Small Business Informatics Tools for the Pangenome (R43 Clinical Trial Not Allowed)

Small Business Informatics Tools for the Pangenome (R43 Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH). This grant supports the development of informatics tools. While not directly HIV program evaluation, if a small business is developing informatics tools relevant to analyzing HIV program data or related health information, it could be a fit.

Expired PAR-25-308: Small Business Informatics Tools for the Pangenome (R43 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

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 National Human Genome Research Institute ( NHGRI ) Funding Opportunity Title Small Business Informatics Tools for the Pangenome (R43 Clinical Trial Not Allowed) R43 Small Business Innovation Research (SBIR) Grant - Phase I only April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 . 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 . February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants­­.

See NOT-OD-23-092 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity Small Business Technology Transfer (STTR) Grants - Phase I See Section III.

3. Additional Information on Eligibility. Assistance Listing Number Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) seeks applications from eligible small business concerns (SBCs) for the development of informatics tools with commercial potential to facilitate uptake and scientific use of the human pangenome reference whose development is supported by the NHGRI Human Genome Reference Program ( HGRP ).

This NOFO specifically calls for innovative Phase I SBIR applications from SBCs to demonstrate feasibility, technical merit, and commercial potential of informatics tools for use of the human pangenome. Emphasis will be on the development of tools to advance compelling use cases that are relevant to sectors of the genomics community, such as clinical, population, and functional genomics.

Funding Opportunity Goal(s) Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. 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.

Required Application Instructions It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply – Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply – Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply – 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.

Notice of 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.

Notice of Funding Opportunity Description The National Human Genome Research Institute (NHGRI) supports the Human Genome Reference Program ( HGRP ), which is transforming the original human genome reference by incorporating data from over 350 diverse, high quality, haplotype resolved genomes in a pangenome representation.

This NOFO seeks applications from eligible small business concerns (SBCs) for the development of informatics tools with commercial potential to facilitate uptake and scientific use of the human pangenome reference. This NOFO calls for innovative Phase I SBIR applications from SBCs to demonstrate proof of principle or viability of informatics tools for use of the pangenome.

Emphasis for this NOFO will be on development of tools for compelling use cases for the pangenome that are relevant to particular sectors of the genomics community, e.g., clinical, population, and functional genomics. Tools should demonstrate commercial potential and enable other genomics researchers to adopt and use the pangenome in their scientific endeavors.

Projects may also build upon existing infrastructure tools in use by the Human Pangenome Reference Consortium (HPRC), but should not aim to create entirely new infrastructure.

Small business applicants interested in submitting a Small Business Technology Transfer ( STTR ) grant application should submit to the related funding opportunity, PAR-25-309 A human genome reference sequence is an accepted representation of the human genome used as a standard to align and assemble genome sequence data. It also serves as a consensus coordinate system for reporting results.

Since the completion of the Human Genome Project, the genome reference has been steadily improved over time by resolving errors and adding information from new assemblies.

The HGRP was established by NHGRI in 2019 to further improve the human genome reference by using new methods for more complete assemblies, increasing genetic diversity, and transforming the reference to represent hundreds of diverse genomes in an accessible and usable resource.

In the ensuing five years, funded investigators formed the Human Pangenome Reference Consortium (HPRC), established an embedded ELSI team which guided the HPRC on issues such as consent and participant community engagement, and initiated collaborations with international partners to develop a resource representative of global populations.

An initial draft pangenome consisting of nearly 50 human genome assemblies was released on May 10th, 2023; currently over 140 assemblies have been produced and will soon be incorporated into the pangenome, working towards a total of 350 to be available within the next six months. These efforts constitute a strong foundation for the further improvement of the human pangenome reference.

In October 2022, NHGRI hosted The Human Genome Reference Program (HGRP) Planning Meeting to identify future directions for the HGRP. Meeting participants strongly encouraged the continuation of the program, with key recommendations emerging from the participants' individual input including: Prioritize utility over quantity and focus on sample selection and data generation of highest benefit to the broader genomics research community.

Emphasize adoption of the new pangenome by identifying use cases, building user-friendly tools, and minimizing disruption to existing workflows. Establish partnerships with international organizations and global participant communities and strive to ensure equitable benefit of the pangenome.

Integrate ethical, legal and social implications (ELSI) at all stages of research including project design, recruitment, adoption, dissemination, and access. Considering these recommendations, NHGRI renewed the program.

The goals for the renewal include: 1) continuing to maintain and improve the pangenome reference, adding diverse, reference quality sequence assemblies; 2) facilitating adoption of the pangenome reference by the research and clinical genomics communities; 3) fostering the development and deployment of informatics tools for the pangenome; 4) embedding ELSI research; and 5) forming international partnerships to maximize the chances that the human pangenome reference will represent populations worldwide, and encourage the collaboration of scientists worldwide in its creation and use.

Overall, there will be a shift in emphasis towards evaluating HGRP progress in terms of how useful the pangenome resource is for clinical and basic genomics research communities. The overall goal of the HGRP during the renewal will be to produce a human pangenome reference that optimizes both the population genetic diversity represented, and also the utility for, and adoption by, the genomics research community.

As a component of the program, four U01 awards were made for informatics tools development. Research and development performed by small businesses is an important element to achieving the goal or optimizing the utility of the HGRP. Importantly, commercial bioinformatics products and services may help enhance the applicability and widespread adoption of genomics in expanded settings.

Commercial products offer robust genomic data analysis and interpretation solutions to researchers and scientists outside the smaller subset of research groups with highly specialized computational genomics skillsets.

Commercial computational approaches are also required to lower the barriers to adoption of the pangenome in clinical settings, providing robust and user-friendly clinical tools to enhance the diagnostic capabilities of genomics data and improve health outcomes.

Tools for using the pangenome For this NOFO NHGRI seeks applications from SBCs proposing to develop informatics tools that will allow the full range of biomedical community that uses genomic data to use the human pangenome reference being developed by the HGRP.

Proposed projects can be wholly new tools that take advantage of the new information in the pangenome reference, and its graph representation to produce improved results, or modifications of existing tools to enable important use cases of the pangenome.

The current representations are graph-based, but other representations (e.g. k-mer) may evolve to accommodate scale and complexity and strategies for compression and efficient data structures may be relevant. NHGRI supports development of genomics methods, tools, and technologies that can be used by the community of biomedical researchers.

This NOFO has a focus on developing tools that will catalyze routine use of the human pangenome by a broad range of genomics researchers. These tools are expected to break the path for scientists to benefit from the pangenome reference. Ideally such tools will be usable by investigators or clinicians with a range of genomics informatics expertise and resources.

Emphasis will be on tools for compelling use cases that are relevant to different sectors of the genomics research community: clinical, population, functional genomics, etc. Applications may propose wholly new tools, or modifications of existing tools.

Proposed tools may facilitate the use and uptake of the pangenome as a whole or any aspect of it (e.g. high quality assemblies from diverse individuals, reference representations, annotations, etc...) However, applications should not aim to re-create new versions of existing infrastructure for creating the pangenome itself (e.g. new assemblers, new whole pangenome annotation pipelines, new graph reference representations, etc?)

unless they are integral to the development of tools to address identifiable uses for a particular set of pangenome end-users.

Possible examples of tools include applications that use the human pangenome reference for: Selecting the best subset of linear genomes or paths along the pangenome graph for use in genome alignments of short read sequence data Creating a data visualization tool to aid in identifying structural variation in the pangenome Using the distribution of genetic variation in the pangenome to inform population genetic or comparative genomic analysis Integrating the pangenome with multi-omic or functional genomic data to improve variant characterization in genomically diverse populations Integration of pangenome information into existing genomics tools such as variant calling or assemblers Visualizing regulatory elements, or other functional genomic features within the pangenome Using the pangenome reference to improve fine mapping and polygenic risk scores Using the pangenome to annotate disease associations or clinically relevant variants Integrating controlled access genomic data with open access pangenome data in ways that enable secure and private use of protected data.

While Phase I SBIR projects focus on early-stage development of products and services, demonstrating feasibility and technical merit of the approach, the informatics tool being developed in the application should also demonstrate commercial potential and a clearly defined potential user-base.

Awardees from this NOFO will be eligible to become associate members of the Human Pangenome Reference Consortia (HPRC) and are encouraged to attend the HPRC annual meeting.

The following applications will be considered non-responsive to this NOFO: Applications that do not focus on developing tools for use of the pangenome produced by the HGRP Applications that propose tools that are applicable to only one or a small number of diseases or biological systems Applications that propose extensive wet-lab data generation, other than a small amount (10% of direct costs) that may be needed to validate the tool.

All applicants are strongly encouraged to contact NHGRI Staff to discuss the responsiveness and alignment of their proposed work with the goals of this program. An informational webinar will be held in January, 2025. NIH staff will be available to answer questions related to this NOFO.

Time, date, and dial in information will be provided at https://www. genome. gov/Funded-Programs-Projects/Human-Genome-Reference-Program#events .

During the webinar, NHGRI staff will present overviews of the program and answer RFA-related questions from prospective applicants. The informational webinar is open to all prospective applicants, but participation is not a prerequisite for submission of an application. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply – Application Guide provide details on these application types. Only those application types listed here are allowed for the NOFO. 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. Budgets up to $400K total costs for Phase I may be requested. Duration of up to 1 year for Phase I may be requested.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. 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: 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; 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.

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.

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 How to Apply – 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-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 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-fiscal year period, excluding the two most recently completed fiscal years.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply – 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.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2. 3. 9.

2 Electronically Submitted Applications for additional information. 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. Unique Entity Identifier (UEI) – A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. SBA Company Registry – See How to Apply – Application Guide for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a UEI to complete this registration.

SBA Company registration is NOT required before SAM, Grants. gov or eRA Commons registration. eRA Commons – Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; 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 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. and Notice of NIH's Interest in Diversity, NOT-OD-20-031 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. 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 How to Apply – 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 How to Apply – Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

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 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, NIH Grants Policy Statement 2. 3. 7.

4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). 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.

Recipients of Phase I and Phase II grants, cooperative agreements, or contracts are eligible to submit Phase II and Phase IIB grant applications, respectively, for this opportunity in accordance with each awarding component's guidance in the current SBIR/STTR Program Descriptions and Research Topics for the NIH, CDC and FDA .

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,