Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov)
Title: Longitudinal Surveys of the Elderly: STTR Initiative (R41/R42)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
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-06-464
Complex and large-scale socio-behavioral surveys related to adult health and aging are being developed all over the world. The demand for new, innovative technologies such as computer assisted interviewing, incorporation of biological and physiological measures, and user-friendly longitudinal databases associated with this trend has been expanding for several years. Longitudinal surveys often become more difficult to use over time due to increased complexity in the composition of the sample and/or the addition of new survey components, coupled with inconsistent data files and inadequate documentation. User friendly data use files are of interest not only to academic researchers, but to insurers, health care providers, HMOs, pharmaceutical companies and policy analysts.
The purpose of this FOA is to encourage small businesses to develop the following areas via the STTR (R41/R42) mechanisms:
Survey Development/Archiving: Produce and/or archive improved user-friendly public use data files from existing large-scale population-based data collection and behavioral intervention efforts to facilitate secondary data analysis.
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 National Institute on Aging (NIA) has supported the development of major
longitudinal survey data collection efforts and behavioral interventions in
areas such as cognition, genetics, long term care, retirement and economic
status, caregiving, behavioral medicine, and the dynamics of health and functional
change at older ages. See http://www.nia.nih.gov/NR/rdonlyres/7AE4D0D9-9DF7-4DF4-B8B9-468F19106E23/0/PubliclyAvailDatasetsJul_2006B.pdf
for descriptions of publicly available databases for aging-related secondary
analyses supported by the NIA
In February 2003 NIH reaffirmed its support for the concept of data sharing and stated that data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data (http://grants.nih.gov/grants/policy/data_sharing/index.htm). Many datasets were assembled prior to the implementation of this policy and although they have been archived, they have not been made available to the research community in user-friendly formats. Longitudinal surveys often become more difficult to use over time due to increased complexity in the composition of the sample and/or the addition of new survey components. In addition, the formats of the data files and the documentation are not always consistent across the survey years. Socio-behavioral surveys are being used all over the world by continuously expanding research and policy communities. User friendly, data use files could be of interest not only to academic researchers, but to insurers, health care providers, HMOs, pharmaceutical companies and policy analysts. Therefore, the commercial potential of making survey data more accessible is quite large. The purpose of this FOA is to encourage small businesses to develop the areas listed below via the STTR (R41/R42) mechanisms. The following list presents examples of such topics. This list of topics is not comprehensive, nor are the examples exhaustive.
Survey Development/Archiving
Examples of population-based surveys and behavioral interventions of priority to the NIA include: the Health and Retirement Study (HRS), English Longitudinal Study of Aging (ELSA), National Social Life, Health and Aging Project (NSHAP), National Health and Nutrition Examination Survey (NHANES), National Survey of Midlife Development in the United States (MIDAS), Wisconsin Longitudinal Study (WLS), The Whitehall II Study, The National Long-term Care Survey (NLTCS), Panel Study of Income Dynamics (PSID), Social Environment and Biomarkers of Aging Study (SEBAS), the World Health Organization’s Survey of Global Aging (SAGE), the International Networks for the Continuous Demographic Evaluation of Populations and their Health in Developing Countries (INDEPTH), Resources for Enhancing Alzheimer’s Caregiver Health (REACH), and Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE). See http://www.nia.nih.gov/NR/rdonlyres/7AE4D0D9-9DF7-4DF4-B8B9-468F19106E23/0/PubliclyAvailDatasetsJul_2006B.pdf for descriptions of many of these and other studies.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism 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.
Applicants may not simultaneously
submit identical/essentially identical applications under both this funding
opportunity and another HHS FOA, including the current parent SBIR or STTR
FOAs.
Phase II applications in response to this funding
opportunity will only be accepted as competing renewals (formerly “competing
continuations”) of previously funded Phase I STTR awards. 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.
The applicant SBC will be solely responsible for planning, directing, and
executing the proposed project. Future unsolicited, competing renewal applications
based on this project will compete with all STTR applications and will be
reviewed according to the customary peer review procedures. Applications that
are not funded in the competition described in this FOA may be submitted as
RESUBMISSION applications through Grants.gov/Apply
using the standard NIH, CDC, and FDA submission dates
of April 1, August 1, and December 1 (or January 2, May 1, and September 1
for AIDS and AIDS-related STTR applications).
This funding opportunity uses just-in-time
concepts. The modular budget format is no longer 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.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism, numbers, quality, duration and costs of the applications received.
All awards are subject to the availability of funds.
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:
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in Title 13 Code of Federal Regulations (CFR) Part 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.
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.
For a STTR application, the Project Director/Principal Investigator (PD/PI)
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.
As defined in Title 42 Code of Federal Regulations (CFR) Part 52, the PD/PI is the “single individual designated by the grantee in the grant application … who is responsible for the scientific and technical direction of the project.” 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.
The 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 SBC, which is characterized by an official relationship between the SBC 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 12, “Consortium/Contractual
Arrangements,” of the PHS398 Research Plan component of the SF424 (R&R)
application forms.
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.
Applicants may not simultaneously submit identical/essentially identical applications
under both this funding opportunity and another HHS FOA, including the current
parent SBIR or STTR FOAs.
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, 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 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.
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) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly
attached to a specific FOA can be used. You will not be able to use any other
SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although
some of the "Attachment" files may be useable for more than one
FOA.
For further assistance contact GrantsInfo, Telephone
301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-0088.
2. Content and Form of Application Submission
Prepare all STTR applications using the SF424 (R&R) application forms and the SF424 (R&R) SBIR/STTR Application Guide (MS Word) or PDF) instructions.
The SF424 (R&R) 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). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “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 Form
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SBIR/STTR Information
Optional Components:
PHS398 Cover Letter File
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: July 1, 2006 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
Application Submission
Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): Not applicable
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
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
Applications in response to this FOA may only be submitted
to Grants.gov through Grants.gov/Apply.
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.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review (CSR), NIH.
Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the assignment
of an application to a Scientific Review Group is also 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” 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
The NIH requires the 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. 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 “Tips and Tools for Navigating Electronic Submission” on
the front page of “Electronic Submission of Grant Applications
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:
STTR Fast-Track applications:
Note: While each section of the Research Plan needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.
Plan for Sharing Research Data
Applicants requesting $500,000 or more in direct
costs in any year should 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, if they are proprietary, this must be explained in the
application. The Small Business Act requires NIH to protect from disclosure
and nongovernmental use all SBIR and STTR data developed from work performed
under an SBIR and STTR funding agreement for a period of four (4) years after
the closeout of either a Phase I or Phase II grant unless NIH obtains permission
from the awardee to disclose these data. The data rights protection period
lapses only upon expiration of the protection period applicable to the SBIR
and STTR award, or by agreement between the small business concern and NIH.
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/data_sharing_faqs.htm.
(See FAQ #13.)
Sharing Research Resources
NIH policy requires that grant awardee 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/index.htm
and 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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
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.
The 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.
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, and appropriate
to the aims of the project? Is the proposed plan a sound approach for establishing
technical and commercial feasibility? Does the applicant acknowledge potential
problem areas and consider alternative strategies? Are the milestones and
evaluation procedures appropriate?
Innovation: Are the aims original and innovative?
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: Is the PD/PI appropriately trained
and capable of coordinating and managing the proposed STTR? Are the investigators
well suited to carry out this work? Does the investigative team bring complementary
and integrated expertise to the project (if applicable)? Is the work proposed
appropriate to the experience level of the PD/PI and other researchers, including
consultants and subcontractors (if any)? Are the relationships of the key
personnel to the small business and to other institutions appropriate for
the work proposed?
Environment: Is there sufficient access to
resources (e.g., equipment, facilities)? Does 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?
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?
Resubmission Applications (formerly
“amended” applications)
In addition to the above criteria,
the following criteria will be applied to resubmission applications.
1. Are the responses to comments from the previous
scientific review group adequate?
2. Are the improvements in the resubmission application
appropriate?
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 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.
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:
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 item
6 of the 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 five
items described under item 11 of the Research Plan component of the SF424
(R&R) will be assessed.
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: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed research
may be assessed by the reviewers. Is the effort listed for the PD/PI appropriate
for the work proposed? Is each budget category realistic and justified in
terms of the aims and methods?
Period of Support: The appropriateness of the
requested period of support in relation to the proposed research.
2.C. Sharing Research Data
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
and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(See FAQ #13.)
2.D. Sharing Research Resources
NIH policy requires that grant awardee 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/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html). 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.
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration
Information
1. Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written critique)
via the 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
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required
in the NIH
Grants Policy Statement.
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:
For scientific questions please contact:
Anneliese Hahn, MS
Behavioral and Social Research Program
Individual Behavioral Processes Branch
National Institute on Aging/NIH
7201 Wisconsin Ave. Suite 533
Bethesda, MD. 20892-9205
(301) 402-4156
Email: hahnan@nia.nih.gov
For questions regarding the STTR Program please contact:
Michael-David Alphonsus Rodriguez Richardson Kerns,
M.B.A., M.S., Ph.D.
National Institute on Aging/NIH
Gateway Building, Suite 2C-218
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: 301-402-7713
Fax: 301-402-2945
Email: kernsmd@mail.nih.gov
2. Peer Review Contacts:
Not applicable
3. Financial or Grants Management Contacts:
Traci Lafferty
Grants Management Specialist
National Institute on Aging/NIH
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 301-496-8987
Fax: (301) 402-3672
Email: laffertt@nia.nih.gov
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
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
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.
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 (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
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 DHHS 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. Unless otherwise specified
in an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
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
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |