NCRR SCIENCE EDUCATION PARTNERSHIP AWARD (SEPA)

RELEASE DATE:  December 19, 2003

RFA:  RFA-RR-04-004

This RFA replaces the Science Education Partnership Award, PAR-00-036, 
published in the NIH Guide December 22, 1999.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Center for Research Resources (NCRR/NIH) 
 (http://www.ncrr.nih.gov)

LETTER OF INTENT RECEIPT DATE:  January 12, 2004
APPLICATION RECEIPT DATE: February 12, 2004  

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.389

THIS RFA CONTAINS THE FOLLOWING INFORMATION
o   Purpose of this RFA
o   SEPA Objectives
o   Mechanism of Support
o   Eligible Institutions
o   Individuals Eligible to Become Principal Investigators
o   Where to Send Inquiries
o   Submitting an Application
o   Peer Review Process
o   Review Criteria
o   Receipt and Review Schedule
o   Award Criteria
o   Required Federal Citations

PURPOSE

The Science Education Partnership Award (SEPA) Program provides funds for the 
development, implementation and evaluation of innovative K-12 science 
education programs, teaching materials and science center/museum programs.  
SEPA supports partnerships between biomedical, clinical researchers and 
behavioral scientists with K-12 teachers and schools, museum and science 
center educators, media experts, and other interested organizations.  

SEPA’s mission is to foster the development of new programs to improve K-12 
and the general public’s understanding of health science advances created by 
National Institutes of Health (NIH) funded clinical and basic research.  
Particular importance will be given to SEPA applications that target K-12 
educational topics that may not be addressed by existing science curricula or 
other community and media activities. 

SEPA OBJECTIVES

For NIH to fulfill its mission, i.e., to support the pursuit of fundamental 
knowledge about the nature and behavior of living systems and the application 
of that knowledge to extend healthy life and reduce the burdens of illness 
and disability, adequate numbers of underrepresented minority and underserved 
students need to enter science education tracks that lead to careers in the 
biomedical sciences.  It is also important to the mission of NIH that health 
care workers as well as the general public are scientifically literate and 
have an understanding of the process of biomedical research so that they may 
better understand and utilize scientific information reported in the media. 

NCRR is encouraging the submission of grant applications from eligible 
organizations for science education programs whose scope of activity may 
include, but are not limited to, the following: 

o  Stimulate the interest of K-12 students in the scientific processes 
involved in basic and clinical research with innovative, inquiry-based 
programs whose goal is to increasing the number of students, particularly 
members of minority and underrepresented groups, who will pursue careers in 
the biomedical sciences.

o  Create hands-on activities at science centers and museums that teach 
inquiry-based thinking about health-related subjects such as brain/behavior, 
nutrition/exercise/obesity, stem cells/tissue engineering/regenerative 
medicine, etc.

o  Develop multi-media outreach programs using lecture series, plays and 
other audience participation activities. The purpose of these programs should 
be the education of the general public about the process of basic and 
clinical research so that they may better understand current advances in 
health-related research and clinical programs supported by NIH. Proposals for 
films, television series or other multi-media projects where the direct cost 
will exceed the $250,000 SEPA limit will no longer be supported by the SEPA 
program. 

o  Development of traveling exhibits and mobile science laboratories for K-12 
students, teachers and parents.

o  Hands-on laboratory experiences, in both field trip and intern formats, 
for students in research laboratories. This can be implemented for Phase I,  
Phase II and Phase I/II proposals.

o  Develop and evaluate model biomedical and/or behavioral science K-12 
education partnership programs between university and clinical center 
researchers that focus on health-related research.

o  Develop effective strategies for the dissemination of successful and 
innovative biomedical and/or behavioral science education.

While SEPA projects must represent new activities and focus on health-related 
science, coordination with existing science education programs, such as those 
funded by the National Science Foundation, the Howard Hughes Medical 
Institute, the Department of Energy, the Department of Education, and others, 
are encouraged. 

MECHANISM OF SUPPORT
 
This RFA will use the NIH R25 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  The anticipated award date is August/September 2004.  This RFA uses 
just-in-time concepts.  It also uses the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, 
you should follow the instructions for non-modular budget research grant 
applications.

FUNDS AVAILABLE  

NCRR intends to commit approximately $3 million in FY 2004 to fund 10 to 15 
new grants in response to this RFA.  AN APPLICANT MAY REQUEST A BUDGET FOR 
DIRECT COSTS UP TO $250,000 PER YEAR.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary. 

Applicants may choose to submit: (1) a Development (Phase I) application, (2) 
a Dissemination (Phase II) application or (3) a combined Development and 
Dissemination (Phase I/Phase II) application.  Phase I proposals are three 
year awards, Phase II proposals are two year awards and Phase I/Phase II are 
five year awards.  Combined Phase I and Phase II applications are recommended 
for ongoing science education programs or for science museums and technology 
centers

Grant funds may be requested for direct costs that are clearly related and 
necessary to conduct the proposed research plan. Allowable Facilities and 
Administrative (F&A) costs will be reimbursed at eight percent of total 
allowable direct cost base.  The applicant will be solely responsible for the 
planning, direction, and execution of their SEPA program.

Although the financial plans of the NCRR to provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications.   
Programmatic considerations for awards will include diversity of programs in 
the SEPA portfolio and geographic distribution. 

Conditions of Award

All publications, web sites, audiovisual materials and other products 
resulting from SEPA activities supported entirely or in substantial part by 
the NCRR / NIH should include the following or comparable acknowledgement of 
support: "This project was supported by a Science Education Partnership Award 
(SEPA) from the National Center For Research Resources, National Institutes 
of Health. Its content is solely the responsibility of the authors and does 
not necessarily represent the official views of NCRR or NIH".

ELIGIBLE INSTITUTIONS
 
You may submit an application if your institution has any of the following 
characteristics: 
   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic organizations/organizations
o Faith-based or community-based organizations
o Foreign institutions are not eligible to apply 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution and their 
K-12 partners to submit a SEPA application.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are encouraged to apply.   

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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.  NCRR SEPA Program staff encourages potential applicants to contact 
them to discuss potential SEPA projects, scientific content, grant 
application issues or other questions related to the SEPA program.  

o Direct your questions about scientific issues to:

L. Tony Beck, Ph.D.
Program Officer, SEPA 
Division of Clinical Research Resources
National Center for Research Resources
6701 Democracy Boulevard
Room 916   MSC 4874
Bethesda, Maryland  20892-7965
(20817 Zip Code for courier deliveries)
Telephone: (301) 435-0805
FAX: (301) 480-3661  
Email: [email protected]

o Direct your questions about peer review issues to:

Sheryl K. Brining, Ph.D.
Director, Office of Review
National Center for Research Resources
6701 Democracy Blvd., MSC 4874
Bethesda, MD  20892-4874
Telephone: (301) 435-0806
Fax: (301) 480-3660
E-Mail: [email protected]

o Direct your questions about grants management issue to:

Ms. Leslie Le
Office of Grants and Contracts Management
National Center for Research Resources
6701 Democracy Boulevard
Room 1058   MSC 4874 
Bethesda, MD  20892-7965
(20817 Zip Code for courier deliveries)
Telephone:  (301) 435-0856
FAX: (301) 480-3777
Email: [email protected]

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

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 NCRR staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

L. Tony Beck, Ph.D.
Program Officer, SEPA 
Division of Clinical Research Resources
National Center for Research Resources
6701 Democracy Boulevard
Room 916   MSC 4874
Bethesda, Maryland  20892-7965
(20817 Zip Code for courier deliveries)
Telephone: (301) 435-0805
FAX: (301) 480-3661  
Email: [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: [email protected].

SUPPLEMENTARY INSTRUCTIONS: 

o  Face Page 
Item 1, Title:  Indicate whether this is a Phase I, a Phase II or a 
combination Phase I/II application. 
Item 2, Response:  Check "YES" and identify the number and title of this RFA. 
Item 4, Human Subjects Research: Check YES. SEPA programs involve human 
subjects for which an Exemption or Human Subject Assurance must be provided.  
See the REQUIRED FEDERAL CITATIONS section at the end of this RFA for 
guidelines or contact the SEPA Program Officer for assistance.
Item 5, Vertebrate Animals: Check YES or NO as appropriate.  See the REQUIRED 
FEDERAL CITATIONS section at the end of this RFA for guidelines or contact 
the SEPA Program Officer for assistance.
Item 6.  The project period begin date should be the anticipated award date 
(i.e., July 1 or later).  The length of the project period may not exceed 
three years for applications requesting separate support for Phase I 
proposals and two years for Phase II proposals. Applications that request 
support for both Phase I and II may request support for up to five years. 

o  Appendix Material: Information essential for the review of the application 
should not be included in the Appendix section. Appendix materials submitted 
with the application must adhere to the PHS 398 requirements.  

o Summer Interns: If the didactic materials are targeted to high school 
students, both Phase I and Phase II applications may include a summer 
research experience component for high school students.  In these instances, 
the applicant must provide the names and competencies of the selection 
committee, a description of the intern selection process and a summary of the 
research experiences that students will be provided.  

o Exemptions: NIH defines human subjects research as the study of living 
persons with whom an investigator directly interacts, intervenes, or obtains 
identifiable, private information.  If you are claiming a human subjects 
exemption in Item 4 on the face page you must justify it in the human 
subjects section (Research Plan, E. Human Subjects in the Table of Contents) 
of your research plan. See the REQUIRED FEDERAL CITATIONS section at the end 
of this RFA for guidelines or contact the SEPA Program Officer for 
assistance.

o Inclusion:  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.  If applicable, you must justify your 
selection of specific racial and ethnic groups for the proposed SEPA project 
in the human subjects section of your research plan. (See Inclusion Criteria 
included in the section on Federal Citations, below you must justify it in 
the human subjects section or contact the SEPA Program Officer for 
assistance.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and all 
copies of the Appendix materials must be sent to:

Sheryl K. Brining, Ph.D.
Director, Office of Review
ATTN: SEPA
National Center for Research Resources
6701 Democracy Blvd., MSC 4874
Bethesda, MD  20892-4874

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the applicant 
without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as a 
SEPA RFA, is to be submitted in response to a new SEPA RFA, it should be 
prepared as an amended application.  That is, the application for the RFA 
must include an Introduction describing the changes and improvements made, 
and the text must be marked to indicate the changes from the previous 
unfunded version of the application.

APPLICATION RECEIPT DATE: 

Applications must be received by February 12, 2004.  If an application is 
received after that date, it will be returned to the applicant without 
review.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NCRR. Incomplete applications will not be reviewed.  
If the application is not responsive to the RFA, NIH staff will return the 
application to the applicant.   

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NCRR in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

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

REVIEW CRITERIA

The goals of NIH-supported SEPA projects are to enhance the exposure and 
understanding of K-12 students, their teachers and families as well as the 
general public to basic and clinical research. It is the intent of the SEPA 
program to increase the number of underrepresented minority and underserved 
students who will pursue biomedical careers.  In the written comments, 
reviewers will be asked to evaluate the application in order to judge the 
likelihood that the proposed research will have a substantial impact on the 
pursuit of these goals. The scientific review group will address and consider 
each of the following criteria in assigning the application’s overall score, 
weighting them as appropriate for each application. 

o Significance 
o Approach
o Evaluation
o Outreach 
o Innovation
o Personnel
o Environment

The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.

Except as noted below, the following guidelines are applicable to both Phase 
I and Phase II applications. In general, the research plan should be 
structured to provide information sufficient to allow the reviewers to assess 
the project in terms of the review criteria stated below.  SEPA encourages 
applicants to target K-12 topics that may not be addressed in existing 
science curricula or by other community and media activities.  

NOTE: There are two separate sets of review criteria; one for plans to 
develop new SEPA models (Phase I), another for Phase I/II SEPA proposals, 
Phase II SEPA projects or for dissemination of SEPA-type models that have 
already been developed

SIGNIFICANCE:  Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced? What 
will be the effect of these studies on the concepts or methods that drive 
this field? 
(Phase I and Phase II applications):
o Briefly summarize the background leading to the development of this plan. 
Explain why the particular strategy was chosen.  Include information on the 
process and rationale for selecting the scientific area, the educational 
approach, and the target population, and indicate how this project will 
address an unmet need.  
o The proposed program should address the objectives stated in this RFA and 
should reach a broad population, particularly minority and underrepresented 
groups.
o Describe the advantages and limitations of the model selected, and its 
potential for widespread dissemination and adaptability for use by others.     

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

GOALS AND OBJECTIVES (Phase I and Phase II applications): Identify the long-
range goals for the project and describe the specific objectives for the 
proposed project period. 

PRELIMINARY STUDIES (Phase I applications only):  For Phase I (model 
development), include preliminary studies relevant to your application 
conducted by the principal investigator and/or other key personnel.  Also 
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. 

PROGRESS REPORT (Phase II applications only):  For Phase II (dissemination) 
applications, provide a detailed progress report of achievements with the 
existing pilot model, including: 
o  A description of the educational approach, the scientific content, and the 
nature and extent of existing educational and scientific partnerships and 
collaborative interactions. 
o  A detailed description of the educational material produced.  Identify the 
actual materials as "Exhibits" and include in the application.  Do not label 
these materials as appendices.  Some examples of exhibit items are: print 
materials (newsletters, booklets), videos, diskettes, and other computer 
software.  Limit exhibits to items that are readily portable and to materials 
considered to be essential to review. 
o  A description of the evaluation process.  Summarize the results of this 
process.  Include the evaluation instruments in the appendix. 
o  A summary of the impact of the current Phase I SEPA project to date.  
Include numbers of students, teachers and/or the public impacted by this 
approach, and other relevant outreach accomplishments. 
o  A description of any dissemination activities to date, or a description of 
the stage of development of the current model with respect to future 
dissemination plans. 

PROPOSED PLAN (Phase I and Phase II applications):
o  Describe in detail the activities proposed and how they will contribute to 
achieving the stated goals of the program.  
o  Give 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. 
o  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. 
o  Explain clearly the nature and extent of educational and scientific 
partnerships and collaborations to be developed (or, for those already 
established, any plans for expansion or modification), and the roles of key 
participants in the planning and conduct of the project.  
o  Provide documentation of the interest and commitment of partnership 
members to this project. 
o  Discuss how the proposed educational programs or research project
appropriate and adequate to achieve the educational goals outlined. 
o  Discuss how the research plan proposes to develop both the science 
education module as well as the methodology to present the module.
o  If the didactic materials are targeted to high school students, both Phase 
I and II applications may include a summer research experience component for 
high school students.  In these instances, the applicant must: provide the 
names and competencies of the selection committee; describe the selection 
process, including the selection criteria; and provide 3-4 examples of the 
research experiences that students will be provided. 
o  Describe the administrative plan to organize and manage the overall 
project, and provide a timetable for the various tasks and activities for the 
entire project period requested.

EVALUATION:  All applications must include a detailed Evaluation Plan for 
assessing the success of the proposed SEPA program.  TEN PERCENT (10%) OF THE 
DIRECT COST BUDGET REQUESTED SHOULD BE DEVOTED TO PROJECT EVALUATION.  The 
Evaluation Plan should be an integral component of the early planning stages 
and must continue through the life of the SEPA program.  The use of external 
evaluators is required unless a valid justification can be made for an 
internal evaluation team. 

o  Provide a detailed plan for evaluating the effectiveness of the program in 
achieving its objectives. 
o  Document that the evaluation team is appropriate and qualified for your 
type of SEPA project.
o  Describe the development and implementation of the plan for formative and 
summative evaluations of project activities.  Include strategies for 
revisions to evaluative instruments and educational processes and/or 
materials. 

OUTREACH:  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.  

INNOVATION: Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?
o  Discuss how the curriculum, educational, research and/or collaborative 
plans include original and unique approaches for addressing the needs put 
forth in the goals and objectives.
o  Present your plan to include related learning tools, such as teamwork, 
writing and mathematics skills, inquiry-based thinking and problem solving 
under the umbrella of your main science education topic.  If appropriate 
discuss your plans to challenge existing science education paradigms or to 
develop new approaches for improving science literacy.

INVESTIGATOR:  Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)? 
o  Present a discussion as to how the program leadership has demonstrated a 
record of achievements and that their qualifications are appropriate to 
achieving the proposed goals and implementing the stated plan.
o Discuss how the K-12 partners will provide input in the proposed program 
with respect to educational content, sophistication level of the students and 
relevance to state and national testing standards.  As appropriate letters of 
participation and support from collaborators, school officials and teachers 
must be included as Appendix materials.

ENVIRONMENT:  Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?   
o  Discuss how the inquiry-based scientific and educational environment 
described in your proposal will foster student interest and participation, 
increase the awareness of the scientific process and ultimately generate a 
high level of confidence in the students for health science related careers.
o  Describe the institutional commitment to the project in terms of support 
for the SEPA project, adequate space, and classroom time.  If your proposal 
includes teacher training workshops, support for teacher release time should 
be provided.

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

SUSTAINABILITY (Phase I/II and Phase II proposals only):  You must provide a 
detailed plan for sustaining your SEPA program, either through 
institutionalization or other funding sources, after the funding period ends.   
Programmatic emphasis is placed on those SEPA proposals with well-developed 
implementation plans for long term continuation of the proposed program 

SHARING OF TEACHING MODULE AND EVALUATION DATA: Provide a plan for sharing 
the methods, teaching materials and evaluation data generated as a result of 
your SEPA proposal.  

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 criteria included in the 
section on Federal Citations, below).
 
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.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

BUDGET: The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.  

ANNUAL MEETING:  An annual SEPA Principal Investigator Meeting will be 
convened to foster collaboration, discuss newly emerging national strategies, 
coordinate dissemination, share evaluation methodologies and outcomes, and 
minimize duplication of efforts.  Travel funds for these activities should be 
included in the budget request for each year, and a statement regarding 
willingness to participate in these activities should be included in the 
application. 

RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date:          January 12, 2004
Peer Review Date:                       May   June, 2004
Council Review:                         September 2004
Earliest Start Date:                    September 2004

AWARD CRITERIA

Applications will compete for available funds with other recommended 
applications.  Award criteria that will be used to make award decisions 
include:

o Scientific merit as determined by peer review 
o Responsiveness to this RFA
o Programmatic priorities 
o Availability of funds

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

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 - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

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 that is available at 
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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 
284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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