Department of Health and Human
Services
Participating Organizations
National Institutes
of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Center for
Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov)
Title: Tools and
Technology to Measure Patient Adherence in CAM Research (SBIR [R43/R44])
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.
Request For
Applications (RFA) Number: RFA-AT-06-002
Catalog of Federal Domestic Assistance Number(s)
93.213
Key Dates
Release/Posted Date: April 5,
2006
Opening Date: April 24, 2006 (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 Date(s): June 5, 2006
AIDS
Application Submission Date(s): Not Applicable
Peer
Review Date(s): July 2006
Council
Review Date(s): September 2006
Earliest
Anticipated Start Date: September 2006
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration
Date: June 6,
2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
This funding opportunity announcement (FOA) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose development of innovative tools, technology, and devices needed for objective assessment of patient adherence to complementary and alternative medicine (CAM) intervention studies particularly those involving biologically active agents and mind-body strategies.
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.
Sending an Application 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 purpose of this FOA is to encourage SBCs to develop new tools, technologies, and devices to assess patient adherence, in order to enhance the accurate assessment of the use of complementary and alternative medicine (CAM) practices, interventions, and products via the SBIR (R43 and R44 Fast-Track) mechanism. It is anticipated that this would be particularly relevant to biologically active CAM agents and mind-body CAM interventions. Understanding and accurately measuring the extent to which patients and study participants adhere to study protocols is essential information for accurate assessment of outcomes. Several types of CAM procedures, interventions, and modalities are particularly dependent upon high adherence rates among study participants, including adherence to instructions to avoid confounding factors. For instance, studies investigating biologically active CAM agents, examples of which can be found at the following website: http://nccam.nih.gov/health/supplements.htm, require that participants ingest the agents in a specified dose, at specific times, and according to well-described protocols. In addition, participants in these studies must refrain from exposure to unintended sources of the agent. An understanding of the degree to which participants accurately adhere to the study protocol is paramount for accurate interpretation of the outcomes of these studies. Sensitive, non-invasive kits, assays, devices, or sensors are required for detection of biologically active CAM agents, their constituents or metabolites in body tissues or fluids, such as blood or urine, to assess adherence to protocols. These technologies will likely require understanding the chemistry, toxicology, pharmacodynamics, pharmacokinetics or metabolomics of the biologically active CAM agents.
Mind-body interventions also require substantial participant adherence to specific study protocols. NCCAM is supporting a range of CAM mind-body intervention studies, such as those examining the health effects of meditation, yoga, tai chi, and similar interventions. These protocols require participants to regularly engage in these practices on their own in specific formats and under specified protocols. Assessing the level of participant adherence to these protocols is essential in order to understand the dose, the efficacy, the safety, and the feasibility of the intervention. Typically, adherence to behavioral intervention studies is assessed using self-report diary measures or employing handheld devices. Both strategies require participants to record, usually in real time, their behaviors associated with the intervention. Although these adherence assessments have the potential to provide important data, they are limited by potential participant bias, inaccuracy, and patient burden. Better, more accurate, and less burdensome indices of adherence would enhance our understanding of the efficacy and safety of CAM modalities and treatments.
The purpose of this initiative is to stimulate the development of new tools, technology, and devices using innovative designs to objectively assess patient adherence to CAM intervention studies. In particular, CAM interventions involving biologically active agents and mind-body strategies, both of which require substantial participant adherence, are relevant. It is expected that the devices and technologies developed will be designed for, and relevant to, a specific CAM intervention, rather than applicable to a wide range of intervention strategies. The devices, tools and instruments developed should include unique and innovative technologies that capture, in minimally invasive and objective ways, adherence in ambulatory and clinic settings, and from a range of patient groups engaging in specific intervention strategies. Because these devices, tools, and technologies depend on an understanding of the particular intervention for which they are developed, it is expected that small businesses will work collaboratively with CAM investigators. In accordance with the NIH application package, applicants must include a complete section on Human Subjects Research, including a data and safety monitoring plan.
Specifically, the objectives of this section of the FOA include but are not limited to:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This
funding opportunity will use the Small Business Innovation Research (SBIR
[R43/R44] grant mechanisms. Applications may be submitted for support
as Phase I 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 any other HHS FOA, including the current Parent SBIR and 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 SBIR 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 SBIR 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 NEW applications through Grants.gov/Apply using the standard NIH,
CDC, and FDA SBIR submission dates of April 1, August 1, and December
1 (or January 2, May 1, and September 1 for NIH AIDS and AIDS-related SBIR
applications).
This funding opportunity uses just-in-time concepts. The
modular budget format is no longer accepted for SBIR 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 SBIR awards. For
this funding opportunity, budgets up to $250,000 total costs per year and time
periods up to one year for Phase I may
be requested. Budgets up to $750,000 total
costs per year and up to two years may be requested for Phase
II. Total costs include direct costs, Facilities & Administrative (F&A)/indirect
costs, and fee.
The
participating organization(s) NCCAM intends to commit approximately 1.5M dollars
in FY 2006 to fund 6-8 Phase I
and/or Fast-Track applications under the SBIR set-aside funding mechanism.
Although the financial plans of the participating organizations provide support
for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications. At this time, it is not known if competing renewal applications
will be accepted and/or if this RFA will be reissued.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
Only
United States small business concerns (SBCs) are eligible to submit SBIR
applications. A small business concern is one that, at the time of award for
both Phase I and Phase II SBIR 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 SBIR awardee organization must be space that is available to and under the control of the SBIR 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 SBIR 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 SBIR
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 SBIR 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 programs.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be
with the small business concern at the
time of award and during the conduct of the proposed project.
Primary employment means that more than one half of the PD/PI’s time is spent
in the employ of the small business concern. Primary
employment with a small business concern precludes full-time employment at
another organization. Occasionally, deviations from this
requirement may occur. Such deviations must be approved in writing by the
grants management officer after consultation with the NIH SBIR/STTR Program
Coordinator.
As defined in 42 CFR 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.
If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the PD/PI, if at the time of submission of the application, the PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.
If the PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.
This requirement applies also to those individuals engaged currently as the PD/PI on an active SBIR project. All current employment and all other appointments of the PD/PI must be identified in his or her “Biographical Sketch” required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.
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
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 SBIR or STTR Parent FOAs.
Section IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
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 eRA Commons.
Several additional separate actions are required before an applicant institution/organization 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 organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1.
Request Application Information
Applicants must
download the SF424 (R&R) application forms and 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 SBIR 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 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
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SBIR/STTR Information
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: April 24, 2006 (Earliest date
an application may be submitted to Grants.gov)
Letter of Intent Receipt Date: Not Applicable
Application Submission Date(s): June 5, 2006
AIDS
Submission Date(s): Not Applicable
Peer
Review Date(s): July 2006
Council
Review Date(s): September 2006
Earliest
Anticipated Start Date: September 2006
3.A.1. Letter of
Intent
A
letter of intent is not required for this funding opportunity.
3.B. Sending an
Application 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 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.
The NIH will not accept any application in response to
this funding opportunity that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to a funding
opportunity, it is to be prepared as a NEW application. That is, the
application for the funding opportunity must not include an Introduction
describing the changes and improvements made, and the text must not be marked
to indicate the changes from the previous unfunded version of the application.
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.
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
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.
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.
SBIR Phase I applications:
SBIR Fast-Track applications:
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/.and 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
Only the review criteria described below will be considered in the
review process.
2. Review and Selection Process
Applications that are complete and responsive to this funding
opportunity will be evaluated for scientific and technical merit by an
appropriate peer review group convened by NCCAM in accordance with the review
criteria stated below.
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 SBIR 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 SBIR
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
SBIR? 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 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.
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?
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).
Inclusion
of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. See item 7 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.
Section
VII. Agency Contacts
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:
Inquiries related to tools and technologies to
measure adherence to biologically active CAM agents:
Carol H.
Pontzer, Ph.D.
Division of Extramural Research and Training
NCCAM
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892
Telephone: (301) 435-6286
Fax: (301) 480-3621
Email: pontzerc@mail.nih.gov
Inquiries related to tools and technologies to measure adherence to mind-body interventions:
Catherine
M. Stoney, Ph.D.
Division of Extramural Research and Training
NCCAM
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892
Telephone: (301) 402-1272
Fax: (301) 480-3621
Email: stoneyc@mail.nih.gov
2. Peer Review Contacts:
Dr. Martin Goldrosen
Chief,
Office of Scientific Review
National Center for Complementary and Alternative
Medicine
National
Institutes of Health
6707
Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use
20817)
Telephone:
(301) 594 2014
Fax:
(301) 480 2419
Email:
goldrosm@nccam.nih.gov
3. Financial or Grants Management Contacts:
Mr. George Tucker
Grants
Management Branch
National Center for Complementary and Alternative
Medicine
6707
Democracy Boulevard, Suite 401
Bethesda, MD 20892 (for express/courier service use
20817)
Telephone:
(301) 594-9102
FAX:
(301) 480-2419
Email:
gt35v@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.
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
(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.
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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) |
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