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 Institute of
Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National
Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute on Deafness and Other Communication Disorders
(NIDCD) (http://www.nidcd.nih.gov/)
National
Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National
Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
National
Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute
of Nursing Research (NINR) (http://www.ninr.nih.gov/)
Title: Neurotechnology
Research, Development, and Enhancement (STTR [R41/R42])
Announcement Type
New
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 SF 424 (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 should be started at least two weeks in advance of the planned submission. See Section IV.
Program Announcement (PA) Number: PA-07-390
Catalog of Federal Domestic Assistance Number(s)
93.853, 93.242, 93.173, 93.279, 93.866, 93.286, 93.273, 93.361
Key Dates
Release/Posted Date: June 29, 2007
Opening
Date: July 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 Dates(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#STTR for
details.
AIDS
Application Receipt Dates(s): Not Applicable
Peer
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#STTR for
details.
Council
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#STTR for
details.
Earliest
Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#STTR for
details
Additional
Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: May 8, 2010
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
PurposeThe purpose of this Funding Opportunity Announcement (FOA) is to encourage submission of grant applications to support the research and development of innovative technologies, methodologies, or instrumentation, or the improvement and enhancement of currently existing technologies for use in basic or clinical studies of the brain or behavior in human or non-human animals, or in clinical diagnosis and treatment of brain and behavioral disorders. Projects should have as their goals novel or enhanced tools and approaches that would be used broadly by the pertinent research community at-large, using accepted conventions to increase compatibility and interoperability with existing tools and approaches where appropriate.
BackgroundIn biomedicine, new tools and approaches often make possible tremendous advances in research on health and disease, and sometimes shift the manner in which such research is undertaken, and results interpreted. Reciprocally, the complexity of living systems represent interesting challenges to those developing new tools and approaches, providing ample opportunity for expanding the limits of their science and technology.
The brain, and its functional product, behavior, represent a spectacularly complex system. Despite this, significant advances are being made in brain and behavioral sciences, with important discoveries coming to light daily. These discoveries are enhancing our understanding of healthy brain function and offering new promise to the millions suffering from brain and behavioral disorders. To further accelerate the pace of discovery, new tools and approaches are needed.
Technologies and approaches appropriate for study, development, and enhancement under this FOA include hardware (e.g., instruments, devices, etc.), software (e.g., computational algorithms, informatics tools, etc.), and wetware (e.g., imaging probes, genetic tools, etc.) that would be used to study the brain or behavior in basic or clinical research, or for clinical diagnosis and treatment. Research solicited under this program announcement is not limited to any particular type of technology, level of analysis, or approach. Multidisciplinary teams of researchers are especially encouraged to apply. The research topics identified here represent examples of technologies that are appropriate for this solicitation. These examples, some of which are broad, and others very specific, are not a complete list of the technologies sought; they are intended only as examples of what would be considered appropriate research topics.
Research TopicsThis FOA is expected to advance understanding of the nervous system and its product, behavior, or the diagnosis and treatment of nervous system diseases and disorders, through support of research, development, and enhancement of a wide range of technologies. Examples of hardware, software, and wetware that would be considered appropriate under this FOA for research, development and enhancement include, but are not limited to:
o Tissue-specific delivery systems for exogenous agents such as drugs, gene transfer, and cells, including non-invasive methods for in vivo tracking
o Microfluidic systems for in vivo spatial and temporal controlled delivery of neurotransmitters and other biomolecules
o Biosensors that would be selectively activated by neurochemicals, such as particular neurotransmitters or pharmacological compounds, or alcohol and other drugs of abuse
o Protein and antibody arrays for studies of the nervous system, and their data storage and analysis
o Metabolomics analysis of the nervous system
o Technologies to facilitate high-throughput analysis of cognition and behavior
o Genetic approaches to manipulate or monitor synaptic activity, or to study structure and/or function of neural circuits in animal models
o New methods or agents to study neural connectivity in living or post mortem brain, especially human brain
o Probes of brain gene expression that can be imaged non-invasively (e.g., with magnetic resonance or near infrared optical imaging)
o Tools for real-time analysis of neurophysiological events
o Tools, technologies and algorithms for neuroprosthesis development, such as improved electrodes, microcomputer interfaces, and microcircuitry for chronic implantation, monitoring of neural activity, and promoting efferent function
o Microelectromechanical system (MEMS) devices used for monitoring neuron function in slice and culture preparations
o Devices for non-invasive diagnosis and precise identification of pathogens involved in central and peripheral neural infectious diseases
o Tools for relatively non-invasive or minimally invasive ways to assess damage and monitor function in regions of injured or diseased brain tissue, such as dynamic monitors of intracranial pressure and cerebral spinal fluid composition (particularly important in following disease progression or recovery from brain injury)
o Non-invasive optical imaging approaches, and tools to enhance visualization of specific brain markers
o Algorithms for image analysis of brain structures from human neuroimaging data
o Computational approaches and informatics tools for simulating, analyzing, organizing, querying, integrating, sharing, or visualizing data about the brain or behavior
o Tools for data mining for genetic discovery and functional insights into genomics, proteomics, and metabolomics of the nervous system
It is stressed that the examples given above are not meant to be exhaustive; they are merely given to suggest the kinds of projects that would be appropriate.
Applications submitted in response to this FOA may be design-, problem-, need-, or hypothesis-driven. Thus, the application should state the designs, problems, needs and/or hypotheses that will drive the proposed research.
As plans for technology research, development, and enhancement are augmented by specific feasibility tests of the technology and/or milestones, these should be presented in the Research Design and Methods section. Attention should be paid to how the tool or approach can be made widely available to researchers and compatible with other tools and approaches commonly used in a particular research community. Finally, applications should include a plan for making available to the research community the technologies developed or enhanced by grants funded under this FOA; this should be described in the Research Design and Methods section of the application (see Sharing Research Resources , below).
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award
Information
1. Mechanism(s) of Support
This funding opportunity
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.
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 small business concern (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 Research and Related
(R&R) Budget component found in the application package attached to this FOA
in Grants.gov/Apply.
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. If requested budgets and award
durations are expected to exceed the guidelines, prospective applicants are
strongly encouraged to contact the program officer from an appropriate
institute or center, listed in this funding opportunity announcement.
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 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 C.F.R. 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, 13C.F.R. 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 SBIR/STTR program, the organization must be recertified by the SBA prior to any future SBIR/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 their 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 assume this role, the application is not likely to receive a favorable evaluation.
Each PD/PI must commit a minimum of 10% effort to the project and the 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
Applicants
may not simultaneously submit identical/essentially identical applications
under both this STTR Parent funding opportunity and any other HHS FOA,
including the current STTR 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
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 SBIR/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:
PD/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:
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 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 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.
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 Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). 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 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. For STTR, the contact PI must be employed by the small business. 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: July 5, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#STTR for details.
AIDS
Application Submission/Receipt Date(s): Not applicable
Peer
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#STTR for details.
Council
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#STTR for details.
Earliest
Anticipated Start Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#STTR for details.
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
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified 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 assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR), NIH. Incomplete applications will not be reviewed.
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
continuation 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 are to be followed, with the following requirements.
STTR Phase I applications:
STTR Phase II applications:
STTR Fast-Track applications:
Resubmissions:
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
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. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
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 observe the required page limitations may be delayed in the review process. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.
Plan for Sharing
Research Data
The precise content
of the data-sharing plan will vary, depending on the data being collected and
how the investigator is planning to share the data. Applicants who are planning
to share data may wish to describe briefly the expected schedule for data
sharing, the format of the final dataset, the documentation to be provided,
whether or not any analytic tools also will be provided, whether or not a
data-sharing agreement will be required and, if so, a brief description of such
an agreement (including the criteria for deciding who can receive the data and
whether or not any conditions will be placed on their use), and the mode of data
sharing (e.g., under their own auspices by mailing a disk or posting data on
their institutional or personal Web site, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
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 data set may be shared. If the final data are not amenable to sharing (for example human subject concerns, the 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.)
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 (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 plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. 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.
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
Review Process
Applications
submitted for this funding opportunity will be assigned to the ICs for funding
consideration on the basis of established PHS referral guidelines.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) 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:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for (1) Protections for Human Subjects, and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment
in which the work will be done contribute to the probability of success?
Are the institutional support, equipment and other physical resources available
to the investigators adequate for the project proposed? Will the project
benefit from unique features of the scientific environment, subject
populations, or collaborative arrangements?
Additional Review
Criteria
As
applicable for the project proposed, reviewers will consider
the
following additional items in the determination of scientific and technical
merit, but will not give separate scores for these items.
For Phase II Applications Only. When reviewing Phase II applications, 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?
For Phase I/Phase II Fast-Track Applications Only. When reviewing Phase I/Phase II Fast-Track applications, reviewers will consider the following:
1.
Does the Phase I application specify clear, appropriate, measurable goals
(milestones) that should be achieved prior to initiating Phase II?
2. 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?
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR or STTR applications. The following will be considered in making funding decisions:
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 SBIR/STTR
grantees submit the following reports
within 90 days of the end of the grant budget period unless the
grantee is under an extension.
Failure to submit timely final reports may affect future funding to the organization or awards with the same principal investigator.
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.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, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Daofen
Chen, Ph.D.
Systems
and Cognitive Neuroscience
National
Institute of Neurological Disorders and Stroke
6001
Executive Boulevard, Room 2176, MSC 9523
Bethesda, MD 20892-9523
Telephone:
(301) 496-9964
FAX:
(301) 402-1501
Email: [email protected]
Margaret C. Grabb, Ph.D.
Division
of Neuroscience and Basic Behavioral Science
National
Institute of Mental Health
6001
Executive Blvd. Room 7201, MSC 9645
Bethesda, MD 20892-9645
Rockville, MD 20852 (for express or courier service)
Telephone:
(301) 443-3563
FAX:
(301) 443-1731
Email: [email protected]
Roger
Miller, Ph.D.
Division
of Extramural Research
National
Institute on Deafness and Other Communication Disorders
6120
Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD 20892-7180
Telephone:
(301) 402-3458
FAX:
(301) 402-6251
Email: [email protected]
Thomas G.
Aigner, Ph.D.
Division
of Neuroscience and Behavioral Research
National
Institute on Drug Abuse
6001
Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone:
(301) 443-6975
FAX:
(301) 594-6043
Email: [email protected]
Bradley
C. Wise, Ph.D.
Neuroscience
and Neuropsychology of Aging Program
National
Institute on Aging
7201
Wisconsin Avenue, Suite 350, MSC 9205
Bethesda, MD 20892-9205
Telephone:
(301) 496-9350
FAX:
(301) 496-1494
Email: [email protected]
Todd
Merchak, B.S.
Division
of Inter-Disciplinary Training
National
Institute of Biomedical Imaging and Bioengineering
6707
Democracy Boulevard, Suite 200, MSC 5469
Bethesda, MD 20892
Telephone:
(301) 496-8592
FAX:
(301) 480-1614
Email: [email protected]
Roger G.
Sorensen, Ph.D., M.P.A.
Division
of Neuroscience and Behavior
National
Institute on Alcohol Abuse and Alcoholism
5635
Fishers Lane,
Room 2053, MSC 9304
Bethesda, MD 20892-9304
Telephone:
(301) 443-2678
FAX:
(301) 443-1650
Email: [email protected]
Paul
Cotton, PH.D., RD
Health
Behavior and Minority Health
Division
of Extramural Activities
National Institute of Nursing Research, NIH
One Democracy Plaza
6701
Democracy Boulevard, Suite 710
Bethesda, MD 20892-4870
Phone:
(301) 402-6423
FAX:
(301) 480-8260
Email: [email protected]
2. Peer Review Contacts:
Not Applicable
3. Financial or Grants Management Contacts:
Tijuanna
Decoster
Grants
Management Branch
National
Institute of Neurological Disorders and Stroke
6001
Executive Boulevard, Suite 3254, MSC 9537
Bethesda, MD 20892-9537(use Rockville, MD 20852 for express/courier service)
Telephone:
(301) 496-9231
Fax:
(301) 402-0219
Email: [email protected]
Rebecca Claycamp, CRA
Division
of Extramural Activities
National
Institute of Mental Health
6001
Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone:
(301) 443-2811
FAX:
(301) 443-6885
Email: mailto:[email protected]
Sara
Stone
Grants
Management Branch
National
Institute on Deafness and Other Communication Disorders
6120
Executive Boulevard, Room 400B, MSC-7180
Bethesda, MD 20892
Telephone:
(301) 402-0909
FAX:
(301) 402-1758
Email: [email protected]
Pamela Fleming
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Linda
Whipp
Grants
and Contracts Management Office
National
Institute on Aging
7201
Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone:
(301) 496-1472
FAX:
(301) 402-3672
Email: [email protected]
Nick
Mitrano
Grants
Management Branch
National
Institute of Biomedical Imaging and Bioengineering
6707
Democracy Boulevard, Suite 920, MSC 5469
Bethesda, MD 20892
Telephone:
(301) 451-4782
FAX:
(301) 480-4974
Email: [email protected]
Judy Fox
Grants
Management Branch
National
Institute on Alcohol Abuse and Alcoholism
5635
Fishers Lane,
Room 3023
Bethesda, MD 20892-9304
Telephone:
(301) 443-4704
FAX:
(301) 443-3891
Email: [email protected]
Brian
Albertini
Grants
and Contracts Management Office
National Institute of Nursing Research, NIH
One Democracy Plaza
6701
Democracy Boulevard, Suite 710
Bethesda, MD 20892-4870
Phone:
(301) 594-6869
FAX:
(301) 402-4502
[email protected]
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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