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-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 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.
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
Not Applicable
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
NOTE: Information 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
![]() |
Office of Extramural Research (OER) |
![]() |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
![]() |
Department of Health and Human Services (HHS) |
![]() |
||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |