for a U54 ( Specialized Center-Cooperative Agreement) that will focus on developing new approaches to complete the characterization of teeth and their supporting tissues as an integrated biological and biomechanical system. This program underscores the desire of NIDCR to integrate biological and engineering sciences to provide the engineering specifications required to create blueprints for the design and development of new dental and associated structures.

To address the scope of this and the subsequent RFA the research team must include appropriate expertise in cell and developmental biology, genomics and proteomics, chemistry, material sciences, biophysics, and engineering as well as computational sciences. The Principal Investigator (PI) serves as the project manager and must be capable of leading the proposed effort.

Background

By the age of 50 years, the average American has lost approximately 8 teeth (DHHS Report, 2000). By age 65, approximately 35% of the population is edentulous. Treatment for tooth loss often involves dentures, whose long-term use results in bone resorption of the underlying jaw. Alternative treatments offered by oral surgeons include replacement of lost teeth with dental implants or rarely autologous tooth re-implantation. Approximately 74 million US adults are potential candidates for dental implants. Dental implant procedures are expensive (ranging from $2,000 for a single tooth to $25,000 for an entire jaw), are at times uncomfortable, and frequently eventually fail. For example, the American Academy of Oral and Maxillofacial Surgery defines implant success as 85-90% survival of the implant for only 5-10 years.

Implant failure can have a large economic impact on the patient, particularly since subsequent re-implantation becomes increasingly difficult. Integrated, multidisciplinary approaches to tooth regeneration will be needed to develop new therapeutic strategies (based on biological principles) to meet the pressing patient needs concerning tooth replacement.

The generation of a tooth relies upon a sequence of closely regulated and reciprocal signaling interactions between the ectoderm lining the future oral cavity and neural crest-derived ectomesenchymal cells, followed by precisely choreographed cell interactions with extracellular matrix molecules to generate the tooth and its crucial supporting structures. New genes and their encoded structural and regulatory proteins governing these events have been discovered, and their function(s) have been characterized. Nanostructures and nanomachines on the cell surface have recently been discovered that control the deposition of matrix and the movement of cells. Although considerable progress has been made over the last decade in identifying the individual molecular mechanisms involved in early dental development, areas remain where relatively little is known about their integrated activities resulting in a functional tooth.

Additionally, tooth structures (e.g., enamel, dentine and cementum) are mineralized tissues that require support and anchorage by other connective tissues and bone. Enamel formation has been well-studied in part because it is an ideal system for identifying the factors that specifically control biomineralization and because much is known about enamel proteins, their gene regulation, self-assembly into a matrix, and role in directing mineral crystal deposition. Enamel is possibly the most difficult target in tooth regeneration because it has no intrinsic cellular capacity to undergo self-repair. Also, regenerated enamel must have extremely demanding mechanical properties yet still remain compatible with any remaining enamel. Understanding the mechanisms that regulate the fabrication of highly ordered biocomposite ceramic will provide procedures for the synthesis of novel, high-performance composite materials to repair damaged teeth while enhancing the understanding of biological pathways required to completely regenerate enamel.

To date, substantial progress has been made in using basic principles of biomineralization to accomplish controlled processing of engineering materials. Despite these successes, no integrated understanding of tooth formation is available, and no manufacturing process has yet been devised that approaches the exquisite molecular control evident in nature. Mimicking biological processes is not merely a matter of fabricating films or soluble macromolecules with specific affinities or molecular recognition. Equally important is the spatio-temporal sequence, concentration, and cell-based regulation of the location and orientation of molecules during tissue formation and mineralization.

Modern technologies (at the atomic, nanoscale and microscopic levels) and innovative approaches are emerging that allow the dissection of the mechanical infrastructure, thermodynamic behavior and control of physical and biological networks of tooth development and anchorage. Moreover, the manipulation of the biological processes of tooth development and dynamic adult anchorage, at each size scale and complexity level, are becoming feasible. We anticipate that the collection of precise quantitative data will help develop the concepts, models, and physical tools required for tooth regeneration. In addition, novel computational methods involving modeling and simulation by both computer and experimental tissue models using inputs from physical measurements will reveal additional links and interactions between molecules, assemblies and networks that had not previously been recognized.

Objectives and Scope:

This RFA encourages applications for P20 planning grants for groups of researchers, to develop interdisciplinary research strategies for a U54 ( Specialized Center-Cooperative Agreement) focused on “Building the tooth: Bridging Biology and Material Sciences”.

Planning Activities supported under the P20 will include the development of a 15-20 pages Concept Development Plan (CDP). This should: i) describe a vision for the proposed U54; ii) describe the specific scientific and technical approaches that the applicant team will propose in the subsequent U54 application; and iii) propose an organizational and functional structure for the overall U54 program. The CDP will include a 2 to 3 page public abstract that will be shared with all participants in a meeting to be held at the NIH in approximately six months after the grant award. The NIDCR staff will use the CDP and the information exchanged at the July 2006 meeting, as a basis for the U54. Only applicant teams who have awarded a P20 and have written a CDP will be eligible to apply for a U54 in FY 2007.

The P20 must include:

The concept and ideas outlined here serve only to illustrate what should be considered in the P20 and the CDP. It is expected that applicants will expand on these concepts and provide their ideas and plans for recreating functional teeth using biological principles. Applicants are encouraged to think more broadly than their current research program and begin developing collaborations that would be further cultivated if the P20 results in an U54 award.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the P20 (exploratory grant mechanism) award mechanism. As an applicant, you will have the primary responsibility for planning, directing, and executing the proposed project. The P20 mechanism will be structured to provide funds for six months, to allow applicants to assemble potential team members, hold workshops and to facilitate the planning and writing of the concept plan. Those awarded a P20 and have written a substantive CDP will be invited to a meeting to share and discuss ideas for the U54. Based on discussions at the meeting the NIDCR staff will develop the final solicitation for the U54 “Building a Tooth: Bridging Biology and Material Sciences” to be issued in fiscal year 2006.

This funding opportunity uses just-in-time concepts.

2. Funds Available

The NIDCR intends to commit approximately $500,000 in FY 06 to fund 4-5 P20 grants in response to this RFA. An applicant may request a project period of up to six months and a budget for direct costs up to $50,000. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this RFA 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

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 with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching
Cost sharing is not required.

3. Other-Special Eligibility Criteria
Investigators may submit only one application.

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. 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

Applications must be prepared using the 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/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Section VI.2. Administrative Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
See special receipt dates in Section IV.3.A. below. Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: May 20, 2005
Application Receipt Date(s): June 21, 2005
Peer Review Date: August 2005
Council Review Date: October 2005
Earliest Anticipated Start Date: December 1, 2005

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 NIDCR staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document to:

H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Natcher Bldg. 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

At the time of submission, two additional copies of the application must be sent to:

H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Natcher Bldg. 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this RFA 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 an RFA, it is to be prepared as a NEW application. That is, the application for the RFA 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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

5. Funding Restrictions

All 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 http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Reporting)

6. Other Submission Requirements

Supplemental Instructions

All application instructions outlined in the PHS 398 application kit are to be followed with the following modifications:

1. Face Page, Item 6: Up to a total six months of support may be requested. Total direct costs for the six months may not exceed $50,000.

2. The P20 application should be structured as the applicant finds most effective and may not exceed 10 pages and must be self-contained including any figures. No appendix material or website links for additional information are acceptable.

Specifically, the P20 must include:

Special Requirements

The principal investigator or any other co-investigators listed in the P20 may be the lead author of the CDP, and the lead author or any co-investigator listed in the CDP may be designated as the principal investigator of the U54 application. However, we expect that each P20 can lead to only one CDP, and each CDP can only lead to one U54 application. Investigators may participate in more than one P20. Submission of a Concept Development Plan (CDP) by June 1, 2006, will be an explicit requirement of the Notice of Award for all P20 Awards. All grantees are expected to participate in a meeting to be held at the NIH in approximately July 2006, to which all authors of the CDPs will be invited. Applicants should budget for travel in their requested budget for the principal investigator and for one or two additional investigators to attend the meeting.

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.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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

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 (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm). 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.

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCR in accordance with the review criteria stated below.

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

For this RFA, the review criteria are not organized under the traditional headings of Significance, Approach, Environment, Investigator and Innovation typically used for NIH research grants. Instead the reviewers must consider the following factors in the evaluation of the applications:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application.

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.

2.C. Sharing Research Data

Data sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of the scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing. Program Staff from the NIDCR will be responsible for the administrative review of the plan for sharing research data.

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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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 will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

The applicants will learn about the priority score of their applications one week after the assigned date for the review. The summary statement is mentioned in the section below.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm.

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Notices of Grant Award (NGA) are mailed to authorized officials at the grantee institutions either in electronic format via e-mail or in hard copy if the institutions are not registered in the NIH Commons. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award:
Not applicable

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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:

Eleni Kousvelari, DDS, D.Sc. Chief
Cellular & Molecular Biology
Physiology & Biotechnology Branch
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN 12K
Bethesda, MD 20892-6402
Telephone: (301) 594-2427
FAX: (301) 480-8318
Email: kousvelari@de45.nidr.nih.gov

2. Peer Review Contacts:

H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Natcher Bldg. 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

3. Financial or Grants Management Contacts:

Mary Daley
Chief Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health Natcher Bldg. 45, Room 4AN-44B
Bethesda, MD 20892
Telephone: (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).

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/guide/notice-files/NOT-OD-04-042.html). 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.

Public 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 PA 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

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 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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