Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)
National Institute on Aging (NIA), http://www.nia.nih.gov)

Title: NCRR Science Education Partnership Award (SEPA) (R25)

Announcement Type
This is a reissue with modifications of PAR-06-080, which was previously released November 30, 2005.

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

• May 24, 2010 - This PAR has been reissued as (PAR-10-206).

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-06-549

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release/Posted Date: September 13, 2006
Opening Date: September 29, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 29, 2006, August 22, 2007, August 20, 2008
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): November 29, 2006, September 19, 2007, September 17, 2008
Peer Review Date(s): February/March 2007, 2008, 2009
Council Review Date(s): May 2007, 2008, 2009
Earliest Anticipated Start Date(s): July 2007, 2008, 2009
Expiration Date: September 18, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• The National Center for Research Resources (NCRR) invites applications for Science Education Partnership Awards (SEPA) program whose goals are to foster the development of novel programs to improve K-12 and the general public's understanding of the clinical trial process as well as the health science advances stemming from National Institutes of Health (NIH) funded clinical and basic research. The SEPA program supports the creation of innovative partnerships between biomedical and clinical researchers and K-12 teachers and schools, museum and science center educators, media experts, and other interested educational organizations. Particular importance will be given to SEPA applications that target K-12 science educational topics that may not be addressed by existing science curricula, community-based or media activities.
  
• NCRR encourages applicants to submit proposals that will educate the general public on the clinical trials process and of the safeguards provided for patients participating in these trials. NCRR also encourages proposals that target topics that may not be addressed in existing K-12 science education curricula or by other community and media activities.
  
• This FOA will use the NIH Research Education (R25) grant mechanism.
  
• Funds available: NCRR is providing approximately $3 million per year in FY 2007-2009 to support this initiative. NCRR intends to fund approximately 10 new awards per year in FY 2007-2009 in response to this PAR.
  
• Because the nature and scope of the proposed research education program will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.
  
• Budget and Project Period: The total project period for an application submitted in response to this funding opportunity may not exceed 3 years for a Development (Phase I) application, two years for a Dissemination (Phase II) application or 5 years for a combined Development and Dissemination (Phase I + Phase II) application. Direct costs are limited to $250,000 per year. This FOA uses just-in-time concepts. It also uses the non-modular budgeting formats, so the applicant must follow the instructions for non-modular budget research grant applications.
  
• Eligible Organizations: Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education), Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education), Science Centers and Museums, Indian/Native American Tribal Governments and Designated Organizations with a scientific and/or educational mission, Eligible agencies of the Federal, State or local government; Faith-based or community based organizations with a scientific and/or educational mission.
  
• Eligible Project Directors/Principal Investigators (PDs/PIs): Any individual with the skills, knowledge, and resources necessary to carry out the proposed research education program 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 support. An individual may not be listed as a principal investigator or Key Personnel on more that one SEPA grant application or active SEPA project.
• Research education programs may not be transferred from one institution to another, unless strongly justified (see Section VI.2).
• Initial merit review will be convened by the NCRR Office of Review.
• See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites:
  • http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc (MS Word)
  • http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf (PDF)
• For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

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 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically 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

This funding opportunity announcement (FOA) solicits applications from applicant organizations that propose creative and innovative research education programs to increase the public's understanding of medical research and deliver information about healthy living and career opportunities in science to children and the general public. The NIH Research Education (R25) grant mechanism is a flexible and specialized mechanism designed to foster the development of biomedical, behavioral, and clinical researchers through research education programs. The overall goal of the NCRR’s research education programs are (1) to ensure that highly trained scientists will be available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs in the NCRR’s mission areas and (2) to provide public education and outreach on NIH-funded research and the clinical trials process to a variety of audiences through science centers and museums. The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women. Examples of SEPA activities include:

• Developing, implementing and evaluating content-rich, inquiry-based science education programs, including innovative curricula, designed to enhance science teaching and learning with populations of underrepresented minority, underserved, rural and other disadvantaged students.

• Increasing the interest or participation of underrepresented groups in basic and clinical research career pathways
• Developing and implementing professional development for in-depth school or summer K-12 teacher enhancement in scientific content with appropriate pedagogical methods that are aligned with applicable professional, national, state and local standards.
• Developing science center and museum exhibits, research opportunities, traveling exhibits, programs and public outreach activities that excite, engage and educate the general public on NIH-funded basic and clinical research.
• Designing appropriate evaluation plans to assess efficacy and impact for K-12 and museum/science center-based curriculum development projects, teacher enhancement efforts, exhibits and informal science education programs.
• Educating the K-12 community and the general public on topical issues such as stem cells and regenerative medicine, ethics of research and medicine, the clinical trials process and patient safeguards.
• Exploring innovative approaches, including applications of technology and assessment tools, to strengthen public or K-12 understanding of science and the nature of science.

The proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Research Education Grant (R25) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.

Research education grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments ) of a previously reviewed research education grant application may be submitted. See NOT-OD-03-041, May 7, 2003.

2. Funds Available

Because the nature and scope of the proposed research education program 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 NCRR Provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Duration of SEPA projects are: 3 years for a Development (Phase I) application; 2 years for a Dissemination (Phase II) application and 5 years for a combined Development and Dissemination (Phase I + Phase II) application. Although the size of award may vary with the scope of the research education program proposed, it is expected that applications will stay within the following budgetary guidelines: total direct costs are limited to $250,000 annually.

F&A is limited to 8% of modified total direct costs. Subcontractors are permitted their negotiated F&A rate for this program

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this funding opportunity announcement.

Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, 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:

• Public/State Controlled Institution of Higher Education
• Private Institution of Higher Education
• Hispanic-serving Institution
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Science Centers and Museums
• Indian/Native American Tribal Governments and Designated Organizations with a scientific and/or educational mission.
• Eligible agencies of the Federal, State or local government; Faith-based or community based organizations with a scientific and/or educational mission.

Foreign institutions are not eligible to apply in response to this FOA.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be strongly justified.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research education program as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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. The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., Reporting. )

The PD/PI should be an established investigator in the scientific area in which the application is targeted who is capable of providing both administrative and scientific leadership to the development and implementation of the proposed science education program.

An individual may not be listed as a principal investigator or Key Personnel on more that one SEPA grant application or active SEPA project.

The PD/PI must devote a minimum of 1.2 person months annually to the proposed SEPA project

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

• An organization may either apply for one SEPA, or significantly contribute to the research proposed by the applicant organization (e.g., consortium). An organization with an active SEPA project or with a contractual, fee for service or consortium partnership with an active SEPA project is ineligible to submit a SEPA application.
• An applicant is expected to have a scientific and/or education mission that relates to the NCRR mission areas reflected in this FOA
  SEPA funding is not intended to provide continuing support for ongoing projects. However, it is appropriate to use a successful, existing model for a new project that is responsive to SEPA program needs.
• SEPA funding is not intended to co-support large-scale science center/museum projects, films or televised science education projects where the cost of the proposed project will exceed the SEPA award amount of $250,000 in direct costs per year.
• SEPA projects at science centers and museums must be clearly identifiable, stand-alone exhibits.

Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Applications must contain an evaluation plan and a dissemination plan.

Applications submitted without these sections may be delayed in the review process or not reviewed.

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/GetStarted) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.
• Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:

PHS398 Cover Letter File
Research & Related Sub Award Budget Attachment(s) Form

Research Education Program

While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.

Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine the degree of success or failure. A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives.

All applications must include a detailed Evaluation Plan for assessing the success of the proposed SEPA program. The Evaluation Plan should be an integral component of the early planning stages and must continue through the life of the SEPA project. A minimum of ten percent (10%) of the direct costs budget should be devoted to project evaluation. The use of external evaluators is required unless a valid justification can be made for an internal evaluation team.

A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g. Web postings, presentations at scientific meetings, workshops, etc.

K-12 Phase I + II applications must include a Dissemination plan that may include:

• Expanding the Phase I project to other school districts.
• Collaborations with SEPA and other K-12 programs.
• Website development.
• Presentations and posters at national meetings.
• Published materials such as journal articles and books.

Science Center and Museum projects should include comprehensive plans to develop:

• Public outreach activities that may include public forums, plays, focus groups and other outreach activities that will engage and educate the museum community, the general public and the lay press on NIH-funded research, the clinical trials process and other health-related areas.
• Field trip programs for minority and underserved students, teachers and families.
• Camp-over events and other in-museum activities for students, teachers and families.
• Outreach activities for local public libraries.
• Traveling exhibits on topically relevant health issues are highly encouraged. If proposed, travel and maintenance-related costs must be addressed.

Allowable Costs

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.

Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.

Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.

Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget

Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens. Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.

Participants in the research education program may receive a subsistence allowance, including partial costs of meals and lodging unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition, other education-related, and travel expenses. Expenses for foreign travel must be exceptionally well justified. Funds will not be provided for fringe benefits or health insurance for participants in any research education program. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 mechanism is not intended as a substitute for an NRSA institutional training program (T32), costs to support full-time participants are not allowable. A full-time participant is defined for the research education program as an individual supported for 40 hours/week for a continuous, 12-month period.

Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs, or at the actual F&A cost rate, whichever is less. Subcontractors will receive their full negotiated F&A rate.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: September 29, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 29, 2006, August 22, 2007, August 20, 2008
Application Submission/Receipt Date(s): November 29, 2006, September 19, 2007, September 17, 2008
Peer Review Date(s): February/March 2007, 2008, 2009
Council Review Date(s): May 2007, 2008, 2009
Earliest Anticipated Start Date(s): July 2007, 2008, 2009

3.A.1 Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research.
• Name, address, and telephone number of the PD/PI.
• Names of other key personnel.
• Participating institutions.
• Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

L. Tony Beck, Ph.D.
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Blvd, Room 916
Bethesda, MD 20892
Telephone: (301) 435-0805
FAX: (301) 480-3661
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

• If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
• If the two day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application in response to this FOA 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 an application already reviewed with substantial changes, but such application must include an Introduction (3 pages maximum) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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.

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 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 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 the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

• Research education program applications will use the non-modular budget format and "Just-in-Time" concepts. See Sections II.2 and IV.2 for budgetary guidance.
• Items 2-5 of the Research Plan of the research education program application may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
• The Introduction (required for a resubmission application) is limited to three pages.
• The following materials may be included in the Appendix:
• Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project. Do not include manuscripts submitted for publication. See NOT-OD-06-053.
• Publications in press: Include only a publication list with a link to the publicly available, on-line journal article or the NIH PubMed Central (PMC) submission identification number. Do not include the entire article.
• Manuscripts published but a publicly available on-line journal link is not available: The entire article may be submitted electronically as a PDF attachment.
• Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.
• Evaluation instruments and reports, curricula, surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. Note, however, that any evaluation reports must be summarized within the Research Plan.
• Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the 25-page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan.
• Videos, CDs, and/or DVDs specifically related to the science education program. Applicants should contact the SRA for submission instructions after application assignment.

Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form. Applications that do not conform to the specific instructions detailed below will be returned.

1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. A justification must be included for sites other than the applicant institution in the program narrative.

2. SF 424 Research & Related Other Project Information, Item 9 (Facilities & Other Resources): Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

3. SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program. The PD/PI and any Subcontractor(s) are normally listed as Key Personnel for SEPA projects.

4. Research & Related Budget: Complete for each budget period requested.

A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI must be included here.

B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.

C. Equipment: self-explanatory.

D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the research education program. Applicants must budget for travel funds for attendance by the PI and, if appropriate, Key Personnel at the Annual SEPA Program Directors Conference.

E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program

F. Other Direct Costs: itemize as appropriate and allowed for the research education program.

G. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify.

Personnel Costs - individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions. If mentoring interactions and other activities with students is considered a regular part of an individual's academic duties, then mentoring and other interactions with students are non-reimbursable from grant funds.

Administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.

Consultation costs, equipment, supplies, necessary travel, and other program-related expenses must be justified as specifically required by the program proposed and not duplicate items generally available for educational programs at the host institution.

Funds will not be provided for fringe benefits or health insurance for participants involved in this education program.

5. PHS 398 Research Plan Attachments:

Part 4 of this section (Preliminary Studies/Progress Report) should contain information on steps that have led to the proposed research education program.

Preliminary Studies:

• Include the results of preliminary studies relevant to the application conducted by the principal investigator and/or other key personnel.
• Provide relevant information that will establish the experience and competence of both the program leadership staff and partnership organizations to effectively carry out the proposed project.
• Include Evaluation Reports related to preliminary studies or projects.
• Phase II SEPA applications must provide a detailed progress report of achievements with their Phase I SEPA project including:
• Educational approach, the scientific content, and the nature and extent of existing educational ands scientific partnerships and collaborative interactions.
• Educational material produced. Identify the actual materials and include in the Appendix to the application (see Appendix instructions).
• Evaluation Report for the project or pilot study. Summarize the results of this process. Include the evaluation instruments in the Appendix.
• Impact of the current Phase I SEPA project, or pilot project(s), to date. Include an enrollment table with the numbers of students, teachers, an/or the public impacted by this approach and other relevant outreach accomplishments.
• Dissemination activities to date, or a description of the stage of development of the current model with respect to future dissemination plans.

Part 5 of this section (Research Design and Methods) should be re-titled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

Program Director(s): Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of the NCRR SEPA program, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program. Program Directors must commit a minimum of 1.2 person months annually to the SEPA project.

Program Faculty/Staff:

• Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the NCRR SEPA program.
• Document that these individuals are suitable for their roles in the project and how they will be located and recruited. Include a complete biosketch for each.
• Include in the Appendix, in pdf format, commitment letters from agencies, groups, or persons whose cooperation is important to the achievement of the stated purpose, such as elected and school officials, teachers, museum boards and community groups.

Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops). Expand as needed for the specific FOA.

The Research Education Program Plan should clearly describe why this is an innovative science education project or a model program. Applicants should state the activities to be completed and discuss how these activities will accomplish the project goals. SEPA K-12 projects are based on a partnership between scientists and the teachers, parents and the community. SEPA science center/museum projects involve partnerships with the teachers, parents and the community leaders, the media and the general public.

SEPA K-12 science education projects must target State and National Science Education Standards (http://www.nap.edu/readingroom/books/nses/). The application should include a listing of the educational standards that the project will target and discuss how the project content will be incorporated into the standardized curriculum

Administration:

• Provide a clear and detailed administrative plan to organize, conduct and manage the overall project
• Applicants are encouraged to include a Gantt Chart or other project management tool to show the timetable and deliverables for the various tasks and activities for the entire project period

Preliminary Studies: (Phase I applications only):

• For Phase I (model development), include the results of preliminary studies relevant to the application conducted by the principal investigator and/or other key personnel.
• Provide other relevant information that will establish the experience and competence of both the program leadership staff and partnership organizations to effectively carry out the proposed project.

Partnerships:

• Provide a clear demonstration that the proposed education and scientific partnership(s) are qualified and appropriate for the propose project with letters documenting interest and commitment
• Explain clearly the nature and extent of educational and scientific partnerships and collaborations to be developed
• For those already established, any plans for expansion or modification iii. The roles of key participants in the planning and conduct of the project.

Institutional Support

• Describe the applicant institution's commitment to the proposed project and include protected time or other support for individuals who will participate in the project and any institutional resources that would be devoted to the program such as office and/or laboratory space, computer facilities, administrative support and technical services

Teaching Curriculum and Materials:

• Discuss how the project design plan will develop both the science education module as well as the methodology to present the module.
• Provide specific information, in table or text format, as to how the proposed project adheres to local and state Standardized Curriculum Requirements.

Innovation:

SEPA projects are encouraged to:

• Employ novel concepts, approaches or methods.
• Challenge existing paradigms or develop innovative methodologies or technologies.
• Include related learning tools, such as teamwork, writing and mathematics skills, inquiry-based thinking and problem solving as stealth learning tools under the umbrella of the main science education project
• Provide specific information, in table or text format, as to how the proposed project adheres to local and state Standardized Curriculum

Summer Teacher Training and Internships:

Both Phase I and II SEPA applications may include a summer internship or research component for the students and/or teachers and/or programs to provide innovative mentoring programs for students wishing to learn more about the laboratory research process. If relevant to the application:

• Provide the names and competencies of the selection committee
• Describe the selection process and selection criteria
• Provide examples of the research experience that students and/or teachers will be provided Discuss how the project design plan will develop both the science education module as well as the methodology to present the module.

Sustainability:

The NCRR SEPA program no longer requires a specific plan for sustainability after the SEPA funding ends. Applicants are encouraged to discuss plans within their proposed science education project that may create institutional support for the project, a culture shift for the K-12 science education community in which their project is conducted, increased parental and/or community involvement and other sustained, long-term changes.

Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction.

If such training is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.

Target Audience:

• Discuss how the proposed educational programs are appropriate and adequate to achieve the educational goals outlined.
• Provide quantitative data on the numbers of teachers, students, and/or members of the general public projected to be involved and the quantity and types of educational materials to be produced and/or disseminated.
• Explain the relevance and potential of this project for dissemination to a broad population, including efforts aimed at underrepresented groups in science, both women and minorities.
• Inclusion:
• Applicants must present a plan to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the proposed SEPA project.
• If the proposed plan is to target specific racial and ethnic groups for the proposed SEPA project you must justify this in the Human Subjects section of the Research Plan. (See Inclusion Criteria included in the section on Federal Citations, below.) If you have questions regarding Inclusion Criteria please contact the SEPA Program Officer for assistance. Describe in detail the activities proposed and how they will contribute to achieving the stated goals of the program.

Diversity Recruitment and Retention Plan: Provide a detailed diversity recruitment and retention plan for the research education program. Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that under representation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NCRR, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged. Applications that lack an evaluation plan will be returned.

All applications must include a detailed Evaluation Plan for assessing the success of the proposed SEPA program. The Evaluation Plan should be an integral component of the early planning stages and must continue through the life of the SEPA project. A minimum of ten percent (10%) of the direct costs budget should be devoted to project evaluation. The use of external evaluators is required unless a valid justification can be made for an internal evaluation team. At least one component of the evaluation plan must assess the impact of the project using rigorous methods, such as a well-designed randomized controlled trial or a well-matched comparison-group study design.

Evaluation Plan: K-12 Science Education Projects

• Provide a detailed plan for evaluating the effectiveness of the program in achieving its objectives.
• The Evaluation Plan should:
  • Be an integral part of the program management, delivery and improvement rather than an add-on.
  • Provide feedback for ongoing program improvement (formative assessment) as well as providing a way to measure whether and to what extent program goals and objectives were met (summative assessment).
  • Drive the program-related decision-making.
  • Have an appropriate statistical model built into the evaluation plan
  • Describe the use of comparison or control groups.
  • Revisit the evaluation process throughout the project to ensure that the data being collected are the data that are needed
• Key project staff should become familiar with the evaluation plan, instruments, and implementation timeframes.
• External evaluators should have detailed knowledge of the program and deliverables and interact frequently with program staff and participants

Evaluation Plan: Science Centers and Museums

• Provide a detailed plan for evaluating the effectiveness of the program and in achieving the evaluation and project objectives.
• Document that the evaluation team is appropriate and qualified for a museum/science center-based science education project.
• Describe the development and implementation of the plan for formative and summative evaluation of the project activities, focus groups, pilot studies, etc.

Dissemination Plan: A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g., Web postings, presentations at scientific meetings, workshops, etc.

The Research Education Program Plan must provide a comprehensive description as to how materials generated by the proposed project will be disseminated to a broad audience and/or how the program(s) may be replicated at other sites. Include a plan for the of training and support for scientists to speak to students and teachers in the classroom, teacher workshops, parents, the general public, health care professionals, the lay press and other audiences. These outreach programs should be directed to increasing their knowledge of scientific terms, concepts, reasoning, and their ability to understand scientific public policy issues. Regardless of the intended audience, all projects must involve a partnership between scientists and educators, media experts, community leaders, or other interested organizations

K-12 Phase I + II applications must include a Dissemination plan that may include but it not limited to:

• Expanding the Phase I project to other school districts.
• Collaborations with SEPA and other K-12 programs.
• Website development.
• Presentations and posters at national meetings.
• Published materials such as journal articles and books.

Science Center and Museum projects should include plans to develop:

• Public outreach activities that may include public forums, plays, focus groups and other outreach activities that will engage and educate the museum community, the general public and the lay press on NIH-funded research, the clinical trials process and other health-related areas.
• Field trip programs for minority and underserved students, teachers and families.
• Collaborations with other science centers, museums, public libraries, community health centers and other sites where the general public may be engaged in a health-related dialogue.

Plan for Sharing Research Data

Not applicable

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_2003/NIHGPS_Part7.htm#_Toc54600131). 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.

Research education programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

The initial review group will comment on the appropriateness of the proposed software dissemination plan. Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. 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). See Section VI.3., Reporting.

Discuss plans for dissemination of the SEPA-developed teaching materials, evaluation instruments, pedagogical methods, and other educational products generated by the proposed project to school systems and with SEPA, HHMI, NSF and other K-12 science education projects. Science Center and Museum Projects are encouraged to share and collaborate with other science centers, museums, public libraries and other general public venues.

All products generated by SEPA-funding should plan on providing those materials that are appropriate for web-based dissemination to the SEPA website, www.ncrrsepa.org

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 the NCRR 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 National Advisory Research Resources Council (NARRC).

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review.
• Availability of funds.
• Relevance to program priorities.
• SEPA portfolio diversity in terms of scientific content, target audiences and geographic location of awardee institutions.

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs. The goals of NIH-supported science education projects at science centers and museums are to provide public education and outreach on NIH-supported research at these institutions. 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 education 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. These criteria are not listed in any order of priority.

Significance: Does the proposed research education program address scientific/education areas and/or topics important to the mission of the NCRR? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of the NCRR?

• Does the proposed SEPA project represent innovative activities in health-related science education?
• What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
• Is the rationale for selecting the scientific area, the educational approach, and the target population clear?

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

• Is there evidence that the program is based on sound research concepts and educational principles?
• Is the approach feasible and appropriate to achieve the stated research education goals?
• If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool?
• Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives?
• Is the target population appropriate for the planned educational environment?
• Does the proposed project include an inner city, minority, rural or other underserved target audience?
• If summer teacher professional development, training or internships are proposed, are recruitment plans well developed?
• How effective are the proposed outreach plans? Is there evidence for community demand?
• Will there be public forum outreach in which participants with alternate viewpoints will be included? Are the lay press targeted as part of the outreach effort?

Innovation: Is the research education program 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?

• Does this program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.
• Are there plans to include related learning tools, such as teamwork, writing and mathematics skills, inquiry-based thinking and problem solving under the umbrella of the main science education topic?
• Does the proposal describe innovative approaches for improving science literacy for students, teachers, parents, the general public and the lay press?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the proposed program appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the program (if applicable)? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?

• Has the Principal Investigator committed sufficient time to the project to ensure that it will be implemented as proposed?
• Does the Principal Investigator have a record of achievements and are the qualifications of the key personnel appropriate to achieving the proposed goals and implementing the stated plan.

Environment: Does the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed research education program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? Is the institutional commitment to the proposed program appropriate?

• If multiple sites are participating, is this adequately justified in terms of the research education experiences provided?
• Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?
• Is there institutional commitment to the project in terms of support for the SEPA project, adequate space, and classroom time?
• If the proposal includes teacher training workshops, is there a mechanism to support teacher release time?
• Does the scientific environment in which the work will be done contribute to the probability of success?

Partnerships and collaborations:

• Where partnerships are proposed, are there plans to monitor their effectiveness? Will duplication of effort be avoided?
• Where teaching materials or curricula are to be produced, is support for their acceptability provided? How will materials etc be integrated into standard educational curricula?
• Is the nature and extent of the educational and scientific partnerships and the collaborations that will be developed explained?
• Are there letters of support from key partners and participants in the planning and conduct of the project?
• Science centers and museums are encouraged to develop field trip programs for minority and underserved K-12 students and teachers as well as public outreach activities that will engage and educate the museum community as well as the general public on current health related topics as reported in the popular press.

Sustainability:

• The NCRR SEPA program no longer requires a specific plan for sustainability after the SEPA funding ends. However, applicants are encouraged to discuss plans within their proposed science education project that may create institutional support for the project, a culture shift for the K-12 science education community in which their project is conducted, increased parental and/or community involvement and other sustained, long-term changes.

Progress Reporting (Phase II applications only)

• Phase II applications should provide a detailed progress report of dissemination and other achievements with the existing Phase I or pilot model.
• Are the educational materials produced (print materials (newsletters, booklets), videos, diskettes, and other computer software) described?
• Is there an enrollment table with the numbers of students, teachers, and/or the public impacted by this approach, together with any other relevant outreach accomplishments described?

Evaluation Plan

• Is there an objective and quantitative evaluation plan? The use of external evaluators is required unless a valid justification can be made for an internal evaluation team. NOTE: Many universities have separate departments with evaluation services. Use of such evaluation services is permitted if justified but you must provide evidence that these evaluators will be independent.
• Will the qualifications of the evaluators match the project?
• Will the Evaluation plan provide feedback for ongoing program improvement (formative assessment) as well as providing a way to measure whether and to what extent program goals and objectives were met (summative assessment)?
• Is there a plan to revisit the Evaluation process throughout the project to ensure that the data being collected are appropriate?
• Is the Evaluation Plan an integral component of the early planning stages and does it continue through the life of the SEPA project?

Dissemination Plan:

• Is the dissemination plan strong and of high quality?
• Are dissemination plans, including any website development, published materials and/or traveling exhibits (for Science Center and Museums) described in detail?
• Is the dissemination plan well thought-out and appropriate for the materials that will be available? Is it timely? Is the proposed dissemination target audience convincing?
• Will the dissemination plan include underrepresented groups in science, both women and minorities? K-12 Phase I + II applications
• Will the Phase I project to be shared with other schools and school districts?
• Are there collaborations with SEPA and other K-12 programs?
• Does the project include creation of a project website?
• Does the PI propose presentations and posters at national meetings.
• Is the a plan to published in educational journals and newsletters?

Science Center and Museum projects:

• Does the project include public outreach activities that may include public forums, plays, focus groups and other outreach activities?
• Will the proposed exhibit engage and educate the museum community, the general public and the lay press on NIH-funded research, the clinical trials process and other health-related areas.
• Are there plans for field trip programs for minority and underserved students, teachers and families?
• Will the project include a traveling exhibit?
• Are there plans for dissemination to other science centers, museums, public libraries, community health centers and other sites where the general public may be engaged in a health-related activity?

Resubmission Applications (formerly revised/amended applications): In addition to the above criteria, the following criteria will be applied to resubmission applications:

Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the adequacy of the proposed protection will be assessed.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research education program will be assessed by the reviewers. Is the effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims, methods, educational opportunities, and participant activities?

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research 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, and the review panel's 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. Program staff will judge the acceptability of the revised plan.

Diversity Recruitment and Retention Plan:The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NCRR, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

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_2003/NIHGPS_Part7.htm#_Toc54600131). 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.

All proposed project must present plans for dissemination of the SEPA-developed teaching materials, evaluation instruments, pedagogical methods, and other educational products generated by the proposed project to school systems and with SEPA, HHMI, NSF and other K-12 science education projects.

Science Center and Museum Projects are encouraged to discuss how they might share and collaborate with other science centers, museums, public libraries and other general public venues.

Science education materials from all SEPA-funded projects should be made available for dissemination on the SEPA website, www.ncrrsepa.org

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 NIH 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.

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

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 NCRR to the grantee business official.

2. Administrative and National Policy Requirements

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution:

The research education program may not be transferred from one institution to another, unless very strongly justified. Consultation with the NCRR program staff is strongly encouraged when a change of institution is being considered. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in the original objectives, and the facilities and resources at the new organization will allow for successful performance of the project or activity. If these conditions or other programmatic or administrative requirements are not met, the NCRR may require peer review or may disapprove the request and, if appropriate, terminate the award.

The applicant must provide the following information to the NCRR for review:

• An official letter (with an official institutional signature) addressing the need and circumstances for the requested transfer, and that the aims and objectives of the program to be conducted at the new institution are within the scope of the original peer-reviewed program.
• A relinquishing statement from the original institution and a transfer application by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review.
• All conditions of the award are met at the new institution, including institutional environment and commitment to the program.
• The period of support requested is no more than the time remaining within the existing award.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Funding Credit: For each publication that results from grant support provided by the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), grantees must include an acknowledgment of support and a disclaimer stating the following:

This publication was made possible by Grant Number ________ from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH). or The project described was supported by Grant Number ________ from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH) and Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NCRR or NIH.

Science Center and Museum projects must have clearly visible credit signage at the entrance to the SEPA exhibit stating the following: This exhibit was made possible by a Science Education Partnership Award (SEPA) grant from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH). Additional or follow-on support from other organizations, companies or individuals should be listed as such.

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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

Awards made in response to this FOA are subject to SNAP.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. Applicants should provide Inclusion Enrollment and Targeted Enrollment Tables with their Annual Progress Reports.l

Progress Reports: The Annual and Final Progress Reports should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, award recipients are hereby notified that they may be contacted during and after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.

Final Reports should contain:

• Detailed summary of the project
• Copies of all teaching materials, curriculum, CDs, and other related materials
• Evaluation Reports
• Publications
• Inclusion Enrollment data for each year and for the total project period.

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:

L. Tony Beck, Ph.D.
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Blvd
Room 916-MSC 4874
Bethesda, MD 20892
Telephone: (301) 435-0805
FAX: (301) 480-3661
Email: [email protected]

2. Peer Review Contacts:

Bonnie B. Dunn, Ph.D.
Scientific Review Administrator
Office of Review
National Center for Research Resources
6701 Democracy Blvd
Room 1074
Bethesda, MD 20892
(For courier service, 20817)
Tel: (301)435-0824
Fax: (301) 480-3660
EMail: [email protected]

3. Financial or Grants Management Contacts:

Leslie Le
Grants Management Specialist
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd
Room 1058
Bethesda, MD 20892
Tel: (301)435-0856
Fax: (301) 480-3777
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 (45 CFR 46) 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).

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.

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 SF424 (R&R) application; 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.

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.

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 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 Part 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 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.