Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) , (http://www.nih.gov)

Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)

Title: MBRS Research Initiative for Scientific Enhancement

Announcement Type
This Program announcement (PA) is a re-issue of an earlier announcement, PAR-99-151, which was published in the NIH Guide dated August 20, 1999.

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

Program Announcement (PA) Number: PAR-05-127

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: June 22, 2005
Letter of Intent: Not Applicable
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional Information To Be Available Date (URL Activation Date): May 1, 2005
Expiration Date: September 11, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

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

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

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt and Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

 Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   3. Reporting

 Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

In the National Institutes of Health (NIH) Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities engaged in biomedical and behavioral research. In response to this Congressional Act, the Minority Biomedical Research Support (MBRS) Branch of NIGMS initiated the institutional Research Initiative for Scientific Enhancement (RISE) program to increase the numbers of underrepresented minority faculty, investigators, and students engaged in biomedical or behavioral research and to broaden the opportunities for participation in biomedical or behavioral research of underrepresented minority faculty and students. MBRS RISE grants are offered to eligible minority-serving institutions. These institutional grants may involve one or more biomedical science-related departments.

The specific goal of the RISE program is to increase the number of students from underrepresented groups in biomedical and behavioral research who progress to the next academic step, culminating with the attainment of a Ph.D. degree. Historically, U.S. citizens who are African American, Hispanic American, Native American or natives of the U.S. Pacific Islands have been found to be underrepresented in biomedical and behavioral research.

An analysis of successful science programs by Jolly, Campbell, and Perlman entitled Engagement, Capacity and Continuity: A Trilogy for Student Success (GE Foundation, September 2004) concluded that three factors must be present for students to succeed in the sciences and be able to continue in the education pipeline. These three factors are:

1) Student engagement in the sciences, i.e., awareness, interest and motivation;

2) Knowledge and skills needed to advance to increasingly more rigorous content in the sciences and quantitative disciplines;

3) Presence of an articulated system where the skills, knowledge and information that students need to move to more advanced levels are provided at each earlier, less advanced level.

These three factors are interdependent and each is necessary. No individual factor is sufficient to ensure student persistence or continuance and success. Thus, successful programs select and employ well integrated strategies, rooted in education research, that provide students what they need to progress to the next stage of the science education pipeline.

Because of their diverse institutional settings and institutional missions, RISE applicant institutions must: 1) specify what they want to accomplish or improve in the form of overall goals and specific measurable objectives, 2) present an integrated plan of activities to accomplish the proposed objectives and 3) provide a detailed evaluation plan that will help the institution determine which objectives are being met and which activities are being most effective or require modification.

Mandatory application components include:

Activities that could be proposed include but are not limited to:

Some RISE-eligible institutions may not have enough active researchers with extramural funding to support on-campus research internships to increase student engagement in the sciences. However, such institutions could establish collaborative arrangements with research-intensive institutions to have their students benefit from off-campus research internships.

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 R25 Research Education award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed four-year renewable project grant.

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

Specifically, a detailed itemized budget for the “Initial Budget Period” and the “Entire Proposed Period of Support” is to be submitted with the application.

2. Funds Available

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit a RISE application if your organization has the following characteristics:

1.B. Eligible Individuals

1.B.1 Principal Investigators

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.

Principal Investigators, referred to as Program Directors (PDs), should possess the teaching/research experience, and leadership and administrative capabilities required to carry out the proposed research education activities and should work with their institution to develop an application. The PD must have a regular full-time appointment (i.e., not adjunct, part-time, retired, or emeritus) preferably at the rank of associate or full professor.

PDs are responsible for the administration and management of the overall institutional program and serve as liaison between the grantee institution and NIH. Typically, a PD possesses a Ph.D. or equivalent degree.

1.B.2 Student Participants

Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans, Alaska Natives, Native Hawaiians, and Pacific Islanders. However, if the institution determines other racial or ethnic groups to be underrepresented in biomedical or behavioral research, institutional documentation that validates this finding must be provided. It is the responsibility of the applicant institution to establish the qualifications of students prior to their RISE participation. Only students who are U.S. citizens or non-citizen nationals or permanent residents and matriculated full-time at the applicant institution are eligible to be supported by the RISE-sponsored activities. (A non-citizen national is a person who, although not a citizen of the United States, owes permanent allegiance to the U.S. This is generally a person born in a land that is not a state, but that is under U.S. sovereignty, jurisdiction, or administration -- for example, American Samoa.) An individual lawfully admitted for permanent residence must possess an alien registration receipt card (I-551) prior to appointment on the grant. Individuals on temporary visas, those seeking asylum, or refugees are not eligible for support from the RISE Program.

2. Cost Sharing or Matching
The RISE program grants do not require cost sharing or matching funds.

3. Other-Special Eligibility Criteria

Eligible applicant institutions may not concurrently apply for, or have pending, more than one RISE grant application. Eligible institutions may only hold one RISE award. Institutions awarded an NIGMS-IMSD award are ineligible to apply for a RISE grant.

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.htmlin 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.

See also Section IV.6. for additional information.

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details. Peer Review Date (s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.

3.A.1. Letter of Intent
Not required

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 five collated sets of all copies 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 submitted on or before the dates described above (Section IV.3.A) and at http://grants.nih.gov/grants/dates.htm. If an application is received after that date, it will be returned without review.

Upon receipt applications will be evaluated for completeness by CSR and responsiveness by NIGMS. 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. (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/archive/grants/policy/nihgps_2003/index.htm.

RISE grant awards include some restrictions as to how the funds may be used. The following account summarizes allowable and non-allowable costs under the RISE Program. Please note that RISE applications must present an integrated set of student development activities, and therefore a single consolidated budget is required. Each item in the budget must be clearly justified.

5. A. Allowable costs:

5. B. Unallowable costs:

6. Other Submission Requirements

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and the IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

6. A. Grant Application Content

6. A.1. New Application (Type 1)

The RISE application should be organized to reflect the institutional scope of the proposed program, and it should be presented as an integrated set of student development activities with a single budget, described in detail that ensure student progress to the next step, culminating with the attainment of a Ph.D. degree. For the Student Development Plan (referred to as Research Plan in the application forms), PHS 398 continuation pages should be used. Page limit for this part (sections A-D Form PHS 398) is 25 pages of narrative excluding figures, charts, tables and diagrams. Student Development Plan sections on Human Subjects, Vertebrate Animals, and Literature Cited are also not included in the 25 page limit. Figures, tables, etc., mentioned in the narrative should be placed after the Responsible Conduct of Research Plan (Section D) and before the Literature Cited (see below).

A . Specific Aims:

In the section on the Specific Aims, the application must address the goals and specific measurable objectives (including anticipated milestones) that the institution expects to accomplish. These objectives must be presented as percent improvement over the current baseline and the baseline must be clearly defined.

B. The Background and Significance section should include the following specific items:

1) Data on student enrollment and academic performance in each of the participating departments must be provided. The data may be presented in tabular and narrative forms. (Average numbers for the past four years may be summarized in a tabular form. See sample format tables at MORE Division web site http://www.nigms.nih.gov/funding/rise_sample_tables.html.)

2) Institutional setting and current status of the undergraduate and/or graduate bio-medical science-related academic programs.

The following are examples (not inclusive) of the kind of information to be provided on the institutional programs:

Information on graduate programs should include, but is not limited to , the degree requirements, training faculty and research areas and research infrastructure.

3) Institutional vision of the competencies and knowledge that science graduates acquire and the current career tracks that graduates pursue.

The analysis/evaluation of this information is expected to assist the institution in identifying the areas selected for improvement and to present an overview of strategies that will result in the achievement of the proposed institutional RISE objectives. For example, if biology graduates are expected to have “x” quantitative skills as evidenced by their ability to answer certain standardized questions (e.g., in the GRE examination) and institutional assessment shows that most biology students do not master those quantitative skills, activities to improve students' quantitative knowledge and skills could be designed as part of the RISE program.

4) Anticipated value of the proposed RISE program and other student development programs complementary to RISE. State clearly how the proposed RISE program will enhance and assist the institution's efforts to train students from underrepresented groups who will progress competitively to the next stage of a research career. P rovide details on the number of student participants in other complementary programs.

C. In the section on Research Design and Methods, include the following:

1) Detailed Description of the Proposed Developmental Activities. Include a brief rationale for the activity selection, and concise information on RISE student pool, selection, monitoring of student progress, credentials, experience (i.e., provide biosketches of key personnel) and role of the faculty/personnel involved, equipment, space, and other resources available to implement each activity. For example, if on-site research internships are proposed, it is expected that students will have a meaningful research experience in the laboratory of an active investigator who has extramural support and publishes. Thus, a list of available faculty and faculty bio-sketches and their extramural support must be provided as well as details on how the RISE student will select a research laboratory or be matched with a mentor, the number of hours that the student will spend working in the laboratory per week or during the summer, what the research experience will consist of, and what the student is expected to learn or accomplish. Similar information should be provided if off-campus research experiences are proposed including letters from the external sites expressing their willingness to have the RISE students participate in their summer programs. New programs should provide biosketches for no more than ten potential representative mentors from the proposed external sites.

If an advisory committee will be established to advise the PD, provide detailed information on the committee's functions and anticipated frequency of committee meetings. The role of the committee could include: establishing criteria for and assisting in student selection; advising and assisting the PD on the implementation of program activities as needed; monitoring progress of each activity; monitoring compliance with NIH policies regarding involvement of students in research using human or animal subjects, and/or in which there are research hazards; and addressing potential student grievances as they relate to the RISE program.

2) Evaluation Plan. The main purpose of the evaluation is to provide information useful to the PD for improving the RISE program at the institution by identifying the most effective student development activities as well as those that are not achieving the desired outcomes. The evaluation plan must identify the target group(s); identify baseline data on specific indicators (qualitative and quantitative); specify the goals and specific measurable objectives and the activities; and describe the formative and summative evaluation methods to be used to assess improvement , the timeline of data collection and analysis, and the name and credentials of the evaluator(s).

D. Responsible Conduct of Research Plan. A plan to instruct all RISE student participants in responsible conduct of research must be provided at the end of the student development plan. This instruction plan must include a description of the topics to be covered in scientific integrity and the responsible conduct of research. Although NIH does not establish specific curricula or formal requirements, all programs should consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal research subjects, procedures for students to obtain individual certification for the use of humans or animals as research subjects, and data management. Within the context of training in scientific integrity, it is also beneficial to discuss the mutual responsibilities of the institution and the student researchers regarding publications, intellectual property rights, etc. The plan should address the content, rationale, and format of the instruction, the extent of faculty participation and credentials of the proposed faculty, student attendance, and the frequency and duration of instruction.

E. Human Subjects Research. Not applicable, see H below.

F. Vertebrate Animals. Not applicable, see H below.

G. Biohazards. The RISE PD and the advisory committee, if applicable, must be diligent in working with other institutional offices or units such as the radiation and/or biosafety office to insure that exposure of student participants to research hazards is minimized. Attention should be given to: pre-use training of personnel; storage or containment of the hazard; use of a log to record usage; monitoring exposure to the hazard; decontamination procedures, where applicable; and methods for disposal of hazardous substances.

H. Student Involvement in Research. Although students will not conduct research under the auspices of the RISE grant mechanism, before they are permitted to work on funded research projects of mentors involving vertebrate animals and/or human subjects, applicants are expected to fulfill the institutional and federal requirements for these activities, e.g., IRB and IACUC approvals and obtain the student research certifications.

I. Appendix. Appendix material is generally not needed for RISE applications. Limit it to oversized documents, evaluation questionnaires, brochures, etc. Five collated sets should be submitted.

6. A. 2. Competing Continuation Application (Type 2)

In addition to the components required for a new application, the competing continuation application must include an explicitly identified Progress Report that summarizes the progress achieved during the previous grant period with respect to the originally proposed goals and specific measurable objectives and given baseline data. Competing applications that lack a Progress Report will be returned to the applicant without review. Six to eight pages are recommended for the narrative portion of the Progress Report and are not included in the 25-page limit for the research plan section of the application .

The progress report must provide: 1) a restatement of goals, objectives and baseline data proposed in the previous application; 2) a brief account of the progress towards achieving those goals and objectives and, if any, the impact of the program on institutional environment including graduation and retention rates; 3) a brief account of the results of the evaluation of the program and how the evaluation results were used to improve/change the proposed objectives or activities; 4) major student accomplishments such as publications, awards, etc.; and 5) data on student participants, either narrative or tabular form (see suggested sample tables at http://www.nigms.nih.gov/minority/mbrs.html) such as student name, student type (i.e., undergraduate or graduate), department and program, RISE activities in which he/she participated, dates of participation, degree earned and current status.

Competing continuation applications should provide biosketches for all faculty and investigators who mentored RISE students during the past grant period and up to ten proposed new mentors.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
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:

The following will be considered in making funding decisions:

Funding under this program also takes into consideration the legislative intent (see Section I.1) and evaluates the relevance of the proposed student academic development activities of the RISE program in the context of increasing the number of students from groups underrepresented in biomedical and behavioral sciences who progress to the next stage of their academic training in the pursuit of a research career.

The goals of NIH supported research include increasing the diversity in the scientific workforce engaged to increase 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 program 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 significant in that it accomplishes the MBRS goals and uses an effective approach.

Significance: Does this study address an important problem? Are the proposed goals and specific measurable objectives consonant with the recognized needs of the applicant institution, and with the objectives of the Program Announcement? Is the proposed RISE program likely to achieve an increase in the numbers of students from underrepresented groups moving on to the next academic stage in the pursuit of a research career? If the aims of the application are achieved, how will the RISE program contribute significantly to increasing the number of potential biomedical researchers?

Approach: Are the conceptual 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? Is there an adequate pool of students from underrepresented groups? Are the proposed activities consonant with the proposed objectives and likely to yield the anticipated results? If collaborative arrangements have been proposed, are they reasonable and are they likely to be productive? Is the proposed evaluation plan adequate? How will the ongoing evaluation results be used to improve the program?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches to getting students motivated, academically prepared, and continuing to next step in the pursuit of biomedical/behavioral research careers?

Investigators: Are the investigators and the proposed faculty appropriately trained and well suited to implement the proposed student development activities? Are the proposed activities appropriate to the experience level of the principal investigator and participating faculty? Are the research mentors extramurally funded and experienced in training students in research?

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 institutional environment or employ useful collaborative arrangements? Is there evidence of institutional support? Does the applicant institution enroll and graduate adequate numbers of students from underrepresented groups in biomedical science and related fields?

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:

Overall Progress Report (for Competing Continuation (Type 2) Applications only): Has significant progress been achieved in relation to the originally proposed goals, objectives and baseline data? How were the evaluation results used to change/improve the program developmental activities? What have been the program's contributions to the MBRS goal of increasing the numbers of students from underrepresented groups progressing to the next academic stage in the pursuit of a research career?

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed activities and the number of students involved in the program sponsored activities.

Responsible Conduct of Research: Reviewers should assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, so that the reviewers' evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the NIH awarding component will judge the acceptability of the revised plan.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates

Earliest possible dates when awards will be made will be January for applications reviewed at the October 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 Program Director will also receive a written critique called a Summary Statement.

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

A formal notification in the form of a Notice of 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 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of 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 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 notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

For additional instructions to prepare progress report please see the NIGMS/MORE web site: http://www.nigms.nih.gov/funding/pa/rise2590_inst.html.

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.
Chief, MBRS Branch
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.
Chief, Office of Scientific Review
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301)594-2881
FAX: (301)480-8506
E-mail: sunshinh@nigms.nih.gov

3. Financial or Grants Management Contacts:

Antoinette Holland
Grants Management Officer
Grants Management Branch
Division of Extramural Activities
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2AN.50, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301)594-5132
FAX: (301)480-2554
E-mail: hollanda@nigms.nih.gov

Section VIII. Other Information

Required Federal Citations

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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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 PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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.


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