Required Application Instructions

It is critical that applicants follow the 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies that benefit society. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas the Phase II supports the main R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business concern (SBC) will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. Some projects initiated with SBIR or STTR funding require support beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap, known as the Valley of Death, between the end of the SBIR/STTR Phase II award and the commercialization stage. One funding mechanism many NIH institutes use for this purpose is the Phase IIB, which provides additional support to mitigate the funding gap.

This Funding Opportunity Announcement (FOA), referred to as SBIR Phase IIB, invites SBCs with funded SBIR/STTR Phase II awards or contracts, (i.e., SBCs that have completed Phase II research funded by NIH or other federal agencies in the last 24 months) to submit applications for the validation of promising alternative test methods that replace or reduce animal use in toxicity testing/screening, and can be used to address current US federal agency testing requirements. The method may be utilized as a stand-alone replacement or developed for use as part of a weight-of-evidence approach; however, higher priority will be given to stand-alone replacement alternative test methods. The goal of this FOA is to assist SBCs in pursuing the next appropriate milestone(s) necessary to advance promising alternative toxicological test methods towards US federal agency acceptance. Validation of alternative test methods is needed not only for US federal agency acceptance, but also for international acceptance, and the subsequent commercialization of these test methods for products intended for global markets.

• This FOA is specifically intended to accelerate the validation, acceptance, and commercialization of novel methods, approaches, and technologies that replace or reduce the use of animals in toxicological testing currently required or conducted by US federal agencies.
• Proposed projects MUST ultimately move the industry towards the replacement or reduction of animal use, as related to toxicological testing methods currently required or used by US federal agencies, and for gaining international acceptance of the alternative test method.
• Applicants are encouraged to contact staff at US federal agencies to ensure that their validation plan and objectives follow the relevant requirements or guidance of that authority. Applicants can find appropriate contacts at US federal agenicies through ICCVAM by contacting [email protected].
• Applicants will be expected to work with a US federal agency or agencies post-award to address additional testing or standards required by those agencies. These activities will be coordinated post-award through a Steering Committee and ICCVAM/NICEATM http://ntp.niehs.nih.gov/pubhealth/evalatm/iccvam/index.html

Background

Many projects initiated with SBIR/STTR funding require support beyond the SBIR/STTR Phase II award to complete the necessary studies required to commercialize the technology. In particular, the validation of alternative toxicological test methods often requires additional years and additional support because of the costs associated with conducting validation studies and/or other steps required by validation guidelines (for example, OECD Guidelines for multi-lab and single lab ). US federal agencies may have additional validation requirements, beyond OECD guidelines, which must be met for acceptance of an alternative test method.

This FOA supports the goals of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), within the Division of the National Toxicology Program at NIEHS, to provide assistance and information to test method developers and to conduct evaluations of data from alternative testing approaches. NICEATM supports and administers the activities of the 15 agencies identified in the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act (Public Law 106-545; http://ntp.niehs.nih.gov/iccvam/docs/about_docs/pl106545.pdf). ICCVAM activities include interagency and international harmonization of acute or chronic toxicological test protocols encouraging replacement or reduction of animal use in toxicity testing, including the development and evaluation of new, revised, and alternative methods to identify potential hazards to human health and the environment, with a focus on replacing, reducing, or refining animal use. ICCVAM also coordinates these activities with international organizations such as OECD and the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM).

Validation contributes strongly to the international acceptance of any proposed test method and encourages and supports worldwide Mutual Acceptance of Data (MAD). The regulatory acceptance of tests that have not been subjected to prevailing validation processes is discouraged (OECD, 2005). Following adequate validation studies that demonstrate the utility and the applicability of a test method/approach, as outlined in OECD Guidance Document 34 (a guidance document on the validation and international acceptance of new or updated test methods for hazard assessment), it may be considered for adoption by regulatory agencies. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?doclanguage=en&cote=env/jm/mono(2005)14)

Acceptance of an alternative test method, in the context of this FOA, is its formal acceptance and/or utilization by a US federal agency, indicating that the alternative test method may be used to provide information to meet a specific regulatory or agency requirement. This may include formal adoption of an alternative test method by ICH, EU, and/or OECD and subsequently included in an international agency’s respective guidance documents. However, US federal agencies may have additional requirements that need to be met for acceptance and subsequent commercialization in the US, and meeting these US federal agency acceptance criteria is the focus of this funding opportunity.

Specific Objectives for SBIR Phase IIB Award Applications

A. Scientific/Technical Scope

The technical and commercial objectives described in the SBIR Phase IIB Award application MUST represent an extension of the development efforts that were pursued in a previously funded SBIR/STTR Phase II award. It is essential that significant progress was accomplished during the preceding SBIR/STTR Phase II project and that the proposed alternative test method has direct applicability to replacement or reduction of animals used for toxicological testing. Applicants should also be able to demonstrate that the performance of the proposed alternative test method is at least equivalent to existing animal-based testing methods, and should clearly define an appropriate path toward validation and ultimate test acceptance by US federal agencies and subsequent commercialization. Information requirements can be fulfilled by using data obtained from a prospective study, by a retrospective evaluation of already existing data/information, or by a combination of both. As such, additional in vivo animal studies should not be proposed in the Phase IIB application. Proposed projects must address specific animal-based tests required or used by a specific US federal agency.

Although Phase II projects (grants or contracts) previously funded by another NIH Institute/Center or another federal agency are eligible to apply under this FOA, proposed projects MUST be relevant to replacing or reducing animal use in toxicity testing conducted or required by US federal agencies. Applicants are strongly encouraged to contact NIEHS to discuss whether their proposed project meets this criterion.

The NICEATM program priority areas for alternative test method development and validation include, but are not limited to:

• Ocular Toxicity Testing: Alternative testing approaches (using in vitro or ex vivo assays) to determine eye irritation and corrosion potential remain a high priority. Specifically, tests that are able to differentiate among EPA’s four eye irritation hazard categories (I IV) are highly desirable. In developing ocular toxicity tests, weight-of-evidence approaches that consider, for example, in vivo testing, structure-activity relationships, and read-across for results on similar test materials, or a decision tree approach, to support a classification are acceptable. Developed Ocular Toxicity Testing schemes for the EPA should be predictive of a range of chemistries such as alkaline and acidic chemistries, surfactant and solvent-based chemistries, and oxidizing chemistries (such as hypochlorite, peroxide, percarbonate, oxygen, bleaches). Testing Regulations and Guidelines for eye irritation/corrosion tests may be found at http://ntp.niehs.nih.gov/pubhealth/evalatm/regs-guidelines/.
• Reproductive and Developmental Toxicity Testing, to include testing for Endocrine Disruptors: Reproductive and developmental toxicity testing are among the most animal use intensive areas in regulatory toxicology. Therefore, alternative approaches to assess reproductive and developmental toxicity, including endocrine disruption effects, are highly desirable. Alternative approaches may include new in vitro assays, combinations of assays in an integrated strategy designed to cover mechanisms of action and adverse outcomes, as well as computational methods to predict toxicity. The use of phylogenetically lower organisms may also be appropriate. Testing Regulations and Guidelines from federal agencies for reproductive and developmental toxicity testing, including endocrine disruption, may be found at http://ntp.niehs.nih.gov/pubhealth/evalatm/regs-guidelines/
• Carcinogenicity Testing: Carcinogenesis is a complex process, often involving multiple organ systems; as such, it is unlikely that a single, predictive alternative method will be appropriate for carcinogenicity testing. In vitro and in vivo genotoxicity tests may contribute to the assessment of genotoxic carcinogens; however, few tests for non-genotoxic assessments exist. Examples of non-animal alternative methods include cell transformation assays (CTA) to detect carcinogenic changes and the gap junction intercellular communication (GJIC) method to detect nongenotoxic carcinogens or tumor promotors. Alternative approaches may include new in vitro assays, qualitative structure-activity relationship and computational methods to predict toxicity, or combinations of assays in an integrated strategy designed to cover mechanisms of action and adverse outcomes. Mutagenicity and genotoxicity assays may also inform the carcinogenesis process. Testing Regulations and Guidelines from federal agencies for genotoxicity and carcinogenicity may be found at http://ntp.niehs.nih.gov/pubhealth/evalatm/regs-guidelines/
• Acute Toxicity Testing: Current in vivo acute systemic toxicity testing involves an assessment of the general toxic effects of a single dose or multiple doses of a chemical or product, by a particular route (oral, dermal, inhalation), and that occur during a subsequent observation period. Acute toxicity data are common requirements under many regulatory frameworks to provide classification and labelling warning or the possible consequence of exposure to a chemical. Substances that require classification and labeling include industrial chemicals, biocides, and pesticides. While a number of acute toxicity testing approaches have been developed and adopted by OECD, additional validated methods are needed. Alternative test methods for oral and acute inhalation toxicity testing are a high priority area for this FOA. Testing Regulations and Guidelines from federal agencies Acute Toxicity Testing may be found at http://ntp.niehs.nih.gov/pubhealth/evalatm/regs-guidelines/

B. Post-Award Expectations.

This Phase IIB funding support is intended to assist the small business in conducting a validation program that will facilitate the adoption of the alternative test method by US federal and international agencies, which in turn will facilitate subsequent commercialization of the test method for products intended for global markets. As a cooperative agreement, post-award, the Scientific Officer and Steering Committee, which may include NICEATM staff, will work together with the SBC to ensure that the validation plan, including applicable regulations and/or guidances from a US ederal agency or agencies, are appropriate for the commercialization objectives. NICEATM’s approach to validation of alternative test methods is aligned with the validation principles provided in OECD Guidance Document 34, which are summarized below. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?doclanguage=en&cote=env/jm/mono(2005)14).

Validation studies should include:

1. A detailed protocol for the test method and data analysis must be available. Through the Steering Committee (SC) NICEATM Staff can provide assistance in developing a robust test method protocol, after a Phase IIB award is made.

2. Test method performance (accuracy, reproducibility, etc.) must be evaluated. The SC/NICEATM Staff can provide assistance in developing appropriate metrics, after a Phase IIB award is made.

3. The test method’s performance must have been demonstrated using coded reference chemicals. Coded reference chemicals will be sourced and provided by NTP, after a Phase IIB award is made.

4. The validation study design and accompanying data will be peer reviewed. The SC will assemble the peer panel and organize the review, after the Phase IIB award is made.

Previous work completed through the SBIR/STTR Phase II should include demonstration of method feasibility through testing of a small number of known materials of appropriate types supported by reliable in vivo data and development of Standard Operating Procedures (SOP) for the method. The SBIR Phase IIB focuses on reproducibility and test method metrics, to include laboratory transferability through multi-laboratory ring-trials , and testing of an expanded list of known materials (See OECD Guidance Document 34). Single laboratory validation of alternate approaches is also an acceptable approach (see http://www.oecd.org/env/ehs/testing/GD%20on%20chemistry%20analytical%20method%20validation_30%20April%202013.pdf).

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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. 1. 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
   2. 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
   3. 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 for a Phase I 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 receive New Phase I, Fast-track or Direct Phase II awards for a period of one year.

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.

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 New requirement. 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.

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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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.

In Phase II and Phase IIB, 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.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide, including Supplemental Grant Application Instructions 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Sally Tilotta. PhD
Scientific Review Officer
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
PO Box 12233, MSC K3-03
111 T.W. Alexander Drive
Research Triangle Park, NC 27709-2233
Telephone: 919-541-1446
Fax: 301-480-3719
Email: [email protected]

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.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

Other Attachments:

1. SBA Company registry

All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and .pdf file. If applicants have previously registered, you are still required to attach proof of registration. The SBA Company Registry recommends verification with SAM, but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM. If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.

a. Navigate to the SBA Company Registry.

b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided. Identify your company and click Proceed to Registration .

c. If you are a first time applicant, click the "New to the SBIR Program?" link on lower right of registry screen.

d. Fill out the required information on the Basic Information and Eligibility Statement screens.

e. Press Complete Registration on the lower right of the Eligibility Statement screen and follow all instructions.

f. Download and save your SBA registry PDF locally. The name will be in the format of SBC_123456789.pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID. DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.

g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking "Add Attachments" located to the right of the Other Attachments field on the Research and Related Other Project Information form.

For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.

2. 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 SBIR Application 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.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:

Research Strategy: In addition to standard content of Research Strategy, the applicants must address the following items.

Commercialization Readiness and Competitive Advantage. Applicants should demonstrate in their application that significant progress has been accomplished during the previous SBIR or STTR Phase II project, and also that the assay or approach has significant commercial potential. Previous work completed through the SBIR/STTR Phase II should include demonstration of method feasibility through testing of a small number of appropriate reference compounds supported through comparison with in vivo data and development of Standard Operating Procedures (SOP) for the method. Applicants should also demonstrate that the proposed assay/approach has a clear advantage over existing and/or competing approaches or testing strategies and should clearly define an appropriate path toward validation and ultimate commercialization.

Milestones. Applicants should propose milestones and timelines to be achieved during the proposed project period toward accomplishing the stated aims of the project. Milestones proposed should be specific and quantitative, if possible. Milestones will be refined in consulation with the Steering Committee post-award.

Validation Plan. Applicants must provide a validation plan describing the regulatory pathway that is being or will be pursued and a timeline for achieving regulatory approval with discrete milestones. Applicants may also provide details of their consultation with the US federal agency staff in the description of their Validation Plan. The Validation Plan should outline a strategy that will enable federal agencies to assess the accuracy (i.e., agreement between a test method result and an accepted reference value); reliability (i.e., extent that a test method can be performed reproducibly within and between laboratories over time, when performed using the same protocol) for a specific testing purpose; and its relevance (i.e., the ability of the test method to correctly predict or measure the biological effect of interest).

Validation studies should also include scientific and regulatory rationale for the test method, including a clear statement of its proposed use, and a detailed protocol for the test method and data analysis.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:

Commercialization Plan: In addition to standard content of Commercialization Plan, the applicants must address the following items.

All applicants must propose a realistic plan (extending beyond the Phase IIB Award project period), which outlines how validation will expedite commercialization as well as when full commercialization can be accomplished, which may include appropriate third-party commitments. The full commercialization of the product or service should be carried out with non-SBIR funds.

SBIR/STTR Commercialization History

Applicants should provide an SBIR/STTR Commercialization History that addresses the questions listed below. The following questions should be addressed for all SBIR/STTR awards (grants or contracts) received from ANY federal agency:

• Has the company gone through any name changes within the past five years? If so, then all previous company names should be listed in the application.
• Is the company a subsidiary or a spin-off? If so, then the name of the parent company should be provided.
• What percentage of the company’s revenue was derived from SBIR/STTR funding during each of the past 5 years, including both Phase I and Phase II awards? Applicants should report a percentage value for each year individually.
• What is the total number of SBIR/STTR Phase II awards that the company has received from the Federal government? For each award, companies should provide the award number, the award amount, project duration, and the name of the awarding agency

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,

Appendix: Do not use the Appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide,

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

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.

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.

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.

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

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).

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? 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?)

Specific to this FOA - Is the method at an appropriate point of development to be ready for validation? If the project is successful, would the proposed technology reduce animal testing?

Will the proposed project facilitate the adoption of the alternative test method by US Federal and International agencies? Does the proposed method address an important niche or broadly support alternative testing?

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?

Specific to this FOA - To what extent do the prior experience and qualifications of the project team members lend confidence that the team will be successful in commercializing the proposed product/technology? For example, if the PD(s)/PI(s) have had other Phase II awards, how successful have they been in commercializing those technologies and discoveries?

Do the investigators have demonstrated expertise in validation methods? Do the investigators demonstrate knowledge of validation requirements for a US federal fgency and International agencies?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves 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?

Specific to this FOA - Does the approach enable US federal agencies to assess the accuracy (i.e., agreement between a test method result and an accepted reference value); reliability (i.e., extent that a test method can be performed reproducibly within and between laboratories over time, when performed using the same protocol) for a specific testing purpose; and its relevance (i.e., the ability of the test method to correctly predict or measure the biological effect of interest)?

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?

Specific to this FOA - To what extent does the applicant's environment facilitate their ability to address US federal agency requirements, either through their own staff members or through appropriate arrangements with external consultants?

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.

How well has the applicant demonstrated an understanding of the competitive environment in which they plan to sell their product? How well has the company addressed potential hurdles that may delay or prevent acceptance of their alternative test method as a product?

How strong is the applicant s intellectual property (IP) portfolio/position (pertinent to the proposed project), and to what extent does the company have a reasonable strategy to protect its IP going forward?

Has the applicant included a realistic plan (extending beyond the Phase IIB Award project period), which outlines how validation will expedite commercialization as well as when full commercialization can be accomplished?

Not Applicable

Not Applicable

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.

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

For Phase IIB Applications, the committee will consider the progress made in the last funding period.

Not Applicable

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) Genome Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIEHS, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. 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.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

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.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of research and in accordance with terms and conditions of the award.

All PD(s)/PI(s) will have the primary responsibility for:

• Overseeing the budget and activities of the award, as detailed, above.
• Providing appropriate timeline and schedule for validation studies.
• Consulting with ICCVAM/NICEATM members and the appropriate US federal agency or agencies on required guidelines and testing strategies for acceptance of the alternative test method by the Agency or Agencies.
• Providing data from the assay or testing approach for review by ICCVAM/NICEATM using appropriate test compounds, including compounds that may be provided to the PI by ICCVAM/NICEATM.
• Assist in the development of performance standards consisting of essential test method components, list of reference substances, and standards for accuracy/reliability that can be used by other test method developers to assess the performance characteristerics of subsequent methods that are functionally and mechanistically similar. The development of these standards is a key component of acceptance by international organizations such as OECD and EURL-ECVAM.
• Providing logistical support for the conduct of steering committee conference calls, virtual and face to face meetings including generation, review and sharing of meeting minutes in a timely fashion.
• Interacting and complying with requests for information from the Steering Committee and other sub-committees as appropriate.
• Cooperating in the program evaluation activities.
• Accepting and implementing all scientific, practical, and policy decisions approved by the Steering Committee to the extent consistent with applicable grant regulations.
• Serving on the Steering Committee (for details, see "Areas of Joint Responsibility" below).
• Providing information to the NIH Program Directors and Project Scientists concerning progress by submitting annual progress reports in a standard format.
• Complying with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

One or more NIEHS Program Directors will be substantially involved in the Phase IIB Validation Project as NIH Project Scientists. NIH Project Scientists will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards. NIEHS Project Scientist(s) will have the following responsibilities to all Ph IIB awardees:

• Have substantial involvement to guide, coordinate, and participate in the conduct of the PH IIB activities.
• Attend and participate in all Steering Committee and subcommittee meetings.
• Coordinate and facilitate the interactions among the awardees under this cooperative agreement.
• Serve as a liaison between the Steering Committee, the NIH and other federal agencies as needed.
• Facilitate and coordinate the exchange of information and interactions between awardees to support collaborative efforts.
• Participate in organizing and coordinating Validation Project Scientific meetings as required.
• Advise on the design of validation activities, availability of resources, and/or management and technical performance of projects, as appropriate.
• Participate as collaborators to Phase IIB investigators in some shared activities, as appropriate.
• Evaluate the adherence of grantees to any approved data sharing plans or intellectual property plans.
• dditionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to SBC(s) that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance. The NIH Program Official will be responsible for monitoring the level of performance and making recommendations for any corrective actions.

Areas of Joint Responsibility include:

A Steering Committee will serve as the governing board for the Validation Projects.

The Steering Committee will have primary responsibility for:

• Overseeing the overall organization of the Phase IIB Validation Project for reviewing the research goals. Evaluating the adherence of the investigators to any approved data sharing plans or intellectual property plans.
• Developing the appropriate strategy for exchange of materials, protocols, novel research findings, between ICCVAM/NICEATM and the SBC(s).
• Sharing and reviewing annual progress of Phase IIB Validation Projects.
• The Steering Committee will be comprised of the following voting members:
• The Principal investigators from the SBCs will have one vote.
• The NIEHS Program Director will have one vote.
• The NIH Project Scientist and other staff members may participate in Steering Committee meetings as non-voting members.
• A Steering Committee Chair will be elected every twelve months from amongst the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair.
• In the event that PD(s)/PI(s) cannot agree on critical aspects of the Validation Project then the Steering Committee, in consultation with NIH Program Staff, will vote on a recommendation for how to proceed. NIEHS Staff will have final authority to implement proposed recommendations. All activities must comply with NIH, DHHS, and Federal Guidelines.
• Other guidelines for the Steering Committee, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the Steering Committee will meet at least once per month by teleconference.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16

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.

• Final Progress Report (requirements have recently changed - please see the NOT-OD-12-152)
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Federal Financial Report (FFR) replaced the Final Cash Transaction Report (PSC 272)
• Phase II Data Collection Requirement for Government Tech-Net Database

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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (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: https://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

Daniel Shaughnessy, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2506
Email: [email protected]

Sally Tilotta, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1446
Email: [email protected]

Pamela Clark
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7629
Email: [email protected]

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.

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, and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.