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Grant Details

https://www.grants.gov/search-results-detail/350841

Grant Analysis

Purpose & Target

The core objective of this grant is to advance small molecule drug discovery and development projects, specifically for disorders of the nervous system, towards clinical application. It targets United States small business concerns (SBCs) that have projects in either the Discovery (early-stage optimization) or Development (pre-clinical to Phase I clinical testing) phase. - Single, clear statement of grant's core objective: To facilitate the discovery and development of small molecule neurotherapeutics from pre-clinical stages through Phase I clinical trials by providing funding, resources, and expert support to small business concerns. - Explicit identification of target recipient type and size: Small Business Concerns (SBCs) with not more than 500 employees. - MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Neuroscience, Small Molecule Drug Development). - Geographic scope and any location requirements: Organizations must be located in the United States and operate primarily within the US. - Key filtering criteria for initial grant screening: - Must be a US-based small business concern. - Focus on small molecule drug discovery and development for nervous system disorders. - Project must be in Discovery or Development stage (pre-clinical to Phase I clinical trials). - Projects focusing on biologics, biotechnology products, devices, basic research, or beyond Phase I clinical testing are not eligible. - Grant frequency and program context: This is a reissue (PAR-24-063) and offers recurring application due dates, indicating it is a recurring opportunity within the Blueprint Neurotherapeutics Network (BPN) program.

Financial Structure

  • Funding Instrument: Cooperative Agreement.
  • Budget Range:
  • Phase I: Up to $500,000 total cost per year.
  • Phase II: Up to $1,500,000 total cost per year.
  • Total combined support period: Maximum 5 years (e.g., 2 years Phase I + 3 years Phase II). The total possible funding for a single project spanning 5 years would be $5,500,000.
  • Budgets must reflect the actual needs of the proposed project.
  • Eligible Costs:
  • Work performed by the Principal Investigator (PI) and their staff.
  • Costs for the PI's institution to assemble and file the Investigational New Drug (IND) application.
  • Travel costs for one or two trips per year to attend meetings of the BPN External Oversight Committee or Lead Development Team (LDT)/Clinical Development Team (CDT).
  • Ineligible Costs:
  • Expenses for work conducted by NIH Blueprint Neurotherapeutics Network (BPN) contractors and consultants, as NIH directly pays these entities.
  • Equipment requests are generally not encouraged and considered only if absolutely necessary and not supported by other means.
  • Matching Fund Requirements: Not required (the Notice of Funding Opportunity states 'This NOFO does not require cost sharing').
  • Co-financing Requirements: Not specified, implies no mandatory co-financing outside of the budget structure.
  • Financial Reporting Requirements: Annual Research Performance Progress Report (RPPR), Federal Financial Report (FFR), Final Invention Statement and Certification (HHS 568), Annual Invention Utilization Reports, SBIR.gov reports, Federal Subaward Reporting System (FSRS) for subawards over $10,000,000.
  • Indirect Cost Policies: Considered within the total amount requested for calculation of subcontracting limits.
  • Budget Flexibility: Application budgets are not limited, but should be reasonable and appropriate for the proposed project.
  • Financial Guarantees Required: Not mentioned.
  • Subcontracting Limits:
  • Phase I: Minimum 67% of research/analytical effort must be performed by the small business concern. Consultant and contractual arrangements generally may not exceed 33% of the total requested amount (direct, F&A/indirect, and fee).
  • Phase II: Minimum 50% of research/analytical effort must be performed by the small business concern. Consultant and contractual arrangements generally may not exceed 50% of the total requested amount (direct, F&A/indirect, and fee).

Eligibility Requirements

Organizational Type and Status
  • Eligible applicants are United States small business concerns (SBCs).
  • Must be organized for profit, with a primary place of business in the United States or making significant contributions to the U.S. economy.
  • Acceptable legal forms include individual proprietorship, partnership, limited liability company (LLC), corporation, joint venture, association, trust, or cooperative.
  • Joint ventures must have less than 50% foreign business entity participation.
  • Ownership requirements:
  • More than 50% directly owned and controlled by one or more U.S. citizens/permanent residents, other U.S.-owned business concerns, Indian tribes, Alaska Native Corporations (ANCs), Native Hawaiian Organizations (NHOs), or a combination.
  • OR more than 50% owned by multiple venture capital operating companies, hedge funds, or private equity firms (each must be US-based, created/organized in the US), provided no single entity owns more than 50% (unless that entity is itself a small business).
Organizational Size
  • Must have, including affiliates, not more than 500 employees.
Geographic Requirements
  • Applicant organization must be based in the United States.
  • Non-domestic (non-U.S.) entities are not eligible to apply.
  • Non-domestic components of U.S. Organizations are not eligible to apply. Foreign components may be allowed but require thorough justification.
Performance Benchmarks (for companies with prior SBIR/STTR awards)
  • Phase I to Phase II Transition Rate Benchmark:
  • Companies with >20 Phase I awards in the past 5 fiscal years (excluding most recent) must meet or exceed a 0.25 (25%) transition rate. Failure results in 1-year ineligibility for new Phase I, Fast-Track, or Direct Phase II.
  • Companies with >50 Phase I awards in the past 5 fiscal years (excluding most recent) must meet or exceed a 0.5 (50%) transition rate. Failure limits to 20 total Phase I/II awards for 1 year.
  • Phase II to Commercialization Benchmark:
  • Companies with >15 Phase II awards from all agencies over the past 10 fiscal years (excluding 2 most recent) must show an average of at least $100,000 in revenues and/or investments OR at least 0.15 patents per Phase II award. Failure results in 1-year ineligibility for new Phase I, Fast-Track, or Direct Phase II.
  • Companies with >50 Phase II awards from all agencies over the past 10 fiscal years (excluding 2 most recent) must show an average of at least $250,000 of aggregated sales and investment per Phase II award. Failure limits to 20 total Phase I/II awards for 1 year.
  • Companies with >100 Phase II awards from all agencies over the past 10 fiscal years (excluding 2 most recent) must show an average of at least $450,000 of aggregated sales and investment per Phase II award. Failure limits to 20 total Phase I/II awards for 1 year.
Principal Investigator (PD/PI) Requirements
  • The primary employment of the PD/PI must be with the small business concern at the time of award and throughout the project duration.
  • For projects with multiple PDs/PIs, at least one must meet this primary employment requirement.
  • Each PD/PI must commit a minimum of 10% effort to the project.
Project Specific Eligibility
  • Project must focus on small molecule drug discovery and development for disorders of the nervous system.
  • Projects can enter at either the Discovery stage (requiring medicinal chemistry optimization) or the Development stage (preclinical candidate chosen, no medicinal chemistry optimization needed).
  • Exclusion criteria for projects:
  • Development of biologics or biotechnology products (e.g., oligonucleotides, proteins) or devices.
  • Screening to identify hit compounds.
  • Basic research and studies of disease mechanism.
  • Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers or PET ligands.
  • Development of diagnostics and diagnostic devices.
  • Studies directed beyond Phase I clinical testing.

Application Process

Application Submission
  • Application Due Dates (latest first):
  • July 15, 2026
  • January 15, 2026
  • July 15, 2025
  • January 15, 2025
  • July 15, 2024
  • February 9, 2024
  • All applications are due by 5:00 PM local time of the applicant organization.
  • Applicants are encouraged to submit early to allow time for corrections.
  • Submission Methods: Applications must be submitted electronically via Grants.gov using either NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
  • Application Tracking: Applicants must track the status of their application in eRA Commons.
Letter of Intent (LOI)
  • LOI Due Date: 30 days prior to the application due date.
  • LOI Content: Descriptive title of proposed activity, name(s), address(es), and telephone number(s) of the PI(s), names of other key personnel, participating institution(s), and the funding opportunity number and title.
  • LOI is not required or binding but assists NIH staff in estimating review workload.
Required Registrations
  • System for Award Management (SAM): Must complete and maintain an active registration (renewed at least annually). Requires a Unique Entity Identifier (UEI).
  • SBA Company Registry: Required prior to application submission. Proof of registration (PDF with SBC Control ID) must be attached to the application package.
  • eRA Commons: Organizations must register with eRA Commons. Requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account. Obtaining an account can take up to 2 weeks.
  • Grants.gov: Requires an active SAM registration to complete Grants.gov registration.
  • All registrations must be completed prior to application submission and can take 6 weeks or more.
Required Documentation and Materials
  • Follow the SBIR/STTR (B) Instructions in the How to Apply - Application Guide and specific instructions in this NOFO.
  • Other Attachments:
  • SBA Company Registry PDF (must use original file name, e.g., SBC_1234556789.pdf).
  • SBIR Application Certification (VCOC Certification.pdf) for majority venture capital operating company (VCOC)-owned small business concerns, if applicable.
  • PHS 398 Research Plan:
  • Specific Aims: Delineate aims for U44 Phase I and Phase II awards; define aims of any proposed clinical study.
  • Research Strategy: Include a table specifying the project entry stage and activities conducted by the PI/co-investigators versus NIH contractors. Detail experimental designs for PI's work.
  • Sections on Clinical Impact, Biological Rationale and Compound Profile, Testing Strategy (including Target Product Profile (TPP) and Compound Profile Table), and Innovation are required.
  • Letters of Support: Required from each institution if research is performed at multiple institutions, clarifying intellectual property (IP) management.
  • Resource Sharing Plans: Compliance with instructions, including a Data Management and Sharing Plan (DMS Plan).
  • Commercialization Plan: Required for all applicants, including a Statement of Need, SBIR Commercialization History, and Intellectual Property (IP) Strategy.
  • PHS Human Subjects and Clinical Trials Information (if applicable): Follow instructions for Study Record (e.g., Protocol Synopsis, Outcome Measures) and Delayed Onset Study.
Project Implementation Timeline
  • Phase I: Up to 2 years.
  • Phase II: Up to 3 years.
  • Total combined support period: Maximum 5 years.
  • Go/No-Go milestones will be established (typically every six months, at least annually) by the Lead Development Team (LDT) and reviewed by NIH.
  • Progression from U44 Phase I to Phase II is based on administrative review.
Reporting Obligations
  • Annual Research Performance Progress Report (RPPR).
  • Financial statements (Federal Financial Report - FFR).
  • Final RPPR (within 120 days of budget period end).
  • Final Invention Statement and Certification (HHS 568).
  • Annual Invention Utilization Reports.
  • SBIR.gov reports.
  • Federal Subaward Reporting System (FSRS) for subawards greater than $10,000,000.
  • Semiannual disclosures regarding civil, criminal, and administrative proceedings.
Post-Award Requirements & Compliance
  • Recipients must comply with federal civil rights laws (non-discrimination based on race, color, national origin, age, sex, disability), provide meaningful access to limited English proficient individuals, and ensure effective communication with persons with disabilities.
  • As a Cooperative Agreement, substantial NIH programmatic involvement is expected. The recipient retains primary rights to data and software.
  • The PI is responsible for determining experimental approaches, co-chairing the LDT/CDT, presenting project updates, coordinating with NIH staff/contractors, ensuring data deposition, adhering to BPN policies, managing intellectual property, submitting IND applications, and including NIH in FDA meetings.
  • Registration and results submission on ClinicalTrials.gov is required for applicable clinical trials.
  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for human subjects research.
  • Data and Safety Monitoring is required for NIH-funded clinical trials.
  • Compliance with Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements is mandatory for investigational products.

Evaluation Criteria

Overall Impact
  • Reviewers will assess the likelihood of the project to significantly influence the research field.
  • Higher risks are acceptable for earlier-stage projects (Discovery) due to less existing data, but these risks are managed through NIH staff and Lead Development Teams.
  • Projects are evaluated based on the expectations for their proposed entry stage.
  • Projects will not be penalized if the compound's mechanism of action is unknown; phenotypic projects are acceptable if assay throughput supports chemical optimization.
Scored Review Criteria
  • Significance:
  • Does the project address a critical problem, barrier, or unmet need in the field?
  • Is the supporting prior research rigorous?
  • How will scientific knowledge, technical capability, and/or clinical practice improve?
  • What is the commercial potential, and for Phase II, does the Commercialization Plan demonstrate a high probability of success?
  • Specific to NOFO:
    • How significant is the advantage of the proposed new drug over existing or developing treatments?
    • Does the proposed Target Product Profile (TPP) align with clinical practice and BPN goals?
    • Is there a clear path to clinical application for the therapy?
    • How strong is the data supporting the choice of drug target and compound?
    • For Discovery projects: Are hit compounds sufficiently active in relevant assays?
    • For Development projects: Is the compound well-profiled, optimized, and does it have convincing in vitro and in vivo activity data relevant to clinical use?
  • Investigator(s):
  • Are the PD(s)/PI(s), collaborators, and other researchers qualified and committed?
  • Is their leadership, governance, and organizational structure appropriate for collaborative efforts?
  • Does the team have expertise for commercialization in later stages?
  • Specific to NOFO:
    • If PIs propose to perform work typically handled by BPN contractors, is their expertise appropriate for that work?
    • Does the PI have sufficient leadership experience to manage the grant-funded aspects in collaboration with the NIH-provided BPN Lead Development Team (LDT)?
  • Innovation:
  • Does the proposed product represent an innovative approach to an important problem?
  • Will the product significantly advance existing approaches or methodologies?
  • For Phase II, is there a reasonable plan to protect intellectual property?
  • Specific to NOFO:
    • How would the proposed drug lead to significantly better clinical outcomes than previous efforts on the same target?
  • Approach:
  • Are the research aims appropriate for the project's development stage?
  • Are the overall strategy, methodology, and analyses well-reasoned and appropriate?
  • Are potential problems, alternative strategies, and benchmarks presented?
  • For Phase I: Will the strategy establish feasibility and manage risky aspects? Are there clear, measurable milestones for Phase II?
  • Specific to NOFO (Discovery stage):
    • Strength of rationale for assay choice, design, and SAR advancement criteria.
    • Strength of assay validation data or plans.
    • Suitability of compounds for SAR studies and optimization.
    • Strength of medicinal chemistry strategy if conducted by applicant.
    • Rigor of animal model design.
    • Appropriateness of study design for in vivo bioactivity, data analysis, and go/no-go criteria.
  • Specific to NOFO (Development stage):
    • Does the data package support the preclinical candidate declaration?
    • Does the preparatory stage address deficiencies for IND-enabling studies?
    • Feasibility of scaling up the development candidate.
    • Completeness of Development plan for obtaining IND and realistic timelines.
  • Environment:
  • Will the scientific and business environment contribute to success and commercialization?
  • Are the available resources (support, equipment, physical) adequate?
  • Does the project benefit from unique environmental features or collaborations?
  • For Phase I: Does the company have or plan for appropriate business expertise/resources?
  • For Phase II/Fast-Track: Does the applicant have access to necessary business experts and resources for commercialization?
Additional Review Criteria (not scored, but considered)
  • Study Timeline (Clinical Trials): Detailed, feasible, justified timeline including start-up, enrollment, follow-up, and efficiency utilization.
  • Market, Customer, and Competition: Compelling value proposition, clear market niche, understanding of competitive environment, revenue generation plans, team's commercialization track record.
  • Company: Ability to sustain and grow, impact of business alliances.
  • Intellectual Property (IP): Strength of IP portfolio, protection strategy, absence of legal constraints, institutional infrastructure for IP management.
  • Phase II Applications: Demonstrated progress from Phase I objectives.
  • Phase I/Phase II Fast-Track Applications: Clear Phase I milestones for Phase II, evidence of external funding commitments.
  • Commercialization (Phase II and Fast-Track Only): Understanding of market barriers, strategies to address them, post-SBIR development milestones, funding plan, team expertise, revenue generation strategy.
  • Protections for Human Subjects, Inclusion, Vertebrate Animals, Biohazards, Foreign Components, Select Agent Research, Resource Sharing, Authentication of Resources, Budget and Period of Support: These will also be assessed for appropriateness and compliance.

Compliance & Special Requirements

Regulatory Compliance
  • All Investigational New Drug (IND)-enabling nonclinical studies must conform to Good Laboratory Practices (GLP) and current FDA guidance.
  • All clinical trials must adhere to Good Clinical Practices (GCP) and the NIH Policy for Data and Safety Monitoring.
  • Investigational products for clinical trials must be manufactured under current Good Manufacturing Practice (cGMP).
  • Recipient institutions are responsible for ensuring all research protocols involving human subjects are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
  • Compliance with FDA IND/IDE requirements is mandatory for all investigational therapeutics or devices used in human research protocols.
  • Adherence to federal civil rights laws prohibiting discrimination and ensuring access for individuals with limited English proficiency and disabilities.
  • Compliance with federal religious non-discrimination and conscience protection laws.
  • Reporting of civil, criminal, and administrative proceedings to the Federal Awardee Performance and Integrity Information System (FAPIIS) is required for awards over $10,000,000.
Intellectual Property (IP) Policies
  • The small business concern (SBC) retains primary assignment of IP rights generated under the award.
  • The SBC gains assignment of IP rights from BPN contractors, allowing the SBC to control patent prosecution and licensing negotiations for developed drug candidates.
  • The SBC is responsible for patent filings, maintenance, and licensing efforts to achieve eventual commercialization.
  • Award recipients are encouraged to seek potential licensing and commercialization partners early in the development process.
  • For multi-institutional projects, a letter of support clarifying IP sharing and management across institutions is required to ensure IP remains unencumbered.
  • SBIR/STTR recipients may retain rights to data generated for up to 20 years after the award date.
  • Applicants seeking patent protection must explain their data sharing plans after patent filing to enable further research and commercial product development.
Data Protection and Sharing
  • A Data Management and Sharing Plan (DMS Plan) is required for all applications, regardless of direct costs requested.
  • Primary and secondary screening data and assay protocols must be deposited in a centralized BPN database.
  • Data generated under the U44 award and through collaborations are considered confidential and business privileged information of the recipient, subject to government access rights.
Risk Management and Security
  • The program acknowledges inherent higher risks in earlier-stage projects, which are managed through close interactions with NIH staff and Lead Development Teams.
  • Security risk assessments include review of ties to foreign countries, particularly those of concern (e.g., People's Republic of China).
  • Owners and covered individuals (senior key personnel) must disclose all funded and unfunded relationships with foreign countries via the Just-In-Time (JIT) process.
  • Identified foreign involvement with 'countries of concern' that meets specific risk criteria (e.g., interference with NIH activities, conflicts of interest, national security risk) may lead to denial of award or termination/repayment of funds.
Unique Aspects and Collaboration Structure
  • The grant is a Cooperative Agreement, signifying substantial Federal scientific and programmatic involvement from NIH.
  • Lead Development Teams (LDTs)/Clinical Development Teams (CDTs) are assembled by NIH, co-chaired by the PI and an NIH-contracted consultant. These teams provide strategic direction, guide workflow, and coordinate activities.
  • NIH provides access to NIH-funded consultants and contract research organizations (CROs) specializing in areas like medicinal chemistry, pharmacokinetics, toxicology, formulations, GMP chemical synthesis, and Phase I clinical testing.
  • Funding is milestone-based; continuation of funding is contingent upon successful achievement of established milestones.
Ethical Standards
  • Adherence to ethical standards is expected, including for human subjects and vertebrate animal research.
  • Emphasis is placed on rigor and reproducibility in research conduct and reporting.
  • NIH is committed to supporting a safe and respectful work environment, with expectations for institutions and individuals involved.

Grant Details

neuroscience small molecule drug discovery drug development nervous system disorders neurotherapeutics pre-clinical clinical trials phase i sme startup biotechnology medicinal chemistry pharmacokinetics toxicology formulations gmp ind-enabling nih sbir ninds nei nia niaaa nidcr nida nimh nccih cooperative agreement research and development healthcare innovation
Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
PAR-24-063
Blueprint Neurotherapeutics Network (BPN)
SME
US
HEALTHCARE TECHNOLOGY
DEVELOPMENT EARLY_MARKET
0-10 11-50 51-250 251-500
SDG3
FUNDING MENTORSHIP RESEARCH_DEVELOPMENT
None
500000.00
5500000.00
USD
None
July 15, 2026, 5 p.m.
April-June 2026