Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
Office of Dietary Supplements (ODS/NIH), (http://ods.od.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://nccam.nih.gov)
National Cancer Institute (NCI), (http://nci.nih.gov)

Title:  Pre-Application for Dietary Supplement Research Centers: Botanicals (X02)

Announcement Type
New

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

Request for Applications (RFA) Number: PAR-09-091

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 (4) weeks prior to the grant submission date. See Section IV

For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport

Catalog of Federal Domestic Assistance Number(s)
93.213

Key Dates
Release/Posted Date: January 30, 2009
Opening Date: March 30, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: Not Applicable
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 Due Date:  April 30, 2009
Peer Review Date: August 2009
Council Review Date: Not Applicable
Additional Information To Be Available Date (Activation Date): Not Applicable
Earliest anticipate start date(s): Not applicable
Additional information To Be Available: Not Applicable
Expiration Date: May 1, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information

1. Mechanism 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. Receipt, 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
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 Contacts
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

Since 1999 ODS and NCCAM have supported Dietary Supplement Research Centers focused on botanicals, collectively referred to the Botanical Research Center (BRC) Program. As the BRC Program developed, it became clear that high quality basic and preclinical research is a  necessary precursor to clinical studies and should employ contemporary research technologies. Further, the chemical complexity of botanicals required something other than a reductionist approach. Both factors are emphasized in the FOA (RFA-OD-09-001) to announce a competitive 5-year renewal of the BRC Program.  Details concerning current BRCs can be found at http://ods.od.nih.gov/Research/Dietary_Supplement_ResearchCenters.aspx .

The research conducted by a BRC must be relevant to the mission of NIH. The focus is on significant and potentially innovative research projects supported by research cores and conducted in a collaborative interdisciplinary environment. A hallmark of the P50 funding mechanism used by the BRC Program is that the whole must be greater than the sum of the individual parts (i.e. interaction among researchers along with careful selection of integrated research projects and cores is expected to be synergistic.)

BRC applications are complex, typically requiring significant investment of time to prepare and review. To minimize the burden on both the applicant and reviewer communities, the X02 pre-application mechanism is used to identify applicants who will be notified of the opportunity to prepare a full BRC application. The selection process involves both the critiques of the reviewers as well as programmatic considerations such as the number of BRCs working in similar areas. Applicants are encouraged to contact members of program staff with questions about the X02 or P50 funding FOAs.

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

Section II. Award Information


1. Mechanism of Support

This announcement utilizes the X02 mechanism for submission of pre-applications for RFA-OD-09-001. Pre-applications are a necessary first step in applying for a BRC Award. Pre-applications will be evaluated by a group of external reviewers.  Those investigators whose submissions are judged to be the most outstanding will be notified of the opportunity to submit full (P50) applications under RFA-OD-09-001. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

2. Funds Available

Not applicable. No Awards will be made under this FOA. All awards will be made under RFA-OD-09-001.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Applications from foreign institutions are not allowed.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Only one PD/PI may be designated on the pre-application.

The PD/PI must be Center Director, Director of the Administrative Core, and a Project Leader of one R01 level Research 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

Pre-applications are required from all investigators (PIs/PDs) who plan to apply for RFA-OD-09-001.

An individual may not submit more than one pre-application.  There is no limit to the number of pre-applications an institution may submit. 

If notified to submit a full BRC application, applicants may not make significant changes in the full application from what is proposed in the X02 application

All applicants for the RFA-OD-09-001 P50 must submit an X02 application.

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, use the “Apply for Grant Electronically” button in this FOA or 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:

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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

Individuals submitting a pre-application must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

2. Content and Form of Application Submission

Prepare all pre-applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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 “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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
PHS398 Cover Page Supplement
PHS398 Research Plan

Optional Components:
PHS398 Cover Letter File
Note: Cover letters should be submitted only when submitting a Changed/Corrected Pre-application after the submission date and should include an explanation for the late submission.

Pre-applications with multiple PDs/PIs are not allowed.  Applications from foreign institutions are not allowed.

ADDITIONAL PRE-APPLICATION INSTRUCTIONS

The following instructions are specific to the Botanical Research Center Award X02 pre-application and are exceptions to the general SF 424 instructions.  Pre-applications that do not conform to the specific instructions detailed below will not be reviewed. 

1.     Download and submit the pre-application with the Grants.gov application package.

2.     Include the project title at the top of the abstract page. The project title will not be included in the 300 word limit.

I.   Abstract: An abstract of no more than 300 words and not to exceed one page, describing the goals of the proposed BRC Center. Include the Project Title at the top of the abstract page; these do not count toward the 300 word limit. The abstract must contain text only – no figures, animations, or web links to provide further information. The Abstract is uploaded as an attachment for item 6, Project Summary/Abstract, on the Other Project Information component of the pre-application.

II. Public Health Relevance Statement: A brief statement written in plain language about how the proposed research can positively impact public health. This statement is uploaded for Item 7, Project Narrative, on the Other Project Information component of the pre-application.

III.  Center Research Plan: 

A plan of not more than 20 pages should address (1) the significance and potential impact of the proposed BRC, (2) what makes the research approach(es) innovative, (3) how the PD/PI will address risks and challenges, (4) the purpose and justification of the center cores, (5) how research integration and synergy will be achieved, and (6) the qualifications of the Center director to lead a BRC. The plan should include the following sections within the 20-page limit, in the following order, with the headings shown:

Preliminary data are not required for an X02 application.  Give enough information to enable reviewers to assess the rationale for the research projects. Figures and illustrations may be included, but must fit within the 20-page limit. Bibliographic citations (references) are not included in the page limit, Do not include links to websites to provide further information. No animations (movies) are allowed in any documents. The Center Research Plan is uploaded in the Research Design and Methods attachment of the Research Plan Component. Omit the Specific Aims, Background and Significance, and Preliminary Studies Sections.

V.   Biographical sketch:  A two-page biographical sketch for the PD/PI (Use the format for biographical sketches shown in Section 4.5.2 of the Application Guide, omitting Section C, Research Support.) Biographical sketches for other key personnel should not be submitted and will not be accepted. The Biographical Sketch is uploaded on the Research & Related Senior/Key Person Component form.

VI.  List of Current and Pending Research Support of PD/PI: A list of current and pending research support from all sources, including current year direct costs and percent effort devoted to each project. (Use the format shown in the Application Guide, Part III, Section 3.1.8). The PD/PI must include an Effort Commitment statement, described below. This document is uploaded on the Research & Related Senior/Key Person Component form.

VII. Effort Commitment:   PD/PIs are required to commit at least 25% of their administrative and research effort to the project supported by Botanical Research Center Award. In the list of current and pending support, the PD/PI must include a statement that, if chosen to receive an award under RFA-OD-09-001, the PD/PI will commit a minimum of 25% of his/her effort to the project supported by the BRC Award.

Special requirements for completing the SF424 (R&R) pre-application are specified below. In addition:

Format specifications for Text (PDF) Attachments: All attachments must be in PDF format. Follow format specifications for PDF attachments in the Application Guide (http://gkrants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf).

All instructions outlined in the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf) are to be followed, incorporating “Just-in-Time” information concepts, with the following exceptions, which are specific requirements for BRC Program pre-applications. Pre-applications that do not conform to the specific instructions detailed below will not be reviewed.

1. SF424 (R&R) COVER COMPONENT

Item Number and Title

Instructions

1. Type of Submission

Must be “Pre-Application”

8. Type of Application

Must be “New”

13. Proposed Project

Enter start date: xx/xx/2009; Enter end date: xx8/xx/20xx

Estimated Project Funding

Enter $0

2. RESEARCH & RELATED PROJECT/PERFORMANCE SITE LOCATIONS

Complete as appropriate

3. RESEARCH & RELATED OTHER PROJECT INFORMATION COMPONENT:

Item Number and Title

Instructions

1. Are Human Subjects Involved?

Check “No” – Detailed plans regarding protection of human subjects, inclusion of women and minorities, targeted/planned enrollment, and inclusion of children are not required and should not be submitted with this pre-application.

2. Are Vertebrate Animals Used?

Check “No” – Detailed information regarding the use of vertebrate animals is not required at the time of submission.

6. Project Summary/Abstract

Attach Abstract (maximum of 300 words and not to exceed one page). Include Project Title at top of page. PDF format; text only – no figures, animations, or web links.

7. Project Narrative

Attach Public Health Relevance Statement (2-3 sentences), explaining the relevance of the research to public health); PDF format

8. Bibliography & References Cited

Attach Bibliography; PDF format.  

9. Facilities & Other Resources

Do not use.

10. Equipment

Do not use.

11. Other Attachments

Do not use.

Note: Pre-applications found not to comply with the page limit requirements or that contain attachments other than those specified will be rejected during the agency validation process.

4. SF424 (R&R) SENIOR/KEY PERSON PROFILE COMPONENT:

Complete items only for Project Director/Principal Investigator. Do not submit profiles for other senior/key personnel.

Item Title

Instructions

Profile- PD/PI – Attach Biographical Sketch

Attach biographical sketch here (two-page maximum; PDF format). Use the form shown in the URL in Section 4.5.2 of the Application Guide, omitting Section C, Research Support (see below).

Profile- PD/PI – Attach Current & Pending Support

Attach a list of Current and Pending Support here (no page limit; PDF format). Use the format shown in Part III, Section 3.1.8 of the Application Guide. Be sure to include a statement affirming that you will devote at least 25% of administrative and research effort to Botanical Research Center Award project. Also, include in this section a brief statement of the facilities to be used for the conduct of the research.

Profile – Senior Key Person 1

Submit information only for leaders of research projects and cores. Information on other collaborators may be included in the research plan.

Note: Pre-applications found not to comply with the page limit requirements will not be reviewed.

No other documentation, such as letters of reference or collaboration or other biographical sketches will be accepted. Information about personnel other than the PD/PI is not required but may be included within the 20-page research plan.

4. PHS398 COVER PAGE SUPPLEMENT

Item Title

Instructions

2. Human Subjects

Omit.

4. Human Embryonic Stem Cells

Omit.

5. PHS398 Research Plan Component Sections

Item Number and Title

Instructions

1. Introduction to Application (for Resubmission or Revision only)

Omit

2. Specific Aims

Omit

3. Background and Significance

Omit

4. Preliminary Studies/Progress Report

Omit

5. Research Design and Methods

Attach 20-page document (PDF format) following the instructions outlined above. Include the project title on the first page. Literature references are not included in the 20-page limit.  Figures and illustrations may be included but must also fit within the 20-page limit. Do not include links to websites for further information. Do not include animations.

Appendix Materials

Appendices are not allowed and will not be accepted. Pre-applications that contain attachments other than those specified may be rejected during the agency validation process.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 30, 2009 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date: Not Applicable
Application Due Date: April 30, 2009
Peer Review Date: August, 2009
Council Review Date: Not applicable
Earliest Anticipated Start Date: Not applicable

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit a pre-application in response to this FOA, PDs/PIs should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Pre-applications must only be submitted electronically.  PAPER PRE-APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Pre-a
pplications 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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

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 weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

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

There will be an acknowledgement of receipt of pre-applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of a pre-application to a review group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any pre-application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. All applications for PAR-09-091 should be prepared as new pre- applications.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Not Applicable

6. Other Submission Requirements and Information

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) 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.

Organizational DUNS

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 “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA.

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

Pre-applications that are complete and responsive will be evaluated by a group of external reviewers including reviewers with expertise in botanicals and other relevant areas.

The review criteria will emphasize the importance and potential impact of the proposed research.  Specifically the reviewers will evaluate:

The scientific problem to be addressed by the BRC: Does the Center focus on an important area of biomedical science? Would addressing this area have a major impact on the field? What knowledge would be gained? How would the proposed research move the field forward? What would be the overall impact of the Center? Would the proposed project accomplish more as a Center than as individual R01 projects? What is the evidence that the proposed research program is likely to be collaborative and integrated? Does the Center appear to be well organized to accomplish the stated goals?

Innovativeness of the proposed Center: Has a unique and innovative Center been proposed? Does the overall research theme challenge existing paradigms? Will innovative hypotheses or critical barriers to progress in the field be addressed?

Research Projects: Have significant and innovative research projects been proposed? Are the research projects feasible? Will the goals of the individual projects contribute to the Center goals?

Research Cores: Will the research cores provide important and necessary support for the projects? Will the cores promote the proposed research projects?

Investigator qualifications: Is the PI qualified to lead a complex research program? Has evidence been provided that the PI has experience with developing unique collaborations, with integrating diverse sources of information or with developing novel approaches? Do the PI and investigative team bring complementary expertise to the program?

2.A. Additional Review Criteria

None.

2.B. Additional Review Considerations

For this FOA, no specific budget information is to be submitted with the application.

2.C. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

3. Anticipated Announcement and Award Dates

Those investigators whose submissions are judged to be the most outstanding will be notified in August 2009 of the opportunity to submit full (P50) applications under RFA-OD-09-001.  Awards under RFA-OD-09-001 will be announced in June 2010 and will begin in July 2010.

Section VI. Award Administration Information


1. Award Notices
Not Applicable

2. Administrative and National Policy Requirements

Not Applicable

3. Reporting

Not Applicable

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 two areas: scientific/research (program), and peer review.

1. Scientific/Research Contact(s):

Christine A. Swanson, Ph.D.
Director, Botanical Research Centers Program
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, MD  20892-7517
Telephone: (301) 435-2920
FAX: (301) 480-1845
Email: Swansonc@od.nih.gov

2. Peer Review Contact(s):

Martin Goldrosen, Ph.D.
Director, Division of Extramural Activities
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594 2014
Fax: (301) 480 2419
Email: goldrosm@mail.nih.gov

3. Financial/Grants Management Contact(s):

Not applicable

Section VIII. Other Information


Required Federal Citations

NOTEInformation responsive to the following federal citations should not be submitted with the X02 BRC Program Award pre-application.

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).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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

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.

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

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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NIH Funding Opportunities and Notices


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