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 General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)

Title: Centers for Innovative Wound Healing Research

Announcement Type
New

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

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: May 13, 2005
Letters of Intent Receipt Date(s): September 20, 2005
Application Receipt Dates(s): October 20, 2005
Peer Review Date(s): February to April 2006
Council Review Date(s): May 2006
Earliest Anticipated Start Date: August 1, 2006
Additional Information To Be Available Date: A public briefing to answer questions about this announcement is anticipated. Additional information about the public briefing will posted on the web site of the National Institute of General Medical Sciences (http://www.nigms.nih.gov/) two weeks after the publication date of this announcement.
Expiration Date: October 21, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

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

 Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2.Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt 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
   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

1) Discovery and development of small molecules to replace or augment growth factors, cytokines, chemokines, or other signaling components (i.e., cell to matrix, cell to cell, etc.) that are involved in wound healing;

2) Characterization and integration of the processes and pathways involved in wound healing to address how to accelerate wound healing, how to promote scarless healing, or how to induce regeneration in place of repair;

3) Development of a quantitative model of the systems biology of wound healing;

4) Studies to recruit or use stem cells (adult, embryonic, etc.) to improve wound healing.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the P20 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NIGMS intends to commit approximately 2,500,000 dollars in FY 2006 to fund 3 to 4 new grants in response to this RFA. An applicant may request a project period of up to 4 years and a budget for direct costs up to 500,000 dollars per year. The budget may not exceed 500,000 dollars in any year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC provides support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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:

Foreign institutions are not eligible to apply, but foreign components may be included as subcontractors, where unique opportunities are offered. These circumstances should be described and justified in the application.

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.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

An applicant may submit only one application as the principal investigator in response to this RFA. An institution or organization may submit more than one application in response to this RFA.

The Principal Investigator of an Exploratory Research Center in Wound Healing will be required to commit a minimum of 20% effort to this center.

The NIGMS expects to convene meetings of the awardees of the Exploratory Centers in the second, third, and fourth years of the awards. It is expected that these meeting will be held in or near Bethesda, MD. At these meetings awardees will be expected to share their results and to help evaluate the progress of the Centers. Attendance at these meetings is required. Travel funds should be requested for this purpose for the Principal Investigator and for one or two other participants.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 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 most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: September 20, 2005
Application Receipt Date(s): October 20, 2005
Peer Review Date: February to April 2006
Council Review Date: May 2006
Earliest Anticipated Start Date: August 1, 2006

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 at the beginning of this document.

The letter of intent should be sent to:

Richard A. Ikeda, Ph.D.
Pharmacology, Physiology and Biological Chemistry Division
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 2As.43B, MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
FAX: 301-480-2802
Email: ikedar@nigms.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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all (5) copies of the appendix material must be sent to:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 3An.12, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.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. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIGMS. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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 NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 continuation 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 or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Applicants should use the following guidance, in addition to the instructions accompanying the PHS398 form.

Description: The Description must identify the specific goal of the project, the innovative or high risk-high nature of the project, the relationship to current knowledge or capabilities, the need for a multidisciplinary research team, the approach(es) planned to achieve the proposed goal, and the expected impact on the field of wound healing. This portion of the Description should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate reader. The final component of the Description is relevance. Using no more than two or three sentences, describe the relevance of the research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience.

The term “Abstract” is not used in the PHS 398 and should not be used here.

Table of Contents: Prepare a detailed Table of Contents that includes all elements of the application (i.e., time-line, letters of commitment, management plan, subprojects if applicable, etc.).

Budget: A detailed budget should be prepared and submitted. The modular budget format should not be used. An applicant may request a project period of up to 4 years and a budget of up to $500,000 in direct costs in each year where this total excludes F&A costs of consortium subcontracts. The budget may not exceed $500,000 in direct costs in any year.

Biographical Sketches: Biographical sketches must be included for all key personnel, collaborators, and consultants.

Letters of Commitment: Letters of commitment must be included for all collaborators and consultants. The letter should clearly acknowledge the roles and responsibilities of the collaborator or consultant in the project. The letters should be arranged in alphabetical order.

Research Plan: The page limit for the entire research plan (sections a-d) is 30 pages. This includes the Specific Aims, the Timeline and Milestones, the Management Plan, the Plans for Continuation of the Project, the Background/Significance, the Preliminary Studies, and the Research Design and Methods.

Specific Aims—this section should identify the goal of the project and list what will be done during the proposed funding period. The need for a multidisciplinary approach for the project and the innovation and potential impact of the project should be apparent from these specific aims.

Timeline and Milestones—a Timeline and Milestones section must be included following the Specific Aims. The timeline should describe the expected progression of the research activities over the life of the four-year project. Project milestones and deliverables (if appropriate) should be identified along the timeline. Milestones and deliverables should be well described, quantifiable, and scientifically justified. The milestones should be regarded as criteria for evaluating the progress and direction of the research project and should not be just a restatement of the specific aims. During the project period, the applicant will be expected to refer to these milestones and deliverables in his or her annual progress reports. The Institute will use the milestones and deliverables, the annual progress reports, and other measures of productivity and success to judge the progress, impact, and value of the program.

Management Plan—this section should include a description of the multidisciplinary team and its organization, a management plan for the project, a description of what will be done to achieve the goals of the project, and a plan for managing intellectual property issues while ensuring rapid public dissemination of research data and resources. Describe the organization of the multidisciplinary research team and explain how the structure of the team facilitates the research. Provide an administrative and project management plan that outlines plans and mechanisms to keep the project focused and progressing, explains how collaborators and/or consultants can be added or removed as the expertise, knowledge, and skills necessary to advance the project change, and explain how decisions will be made to alter the project depending on the success or failure of individual milestones.

Plans for Continuation of the Project—the grants for the P20 Centers for Innovative Wound Healing Research will not be renewable. Support for full-scale research centers in wound healing may be sought through the NIGMS P50 program for Research Centers in Trauma, Burn, and Perioperative Injury PAR-02-092 (http://grants.nih.gov/grants/guide/pa-files/PAR-02-092.html). Applicants must address how the proposed P20 Centers will/may be transformed into P50 Centers in the future. Applicants should note that the P50 Centers require the inclusion of a bench to bed-side or bed-side to bench translational component

Background and Significance—this section should explain why the research project is important. Define why a multidisciplinary approach is required to solve the proposed problem. Elaborate on the innovation, risk, and impact of the project. Identify how the project, if it is successful, could produce significant improvements in the quality of wound healing or a greater understanding of the integrated systems biology of wound healing.

Preliminary Studies—preliminary results that directly substantiate the feasibility of the project or provide proof-of-principle are not required or expected. This solicitation seeks innovative, high-risk, high impact research on wound healing by multidisciplinary teams of investigators. If feasibility has already been demonstrated by direct preliminary results or proof-of-principle data, the project may be deemed unresponsive to the solicitation. This section should be used to explain how current evidence or thinking in the field of wound healing suggests that the proposed problem can be addressed and that the approaches are rational.

Research Design and Methods—this section should explain how the specific aims will be accomplished, and what approaches will be taken during the research project in order to achieve the goals of the project. Describe how the specific experiments will be conducted and explain how success or failure at critical milestones might change the proposed plans. Provide plans for sharing research data and research resources as described in following sections. Include a description of how intellectual property issues will be resolved in order to ensure rapid public dissemination of the results and/or resources.

Affiliations: For all key personnel, collaborators, and consultants include a list of all institutional and company affiliations and the individual's roles and responsibilities at these institutions and companies. This information should be the first item 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 (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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

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 the NIGMS in accordance with the review criteria stated below.

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

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.

Applications responding to this solicitation must propose a multidisciplinary team and a project in wound healing with a specific goal that is highly innovative and potentially high impact. Specifically, this solicitation seeks applications that propose to substantially extend and expand our knowledge and abilities in the area of wound healing. This solicitation is not intended to support projects that would result in routine or incremental progress. NIGMS understands and accepts that applications that are responsive to this solicitation will be much riskier than most proposals. Reviewers should expect that applications which satisfy the requirement for high innovation, high significance, and potential high impact are likely to have much higher than average risk and little or no preliminary data.

A combination of a multidisciplinary team, high innovation, high significance, high potential impact, and appropriate risk are required for high scientific and programmatic merit. Additionally, the approach should not only contain the experimental design but also a description of the structure of the multidisciplinary team, a timeline, a set of milestones, and a management plan. The evaluation of these additional components should be included in the determination of the scientific merit of the project.

1. Significance. Does the project address a unique, highly innovative, and/or significant problem? Will achievement of the specific goals of the research have a high impact on wound care or the understanding of the pathophysiology or systems biology of wound healing?

2. Approach. Does the project require a multidisciplinary team and is the team effectively integrated? Is the timeline reasonable? Are the milestones well described, quantifiable, and scientifically justified? Can the milestones be used to evaluate the progress of the project? Does the management plan ensure that there will be extensive coordination and collaboration? Does the plan explain how the focus and progress of the project will be maintained, how collaborators and/or consultants will be added or removed if the expertise, knowledge, and skills necessary for the project change, and how decisions will be made to alter the project as milestones are or are not achieved? Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigator, collaborators, and consultants appropriately trained and well suited to carry out the work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the multidisciplinary research team have the right mix of skills, expertise, knowledge, time, and resources to efficiently address the research problem?

5. 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?

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 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 instructions will be assessed.

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: 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. Reviewers will assess the merit of the data sharing plan and note whether the plan ensures timely public access to the results of the project. Reviewers will also assess the merit of the plans for managing intellectual property issues and controversies and should note how these plans impact timely public access to the results of the project.

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/archive/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.

Reviewers will assess the merit of the resource sharing plan and note whether the plan ensures timely public access to the resources generated by the project. Reviewers will also assess the merit of the plans for managing intellectual property issues and controversies and should note how these plans impact timely public access to the resources generated by the project.

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 awardee 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
Not applicable

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/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

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

2. Administrative and National Policy Requirements

Awards through this program will include the following special terms and conditions:

1) The Principal Investigator of an Exploratory Research Center in Wound Healing will be required to commit a minimum of 20% effort.

2) The NIGMS expects to convene meetings of the awardees of the Exploratory Centers in the second, third, and fourth years of the awards. It is expected that these meeting will be held in or near Bethesda, MD. At these meetings awardees will be expected to share their results and to help evaluate the success of the Centers. Attendance at these meetings is required. Travel funds should be requested for this purpose for the Principal Investigator and for one or two other participants.

3) Program staff will negotiate modifications of the data, resource sharing, and intellectual property plans with the Principal Investigator before recommending funding of an application. The final version of these negotiated plans 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).

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

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. In addition, awardees will address in the progress report the current status of the project in relation to the appropriate milestones on the timeline proposed for the project.

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:

Richard A. Ikeda, Ph.D.
Pharmacology, Physiology and Biological Chemistry Division
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 2As.43B, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
FAX: 301-480-2802
Email: ikedar@nigms.nih.gov

2. Peer Review Contacts:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 3An.12, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.nih.gov

3. Financial or Grants Management Contacts:

Antoinette Holland
Grants Administration Branch
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 2An.50B, MSC 6200
Bethesda , MD 20892-6200
Telephone: (301) 594-5132
FAX: (301) 480-2554
Email: hollanda@nigms.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/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.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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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