and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), ( http://www.nih.gov)
Components of Participating Organizations
The Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), ( http://www.nichd.nih.gov)
Update: The following update relating to this announcement has been issued:
Program
Announcement (PA) Number: PAR-08-106
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.
Catalog
of Federal Domestic Assistance Number(s)
93.865
Key Dates
Release/Posted Date: March 13, 2008
Opening Date: May 17, 2008 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): May 17, 2008
NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt Date(s): June 17, 2008
AIDS Application Submission/Receipt Date(s): Not applicable
Peer Review Date(s): October/November, 2008
Council Review Date(s): January 2009
Earliest Anticipated Start Date(s): April 1, 2009
Additional Information to Be Available Date (Activation Date): Not applicable
Expiration Date: June 18, 2008
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. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission
Requirements 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
A.
Cooperative Agreement Terms and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3.
Collaborative Responsibilities
4. Arbitration
Process
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
Purpose
The National Institute of Child Health and Human Development (NICHD), Extramural Associates Program, invites applications from current EARDA-supported institutions to conduct health disparities-related workshops, meetings, and symposia with the community. The purpose of this project is for NICHD to assess the value of bringing communities and academic institutions together through meetings/workshops/symposia, to identify health disparities conditions and conduct health disparities reduction and elimination research within the communities in which they are located. The purposes of these workshops/symposia/meetings will be to identify community partners and community research priorities, and to develop a long-term research agenda and subsequent intervention projects. It is expected that the academic-community partnerships developed through this initiative will lead to grant applications for the support of research projects designed to meet identified community needs. These projects can focus on one or more of the following areas: infant mortality; pediatric and maternal HIV/AIDS prevention, childhood, adolescent, and/or adult obesity; literacy; fibroid tumors; violence prevention; and/or techniques for outreach and information dissemination.
Background
The NIH recognizes the value of supporting academic and community partnerships that are relevant to achieving the health promotion and disease prevention goals of Healthy People 2010" to increase the quality and years of healthy life, and to eliminate health disparities. The program described in this solicitation builds on NICHD’s mission of conducting research to understand the biological, behavioral, and social processes that dictate physical, emotional, and cognitive growth. NICHD creates the knowledge to understand the complex interplay of processes that transform cells into healthy functioning individuals, free of disease and disabilities. When this is not achieved, or is achieved unequally by different segments of the population, (health disparities), NICHD's mission is to understand why and to develop remedies.
NICHD also aims to build bridges to communities by employing the principles of Community-Based Participatory Research (CBPR) to bridge its research priorities with the community’s health needs. CBPR is a collaborative process of research involving researchers and community representatives that (1) engages community members, (2) employs local knowledge in the understanding of health problems and the design of interventions and (3) invests community members in the processes and products of research. Construction of these bridges must be thoroughly and carefully designed with foundations rooted in science, but firmly grounded in the communities to be served. Health disparities do not merely occur, they develop over time as natural biological and behavioral forces interact with such factors as poverty and unequal opportunities, and are modified by a variety of community, social, educational, and economic influences. Closing the health disparities gap requires an in-depth understanding of these processes and mechanisms as they interact over time. Finally, it requires the conscientious design of educational and behavioral interventions, rooted in science, but implemented through the acts of individuals and communities working together.
Scope
The major goals of this program are to:
(1) Establish partnerships between academic institutions and the local community, including but not limited to schools and school communities;
(2) Identify, document and highlight local health disparity conditions and the community’s view of its health problems;
(3) Form an alignment between the identified health problems and the EARDA institution’s research priorities; and
(4) Design and conduct CBPR, translational research addressing these areas. For the purpose of this solicitation, translational research is defined as knowledge gained through basic research that is applied in the community. Research goals developed through this partnership will incorporate existing research findings that are appropriate for implementation in the community setting and for the development of new interventions.
Activities relating to these goals will be accomplished through an ongoing series of conferences, meetings, seminars, workshops, focus groups, etc., where the academic and community partners work together to develop a strong working relationship and a set of research goals focused on community priorities in one or more of the following required areas:
Special emphasis should be placed on:
Applications should propose a comprehensive, coordinated, and integrated plan of activities organized around defined program goals.
Please note: Partnerships with community organizations/leaders do not have to be in place to qualify an institution to apply for these cooperative agreement awards. When appropriate, the cooperative agreement award support may be used to support the formative stages of such partnerships.
Specific examples of collaborative activities within each of the required categories include, but are not limited to, the following:
Partnerships between the Grantee Institution and Community Organizations
Identification of Health Disparities Conditions and Community Health Needs
Translational Research
In addition, consideration for support will be given to relevant topics where research is lacking or nascent and where stimulation of such research will meet the expressed needs of the community.
Expected Timeline
Awards through this U13 program will provide support for up to three years at a maximum of $30,000 direct costs per year to:
While not included in this current solicitation, NICHD plans to encourage submission of research project grant applications (e.g., R03, R21) to implement proposed research plan and implement partnership goals developed through these academic-community partnerships.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
The NIH U13 is a
cooperative agreement award mechanism. Under the U13 mechanism, the Project
Director/Principal Investigator (PD/PI) retains the primary responsibility and
dominant role for planning, directing, and executing the proposed project, with
NIH staff being substantially involved as a partner with the PD/PI, as
described in Section
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award".
This funding opportunity uses just-in-time budget concepts. It also uses the non-modular budget format. Applicants must complete and submit a detailed categorical budget as described in Section 4.7 of the SF424 (R&R) Application Guide.
All foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2.
Funds Available
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. Although
the financial plans of the IC(s) provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004.
An applicant may request a project period of up to three years and a budget for direct costs of up to $30,000 per year.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
Applicants must have a current EARDA award from NICHD and an established
Office of Research Development or equivalent.
The following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
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
You may submit an application(s) if your organization has both of the following characteristics:
Institutions may submit only one application in response to this solicitation.
Applicants may submit a resubmission application, but such applications must include an Introduction addressing the previous peer review critique (Summary Statement).
Applications can be renewed by competing for additional project periods through this FOA.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR
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 SBC 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(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact GrantsInfo --
Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide 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
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget,
as appropriate (See Section IV.6., Special Instructions, regarding appropriate
required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations (Non-domestic [non-U.S.] Entities)
NIH
policies concerning grants to foreign (non-U.S.) organizations can be found in
the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review and Anticipated Start Dates
Opening Date: May 17,
2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): May 17, 2008
NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt Date(s): June 17, 2008
AIDS Application Submission/Receipt Date(s): Not applicable
Peer Review Date(s): October/November, 2008
Council Review Date(s): January 2009
Earliest Anticipated Start Date(s): April 1, 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The letter of
intent is to be sent by the date listed in Section IV.3.A.
The letter of
intent should be sent to:
Regina Smith James, M.D.
Director,
Extramural Associates Program
The Eunice
Kennedy Shriver National Institute of Child Health and Human Development
6100
Executive Boulevard, Room 5E03,
MSC 7510
Bethesda, MD 20892-7510
Telephone:
(301) 435-2692
FAX: (301)
480-0393
Email: [email protected]
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this
FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application 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, applications will be evaluated for completeness by the Center for
Scientific Review, NIH. Incomplete applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5.
Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
renewal award if such costs: 1) are necessary to conduct the project, and 2)
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new or competing renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against future
support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements and Information.
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration 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.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Requirements
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.
The appendix is limited to announcements and reports of previous meetings under the same sponsorship. No other information or material should be submitted as appendices.
Resource Sharing Plan(s)Foreign Applications (Non-domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.
Research Plan
Use this section of the application to describe the objectives, specific program, and logistical arrangements for the proposed meetings. Describe the meeting format (seminar, workshop, colloquia, town hall meeting, etc.), including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate. Describe the types of participants (e.g., community, university), and how the meetings will relate to ongoing research at the institution and the characteristics of the community.
Provide a detailed justification for the meetings, including the scientific need, timeliness, and usefulness of the meeting to the scientific and local community. Specifically, describe how the proposed effort will meet the goals of this initiative as described above under Research Objectives. Describe the composition and role of the organizing and advisory committees, and provide the names and credentials of key participants in the meeting, including the basis for their selection and documentation of their agreement to participate.
Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning and implementation of the proposed meetings. Estimate the expected size and composition of the audience, as well as the method of selection. Describe plans for publicizing the meetings/symposia/conferences and publication of proceedings. Identify related meetings held on the subject during the past three years. If this is one of a series of periodic meetings held by a permanent sponsoring organization, briefly describe and evaluate the last meeting in the series.
The following instructions are to be used in conjunction with the SF424 (R&R) Application Guide accompanying the SF424 (R&R) application form.
SF424 (R&R) Cover Component: Enter the title of the conference or scientific meeting on line item 11.
Research and Related Project/Performance Site Locations: Enter the site of the conference or meeting as the Performance Site.
Research and Related Senior/Key Person: Personnel are defined as the PD/PI and those responsible for the scientific planning and organization of the meeting. Attach a biographical sketch for PD/PI, Co-Chair, key personnel, and confirmed key speakers.
Research and Related Budget: The appropriate NICHD conference award program contact should be consulted for guidance regarding any specific budget requirements (see Section VII. 1.). Enter the direct costs requested. Provide a narrative justification for each proposed personnel position, including role and proposed level of effort. Include information regarding efforts to obtain funding for this conference/meeting from other sources. Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible: meeting topic(s); tentative dates, locations, and participants; and contingency plans for future meetings dependent upon, for example, the outcome of the first year s meeting or developments in the field.
Allowable Costs: Salary (in proportion to the time or effort spent directly on the conference/meeting); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the meeting (only if received for use during the budget period); conference services; publication costs; registration fees; speakers fees.
Non-allowable costs: Purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; facilities and administrative costs/indirect costs. Please also refer to the NIH Grants Policy Statement for additional information regarding costs.
PHS 398 Checklist Component: The checklist is required; however, no information regarding F&A should be included as this is not an allowable cost for this mechanism.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Applications that
are complete and responsive to this FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the NICHD
Division of Scientific Review and in accordance with NIH peer review procedures
( http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted for
this funding opportunity will be assigned to the NIH ICs on the basis of an
advance permission letter. Applications lacking such a letter will not be
reviewed. Dual assignments will be made on the basis of established PHS
referral guidelines. An appropriate evaluation group convened by the accepting
IC will evaluate the application for scientific and technical merit.
The following will be considered in making funding decisions:
In their critiques, reviewers
will be asked to comment on each of the following criteria, which will be
addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to deserve a high priority score.
Significance: Does this
conference/scientific meeting address an important health problem? If the aims
of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these endeavors on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Is the format and agenda for the meeting appropriate for achieving the goals of the conference? Is the meeting timely for the subject matter? How well do the plans for inclusion of women, minorities, and persons with disabilities provide for their appropriate representation in the planning, organization, and implementation of the proposed meeting?
Innovation: Does the meeting employ novel approaches or methods to fulfill its purpose?
Investigators: Is
the PD/PI well suited for organizing and fulfilling the goals of this
conference? Are the qualifications of the PD/PI appropriate and past
performance adequate? Are the key personnel and selected speakers appropriate
and well suited for their described roles in the conference?
Environment: How appropriate is the
meeting site? Does the applicant organization have the ability to contribute to
the probability of success? Do the proposed meetings, exhibits, interactions,
etc., take advantage of unique features of the environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
2.A.
Additional Review Criteria
In addition to
the above criteria, the following items will be considered in the determination
of scientific merit and the rating:
Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398
Research Plan component of the SF424 (R&R).
2.B.
Additional Review Considerations
Budget and Period of
Support: The reasonableness of the proposed budget and the appropriateness of the
requested period of support in relation to the proposed research may be
assessed by the reviewers. The priority score should not be affected by the
evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Resource Sharing Plan(s)The following resource sharing policies do not apply to this FOA:
3. Anticipated Announcement and Award Dates
Not Applicable
Section
VI. Award Administration Information
1.
Award Notices
After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification
in the form of a Notice of Award (NoA) will be provided to the applicant
organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding
Restrictions.
2.
Administrative and National Policy Requirements
All NIH grant
and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
2.A. Cooperative Agreement
Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable
U.S. Office of Management and Budget (OMB) administrative guidelines, U.S.
Department of Health and Human Services (DHHS) grant administration regulations
at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local
Governments are eligible to apply), ad other HHS, PHS, and NIH grant
administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement, an "assistance"
mechanism (rather than an "acquisition" mechanism), in which
substantial NIH programmatic involvement with the awardees is anticipated
during the performance of the activities. Under the cooperative agreement, the
NIH purpose is to support and stimulate the recipients' activities by
involvement in and otherwise working jointly with the award recipients in a
partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the dominant
role and prime responsibility resides with the awardees for the project as a
whole, although specific tasks and activities may be shared among the awardees
and the NIH as defined below.
2. A.1. Principal
Investigator Rights and Responsibilities
The PD(s)/PI(s) will have the primary responsibility for:
The PI will have the primary responsibility for:
Awardees will
retain custody of and have primary rights to the data and software developed
under these awards, subject to Government rights of access consistent with
current DHHS, PHS, and NIH policies.
2. A.2. NIH
Responsibilities
An NIH Project Scientist will
have substantial programmatic involvement that is above and beyond the normal
stewardship role in awards, as described below. Substantial
involvement as a partner would include, for example, assisting in such
activities as planning the agenda, selecting speakers, organizing a symposium,
determining the content of the meeting, or
determining the acceptability of submitted papers. Substantial involvement
would not include serving as an invited speaker or providing limited advice.
Additionally, an agency
Program Official will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
(optional)
PD/PIs will participate in periodic meetings or conference
calls to share progress and experiences with other
Academic-Community Partnership programs.
Each full member
will have one vote. Awardee members of the Steering Committee will be required
to accept and implement policies approved by the Steering Committee.
2.A.4. Arbitration Process
Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to arbitration. An Arbitration Panel composed of
three members will be convened. It will have three members: a designee of the
Steering Committee chosen without NIH staff voting, one NIH designee, and a
third designee with expertise in the relevant area who is chosen by the other
two; in the case of individual disagreement, the first member may be chosen by
the individual awardee. This special arbitration procedure in no way affects
the awardee's right to appeal an adverse action that is otherwise appealable in
accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45
CFR Part 16.
3.
Reporting
When multiple
years are involved, awardees will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Jean Flagg-Newton, Ph.D.
Health Scientist Administrator
Extramural Associates Program
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100
Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2736
FAX: (301) 480-0393
Email: [email protected]
Carl V. Hill, Ph.D. M.P.H., Health
Scientist Administrator
Extramural Associates Program
The Eunice Kennedy Shriver National Institute of Child
Health and Human Development
6100
Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2736
FAX: (301) 480-0393
Email: [email protected]
2. Peer Review Contact(s):
Robert Stretch, Ph.D.
Director, Division of Scientific Review
The Eunice Kennedy Shriver National Institute of Child
Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]
3. Financial/Grants Management Contact(s):
Victoria Bishton
Grants Management Specialist
Grants Management Branch
The Eunice Kennedy Shriver National Institute of Child
Health and Human Development
6100
Executive Boulevard, 8A01B, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 451-5510
Email: [email protected]
Section VIII. Other Information
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).
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/.
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 PA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is described in
the Catalog
of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review. Awards
are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR 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
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