Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed)

Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH) Office of Research Infrastructure Programs (ORIP). This grant encourages small businesses to develop novel tools and devices to improve animal welfare, ease management of individual animals and colonies, and improve monitoring and control of environmental conditions in animal research facilities.

Expired PAR-21-225: Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) Funding Opportunity Title Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed) R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track Reissue of PAR-19-265 - Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed) June 6, 2024 - Notice of Extension of the Expiration Date for PAR-21-225 "Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed)".

See Notice NOT-OD-24-130 November 14, 2023 - Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See Notice NOT-OD-24-029 June 12, 2023 - Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See NOT-OD-23-139 .

( See updates incorporated into NOFO content in Sections IV, V, VI, and VIII applicable for applications submitted for due dates on or after September 5, 2023. ) February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants. See Notice NOT-OD-23-092 .

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 May 20, 2021 - Correction to the Budget Section of PAR-21-225.

See Notice NOT-OD-21-123 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-21-226 - Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R41/R42 Clinical Trial Not Allowed) See Section III. 3.

Additional Information on Eligibility .

Assistance Listing Number Funding Opportunity Purpose This funding opportunity announcement (FOA) encourages applications from small business concerns (SBCs) for Small Business Innovation Research (SBIR) projects to facilitate the design, creation, and implementation of novel tools and devices for the health and management of research animals, and to advance equipment that improves the operation and environmental conditions of animal facilities that support biomedical and bio-behavioral research.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The first standard due date for this FOA is September 5, 2021 All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) *** SBIR/STTR applications are no longer accepted on Standard AIDS Due dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date New Date January 06, 2025 (Original Date: September 06, 2024) per issuance of NOT-OD-24-130 Required Application Instructions 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. Part 1. Overview Information Part 2.

Full Text of 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 Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Many NIH-funded research projects rely on vertebrate and invertebrate animal models to study the basics of biology and physiology, to investigate pathological conditions, to examine disease mechanisms and treatments, and to design novel therapies and translational procedures.

In this regard, the Office of Research Infrastructure Programs (ORIP) plays a vital role through its support of research infrastructures and animal models of human diseases.

With this FOA, ORIP encourages applications from small business concerns (SBCs) for Small Business Innovation Research (SBIR) projects to develop and implement novel tools and devices to improve animal welfare, to ease the management of individual animals and animal colonies, and to improve the monitoring and control of environmental conditions (e.g., temperature, humidity, vibrations, and ultrasonic noise) which affect outcomes and reproducibility in animal model research.

Poor reproducibility of experiments that use animal models has negatively impacted biomedical research for many decades. The difficulty of improving reproducibility can be realized when considering the broad range of intrinsic factors (e.g., age, species, health status, and sex) and extrinsic factors (e.g., climate, illumination, physical restraints, odors, and noise) that can affect the physiological and biological response of animals.

The variation of extrinsic factors between different animal facilities has been cited as a source of irreproducibility in animal research. Often, different laboratory animals require different environmental conditions for their optimal growth and well-being. Also, the amount and type of pathogens, or pollutants in a facility can influence the physiological response and welfare of animals.

Even small differences in the handling and diets of animals can affect their physiological response. Accurate accounting for and monitoring of these factors can reduce variations between experiments and lead to improvements in animal model validations and translatability to human studies.

To consistently maintain an optimal environment for research animals, there is a need for devices in animal facilities that can precisely and accurately monitor the environmental conditions, especially those that are challenging to account for such as humidity, vibrations, odors, and ultrasonic noise.

Ideally, these devices will facilitate innovative and efficient operational procedures that utilize novel and green technologies to control and optimize the environmental conditions in animal facilities. Devices that can sensitively identify types and levels of various pathogens, allergens, and/or other pollutants are especially desired in environments supporting laboratory animals.

The level and type of infectious agents and other contaminants are factors that often contribute to differences in the physiological response between animals in different colonies or animal research facilities. These factors are especially hard to account for when comparing and monitoring species in the same and/or different geographical locations.

Additionally, needed are noninvasive or minimally invasive bio-logging devices for real-time monitoring of the behavior, food/water consumption, and bodily functions of animals. Such devices should be discreet, robust, easy to apply, and mobile, while being sensitive enough to register the physiology of different animals.

Not only should these devices aid in the study and management of individual animals or entire colonies, but they should also lead to improvements in the performance of research protocols and data analysis. To implement such goals, there is a simultaneous need for new software that can combine data from different types of monitoring devices while being compatible with different data formats and linkable to existing databases.

Novel devices and tools are also needed to help ease the process of handling and restraining of animals. These devices should reduce the stress to both the animals and researcher; stress is an experimental variable and must be minimized. Importantly, these devices should bring improvements in the efficiency of animal-handling practices and experimental procedures.

Connecting diet, environmental conditions, and physiological measurements will provide a global picture of the health and life-history of individual animals and colonies. Properly accounting for these factors will further help to understand the effects of extrinsic factors on experimental outcomes.

Innovation is an important component of productive engineering efforts; however, new ideas are not a sufficient factor for designing and building a useful tool or device. The concept of innovation in the context of engineering endeavors and non-hypothesis driven research should be understood broadly.

For example, a technology which is well established in one field and adapted to a different field may open new research areas, enable novel research projects, improve experimental procedures, and have a wider impact than its original scope.

These efforts are important for a broad class of animal models, including but not limited to widely used model organisms such as fruit fly, worm, mouse, rat, zebrafish, frog, rabbit, swine, and nonhuman primates amongst others. We emphasize that this FOA applies to invertebrate and vertebrate animals.

Disease-specific devices are not covered under this FOA (e.g., glucose monitors, brain probes for specific neurological conditions, or cancer imaging tools). Nor are reagents and experimental protocols appropriate for this FOA.

The development and implementation of novel tools and devices, and enhancement of existing equipment includes, but are not limited to, the following specific examples: Portable and robust software to help manage (including husbandry protocol procedures and assessment) and evaluate animal colonies; Reliable and discreet noninvasive or minimally invasive technology for the tracking and monitoring of animals, that either connect to or can easily communicate with existing formats and electronic management systems; Novel automated feeding systems, compatible with tagging and tracking devices to allow quantitation of feed consumption of individual animals; Devices and equipment to automate and support drug delivery by oral, subcutaneous, arterial, venous, or intracerebroventricular/intracerebral routes, and related methods to measure drug uptake and their technological implementation in species-specific devices; Robust and accurate devices for non-invasive measurement of physiological parameters such as heart rate and blood pressure in rodents and other model organism used in research; Improved systems for the collection of multi-source data (including telemetric and extrinsic variables) and their analysis for comprehensive behavioral assessment of animal models; Better devices for phenotyping at the organismal as well as at the molecular levels; Safe and improved holding, restraining, and transfer devices for routine care, and for intra-facility transport such as large animal transfer chutes and nonhuman primate restraints; Better air and water filters for metabolic cages, aquaria, and other animal facility equipment; Better bedding materials (e.g., self-displaying levels of contaminants and microorganisms, odor-absorbent, recyclable) for animals; Better and easy to use tools and devices to measure levels of pathogens and contaminants in cages, aquaria, and animal facilities; Better devices/tools/equipment to sanitize and disinfect animal facilities and related equipment.

Applicants are advised to discuss their projects with the Scientific/Research contacts before submitting an application. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Resubmission (all phases) New (Phase I, Fast-Track) The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for the FOA. Not Allowed: Only accepting applications that do not propose clinical trials Need help determining whether you are doing a clinical trial? 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.

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $259,613 for Phase I awards and $1,730,751 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% as a hard cap ($389,420 for Phase I and $2,596,127 for Phase II).

However, NIH has received a waiver from SBA, as authorized by statute, to exceed the hard cap of $389,420 for Phase I or $2,596,127 for Phase II for specific topics. The current list of approved topics can be found at https://sbir. nih.

gov/funding#omni-sbir . Navigate to the Program Descriptions and Research Topics document, Appendix A or the current "SBA approved topics list for budget waivers". Applicants are strongly encouraged to contact program officials prior to submitting any application in excess of the hard caps 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. 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 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: 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; 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; 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 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 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.

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. 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.

Performance Benchmark Requirements 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 and the SBIR and STTR Extension Act of 2022.

The benchmark establishes a minimum number of Phase II awards the company must have received relative to a given number of Phase I awards received during the 5-fiscal year time period.

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 Transition Rate requirement, agreed upon and established by all 11 SBIR agencies, was published for public comment in a Federal Register Notice on October 16, 2012 (77 FR 63410) and amended on May 23, 2013 (78 FR 30951).

For 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): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0. 25 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.

This requirement does not apply to companies that have received 20 or fewer Phase I awards over the prior 5-fiscal year period. For application deadlines that fall on or after April 5, 2023: For SBIR and STTR Phase I applicants that have received more than 50 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.

5 will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase I awards over the 5-fiscal year period. On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements.

SBA calculates individual company Phase I to Phase II Transition Rates using SBIR and STTR award information across all federal agencies. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase I to Phase II Transition Rate requirement is available at SBIR.

gov. Phase II to Commercialization Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Programs are implementing the Phase II to Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022.

The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 ( 78 FR 48537 ), with a reopening of the comment period published on September 26, 2013 (78 FR 59410).

For companies that have received more than 15 Phase II awards from all agencies over the past 10 fiscal years (excluding the two most recently completed fiscal year): 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 during the past 10- fiscal year period.

Applicants that fail this benchmark 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. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.

For application deadlines that fall on or after April 5, 2023: For companies that have received more than 50 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $250,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period.

Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase II awards over the 10-fiscalyear period, excluding the two most recently-completed fiscal years.

For application deadlines that fall on or after April 5, 2023: For companies that have received more than 100 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $450,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period.

Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 100 or fewer Phase II awards over the 10-fiscalyear period, excluding the two most recently-completed fiscal years.

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 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 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. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization.

This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ).

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure.

To maintain eligibility to seek Phase II or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively. Contractual/Consortium Arrangements In Phase I, normally, 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). We encourage you to contact a program officer listed in Section VII with questions about this because occasionally, deviations from these requirements may occur, and must be approved in writing by the