Face Page (PHS398 Form Page 1).The title of the partnership (Item 1) should be the same for both the MSI and the Cancer Center linked applications. The title should be unique to specific partnership (do not repeat the title of this PA) and should include the suffix (1 of 2) or (2 of 2) for applications from MSI and cancer center, respectively. Attach additional Form Page 1 sheets for each additional PI.

Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS398 Form Page 2). List the lead PI first followed by the other PIs (the lead PI on the partnering application should be included as one of the PIs). Then list all Key Personnel for the Administrative Core and all Pilot projects/program in this application in alphabetical order. Finally, list the members of the IAC.

Detailed Budget for Initial Budget Period (PHS398 Form Page 4). In addition to the standard Detailed Initial Budget for the entire application, use separate PHS 398 Form Page 4 sheets to provide detailed initial budget individually for I. Separately break out the budget into sections using different Form Page 4 for each stage, as follows: (i) Planning Stage; (ii) Priority-Setting Stage; and (iii) Implementation Stage Budget.

It is expected that total requested costs in the first year will be less than costs in the second or third years, given that planning and priority-setting are not as expensive as the implementation of a project or a program.

Budget for Entire Proposed Period of Support (PHS398 Form Page 5). In addition to the standard Budget for Entire Proposed Period of Support for the entire application, use separate PHS 398 Form Page 5 sheets to provide individual budgets for each stage of partnership development during entire proposed period of support (i.e., separate budgets for the entire period of support for (i) planning stage, (ii) priority-setting stage, and (iii) implementation stage).

Use PHS398 Form Page 5 for the entire application (and continuation sheets, if needed) to provide budget justification. Provide specific justifications for costs for each year requested appropriate to the stage of development. Costs for each year would include administrative costs and developmental costs as needed within the $275,000 direct cost cap (for both linked applications together). A three percent cost-of-living escalation may be included in future years.

Budgets Pertaining to Consortium/Contractual Arrangements. Follow the PHS398 instructions to complete this information if your application (either the MSI application or Cancer Center application) involves a consortium of more than one institution of its type. One of these institutions will serve as the primary applicant institution (the one formally submitting the application) and the other one will be involved under a subcontract.

Biographical Sketches. Follow the PHS398 instructions and use the PHS 398 Biographical Sketch Format Page to provide biosketches (not to exceed four pages each) for all the individuals listed on Form Page 2 (collated in the same order).

GUIDELINES FOR THE RESEARCH PLAN SECTION

To match the unique needs of the MI/CCP application, the standard Sections A-D of the PHS 398 Research Plan are replaced by new Sections 1-6. The standard page limit of 25 pages for Sections A-D is replaced by a new limit of 25 pages for these new Sections 1-6.

Other sections of the PHS 398 Research Plan (Sections E-L) in the main body of the application are not modified and should be completed as per the standard PHS 398 instructions.

On the top of this limit for the main body of the application, additional page allocation is allowed for the specific sub-elements (pilot projects/programs and career development plans, if needed) covered in Section 6 whose numbers may vary from application to application. These additional limits are specified below in the guidelines to new Section 6.

Applicants are encouraged to use the minimum number of pages necessary to clearly and succinctly describe each element the Research Plan following the organization as described below.

Introduction to Revised/Resubmission Application (if applicable, not to exceed 3 pages; this section should be identical for both the MSI and Cancer Center applications). Include a summary of the additions, deletions, and changes in the revised application, placing particular emphasis on responses to the criticisms and issues raised in the previous summary statement. Include a chronological description of activities conducted since the original submission (meetings, research activities, etc.). The important changes must be clearly marked in the text.

New Section 1. Background and Objectives: This section should be identical for both the MSI and the Cancer Center linked applications (2-5 pages suggested).

Describe the characteristics of the MSI and the Cancer Center that will contribute to the planning effort. The description should clearly denote the nature of the interactions and deliberations that occurred between the MSI and the Cancer Center during the preparation of these applications (and identify the individuals involved). State the objectives of the collaboration.

When Cancer Centers are not NCI-designated Cancer Centers, there should be a clear summary of the qualities of the institution that demonstrate that it has a highly organized and integrated cancer research program comparable to an NCI-designated Cancer Center.

New Section 2. Letters-of-Commitment: This section should be different for the MSI and Cancer Center applications in the linked pair (2-3 pages suggested).

The section must contain Letters-of-Commitment from the MSI leadership and the Cancer Center leadership that document: (i) full support of the proposed activities; and (ii) any commitment of resources necessary to ensure that these partnerships will have the maximum chance of success. A complete and specific description of such resources would include the following:

• A specific statement detailing the percent effort of release/protected time of faculty (minimum of 25 percent for MSI faculty and 10 percent for the Cancer Center faculty) as well as the activities that each faculty involved are being released from (e.g., teaching, clinical, administrative duties).
• Provisions for space and facilities for new projects/programs, capital improvements, recruitment of new faculty, and other resources that will ensure the success of the partnership. This is especially important in cases where the application will require significant institutional commitments to ensure its success, such as a training program or an education program. The commitments must come from both institutional leaders of the MSI (e.g., President, Dean) and the Cancer Center (e.g., Cancer Center Director).
• If the Principal Investigators of the MSI or Cancer Center are less experienced individuals, a letter of support should be from a senior member of the MSI (e.g., Department Chair, Dean), or Cancer Center (e.g., Dean, Cancer Center Director), and should include a statement describing how the Principal Investigator will be provided with appropriate mentoring and the necessary support to ensure the success of this collaborative planning effort. This support could be in the form of protected time for junior faculty to participate in and focus on the objectives of this grant and discretionary resources that will be made available to the Principal and Co-Principal Investigators (See Section I. Scope).

New Section 3. Chronological Estimate of Planning, Priority-Setting, and Implementation Stages: This section should be identical for both the MSI and the Cancer Center application (up to 5 pages suggested).

Include a chronological narrative or table listing the specific first year, second year, third year, and fourth year objectives that are expected to be achieved. For each objective, a brief statement should be made about the separate contributions of the MSI and the Cancer Center in order to achieve success. The final objective of the P20 must be the submission of a specific grant application (R03, R01, T32, K12, R25T, R25E, project on Program Project Research Grant [P01], or Spore Grant [P50]) to the NCI or other funding agencies.

New Section 4. Initial Planning Stage: This section should be identical for both the MSI and the Cancer Center application (up to 5 pages suggested).

The applicants should clearly describe the kinds of planning activities that the MSI and the Cancer Center will conduct to ensure a highly interactive and integrated effort between their faculty and scientists. These applicants should also relate each planning activity (e.g., workshop, retreat, executive meeting) to specific objectives above and name the specific faculty and interests (e.g., training, clinical oncology researchers, research in prostate cancer, establishing new curriculum in cancer health disparities, nutrition, etc.) involved in each activity.

New Section 5. Priority-Setting Stage: This section should be identical for both the MSI and the Cancer Center application (up to 5 pages suggested).

Clearly describe how the specific projects/programs will be prioritized and selected for implementation based on their merit and greatest potential for success.

New Section 6. Implementation Stage: This section should be identical for both the MSI and the Cancer Center application (not counting towards the overall page limit). For each project/program (and Career Development Plan, if needed), page limits specified below apply.

In this section, application must describe at least one (required) or more joint pilot Projects/Programs in any of the four targeted areas. Pilot Projects/Programs proposed for funding cannot exceed $120,000 per project/program in direct costs per year for up to 3 years. The description of these projects/programs should be provided in the following format.

• Title Page including: project/program title, names of co-leaders from the MSI and the Cancer Center, and one paragraph abstract stating the objectives of the project/program (not counted towards the page limits);
• Detailed budget page for initial budget period (using Form Page 4 of the Form PHS 398, not counted towards the page limits);
• Budget for entire proposed period of support (using Form Page 5 from the Form PHS 398, not counted towards the page limits);
• Biographical Sketches of Co-Leaders (even if already included among the biosketches for the entire application);
• Research Plan (using standard Sections A-L as per PHS398 instructions).
• Section A-D (Specific Aims; Background and Significance; Preliminary studies; and Research Design and Methods) must not exceed 15 pages per each project/program.
• Describe how this pilot project/program relates to the overall priorities of the partnership and the target area(s). Include any preliminary data (if available). Describe, as appropriate for the nature of the project/program, experimental methods/study design, or the training, outreach and/or education plans and objectives. For example, include the identification of the target pool (students or minority population), and/or the method of program evaluation and tracking. Describe the role played by the MSI and Cancer Center co-investigators/ mentors. Identify which aspects of the pilot project/program will be conducted primarily at the MSI and which at the Cancer Center. Research projects conducted primarily at the MSI may be in any area of cancer research, but research projects conducted primarily at the Cancer Center must specifically address cancer health disparities research.
• Other Sections of PHS 398 Research Plan (Sections E-L) must also be completed for each pilot project/program (but are excluded from page limitations).
• Career Development and Mentorship Plan (if needed). For the less experienced co-leaders, career development and mentorship plan should be provided. The plan description should follow the format of Career Development Awards (K Awards), Section II. Specialized Information, sub-sections: 1. The Candidate; 2. Statements by Sponsor, Co-Sponsor(s),*Consultant(s),* and Contributor(s); and 3. Environment and Institutional Commitment to Candidate (http://grants.nih.gov/grants/funding/phs398/phs398.html). Only sub-section 1 (The Candidate) is subject to the page limit of 10 pages. In case of a PI for whom a career development plan is already required and included under new Section 5, refer to that section.

**NOTE: (1) All NIH-supported biomedical or behavioral research projects involving human subjects must consider appropriate inclusion of Gender and Minorities and Children as noted on pages 17-27 of the PHS 398 application instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on page 27 of the PHS 398 application instructions; and (3) Research components involving clinical trials must include provisions for rigorous data management, quality assurance, and auditing procedures. Funds should be budgeted for these activities and should be justified. The proposed provisions should not duplicate review and monitoring systems already in place at the institution.

For any cancer treatment protocol supported directly or indirectly by the P20 MI/CCP, informed consent forms, early stopping rules, and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application, or in the case of protocols subsequent to funding of a P20 MI/CCP, to the NCI program director.

Plan for Sharing Research Data

Not Applicable.

Sharing Research Resources

NIH policy expects that grant 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 at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at 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.

Appendix Materials

IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

For details on what items are generally allowed as Appendix materials see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

At the end of the entire application, include a List of Appendix Materials. However, do not attach Appendix materials to the application. These materials must be submitted in pdf format, see Section III. 3.B. Sending an Application to the NIH)

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review;
• Availability of funds;
• Relevance of program priorities; and
• Geographical diversity.

2. Review and Selection Process

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

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
• Receive a written critique; and
• Receive a second level of review by National Cancer Advisory Board.

The linked applications submitted in response to this FOA will be reviewed together and will receive one (i.e., the same) priority score.

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

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.

This FOA is broad in scope with emphasis on objectives raging from cancer research, training and career development, to education and outreach objectives. Therefore, in addition to the standard criteria of Significance, Approach, Environment, Investigators, and Innovation typically used for NIH research grants, additional review criteria for the evaluation of the specific components/aspects of the partnership are listed below.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

MSI-Cancer Center Partnership-specific aspects:

Initial Planning Stage --

• Are the different planning methods proposed by the MSI and the Cancer Center to explore areas of research and training opportunities adequate to ensure highly interactive and integrated efforts between individual scientists (e.g., research cancer project) and/or between faculty and scientists (e.g., training program, education program)?
• Is the duration of the initial planning stage needed to identify areas of potential collaboration, adequate?

Priority-Setting Stage

• What are the qualifications and experience of the individuals from the IAC who will take part in prioritizing and selecting specific pilot projects/programs for implementation?
• Is the proposed process for selecting pilot projects/programs for implementation based on their merit and their potential for successful acquisition of preliminary data during the period of requested grant support, adequate?

Pilot Research Project(s) (if applicable) --

• What is the potential and qualifications of the co-Investigators and the collaborative plan to prioritize and implement specific pilot projects and the relevance to the goals and priorities of the collaboration?
• What is the merit of the project/program and its potential to acquire the necessary preliminary data to become competitive for specific grant support (e.g., as provided through the R03, R01, P01, R21, T32, R25, K12, etc., grant award mechanisms)?
• Is the Career Development and Mentorship Plan (if needed) adequate?

Pilot Program(s) (i.e., training and education, if applicable)

• What are the qualifications of the Co-Leaders from the MSI and the Cancer Center to develop the proposed program?
• Is/are the mentor(s) appropriate as related to the level of education of the trainees?
• What are the objectives, design, and direction of the program?
• What is the merit of the proposed program and its relation to the goals and priorities of the partnership?
• Is the quality of the institutional environment (access to institutional resources, mentors accessibility, etc.) adequate?
• Is there evidence of integrating the proposed program with other program(s) in the MSI and the Cancer Center?
• How will the training/education pool (high school, undergraduate, graduate, medical students, minority populations, etc.) be identified?
• What is the quality of the proposed program evaluation and the tracking process?
• What is the potential of the application to develop into a fundable program in the NIH peer review system or other agency?

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 (if applicable)? Is the leadership plan for multiple PIs appropriate?

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?

MSI-Cancer Center Partnership-specific:

Collaboration in Partnership --

• What is the strength of the evidence that the researchers and faculty of the MSI and the Cancer Center worked closely together in the preparation of the application?
• To what degree do the letters-of-support from senior faculty and/or institutional/center leaders address the need for mentoring of inexperienced PIs or for specific institutional/center commitments to ensure the success of the collaboration?
• If any of the MSI PIs are junior investigators, is there an adequate Career Development and Mentorship Plan described?
• As applicable, are the provisions made for day-to-day oversight, coordination, support, and logistical services needed to make the collaboration successful, adequate?

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:

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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
.
Not Applicable.

2.D. Sharing Research Resources

NIH policy expects that grant 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 at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://ott.od.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.

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 PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in Item 12 on the Application Face Page).

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

2. Administrative and National Policy Requirements

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

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.

For those applications that are funded, the NCI will provide special instructions for submitting the Non-Competing Grant Progress Report (PHS 2590) each year.

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:

H. Nelson Aguila, D.V.M.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028, MSC 8350
Bethesda, MD 20892-8350 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: [email protected]

Peter O. Ogunbiyi, D.V.M., Ph.D.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028, MSC 8350
Bethesda, MD 20892-8350 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: [email protected]

Belinda Locke, M.S.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028, MSC 8350
Bethesda, MD 20892-8350 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: [email protected]

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 496-0275
Email: [email protected]

3. Financial or Grants Management Contacts:

Amy Knight
Office of Grants Administration
National Cancer Institute
1003 West 7th Street, Suite 300
Frederick, MD 21701
Telephone: (301) 846-6701
Fax: (301) 846-5720
Email: [email protected]

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); and 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 institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

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

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

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

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

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

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

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

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 2 years to the research. For further information, please see http://www.lrp.nih.gov/.