The SC1 mechanism is for faculty at the most advanced stages of development, i.e., who are engaged in the state-of-the-art biomedical/behavioral research and productive as evidenced by a steady track record of peer-reviewed publications and are planning to transition to non-SCORE sources of support. An SC1 proposal should identify a specific unsolved problem and means to obtain data pertinent to the problem to advance the knowledge in a biomedical or behavioral area limited to the NIH mission. In addition, SC1 applicants are expected to develop their research competitiveness by enhancing their research productivity. SC1 PIs are encouraged to establish meaningful collaborations that will increase the progress and productivity of the project. Additionally, SC1 investigators must participate in other MORE activities that foster their development and accelerate their transition to non-SCORE support. These activities include participation in a MORE-sponsored grant-writing workshop and a biennial meeting of SCORE SC1 PIs. SC1 awards may be renewed once.

PIs who have had SC1 support may only apply for an SC2 award if they intend to develop a new line of research. Although the expectation of the SC1 mechanism is that grantees who receive two cycles of support will succeed in securing non-SCORE support, PIs may apply at this stage for SC3 support provided convincing evidence of having sought non-SCORE support is supplied.

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 SC1 grant award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

• Thirty to 35 SC1 awards totaling $6.5-7.0 million dollars (direct costs) are expected to be made each year.
• The anticipated amount of individual SC1 awards is expected to range between $125,000 to $250,000 maximum direct costs per year.
• New applicants who have never received SCORE S06 subproject or individual awards may apply for a maximum of five years of support.
• Applicants who have received previous SCORE S06 subproject or individual awards of any type for any length of time may apply for renewals for a maximum of four years of support.

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:

• A public or private post secondary educational institution, such as a university or college awarding associate, undergraduate or graduate degrees located in the United States of America or its territories including Puerto Rico, Guam and Virgin Islands with more than 50 percent student enrollment at the applicant institution from groups underrepresented in the biomedical and behavioral sciences such as African American, Hispanic American, Native American, Alaska Natives or natives of the U.S. Pacific Islands.
• An Indian tribe that has a recognized governing body and that performs substantial governmental functions, or an Alaska Regional Corporation (ARC), as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et. Seq.).
• If the applicant institution has a significantly high student enrollment from groups underrepresented in the biomedical or behavioral sciences but less than 50%, the institution may be eligible if the Secretary of the Department of Health and Human Services, through the MBRS Chief, determines that the institution has demonstrated special commitment to the retention and graduation of students from groups underrepresented in the biomedical and behavioral sciences and to the hiring and retention of science faculty from underrepresented groups. Additionally, institutions should demonstrate a clear and compelling institutional need for SCORE developmental support. Institutions with well-developed environments for the conduct of research and/or research training and significant support from NIH R01 or equivalent awards are generally not suitable applicants for the SCORE program. For information regarding eligibility please contact MBRS Chief (see Section VII. Agency Contacts).
• Foreign Institutions are not eligible to apply.
• Eligible MSIs need not have an S06 award for its faculty to apply for SCORE individual awards.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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 support. Typically the PI of a SCORE application possesses a Ph.D. or M.D./Ph.D. degree. He/she must also have a full-time faculty appointment at the applicant institution and be eligible to apply for a NIH R01 research grant. Postdoctoral fellows, research fellows, and part-time or adjunct faculty are not eligible to apply for SCORE individual awards. An applicant may not be the Principal Investigator of any other NIH investigator-initiated research grant such as an R01, R21, etc., or a PI of an S06 subproject at the time an SC1 award is made.

SC1 awards may not be transferred form one PI to another.

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

The maximum number of individual SCORE applications/awards (SC1, SC2 or SC3) that a combination of individual investigators from a single MSI may hold is 25. Research at foreign sites and/or foreign collaborations/components are not allowed.

A PI may only apply for/receive one individual SCORE award at a time. Additionally, a PI may receive a maximum of two cycles of support through the SC1 mechanism. Emeritus/retired professors or investigators who have or have had a significant track record of non-MBRS external research funding are considered fully developed and may not apply for any of the SCORE investigator-initiated research awards. Because of the developmental nature of the SC1 award mechanism, no Co-PIs are allowed. Similar SC1 and R01 or other NIH applications may not be submitted concurrently

New PIs, who have never received SCORE support (including S06 subprojects), may apply for a maximum of five years of support. PIs who have received previous SCORE support for any length of time may apply for a maximum of four years. SC1 renewals are for a maximum of four years.

Institutions receiving a new or renewal S06 award during January-September, 2006 may submit individual SC1, SC2 or SC3 (not S06) applications to a combined maximum of 25 total S06 subprojects and SCORE SC1, SC2 or SC3 individual investigator awards.

However, in this case, individual investigator-initiated SC1, SC2 or SC3 applications may only be submitted by PIs who are not already receiving S06 support (see I.B. Eligible Individuals).

Institutions that have an S06 grant in place prior to January, 2006 are not eligible to apply for any of the new SCORE individual or institutional awards until the submission of a renewal application.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, 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.

SCORE investigator-initiated research projects are limited to the NIH mission. SCORE PIs are strongly encouraged to visit the NIH website, http://www.nih.gov, to search the NIH archives for all past and currently funded NIH grants and research areas.

In the preparation of SC1 research projects, follow the PHS 398 instructions. The 25-page limit set for a research project plan in PHS 398 also applies to the SC1.

If animal and/or human subjects are to be used in the research carefully follow PHS 398 instructions regarding the questions that need to be answered and the submission of the required Targeted/Planned Enrollment Tables and Inclusion Enrollment Report Tables (for additional information refer to

http://grants.nih.gov/grants/funding/phs398/instructions2/p2_human_subjects_definitions.htm).

Additional Instructions:

Modular Budget Format Page. Follow instructions in PHS 398 (4/2006 revision). Refer to the Budget Instructions of the research grant application at http://grants2.nih.gov/grants/funding/phs398/phs398.html for step-by step-instructions for preparing modular budgets. Note that applicants request direct costs in $25,000 modules and that the total direct costs each year must not exceed $250,000.

In the Biographical Sketch of the PI list the education and training, selected publications with full citations, position(s); any honors, and any grant support, with information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. Also provide for the PI only information on his (her) previous or current experience supervising students from underrepresented groups in research, and/or other relationships within the institutional framework (e.g., cross-departmental research collaborations).

The Research Plan of an SC1 Application should be prepared following PHS 398 instructions (4/2006 revision). Under the Research Plan’s Specific Aims section, include not only the project’s research objectives but the PI’s developmental objectives as related to when the transition to non-SCORE support will occur.

Include in the Background and Significance section of the Research Plan a subheading entitled Institutional Data. In this part, which is limited to two pages (counted as part of the 25-page limit for items A-D of the Research Plan), include the following:

Letters of collaboration should be placed after the Literature Cited section (refer to PHS 398 instructions).

Appendix. Follow instructions in PHS 398. Limit appendix to papers published or in press (note that publications must conform to NOT-OD-06-053, see http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-06-053.html).

Renewal Applications

PIs who have previously received SCORE support (i.e., S06 subproject) submitting a first SC1 application and those PIs submitting renewal applications must include a detailed progress report (refer to PHS 398) and a list of peer-reviewed publications resulting from SCORE support. Information on the level of funding (dollars per year) during the previous grant period and on the number of technical personnel (technicians, postdoctoral research associates, and other research associates) who participated in the project (whether or not paid with SCORE funds) must be included in the progress report. The progress report section must be placed immediately after the section on background and significance as described in PHS 398. Applications lacking the required progress report will be returned to the applicant without review.

Revised Applications

A revised application may be submitted. The revised application must include an Introduction that addresses fully the questions/issues raised by the reviewers of the previous application. In addition, the body of the application must indicate, by changes in font or other means, the revised sections (see PHS 398 instructions).

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt/Submission Date(s): September 18, 2006, January 18, 2007, May 18, 2007; September 18, 2007, January 18, 2008, May 18, 2008; September 18, 2008, January 18, 2009, May 18, 2009; September 18, 2009, January 18, 2010, May 18, 2010
Peer Review Date(s): February-March, June-July, October-November
Council Review Date(s): May, September, January
Earliest Anticipated Start Date(s): July, January, April

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 single-sided, signed photocopies of the complete application and all copies (five collated sets) of appendix materials must also be sent to:

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, Maryland 20892-6200
Telephone: (301) 594-2881

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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 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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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. (See also Section VI.2 Award Administration Information).

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.

SCORE SC1 awards include some restrictions as to how the funds may be used. The following account summarizes allowable and non-allowable costs under the SCORE SC1 mechanism.

Allowable Costs

Unallowable Costs

6. Other Submission Requirements

Not applicable.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NIGMS 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
• Receive a second level of review by the NIGMS National Advisory Council.

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
• Potential contribution to achieving the MBRS goal of increasing the number of individuals from underrepresented groups who participate in biomedical and behavioral research

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?
What is the likelihood that the PI will transition to non-SCORE support for a biomedical- or behavioral-relevant project?

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 (if applicable)? Does the investigator’s past publication and productivity record provide convincing evidence that the applicant is positioned to benefit from SCORE support and achieve his/her developmental objectives in a reasonable time frame?

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?

Overall Evaluation: Summarize the major factors from the five review criteria above that contribute or detract from scientific merit. In addition, evaluate whether the proposed project addresses the developmental objectives of SCORE, especially of the SC1 mechanism, which are to increase the number of investigators from MSIs that enhance their research competitiveness to a stage where they can successfully compete for non-SCORE 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:

Progress Report (for competing renewal (Type 2) applications only): Has the investigator been productive in documenting his/her research findings in refereed journals? Has the investigator’s productivity accelerated/improved as he/she develops?

Resubmitted Applications: Response to previous critiques.

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 requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://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

Earliest possible dates when awards will be made will be January for applications reviewed at the September Council meeting, April for applications reviewed at the January Council meeting and July for applications reviewed at the May Council meeting.

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). If a grantee is not email enabled, a hard copy of the NoA 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 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.)

The annual progress (refer to PHS 2590) must detail the progress accomplished towards each specific aim and provide a list of peer-reviewed publications resulting from SCORE support. Information on the level of funding (dollars per year) during the previous grant period and on the number of technical personnel (technicians, postdoctoral research associates, and other research associates) who participated in the project (whether or not paid with SCORE funds) must be included in the progress report.

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:

Hinda Zlotnik, Ph.D.
Minority Opportunities in Research Division
National Institute of General Medical Sciences, NIH
45 Center Drive
Room 2As.37, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3900
FAX: (301) 480-2753
Email: zlotnikh@nigms.nih.gov

2. Peer Review Contacts:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences, NIH
45 Center Dr.
Room 3AN.12F, 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
Division of Extramural Activities
National Institute of General Medical Sciences, NIH
45 Center Dr.
Bldg. 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).

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 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. See also Senate Appropriations Committee Report, No. 92-316, July 29, 1971, Executive Order 12900, Educational Excellence for Hispanic Americans February 22, 1994, Executive Order 12876, Historically Black Colleges and Universities, November 1, 1993, and Executive Order 13021, October 21, 1996 and Outline of Work Plan, August 18, 1998, White House Initiative on Tribal Colleges and Universities. 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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