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 Small Business Innovation Research (SBIR) and Small Business
Technology Transfer (STTR) programs, also known as America's Seed Fund, are one
of the largest sources of early-stage capital for technology commercialization
in the United States. These programs enable US-owned and operated small businesses
to conduct research and development that has a strong potential for
commercialization. National Institutes of Health (NIH), Centers for Disease Control
and Prevention (CDC), and the Food and Drug Administration (FDA) support small businesses
through the SBIR and STTR programs to translate promising technologies and
products to the private sector that align with their mission to improve health
and save lives.
The SBIR program, as established by law and reauthorized under
Public Law 114-328, Section 1834 and Public Law 115-232, is intended to meet
the following goals: stimulate technological innovation in the private sector;
strengthen the role of small business in meeting federal research and development
needs; increase the private sector commercialization of innovations developed
through federal research and development funding; foster and encourage participation
in innovation and entrepreneurship by women and socially or economically
disadvantaged persons. In addition, the STTR program aims to foster technology
transfer through cooperative research and development between small businesses
and research institutions. Federal agencies with extramural research budgets
over $100 million are required to set-aside 3.2% of their budget to SBIR, and
those with research budgets over $1 billion are required to set aside 0.45% of funds
for STTR.
The SBIR/STTR program is a phased program. The main
objective in SBIR/STTR Phase I is to establish the technical merit and
feasibility of the proposed research and development efforts, whereas in SBIR/STTR
Phase II it is to continue the R&D efforts to advance the technology toward
ultimate commercialization.
An objective of the SBIR and STTR programs is to increase private
sector commercialization of innovations derived from federally supported research
and development. At the conclusion of an SBIR/STTR Phase II, it is expected that
the small business will fully commercialize their product or technology using
non-SBIR/STTR funds (either federal or non-federal).
This Funding Opportunity Announcement (FOA) issued by the
National Institutes of Health (NIH), Centers for Disease Control and Prevention
(CDC), and the Food and Drug Administration (FDA) invites eligible United
States small business concerns (SBCs) to submit Small Business Innovation Research
(SBIR) Phase I, Phase II, Direct to Phase II (NIH Only), Fast-Track (NIH only),
and Phase IIB (NIH only) grant applications. Small business applicants interested
in submitting an STTR grant application should submit to PA-20-261 or PA-20-265.
Applicants are not required to identify a potential awarding
component prior to submission of the application but may request one on the
Assignment Request Form. Staff within the NIH’s Center for Scientific Review (CSR)
office, the single receiving point for all NIH, CDC, and FDA grant applications,
will assign all applications to the most appropriate Agency and
Institute/Center (IC) based on their mission and the science proposed. For
specific information about the mission of each NIH IC, visit the List
of NIH Institutes, Centers, and Offices website.
All applications submitted to this Parent Funding Opportunity
Announcement must propose clinical
trial(s). SBIR applications that do not propose clinical trial(s) should be
submitted to PA-20-260.
Applicants should note that some ICs only accept applications
proposing mechanistic studies through this funding opportunity announcement and
are noted in the PHS
2020-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA.
A mechanistic study is designed to understand a biological or behavioral process,
the pathophysiology of a disease, or the mechanism of action of an intervention.
If the proposed research project includes clinical trial other than a mechanistic
study that would be assigned to one of these ICs, applicants are advised to
contact relevant Scientific/Research
staff to discuss alternative mechanisms of support of these studies.
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- NIH Only)
New (SBIR Direct Phase II - NIH Only)
Renewal (Phase II)
Resubmission (all phases)
Renewal (Phase IIB)
Revision (all phases)
The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application
types. Only those application types listed here are allowed for this FOA.
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
Total funding support (direct costs, indirect costs, fee)
normally may not exceed $256,580 for Phase I awards and $1,710,531 for Phase
II awards. For specific topics, NIH may exceed these total award amounts. The
current list of approved topics can be found at https://sbir.nih.gov/funding#omni-sbir or in Appendix A of PHS
2020-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and
FDA.
Each participating component may also set their own budget
limit (higher or lower than the above) in the Limited Amount of Award Section
of their respective topics section. Applicants are strongly encouraged to contact
program officials prior to submitting any application in excess of the total
award amounts listed above and early in the application planning process. In
all cases, applicants should propose a budget that is reasonable and appropriate
for completion of the research project.
Phase IIB budgets must be submitted in accordance with
participating IC-specific budget limitations described in the current PHS
2020-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and
FDA.
Award Project Period
According to statutory guidelines, award
periods normally may not exceed 6 months for Phase I and 2 years for
Phase II. Applicants are encouraged to propose a project duration period that
is reasonable and appropriate for completion of the research project.
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), an Indian tribe, ANC or NHO
(or a wholly owned business entity of such tribe, ANC or NHO), 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, unless that single venture
capital operating company, hedge fund, or private equity firm qualifies
as a small business concern that is more than 50% directly owned and controlled
by individuals who are citizens or permanent resident aliens of the United
States; 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.
- ANC means Alaska Native Corporation.
- NHO means Native Hawaiian Organization.
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 apply for a new Phase
I award. Fast-Track, or Direct Phase II (if available). This requirement does not apply to companies
that have received 20 or fewer Phase I awards over the 5 year period.
Companies that do not meet or
exceed the benchmark rate will not be eligible to apply for a Phase I Fast-Track,
or Direct Phase II (if available) 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 (if applicable) 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) 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 to register in eRA Commons. Organizations can
register with the eRA Commons as they are working through their SAM or Grants.gov
registration, but all registrations must be in place by time of submission. 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.
Only one Phase II application may be awarded for a specific
project supported by a Phase I award. Only one Phase IIB application may be
awarded for a specific project supported by a Phase II award. Only those small
business concerns who have been awarded a Phase II are eligible to apply for a
Phase IIB Competing Renewal award.
Contractual/Consortium Arrangements
In Phase I, normally, two-thirds or 67% of the research or
analytical effort is 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 is generally not more than 33% of the
total amount requested (direct, F&A/indirect, and fee).
In Phase II, normally, one-half or 50% of the research or analytical effort is
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
is generally not more than 50% of the total Phase II amount requested (direct,
F&A/indirect, and fee).
Deviations from these requirements may be considered on a case
by case basis. Please contact a program officer for additional information.
Deviations must be approved in writing by the Grants Management Officer (GMO) after
consultation with the agency SBIR Program Manager/Coordinator.
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
The application forms package specific to this opportunity
must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system
solution. Links to apply using ASSIST or Grants.gov Workspace 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.
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, with the following additional instructions:
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:
Phase
IIB
Letters
of Support:
If applicable, Phase IIB applications should include letters
of support documenting commitments from third-party investors. Letters of
support from these institutional partners should indicate any actual or planned/conditional
financial commitment. Appropriate documentation of third-party investor commitment(s)
may include a conditional letter of support stating that the third-party
funding is contingent upon NIH selecting the application for an award. SBIR-eligible
public companies may include the issuance of stock to indicate the ability to secure
independent funds. In such a case, the preferred documentation is a letter of
support, signed by the Chairperson of the Board of Directors, which stipulates
the following: (1) the amount of capital raised from the issuance of stock and (2)
the amount of capital that will be dedicated to the proposed project.
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. Only 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
When involving human subjects research, clinical research,
and/or NIH-defined 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
Note: Delayed
onset does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).
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 How to
Apply Application Guide. If you encounter a system issue beyond your
control that threatens your ability to complete the submission process on-time,
you must follow the Dealing
with System Issues guidance. 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
Only the review criteria described below will be considered
in the review process. Applications
submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review
system.
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 the
prior research that serves as the key support for the proposed project rigorous?
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?)
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?
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?
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 included plans to address weaknesses in the rigor of prior
research that serves as the key support for the proposed 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 individuals of all ages (including children and older
adults), justified in terms of the scientific goals and research strategy proposed?
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?
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.
Study Timeline
Is the study timeline described in detail, taking into
account start-up activities, the anticipated rate of enrollment, and planned follow-up
assessment? Is the projected timeline feasible and well justified? Does the project
incorporate efficiencies and utilize existing resources (e.g., CTSAs,
practice-based research networks, electronic medical records, administrative
database, or patient registries) to increase the efficiency of participant
enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions
discussed (e.g. strategies that can be implemented in the event of enrollment shortfalls)?
Protections
for Human Subjects
For research that involves human
subjects but does not involve one of the 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 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 Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) 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 II Applications
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?
Phase IIB Competing Renewals
For Phase IIB Applications, the committee
will consider the following:
1) the progress made in the last
funding period.
2) the commercial potential (i.e. the
probability that an application will result in a commercial product), which may
be validated by the applicant's ability to secure substantial independent
third-party investor funds (i.e., third-party funds that equal or exceed the
requested NIH funds).
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 the Center for
Scientific Review (CSR), 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 HHS Institute or Center. Applications
will compete for available funds with all other recommended applications submitted
in response to this FOA within an Agency. Following initial peer review, recommended
applications will receive a second level of review by the appropriate national
Advisory Council or Board (NIH only) or by the appropriate Center/Institute
(CDC only). 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.
Additionally, ICs may specify any special reporting requirements
for the proposed clinical trial to be included under IC-specific terms and
conditions in the NoA. For example: If the proposed clinical trial has elevated
risks, ICs may require closer programmatic monitoring and it may be necessary
to require the awardee to provide more frequent information and data as a term
of the award (e.g., to clarify issues, address and evaluate concerns, provide
documentation). All additional communications and information related to programmatic
monitoring must be documented and incorporated into the official project file. 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 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 laws that
prohibit discrimination on the basis of race, color, national origin, disability,
age and, in some circumstances, religion, conscience, and sex. This
includes ensuring programs are accessible to persons with limited English proficiency.
The HHS Office for Civil Rights provides guidance on complying with civil
rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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.
- Recipients of FFA must ensure that their programs are accessible
to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
- 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.
- HHS funded health and education programs must be administered in
an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html;
https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.
For information about NIH's commitment to supporting a safe and respectful work
environment, who to contact with questions or concerns, and what NIH's
expectations are for institutions and the individuals supported on NIH-funded
awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- Recipients of FFA must also administer their programs in
compliance with applicable federal religious nondiscrimination laws and applicable
federal conscience protection and associated anti-discrimination laws.
Collectively, these laws prohibit exclusion, adverse treatment, coercion, or
other discrimination against persons or entities on the basis of their consciences,
religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.
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 120 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.
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
eRA Service Desk (Questions
regarding ASSIST, eRA Commons, application errors and warnings, documenting
system problems that threaten submission by the due date, and 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)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
grant resources)
Email: GrantsInfo@nih.gov (preferred
method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov
registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
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)
Questions of a general nature about the NIH SBIR/STTR program
may be directed to:
NIH SBIR/STTR Program Office
Telephone: 301-435-2688
Fax: 301-480-0146
Email: sbir@od.nih.gov
For Agency, Institute and Center Scientific/Research
(Program) contacts, please see middle column here:
https://sbir.nih.gov/engage/ic-contacts
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)
For Agency, Institute and Center Scientific/Research
(Program) contacts, please see middle column here:
https://sbir.nih.gov/engage/ic-contacts
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), as reauthorized
and extended under P.L. 114-328, Section 1834, , and P.L. 115-232. 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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