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
National
Cancer Institute (NCI/NIH), ( http://www.cancer.gov/)
National Eye Institute (NEI/NIH), (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI/NIH), (http://www.genome.gov/)
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID/NIH), (http://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS/NIH), (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD/NIH), (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR/NIH), (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH), (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA/NIH), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS/NIH), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS/NIH), (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH/NIH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS/NIH), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR/NIH), (http://www.ninr.nih.gov/)
National Library of Medicine (NLM/NIH), (http://www.nlm.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM/NIH), (http://nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD/NIH), (http://ncmhd.nih.gov/)
National Center for Research Resources (NCRR/NIH), (http://www.ncrr.nih.gov/)
Title: PHS 2007-02 Omnibus Solicitation
of the NIH for Small Business Technology Transfer Grant Applications (Parent
STTR [R41/R42])
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Note: See information on all Parent Announcements for Unsolicited or Investigator-Initiated applications.
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) SBIR/STTR Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-07-281
Catalog of Federal Domestic Assistance
Number(s)
93.113,
93.114, 93.115, 93.118, 93.121, 93.135, 93.136, 93.143, 93.161, 93.172, 93.173,
93.184, 93.185, 93.197, 93.206, 93.208, 93.213, 93.233, 93.242, 93.268, 93.273,
93.279, 93.283, 93.286, 93.307, 93.361, 93.389, 93.393, 93.394, 93.395, 93.396,
93.399, 93.837, 93.838, 93.839, 93.846, 93.847, 93.848, 93.849, 93.853, 93.855,
93.856, 93.859, 93.865, 93.866, 93.867, 93.879, 93.941, 93.942, 93.943, 93.947,
93.978
Key Dates
Release/Posted Date: January 16, 2007
Opening Date: February 5, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): 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 Submission/Receipt
Date(s): April 5, 2007; August 5, 2007; December 5, 2007
AIDS Application
Submission/Receipt Date(s): May 1, 2007; September 1, 2007; January 2, 2008
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be
Available Date (URL Activation Date): Not
Applicable
Expiration Date: January 3, 2008 (now January 8, 2008 per NOT-OD-07-093)
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
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research
Objectives
The STTR program, as
established by law, is intended to stimulate a partnership of ideas and
technologies between innovative small business concerns (SBCs) and research
institutions through Federally-funded research or research and development
(R/R&D). By providing awards to SBCs for cooperative R/R&D efforts with
research institutions, the STTR program assists the small business and research
communities by commercializing innovative technologies.
The STTR program is structured in three phases, the first two of which are supported using STTR funds. The objective of Phase I is to establish the technical/scientific merit and feasibility of the proposed R/R&D efforts. The objective of Phase II is to continue the research or R&D efforts initiated in Phase I. An objective of the STTR program is to increase private sector commercialization of innovations derived from Federal R/R&D. The objective of Phase III, where appropriate, is for the SBC to pursue with non-STTR funds (either Federal or non-Federal) the commercialization objectives resulting from the results of the R/R&D funded in Phases I and II. In some Federal agencies, Phase III may involve follow-on, non-STTR funded R&D, or production contracts for products or processes intended for use by the U.S. Government.
The competition for STTR Phase I and Phase II awards satisfies the competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the Competition in Contracting Act. Therefore, an agency that wishes to fund an STTR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III STTR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is a STTR Phase III award that is derived from, extends, or logically concludes efforts performed under prior STTR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 253(b)(2).
This Funding Opportunity Announcement (FOA) issued by the National Institutes of Health (NIH), invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) Phase I, Phase II, Fast-Track, and Phase II Competing Renewal grant applications.
The PHS 2007-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA represent scientific program areas that may be of interest to applicant SBCs in the development of projects that have potential for commercialization. Small business concerns that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this FOA are encouraged to submit STTR grant applications in these areas. STTR grant applications will also be accepted and considered in any area within the mission of the Components of Participating Organizations listed for this FOA. In addition to the general research areas described above some NIH awarding components have identified additional, specific STTR funding opportunities of potential interest to SBCs. See the NIH Special Announcements for Small Business Research Opportunities. Applicants are not required to identify a potential awarding component prior to submission of the application. Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH grant applications, will assign all applications to the most appropriate Institute/Center (IC) based on their mission and the science proposed.
Some of the NIH ICs offer the opportunity to submit Phase II Competing Renewal applications that will provide additional funding for those Phase II STTR projects that require regulatory approval for the product or service being developed. For those ICs that included these opportunities in the PHS 2007-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA, applications will be accepted through this Parent STTR FOA. All others must be submitted in response to the specific FOA released by the IC. See the NIH Special Announcements for Small Business Research Opportunities for a list of these unique STTR and SBIR funding opportunities.
This FOA is issued pursuant to the authority contained in Public Law 107-50 which authorizes the STTR program through September 30, 2009. Government-wide STTR policy is provided by the Small Business Administation (SBA) through its STTR Program Policy Directive. Federal agencies with extramural R&D budgets over $1 billion annually are required to administer STTR programs using a set-aside of 0.30% for awards to small companies that conduct research in a collaborative relationship with a non-profit research institution.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This FOA will use the
Small Business Technology Transfer (STTR [R41/R42] grant mechanisms. Applications may be submitted
for support as Phase I, Phase II, or Fast-Track grants as described in the SF424
(R&R) SBIR/STTR Application Guide. Applications for Phase II Competing
Renewal grants may be submitted for those ICs that included
these opportunities in the PHS
2007-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and
FDA,
Small
business concerns that have received a Phase I STTR grant may apply for Phase
II funding of that project. The Phase II must be a logical extension of the
Phase I research but not necessarily as a Phase I project supported in response
to this funding opportunity. Phase II applications will compete with all STTR
applications and will be reviewed according to the customary peer review
procedures
The
applicant SBC will be solely responsible for planning, directing, and executing
the proposed project.
This
funding opportunity uses Just-in-Time information concepts. The modular
budget format is not accepted for STTR grant applications. Applicants must
complete and submit budget requests using the SF424 (R&R) Budget component
found in the application package attached to this FOA in Grants.gov/Apply. All other participating
organizations, including the partnering research institution, must complete and
submit requests using the Research & Related
Subaward Budget Attachment(s) Form contained in the application package.
2. Funds Available
The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support
and project duration periods for Phase I and Phase II STTR awards.
Not
all types of biomedical and behavioral research can be completed within the
statutory guideline award amounts for Phase I ($100,000) or Phase II ($750,000)
and statutory project periods (one year for Phase I and two years for Phase
II). Applicants are encouraged to propose a reasonable, appropriate and
justified budget and project period necessary to complete the Phase I or Phase
II research project. Deviations from the statutory guidelines MUST be well
justified and must be discussed with appropriate NIH staff listed in the Awarding Component/Agency Contact Information Table prior to submission of the
application.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
Only United States small business concerns (SBCs) are eligible to submit STTR applications. A small
business concern is one that, at the time of award for both Phase I and Phase
II STTR awards, meets all of the following criteria:
1. Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.
2. Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.
3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in Title 13, Code of Federal Regulations (CFR) Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 CFR 121.103. The term "number of employees" is defined in 13 CFR 121.106.
A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small Business Administration's (SBA) Government Contracting Area Office or Office of Size Standards.
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an STTR awardee organization must be space that is available to and under the control of the STTR awardee for the conduct of its portion of the proposed project.
Title 13 CFR 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the STTR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 CFR 121.106 Small Business Size Regulations.
All STTR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an STTR award until the SBA provides a determination.
Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the STTR program, must be recertified by the SBA prior to any future STTR awards.
1.B. Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research 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, or multiple PDs/PIs, may be designated on the application
for projects that require a team science approach that clearly does 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 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 single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants 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 multiple PDs/PIs, 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 PD/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.
For a STTR application, the Project Director/Principal Investigators (PD/PIs) may be employed with the SBC or the participating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual.
When the proposed PD/PI clearly does not have sufficient qualifications to provide scientific and technical direction of the project, the application is not likely to receive a favorable evaluation.
Each PD/PI must commit a minimum of 10% effort to the project and each PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PI s official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project. Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.
The following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization:
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
In STTR Phase I and
Phase II, at least 40% of the work must be performed by the small business
concern and at least 30% of the work must be performed by the single,
partnering research institution. The basis for determining the percentage of
work to be performed by each of the cooperative parties will be the total of
direct and F&A/indirect costs attributable to each party, unless otherwise
described and justified in Item 15, Consortium/Contractual Arrangements, of
the PHS398 Research Plan component of the SF424 (R&R) application forms.
Applicants may not simultaneously submit identical/essentially identical applications under both this STTR Parent funding opportunity and any other HHS FOA, including the current SBIR Parent FOA. The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Likewise, identical or essentially identical grant applications submitted by different applicant organizations will not be accepted. Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator are the original work of the principal investigator and have not been used elsewhere in the preparation and submission of a similar grant application. Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify multiple grant applications for essentially the same project. In these cases, application processing may be delayed or the application(s) may be returned to the applicant without review.
It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. Essentially equivalent work or effort occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.
Only one Phase II award may be made for a single STTR project.
You may submit a Phase II application either before or after expiration of the Phase I budget period, unless you elect to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I grantee organization should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period.
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 Started
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.
To affiliate the PD/PI with the applicant small business concern:
Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."
Both the PD/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 number 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 numbers and CCR registrations 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 institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download
the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application
Guide for this FOA using the Apply for Grant Electronically button in this
FOA or 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 STTR applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) SBIR/STTR Application Guide for this FOA through Grants.gov/Apply
The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the 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.
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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424
(R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research
& Related Other Project Information
Research
& Related Senior/Key Person
Research
& Related Budget
Research
& Related Subaward Budget Attachment(s) Form
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
SBIR/STTR
Information
Optional
Components:
PHS398
Cover Letter File
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PD/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. The first PD/PI listed must be affiliated with the applicant small business concern and will serve as the Contact PD/PI. For STTR, the Contact PI may be from either the SBC or the single partnering research institution. Note: the Contact PD/PI must have a formal appointment with or commitment to the SBC, which must be in the form of an official relationship between the parties, but need not include a salary or other form of remuneration. All funding for STTR projects goes to the small business awardee, so funding for PD/PIs from other organizations must be requested via a subcontract with the small business using the Research & Related Subaward Budget Attachment(s) Form.
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 of the 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, including 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.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: February 5, 2007 (Earliest date an application may be submitted
to Grants.gov)
Application Submission/Receipt
Date(s): April 5, 2007; August 5, 2007; December 5, 2007
AIDS Application
Submission/Receipt Date(s): May 1, 2007; September 1, 2007; January 2, 2008
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
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 an application in
response to this FOA, applicants may use the Apply
for Grant Electronically button in this FOA or link to 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 submission/receipt
date(s). (See Section IV.3.A. for all dates.) If an
application is not submitted by the receipt date(s) and time, the application
may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR). Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PD/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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction (1 page maximum for Phase I and 3 pages maximum for Phase II) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is
not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH
Grants Policy Statement.
Pre-award costs are allowable. A
grantee may, at its own risk and without NIH prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new or competing renewal award if such costs: are
necessary to conduct the project, and would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new 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 the NIH
Grants Policy Statement.
6. Other Submission
Requirements
PD/PI
Credential (e.g., Agency Login)
The NIH requires each PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
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
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) SBIR/STTR Application Guide (MS Word or PDF) are to be followed, with the following requirements.
STTR Phase I applications:
STTR Phase II applications (including Phase II Compteing Renewals):
STTR Fast-Track applications:
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Appendix Materials
IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) SBIR/STTR 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 observe the required page limitations may be delayed in the review process. Phase I STTR Appendix materials are not permitted unless specifically requested by NIH.
Plan
for Sharing Research Data
Applicants requesting $500,000 or more in direct costs in any year must include a brief one paragraph description of how final research data will be shared, or explain why data-sharing is not possible. The specific nature of the data to be collected will determine whether or not the final dataset may be shared. If the final data are not amenable to sharing (for example human subjects concerns, Small Business Act provisions, etc.), this must be explained in the application. Applicants are encouraged to discuss their data-sharing plan with the Institute/Center (IC) staff likely to accept assignment of their application.
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. For more information on data sharing see http://grants.nih.gov/grants/policy/data_sharing. and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. (See FAQ #13.)
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
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Appropriate
scientific review groups convened in accordance with the standard NIH peer
review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the
initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended STTR applications. The following will be considered in making funding decisions:
The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.
Note
that an application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority score.
Applicants
should include information in relevant sections of the grant application that addresses
the questions for each review criterion below.
All STTR Applications
Significance: Does the proposed project have
commercial potential to lead to a marketable product, process or service? Does
this study address an important problem? What may be the anticipated commercial
and societal benefits that may be derived from the proposed research? If the
aims of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field? Does the application lead to enabling technologies (e.g.,
instrumentation, software) for further discoveries? Will the technology have a
competitive advantage over existing/alternate technologies that can meet the
market needs?
Approach: Are the conceptual or clinical
framework, design, methods, and analyses adequately developed, well-integrated,
well-reasoned, and appropriate to the aims of the project? Is the proposed
plan a sound approach for establishing technical and commercial feasibility? Are
the milestones and evaluation procedures appropriate? Does the applicant
acknowledge potential problem areas and consider alternative tactics? For
applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigator(s): Are the PD/PI(s) and other key
personnel appropriately trained and well suited to carry out this work? Is the
work proposed appropriate to the experience level of the PD/PI(s) and other
researchers, including consultants and subcontractors (if any)? Do the PD/PIs
and investigative team bring complementary and integrated expertise to the
project (if applicable)? Are the relationships of the key personnel to the small
business and to other institutions appropriate for the work proposed?
Environment: Do(es) the scientific and
technological environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support? Is
there sufficient access to resources (e.g., equipment, facilities)?
Phase II
Applications
In
addition to the above review criteria:
1. How well did the
applicant demonstrate progress toward meeting the Phase I objectives,
demonstrating feasibility, and providing a solid foundation for the proposed
Phase II activity?
2. Did the applicant
submit a concise Commercialization Plan that adequately addresses the specific
areas described in the SF424 (R&R) SBIR/STTR Application Guide and the
SBIR/STTR Information component?
3. Does the project
carry a high degree of commercial potential, as described in the
Commercialization Plan?
Phase I/Phase II
Fast-Track Application Review Criteria
For
Phase I/Phase II Fast Track applications, the following criteria also will be
applied:
1. Does the Phase I
application specify clear, appropriate, measurable goals (milestones) that
should be achieved prior to initiating Phase II?
2. Did the applicant
submit a concise Commercialization Plan that adequately addresses the specific
areas described in the SF424 (R&R) SBIR/STTR Application Guide and the
SBIR/STTR Information component?
3. To
what extent was the applicant able to obtain letters of interest, additional
funding commitments, and/or resources from the private sector or non-SBIR/STTR
funding sources that would enhance the likelihood for commercialization?
4. Does the project
carry a high degree of commercial potential, as described in the
Commercialization Plan?
Phase I and Phase II
Fast-Track applications that satisfy all of the review criteria will receive a
single rating.
For Fast-Track
applications, the Phase II portion may not be funded until a Phase I final
report and other documents necessary for continuation have been received and
assessed by IC program staff that the Phase I milestones have been successfully
achieved. Items 2-5 of the Research Plan may not exceed 25 pages. That is, the
combined Phase I and Phase II plans for a Fast-Track application (for Items
2-5) must be contained within the 25-page limitation.
Phase II Competing
Renewal Applications (formerly Phase II Competing Continuation applications)
In
addition to the above review criteria described under All STTR Applications,
the following items will be applied to ALL Phase II competing renewal
applications in the determination of scientific merit and the priority score.
1. Does the activity
as proposed address issues related to Federal regulatory approval processes?
2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR Information component?
3.
Does the project carry a high degree of commercial potential as described in
the Commercialization Plan?
2.A. Additional
Review Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Resubmission
Applications (formerly revised/amended applications): Are the responses to comments from
the previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the Other Research Plan Sections of the PHS398 Research Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
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.
2.C.
Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D.
Sharing Research Resources
NIH policy expects that grant recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding
to this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.
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/her Summary Statement (written critique)
via the 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 also 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.
3. Reporting
NIH requires that STTR
grantees submit the following reports
within 90 days of the end of the grant budget period unless the
grantee is under an extension.
Financial Status Report (OMB 269, http://www.whitehouse.gov/omb/grants/grants_forms.html)
Final Progress Report
Final Invention Statement and Certification (HHS 568)
Annual Invention Utilization Reports
Final Cash Transaction Report (PSC 272, http://www.dpm.psc.gov/Reports.aspx)
Phase II Data Collection Requirement for Government Tech-Net Database (http://technet.sba.gov)
Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF 424 (R&R) SBIR/STTR Application Guide.The SBIR/STTR program solicitation is available on the NIH Small Business Funding Opportunities web site (http://grants.nih.gov/grants/funding/sbir.htm). Small business concerns are encouraged to check the SBIR/STTR homepage for program updates. Any updates or corrections to the solicitation will be posted there. If the small business concern has difficulty accessing the solicitation, contact the PHS SBIR/STTR Solicitation Office (Section II. A).
Questions of a general nature about the NIH SBIR/STTR program should be directed to:
Ms. Jo Anne Goodnight
NIH SBIR/STTR Program
Coordinator
6705 Rockledge Drive
Rockledge I, Room 3534
Bethesda, MD 20892
Phone: 301-435-2688, Fax:
301-480-0146
Email: [email protected] or [email protected]
Ms. Kay Etzler
NIH SBIR/STTR Program
Analyst
6705 Rockledge Drive
Rockledge I, Room 3536
Bethesda, MD 20892
Phone: 301-435-2713, Fax:
301-480-0146
Email: [email protected] or [email protected]
Kathleen
J. Shino, M.B.A.
NIH SBIR/STTR Program
6705 Rockledge Drive
Rockledge I, Room 3522
Bethesda, MD 20892
Phone:
301-435-2689, Fax: 301-480-0146
Email: [email protected]
PHS
SBIR/STTR Solicitation Office
13685
Baltimore Avenue
Laurel, MD 20707-5096
Phone: (301) 206-9385, Fax:
(301) 725-1485
Email: [email protected]
Grants
Information
Division
of Extramural Outreach and Information Resources
Office
of Extramural Research
National
Institutes of Health
Phone:
(301) 710-0267, Fax: (301) 480-0525
Email: [email protected]
The PHS agencies encourage applicants to communicate with staff (see table below) throughout the entire application, review, and award process. Web site addresses and staff phone numbers of relevant NIH awarding components and other PHS awarding components are listed in the table below.
All
inquiries regarding the assignment, review, or recommendation on funding of
applications are to be made only to PHS officials.
1. Scientific/Research and Financial/Grants
Management Contacts:
Scientific/Research and Financial/Grants Management contacts for this funding
opportunity announcement are listed below.
Awarding Component |
Scientific/Research Contact |
Financial/Grants Mgmt. Contact |
National Institute on
Aging |
Dr. Michael-David A.R.R. Kerns |
Ms. Linda Whipp |
National Institute on
Alcohol Abuse and Alcoholism |
Dr. Max Q. Guo |
Ms. Judy Fox |
National Institute of
Allergy and Infectious Diseases |
Dr. Gregory Milman |
Mr. Michael Wright |
National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.niams.nih.gov/ |
Mr. Elijah Weisberg |
Ms. Sheila Simmons Mr. Erik (Timothy) Edgerton |
National Institute of Biomedical Imaging and Bioengineering |
Mr. Todd Merchak |
Ms. Florence Turska |
National Cancer Institute |
Mr. Michael Weingarten |
Mr. Ted Williams |
National Institute of Child Health and Human Development |
Dr. Louis A. Quatrano |
Mr. Bryan S. Clark, M.B.A. |
National Institute on Drug
Abuse |
Dr. Cathrine Sasek |
Ms. Diana Haikalis |
National Institute on
Deafness and Other Communication Disorders |
Dr. Lynn E. Luethke |
Mr. Christopher P. Myers |
National Institute of Dental and Craniofacial Research |
Dr. Rosemarie Hunziker |
Ms. Mary Daley |
National Institute of Diabetes and Digestive and Kidney Diseases |
Dr. Sanford A. Garfield |
Ms. Helen Y. Ling |
National Institute of Environmental Health Sciences |
Dr. Jerrold J. Heindel |
Mr. Dwight Dolby |
National Eye Institute |
Dr. Jerome R. Wujek |
Mr. William Darby |
National Institute of General Medical Sciences |
Dr. Matthew E. Portnoy |
Ms. Patrice Molnar |
National Heart, Lung, and
Blood Institute |
Ms. Susan Pucie |
Ms. Suzanne White |
National Human Genome Research
Institute |
Dr. Bettie J. Graham |
Ms. Cheryl Chick |
National Institute of
Mental Health |
Dr. Michael F. Huerta |
Ms. Rebecca Claycamp |
National Institute of Neurological Disorders and Stroke |
Dr. Randall Stewart |
Ms. Kimberly Campbell |
National Institute of Nursing Research |
Dr. Paul Cotton |
Mr. Brian Albertini |
National Center for Research Resources |
Dr. Amy L. Swain |
Ms. Leslie Le |
National Center for Complementary and Alternative Medicine |
Dr. Carol Pontzer |
Mr. George Tucker, M.B.A. |
National Center on Minority Health and Health Disparities |
Mr. Vincent A. Thomas, Jr., MSW, MPA |
Ms. Monica Shaw-Cortez |
National Library of
Medicine |
Dr. Jane Ye |
Mr. Dwight Mowery |
Not Applicable
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
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 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 scientific merit or the priority score.
Access to Research Data through the Freedom of
Information Act:
The 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 the 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.
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.
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); 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:
NIH-funded investigators are requested to submit to
the NIH Manuscript Submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (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 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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