It is critical that applicants follow the SBIR/STTR (B) Instructions
in the SF424
(R&R) SBIR/STTR Application Guide except where instructed to do
otherwise (in this FOA or in a Notice from the NIH Guide for Grants and
Contracts). Conformance to all requirements (both in the
Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.
The overarching goal of the Small Business Innovation
Research (SBIR) program at the National Institute of Mental Health (NIMH) is to
support small businesses to develop technologies that can advance the mission
of the Institute, including basic neuroscience research relevant to mental
disorders, translational and clinical research of mental disorders, clinical
diagnosis or treatment of mental disorders, and dissemination of evidence-based
mental health care. The NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml)
presents key scientific priorities across these domains, and describes the need
for tools to realize these priorities. Research priorities for the NIMH further
include aspects of HIV/AIDS prevention, treatment, eradication of HIV/CNS
reservoirs and care, in accordance with the Trans-NIH Plan for HIV-Related
Research (https://www.oar.nih.gov/strategic_plan/index.asp).
The SBIR program is one source of support for the research
and development of technologies that correspond to these identified research
priorities. While some tools can be developed with budgets and project
durations within the Congressional SBIR budget caps, others cannot. This
FOA encourages SBIR applications for support of research and development of
particular types of technologies that require funding levels and durations
beyond those reflected in these budget caps. See Appendix A of the
SBIR/STTR topics list for a complete list of technology areas that received a
SBA budget waiver to expand budgets beyond the budget caps, when appropriately
justified and needed: https://sbir.nih.gov/sites/default/files/NIH_Topics_for_Budget_Waivers.pdf ).
For additional tools in which NIMH is interested, but which can be supported
within the SBIR budget caps, see the NIMH-related topics of the SBIR Omnibus
Solicitation Parent FOA.
Applications submitted to this FOA are expected to represent
significant advances and innovation.
Empirical evidence is expected for the biomarker selected;
exploratory studies would be inappropriate for the SBIR program. Studies
proposed in SBIR applications are expected to include: multi-site testing to
inform reproducibility and create standardization of protocols for the
biomarker and its intended use, analytical validation (accurately and reliably
measure the analyte of interest in the laboratory), clinical validation
(detection or prediction of an associated disorder/domain of function in
measurements from targeted patient groups), understanding sources of technical
and biological variability in the biomarker measures, including:
The NIMH supports the development of innovative, state of
the art, user-friendly tools and platforms to efficiently and effectively
disseminate evidence-based treatments/research into services and clinical
practice. Such tools may incorporate applied behavioral science and technology,
software, hardware and associated technologies.
DAR encourages SBIR applications
focused on the development of innovative technologic tools designed to:
It is expected that technology platforms for all projects be
state of the art, considering the latest electronic technologies, so as not to
develop a tool that becomes obsolete during the commercialization phase.
In addition, dissemination of interventions that have not been well-validated
would not be appropriate for commercialization.
An additional criterion that the federal government
considers in supporting a small business with SBIR funds, is past
commercialization performance. It is expected that small businesses who have
received SBIR grants, have made significant effort to commercialize their
previously supported technologies. Small businesses that are mostly
interested in research and development (and not commercialization) should
consider other grant mechanisms at NIH, rather than the SBIR program. Program
staff at NIMH can help identify the most appropriate grant mechanism to
use.
Funding Instrument
Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
New (Phase I, Fast-Track)
New (Direct Phase II)
Renewal (Phase II)
Resubmission (all phases)
Revision
The OER
Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details
on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.
Award Budget
Budgets of up to total $450,000 per year total cost for
Phase I awards and $750,000 per year total cost for Phase II awards, and
$1,000,000 per year total cost for Phase IIB may be requested.
Award Project Period
Durations up to two years for Phase I and up to three
years for Phase II may be requested.
NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made from this FOA.
Section III. Eligibility
Information
1. Eligible Applicants
Eligible Organizations
Only United States small business concerns (SBCs) are
eligible to submit applications for this opportunity. A
small business concern is one that, at the time of award of Phase I and Phase
II, meets all of the following criteria:
1. Is organized for
profit, with a place of business located in the United States, which operates
primarily within the United States or which makes a significant contribution to
the United States economy through payment of taxes or use of American products,
materials or labor;
2. Is in the legal
form of an individual proprietorship, partnership, limited liability company,
corporation, joint venture, association, trust or cooperative, except that
where the form is a joint venture, there must be less than 50 percent
participation by foreign business entities in the joint venture;
3.
i. SBIR
and STTR. Be a concern which is more than 50% directly
owned and controlled by one or more individuals (who are citizens or permanent
resident aliens of the United States), other business concerns (each of which
is more than 50% directly owned and controlled by individuals who are citizens
or permanent resident aliens of the United States), or any combination of
these; OR
ii. SBIR-only.
Be a concern which is more than 50% owned by multiple venture capital operating
companies, hedge funds, private equity firms, or any combination of
these. No single venture capital operating company, hedge fund, or
private equity firm may own more than 50% of the concern; OR
iii. SBIR and
STTR. Be a joint venture in which each entity to the
joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii)
of this section. A joint venture that includes one or more concerns that meet
the requirements of paragraph (ii) of this section must comply with
121.705(b) concerning registration and proposal requirements.
4. Has, including
its affiliates, not more than 500 employees.
If the concern is more than 50% owned by multiple venture
capital operating companies, hedge funds, private equity firms, or any
combination of these falls under 3 (ii) or 3 (iii) above, see Section
IV. Application and Submission Information for additional instructions
regarding required application certification.
If an Employee Stock Ownership Plan owns all or part of the
concern, each stock trustee and plan member is considered an owner.
If a trust owns all or part of the concern, each trustee and
trust beneficiary is considered an owner.
Definitions:
- Hedge fund has the meaning given that term in section 13(h)(2) of
the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund
must have a place of business located in the United States and be created or
organized in the United States, or under the law of the United States or of any
State.
- Portfolio company means any company that is owned in whole or
part by a venture capital operating company, hedge fund, or private equity
firm.
- Private equity firm has the meaning given the term "private
equity fund" in section 13(h)(2) of the Bank Holding Company Act of 1956 (12
U.S.C. 1851(h)(2)). The private equity firm must have a place of business
located in the United States and be created or organized in the United States,
or under the law of the United States or of any State.
- Venture capital operating company means an entity described in
121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have
a place of business located in the United States and be created or organized in
the United States, or under the law of the United States or of any State.
SBCs must also meet the other regulatory requirements found
in 13 C.F.R. Part 121. Business concerns, other than investment companies
licensed, or state development companies qualifying under the Small Business
Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when
either directly or indirectly, (a) one concern controls or has the power to
control the other; or (b) a third-party/parties controls or has the power to
control both. Business concerns include, but are not limited to, any individual
(sole proprietorship) partnership, corporation, joint venture, association, or
cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be
referenced for detailed eligibility information.
Small
business concerns that are more than 50% owned by multiple venture capital
operating companies, hedge funds, private equity firms, or any combination of
these are NOT eligible to apply to the NIH STTR program.
Phase I to Phase II
Transition Rate Benchmark
In accordance with guidance
from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II
Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of
2011. This Transition Rate requirement applies to SBIR and STTR
Phase I applicants that have received more than 20 Phase I awards over the past
5 fiscal years, excluding the most recently-completed fiscal year. For
these companies, the benchmark establishes a minimum number of Phase II awards
the company must have received for a given number of Phase I awards received
during the 5-year time period in order to be eligible to receive a new Phase I
award. This requirement does not apply to companies that have received 20
or fewer Phase I awards over the 5 year period.
Companies that apply for a
Phase I award and do not meet or exceed the benchmark rate will not be eligible to apply for a Phase I or
Fast-Track award for a period of one year from
the date of the application submission. The Transition Rate is calculated
as the total number of SBIR and STTR Phase II awards a company received during the
past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards
it received during the past 5 fiscal years excluding the most
recently-completed year. The benchmark minimum Transition Rate is
0.25.
SBA calculates individual
company Phase I to Phase II Transition Rates daily using SBIR and STTR award
information across all federal agencies. For those companies that have
received more than 20 Phase I awards over the past 5 years, SBA posts the
company transition rates on the Company Registry at SBIR.gov.
Information on the Phase I to Phase II Transition Rate requirement is available
at SBIR.gov.
Applicants to this FOA that
may have received more than 20 Phase I awards across all federal SBIR/STTR
agencies over the past five (5) years should, prior to application preparation,
verify that their company's Transition Rate on the Company Registry at SBIR.gov
meets or exceeds the minimum benchmark rate of 0.25.
Phase
II to Phase III Commercialization Benchmark
In accordance with guidance from the SBA, HHS, including
NIH, SBIR/STTR Programs are implementing the Phase II to Phase III
Commercialization Rate benchmark for Phase I applicants, as required by the
SBIR/STTR Reauthorization Act of 2011. The Commercialization Rate Benchmark was
published in a Federal Register notice on August 8, 2013 (78 FR
48537).
This requirement applies to companies that have received
more than 15 Phase II awards from all agencies over the past 10 years,
excluding the two most recently-completed Fiscal Years. Companies that meet
this criterion must show an average of at least $100,000 in revenues and/or
investments per Phase II award or at least 0.15 (15%) patents per Phase II award
resulting from these awards. This requirement does not apply to companies that
have received 15 or fewer Phase II awards over the 10 year period, excluding
the two most recently-completed Fiscal Years.
Information on the Phase II
to Phase III Commercialization Benchmark is available at SBIR.gov.
Applicants to this FOA that
may have received more than 15 Phase II awards across all federal SBIR/STTR
agencies over the past ten (10) years should, prior to application preparation,
verify that their company's Commercialization Benchmark on the Company Registry
at SBIR.gov meets or exceeds the benchmark rate listed above.
Applicants that fail this
benchmark will be notified by SBA annually and will not be eligible to
apply for New Phase I, Fast-track or Direct
Phase II awards for a period of one year.
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, may be allowed.
Required Registrations
Applicant
Organizations
Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.
- Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants can
begin both SAM, SBA Company registry, and eRA Commons registrations. The same
DUNS number must be used for all registrations, as well as on the grant
application.
- System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.
- SBA Company Registry See Section IV. Application and Submission
Information, "SF424(R&R) Other Project Information Component" for
instructions on how to register and how to attach proof of registration to your
application package. Applicants must have a DUNS number to complete this
registration. SBA Company registration is NOT required before SAM, Grants.gov or
eRA Commons registration.
- eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to
complete the Grants.gov registration.
Program
Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
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. For projects with
multiple PDs/PIs, at least one must meet the primary employment requirement.
Occasionally, deviations from this requirement may occur.
The SF424 (R&R) SBIR/STTR Application Guide should be
referenced for specific details on eligibility requirements. For
institutions/organizations proposing multiple PDs/PIs, see Multiple Principal
Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH
Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.
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 any other HHS funding opportunity, including the SBIR and STTR
Parent announcements.
The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:
- A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.
- A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).
A Phase I awardee may submit a Phase II application either
before or after expiration of the Phase I budget period, unless the awardee
elects to submit a Phase I and Phase II application concurrently under the
Fast-Track procedure. To maintain eligibility to seek Phase II or IIB support,
a Phase I awardee should submit a Phase II application, and a Phase II awardee
should submit a Phase IIB application, within the first six due dates following
the expiration of the Phase I or II budget period, respectively.
Contractual/Consortium Arrangements
In Phase I, normally, a minimum of two-thirds or 67% of the
research or analytical effort must be carried out by the small business concern.
The total amount of all consultant and contractual arrangements to third
parties for portions of the scientific and technical effort generally may not
exceed 33% of the total amount requested (direct, F&A/indirect, and fee).
In Phase II, normally, a minimum of one-half or 50% of the research or
analytical effort must be carried out by the small business concern. The total
amount of consultant and contractual arrangements to third parties for portions
of the scientific and technical effort generally may not exceed 50% of the
total Phase II amount requested (direct, F&A/indirect, and fee).
A small business concern may subcontract a portion of its
SBIR or STTR award to a Federal laboratory within the limits above. A Federal
laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally
funded research and development center, or any center established under 15
U.S.C. 3705 & 3707 that is owned, leased, or otherwise used by a Federal
agency and funded by the Federal Government, whether operated by the Government
or by a contractor.
The basis for determining the percentage of work to be
performed by each of the cooperative parties in Phase I or Phase II will be the
total of the requested costs attributable to each party, unless otherwise
described and justified in "Consortium/Contractual Arrangements" of the PHS 398
Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R)
SBIR/STTR Application Guide.
Section IV. Application
and Submission Information
1. Requesting an
Application Package
Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the SBIR/STTR (B) Instructions
in the SF424
(R&R) SBIR/STTR Application Guide, except where instructed in this
funding opportunity announcement to do otherwise. Conformance to the
requirements in the Application Guide is required and strictly enforced.
Applications that are out of compliance with these instructions may be delayed
or not accepted for review.
For information on Application Submission and Receipt, visit Frequently
Asked Questions Application Guide, Electronic Submission of Grant
Applications.
Page Limitations
All page limitations described in the SF424 (R&R) SBIR/STTR
Application Guide and the Table of Page
Limits must be followed.
Instructions
for Application Submission
The following section supplements the instructions found in
the SF 424 (R&R) SBIR/STTR Application Guide and should be used for
preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) SBIR/STTR
Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) SBIR/STTR
Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) SBIR/STTR
Application Guide must be followed.
Other
Attachments:
1. SBIR Application Certification for small business
concerns majority-owned by multiple venture capital operating companies, hedge
funds, or private equity firms.
Applicant small business concerns that are majority-owned by
multiple venture capital operating companies, hedge funds, or private equity
firms (e.g. majority VCOC-owned) are required to submit a Certification at time
of their application submission per the SBIR Policy Directive.
Follow the instructions below.
Applicants small business concerns who are more than 50%
directly owned and controlled by one or more individuals (who are citizens or
permanent resident aliens of the United States), other business concerns (each
of which is more than 50% directly owned and controlled by individuals who are
citizens or permanent resident aliens of the United States), or any combination
of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification
and should NOT attach it their application package.
a. Download the
"VCOC Certification.pdf" at the NIH SBIR Forms webpage.
b. Answer the 3
questions and check the certification boxes.
c. The
authorized business official must sign the certification.
d. Save the
certification using the original file name. The file must be named "SBIR
Application VCOC Certification.pdf". DO NOT CHANGE OR ALTER THE FILE NAME.
Changing the file name may cause delays in the processing of your application.
e. When you are
completing the application package, attach this certification as a separate
file by clicking "Add Attachments" located to the right of Other
Attachments field on the "Research and Related Other Project Information" form.
SF424(R&R) Senior/Key Person Profile Expanded
All instructions in the SF424 (R&R) SBIR/STTR
Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) SBIR/STTR
Application Guide must be followed.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide
must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) SBIR/STTR Application
Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) SBIR/STTR Application
Guide must be followed, with the following additional instructions:
Resource
Sharing Plans: Individuals are required to comply with the instructions
for the Resource Sharing Plans as provided in the SF424 (R&R) SBIR/STTR
Application Guide, with the following modification:
Appendix:
Note that Phase I SBIR/STTR Appendix materials are not
permitted. Limited items are allowed in the Appendix of other small business
applications. The instructions for the Appendix of the Research Plan are
described in the SF424 (R&R) Application Guide; any instructions provided
here are in addition to the SF424 (R&R) Application Guide Instructions.
PHS Human Subjects and Clinical Trials Information
Use only for applications with due dates on or after January
25, 2018. When involving NIH-defined human subjects research, clinical
research, and/or clinical trials follow all instructions for the PHS Human
Subjects and Clinical Trials Information form in the SF424 (R&R)
Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects
Involved?" on the R&R Other Project Information form, you must include at
least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials
Information form or a Delayed
Onset Study record.
Study
Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide
must be followed.
Delayed
Onset Study
All instructions in the SF424 (R&R) Application Guide
must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) SBIR/STTR
Application Guide must be followed.
3. Unique Entity Identifier
and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), SBA
Company Registry, eRA Commons, and Grants.gov.
4. Submission Dates and
Times
Part I. Overview Information contains information about Key Dates and time. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date and time. If a Changed/Corrected application is submitted
after the deadline, the application will be considered late. Applications that
miss the due date and time are subjected to the NIH Policy on Late Application
Submission.
Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.
Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) SBIR/STTR Application
Guide.
5. Intergovernmental Review
(E.O. 12372)
This initiative is not subject to intergovernmental
review.
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 only as described in the NIH
Grants Policy Statement.
7. Other Submission
Requirements and Information
Applications must be submitted electronically following the
instructions described in the SF424 (R&R) SBIR/STTR Application
Instructions. Paper applications will not be accepted.
Applicants must complete all required registrations
before the application due date. Section
III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application submission, contact
the Application Submission Contacts in Section
VII.
Important reminders:
All PD(s)/PI(s) must include their
eRA Commons ID in the Credential field of the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register in the
Commons and to include a valid PD/PI Commons ID in the credential field will
prevent the successful submission of an electronic application to NIH.
The applicant organization must
ensure that the DUNS number it provides on the application is the same number
used in the organization's profile in the eRA Commons and for the System for
Award Management (SAM). Additional information may be found in the SF424
(R&R) SBIR/STTR Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be
evaluated for completeness and compliance with application instructions by the
Center for Scientific Review, NIH. Applications that are incomplete or
non-compliant will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for
post-submission materials, as described in the policy -. Any instructions below are in
addition to the instructions in the policy:
Section V. Application Review Information
Important Update: See NOT-OD-18-228 for updated review language
for due dates on or after January 25, 2019.
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
In
addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study
design, methods, and intervention that are not by themselves innovative but
address important questions or unmet needs. Additionally, the results of the
clinical trial may indicate that further clinical development of the
intervention is unwarranted or lead to new avenues of scientific investigation.
Overall Impact
Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.
Does the project address an
important problem or a critical barrier to progress in the field? Is there
a strong scientific premise for the project? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change
the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Does the proposed project have commercial
potential to lead to a marketable product, process or service? (In the case of
Phase II, Fast-Track, and Phase II Competing Renewals, does the
Commercialization Plan demonstrate a high probability of commercialization?)
In
addition, for applications involving clinical trials
Are the scientific rationale and
need for a clinical trial to test the proposed hypothesis or intervention well
supported by preliminary data, clinical and/or preclinical studies, or
information in the literature or knowledge of biological mechanisms? For trials
focusing on clinical or public health endpoints, is this clinical trial
necessary for testing the safety, efficacy or effectiveness of an intervention
that could lead to a change in clinical practice, community behaviors or health
care policy? For trials focusing on mechanistic, behavioral, physiological,
biochemical, or other biomedical endpoints, is this trial needed to advance
scientific understanding?
Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or those in
the early stages of independent careers, do they have appropriate experience
and training? If established, have they demonstrated an ongoing record of
accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?
In
addition, for applications involving clinical trials
With regard to the proposed leadership for
the project, do the PD/PI(s) and key personnel have the expertise, experience,
and ability to organize, manage and implement the proposed clinical trial and
meet milestones and timelines? Do they have appropriate expertise in study
coordination, data management and statistics? For a multicenter trial, is the
organizational structure appropriate and does the application identify a core
of potential center investigators and staffing for a coordinating center?
Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?
In
addition, for applications involving clinical trials
Does the design/research plan
include innovative elements, as appropriate, that enhance its sensitivity,
potential for information or potential to advance scientific knowledge or
clinical practice?
Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Have
the investigators presented strategies to ensure a robust and unbiased
approach, as appropriate for the work proposed? Are potential problems,
alternative strategies, and benchmarks for success presented? If the project is
in the early stages of development, will the strategy establish feasibility and
will particularly risky aspects be managed? For a Phase I application, are
there clear, appropriate, measurable goals (milestones) that should be achieved
prior to initiating Phase II? Have the investigators presented adequate plans
to address relevant biological variables, such as sex, for studies in
vertebrate animals or human subjects?
If the project involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or
exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as
well as the inclusion or exclusion of children, justified in terms of the
scientific goals and research strategy proposed?
In
addition, for applications involving clinical trials
Does the application adequately address the
following, if applicable
Study
Design
Is the study design justified and appropriate
to address primary and secondary outcome variable(s)/endpoints that will be
clear, informative and relevant to the hypothesis being tested? Is the
scientific rationale/premise of the study based on previously well-designed
preclinical and/or clinical research? Given the methods used to assign
participants and deliver interventions, is the study design adequately powered
to answer the research question(s), test the proposed hypothesis/hypotheses,
and provide interpretable results? Is the trial appropriately designed to
conduct the research efficiently? Are the study populations (size, gender, age,
demographic group), proposed intervention arms/dose, and duration of the trial,
appropriate and well justified?
Are potential ethical issues adequately addressed?
Is the process for obtaining informed consent or assent appropriate? Is the
eligible population available? Are the plans for recruitment outreach,
enrollment, retention, handling dropouts, missed visits, and losses to
follow-up appropriate to ensure robust data collection? Are the planned
recruitment timelines feasible and is the plan to monitor accrual adequate? Has
the need for randomization (or not), masking (if appropriate), controls, and
inclusion/exclusion criteria been addressed? Are differences addressed, if
applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality
of, and monitor adherence to, the trial protocol and data collection or
distribution guidelines appropriate? Is there a plan to obtain required study
agent(s)? Does the application propose to use existing available resources, as
applicable?
Data
Management and Statistical Analysis
Are planned analyses and
statistical approach appropriate for the proposed study design and methods used
to assign participants and deliver interventions? Are the procedures for data
management and quality control of data adequate at clinical site(s) or at
center laboratories, as applicable? Have the methods for standardization of
procedures for data management to assess the effect of the intervention and
quality control been addressed? Is there a plan to complete data analysis
within the proposed period of the award?
Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangement?
In
addition, for applications involving clinical trials
If proposed, are the administrative, data
coordinating, enrollment and laboratory/testing centers, appropriate for the
trial proposed?
Does the application adequately address the
capability and ability to conduct the trial at the proposed site(s) or centers?
Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed,
does the application adequately address the complexity of executing the
clinical trial?
If multi-sites/centers, is there evidence of
the ability of the individual site or center to: (1) enroll the proposed
numbers; (2) adhere to the protocol; (3) collect and transmit data in an
accurate and timely fashion; and, (4) operate within the proposed
organizational structure?
Additional Review Criteria
As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and technical
merit, and in providing an overall impact score, but will not give separate
scores for these items.
For Phase II Applications, how well
did the applicant demonstrate progress toward meeting the Phase I objectives,
demonstrating feasibility, and providing a solid foundation for the proposed
Phase II activity?
Phase
I/Phase II Fast-Track Applications
For Phase I/Phase II Fast-Track Applications,
reviewers will consider the following:
1. Does the Phase I application
specify clear, appropriate, measurable goals (milestones) that should be
achieved prior to initiating Phase II?
2. To what extent was the applicant
able to obtain letters of interest, additional funding commitments, and/or
resources from the private sector or non-SBIR/STTR funding sources that would
enhance the likelihood for commercialization?
Protections
for Human Subjects
For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.
Inclusion
of Women, Minorities, and Children
When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.
The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
of Animals. Reviewers will assess the use of chimpanzees as they would any
other application proposing the use of vertebrate animals. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.
Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.
For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.
Phase IIB
Competing Renewals
For Phase IIB Applications, the
committee will consider the progress made in the last funding period.
For Revisions, the committee will
consider the appropriateness of the proposed expansion of the scope of the
project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended
for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate
and whether substantial changes are clearly evident.
Additional Review Considerations
As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.
Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether
the following Resource Sharing Plans, or the rationale for not sharing the
following types of resources, are reasonable: (1) Data
Sharing Plan; (2) Sharing
Model Organisms; and (3) Genomic
Data Sharing Plan.
Authentication
of Key Biological and/or Chemical Resources
For projects involving key
biological and/or chemical resources, reviewers will comment on the brief plans
proposed for identifying and ensuring the validity of those resources.
Budget and
Period of Support
Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.
2. Review and Selection
Process
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by Center for
Scientific Review, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.
As part of the scientific peer review, all applications:
- May undergo a committee process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.
- Will receive a written critique.
Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications . Following
initial peer review, recommended applications will receive a second level of
review by the appropriate National Advisory Council or Board. The following
will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as
determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
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. Refer to
Part 1 for dates for peer review, advisory council review, and earliest start
date
Information regarding the disposition of applications is
available in the NIH
Grants Policy Statement.
Section VI. Award
Administration Information
1. Award Notices
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee's business official.
Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any recent
legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to,
and as approved by, the NIH and are subject to the IC-specific terms and
conditions identified in the NoA. ClinicalTrials.gov: If an award provides for
one or more clinical trials. By law (Title VIII, Section 801 of Public Law
110-85), the "responsible party" must register and submit results
information for certain "applicable clinical trials" on the ClinicalTrials.gov
Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov).
NIH expects registration of all trials whether required under the law or not.
For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee
Approval: Grantee institutions must ensure that the application as well as all
protocols are reviewed by their IRB or IEC. To help ensure the safety of
participants enrolled in NIH-funded studies, the awardee must provide NIH
copies of documents related to all major changes in the status of ongoing
protocols. Data and Safety Monitoring Requirements: The NIH policy for data
and safety monitoring requires oversight and monitoring of all NIH-conducted or
-supported human biomedical and behavioral intervention studies (clinical
trials) to ensure the safety of participants and the validity and integrity of
the data. Further information concerning these requirements is found at
http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application
instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption
Requirements: Consistent with federal regulations, clinical research projects
involving the use of investigational therapeutics, vaccines, or other medical
interventions (including licensed products and devices for a purpose other than
that for which they were licensed) in humans under a research protocol must be
performed under a Food and Drug Administration (FDA) investigational new drug
(IND) or investigational device exemption (IDE).
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. More information is
provided at Award
Conditions and Information for NIH Grants.
Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person's race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator's scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.
For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of
Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to
the Federal Awardee Performance and Integrity Information System
(FAPIIS) requirements. FAPIIS requires Federal award making officials to
review and consider information about an applicant in the designated integrity
and performance system (currently FAPIIS) prior to making an award. An
applicant, at its option, may review information in the designated integrity
and performance systems accessible through FAPIIS and comment on any
information about itself that a Federal agency previously entered and is
currently in FAPIIS. The Federal awarding agency will consider any comments by
the applicant, in addition to other information in FAPIIS, in making a
judgement about the applicant's integrity, business ethics, and record of
performance under Federal awards when completing the review of risk posed by
applicants as described in 45 CFR Part 75.205 "Federal awarding agency review
of risk posed by applicants." This provision will apply to all NIH grants and
cooperative agreements except fellowships.
Report fraud, waste and abuse
The Office of Inspector General Hotline
accepts tips from all sources about potential fraud, waste, abuse and
mismanagement in Department of Health & Human Services programs. The
reporting individual should indicate that the fraud, waste and/or abuse
concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
3. Reporting
NIH requires that SBIR/STTR grantees submit the following
reports within 90 days of the end of the grant budget period unless the grantee
is under an extension. When multiple years are involved, awardees will be
required to submit the Research
Performance Progress Report (RPPR) annually and financial statements as
required in the NIH Grants
Policy Statement.
Failure to submit timely final reports may affect future
funding to the organization or awards with the same PD/PI.
For details about each specific required report, see Part
III. Section 5, "SBIR/STTR Award Guidelines, Reporting Requirements, and
Other Considerations," in the Supplement Grant Applications For All Competing
Applications and Progress Reports.
The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this
reporting requirement.
In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 Award Term and Conditions for Recipient Integrity and Performance Matters.
Section
VII. Agency Contacts
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
eRA Service Desk (Questions regarding ASSIST, eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
SBA Company Registry (Questions regarding required
registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg
Scientific/Research Contact(s)
Margaret Grabb, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: mgrabb@mail.nih.gov
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and
contact information (information appears two weeks after the submission due
date).
Financial/Grants Management Contact(s)
Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov
Section VIII. Other
Information
Recently issued trans-NIH policy
notices may affect your application submission. A full list of policy
notices published by NIH is provided in the NIH
Guide for Grants and Contracts. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement.
Authority and Regulations
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 Part 75.
The SBIR Program is mandated by the Small Business
Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation
(P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011),
and as reauthorized and extended under P.L. 114-328, Section 1834. The basic
design of the NIH SBIR Program is in accordance with the Small Business
Administration (SBA) SBIR Policy
Directive.
Department of Health
and Human Services (HHS)
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