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 Eye Institute (NEI), (http://www.nei.nih.gov/)

Title: NEI Translational Research Program On Therapy For Visual Disorders

Announcement Type
This is a reissue of PAR-01-022, Collaborative Research on Therapy for Visual Disorders

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

Program Announcement (PA) Number: PAR-05-110

Catalog of Federal Domestic Assistance Number(s)
93.867

Key Dates
Release Date: May 18, 2005
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htmfor details
Peer Review Date(s): S tandard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): S tandard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htmfor details
Earliest Anticipated Start Date: S tandard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: July 2, 2008 (now September 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

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

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

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt, Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   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

Purpose

The National Eye Institute (NEI) announces the reissue of PAR-01-022, Collaborative Research on Therapy for Visual Disorders. This program continues support of collaborative, multidisciplinary research programs focused on new therapeutic approaches to restore or prevent the loss of function due to visual system diseases and disorders. The rapid and efficient translation of laboratory research findings into clinical development requires a comprehensive and highly integrated approach involving collaborative teams of scientists and clinicians with expertise in multiple disciplines. Such a collaborative approach would be particularly appropriate for research focused on pathways that will likely be targeted by biological intervention, such as gene therapy, cell-based therapy, pharmacological approaches, or development of appropriate delivery systems. The intention of this program is to make resources available to scientists from several disciplines to form research teams to address scientific and technical questions that would be beyond the capabilities of any one research group. It is anticipated that applications funded under this program will lead to therapies that can be tested in a clinical trial.

Background Information

Once development of new modalities or therapies have been identified for the treatment of visual diseases or disorders, collaborative teams comprised of investigators and experts in several disciplines can begin bridging the gap between target identification and the development of clinical treatment modalities. For example, progress in the treatment of retinal degenerations using gene replacement therapy could require collaborations among geneticists who have identified and cloned a defect-specific gene, molecular biologists who can produce appropriate vectors, cell biologists with animal model and cell culture systems in which to test products, and clinical trial experts who can design Phase I and/or II human safety and/or efficacy trials. Similarly, pharmacologic treatments to preserve function, reverse degenerative processes, or facilitate transplantation strategies with neuroprotective agents, growth factors, or other biologics could require collaborations among vision scientists, pharmacologists who can isolate and purify factors, chemists who can synthesize drug delivery systems, cell biologists, toxicologists, and clinical experts. The creativity of such interdisciplinary teams is expected to lead to the development of innovative clinical applications.

Scientific Knowledge to Be Achieved

It is the intent of the program to increase the pace at which basic science discoveries on disease mechanisms can be translated into therapies for complex visual system disorders and diseases. Knowledge is expected to be gained in the most efficient use of cell and molecular therapies to treat and prevent complex visual system disorders.

Objectives

The objective of this program announcement is to encourage collaborative research that facilitates the translation of focused laboratory and animal studies into clinical development. Translational research may target new, or previously identified, genes, molecules and/or pathways that are deemed to be appropriate for therapeutic intervention. Applicants should consider the relevance of their proposed research to NEI programs and priorities as described in the National Plan for Eye and Vision Research 2004 which articulates NEI's current research needs, opportunities, and priorities and which is available at http://www.nei.nih.gov/.

The scope of this program is broad and it is intended to cover all visual system diseases and disorders which are relevant to the mission of the NEI.

Types of Research and Experimental Approaches to Achieve the Objectives

The following topics are presented as general examples, and are not intended to be exclusive or to limit creativity and innovation:

Gene transfer has the potential for novel medical applications. Considerable progress has been made in vector design and therapeutic strategies are emerging. Gene therapy is most likely to reach clinical importance in monogenic disease where the replacement of one mutated gene may be curative (such as juvenile glaucoma, macular corneal dystrophy, retinitis pigmentosa, pseudoxanthoma elasticum, juvenile cataract) or in pathological conditions which require a temporary expression of a transferred gene (such as a growth factor or ribozyme) to achieve a beneficial clinical effect. Alternatively, the use of selectively targeted cell-based therapies using cells expressing various angiostatic or neurotrophic factors might represent another approach to viral gene therapy. Autologous grafts of such cells alone, or after transfection to express a desirable gene product, would avoid some of the immunological problems associated with viral vectors. Expression of trophic factors might achieve generic rescue effects on selected cell populations, possibly circumventing the need to target specific gene defects. Successful gene therapy requires research teams able to contribute resources such as therapeutic genes, cells and vectors capable of appropriate tissue targeting and gene expression, animal models for toxicology and efficacy testing, and clinical expertise.

Human adult bone-marrow-derived stem cells appear to have stabilizing effects on retinal blood vessel loss in animal models of retinal degeneration. In two inherited defects in retinal vascular development, Norrie disease and familial exudative vitreoretinopathy, the Norrin/Fz4 signalling pathway appears to play a role in the incomplete retinal neovasculaization that occurs. Pharmacologic modulation of Norrin and /or Fz4 function might be useful in treating retinal neovascularization.

Characterization of pathways leading to cell degeneration and death could provide target points for therapeutic intervention in retinal diseases such as glaucoma and age-related macular degeneration. Conversely, the identification of factors that enhance cell survival may protect against such degeneration. The development of neuroprotection strategies to arrest or halt the degenerative process, or stimulate the regeneration of damaged tissue, would benefit from a multidisciplinary research approach. Different scientific disciplines may be necessary to: identify and validate appropriate therapeutic targets; devise suitable delivery systems; test the efficacy and safety of such agents in animal models, and initiate design clinical trials for human testing.

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 NIH Resource-related Research Project Grant Award (R24) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

Projects funded under this announcement are non-renewable.

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

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(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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 components to domestic applications will be allowed if the foreign component provides significant scientific input that is critical to the program and for which there is no similar resource in the United States.

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

Not Required

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
Not applicable

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
See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

At the time of submission, two additional copies of the application and all copies of the appendix material should be sent to: Samuel C. Rawlings, Ph.D. Chief, Scientific Review Branch National Eye Institute 5635 Fishers Lane, MSC 9300 Suite 1300 Bethesda, MD 20892-9300.

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission date(s) described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Applicants should include a plan for the organization, coordination and management of the project. Interaction between the various components of the study should be clearly described. Cross-participation between investigators in the study should be clearly explained. Given the complexity of assembling and managing a multi-center, multi-investigator approach to developing a medical therapy, one possible suggested application format is to describe modules of science. Coordination of the modules is the responsibility of the Principal Investigator who will likely arrange for annual or semi-annual group meetings of the investigative team and who is responsible for submitting annual non-competing progress reports to the NIH. An example of how a modular grant application format might be used is in the case of gene therapy. One can envision a team of investigators who can direct modules for vector production, vector improvement and scale up, animal studies and testing, toxicology, and IND development, for example. All modules might not run concurrently but be phased in and out of the study as needs dictate.

While it is possible for a group of investigators from a single institution to come together as a team and submit an application, it is more likely that the expertise need to carry out a complex multi-component translational therapy research project will be located at different institutions. Thus it is the responsibility of the Principal Investigator to assemble the most highly qualified team to carry out the objectives of the project.

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/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.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the NEI on the basis of established PHS referral guidelines.

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

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

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a 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? Is the proposed research relevant to NEI programs and priorities as described in the National Plan for Eye and Vision Research 2004, which is available at http://www.nei.nih.gov/?

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? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project? Is there a clearly documented management plan for organization, coordination, and management of the project by the Principal Investigator? Has the team that has been assembled the best possible multidisciplinary scientific team to accomplish the goals of the study?

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:

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 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. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing. Applicants may seek guidance from NEI program officials in developing a data sharing plan.

2.D. Sharing Research Resources

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

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/grants/policy/nihgps_2003/NIHGPS_part4.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

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).

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:

Peter A. Dudley, Ph.D.
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892
Telephone: (301) 451-2020
FAX: (310) 402-0528
Email: pad@nei.nih.gov

2. Peer Review Contacts:

Samuel C. Rawlings, Ph.D.
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: rawlings@nei.nih.gov

3. Financial or Grants Management Contacts:

Mr. William W. Darby
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda , MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 496-9997
Email: wwd@nei.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.

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/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.

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 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.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


H H S Department of Health
and Human Services

 
  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892