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Grant Analysis

Purpose & Target

The SECTOR-SPECIFIC grant, PAR-24-027, aims to provide investigators with access to Population Assessment of Tobacco and Health (PATH) Study biospecimens (urine, plasma, serum, genomic DNA) and related research data. This access enables research studies consistent with PATH Study objectives and tobacco regulatory science priorities. - Target recipient type: A wide range of organizations including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government entities. - Target size: Not explicitly limited by size. - Geographic scope: Organizations must be based in the United States. Foreign institutions are not eligible. - Key filtering criteria: Research must relate to tobacco regulatory science, and applicants must demonstrate a need for PATH Study biospecimens, with prior confirmation of biospecimen availability. - Grant frequency: Recurring with multiple application due dates until October 31, 2026. This is a reissue of a previous funding opportunity (PAR-21-044).

Financial Structure

This is an X01 Resource Access Award; funds are not awarded via this mechanism.
Applicants will receive access to biospecimens and related research data, not monetary funds.
No budget is directly applied through this application; applicants are instructed to enter $0 for 'Total Federal Funds Requested', 'Total Federal and Non Federal Funds', and 'Estimated Program Income'.
Cost sharing is not required.
Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Financial reporting requirements: Not directly applicable as no funds are disbursed; however, investigators accessing biospecimens will be required to adhere to separate agreements and policies for data sharing and intellectual property.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other than Small Businesses)
Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and Other)
Federal Government (Eligible Agencies, U.S. Territory or Possession)
Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations)
Geographic Location: Must be a U.S. organization. Non-domestic (non-U.S.) Entities are not eligible.
Registrations: Applicant organizations must complete and maintain active registrations with: System for Award Management (SAM) (including Unique Entity Identifier - UEI), eRA Commons, and Grants.gov.

Individual Eligibility (Program Director/Principal Investigator)

Any individual with the skills, knowledge, and resources to conduct the proposed research.
Must have an eRA Commons account, affiliated with the applicant organization.

Project/Application Eligibility

Clinical Trials: Not Allowed; only applications that do not propose clinical trials will be accepted.
Prior Biospecimen Confirmation: Applicants are required to contact the PATH Study team at least five months in advance of the application submission deadline to determine sufficient biospecimen quantity. Applications must include written confirmation from the PATH Study team.
Scientific Distinction: Applicant organizations may submit more than one application, provided each is scientifically distinct.

Application Process

Pre-Application Requirement

Biospecimen Availability Inquiry: Contact the PATH Study team at [email protected] at least five months prior to the application deadline to determine if sufficient biospecimens are available. A written confirmation from the PATH Study team indicating availability must be included in the application.

Application Submission

Application Due Dates (latest first):
October 30, 2026 by 5:00 PM local time of applicant organization.
April 30, 2026
October 31, 2025
April 30, 2025
October 31, 2024
April 30, 2024
Submission Platform: Applications must be submitted electronically through Grants.gov using ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Required Documentation/Materials:
SF424(R&R) forms package.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan (including Significance, Approach, Biospecimen Information, Methodology/Assays, Power and Effect Size, Statistical Analyses, Timeline, Protection of Human Subjects, Biospecimen Availability letter).
Resource Sharing Plan.
Data Management and Sharing Plan (for due dates on or after January 25, 2023).
PHS Human Subjects and Clinical Trials Information form (if applicable, though clinical trials are not allowed).
PHS Assignment Request Form.
Include letter of biospecimen confirmation from PATH Study team.
Describe facilities for laboratory analyses in 'Facilities and Other Resources'.
Describe instrumentation for laboratory analyses in 'Equipment'.
Include biosketches for individuals conducting data analyses, even if not senior/key personnel.
Page Limitations: All page limitations described in the SF424 Application Guide and Table of Page Limits must be followed.

Review and Selection Process

Applications evaluated for scientific and technical merit by the PATH Study Biospecimen Access Committee and PATH Study management.
Only those applications deemed to have the highest scientific and technical merit (generally top half) will be discussed and assigned an overall impact score.
PD/PI will access Summary Statement via eRA Commons after peer review.

Post-Award Requirements

Access to Resources: Successful applicants receive access to resources (biospecimens) provided by the PATH Study, not a Notice of Award (NoA).
Reporting: Investigators must inform the PATH Study team of their progress in project initiation, biospecimen analysis, and dissemination of results as outlined in the Policies and Procedures for Investigators document on the PATH Study Biospecimen Access website.
Data Sharing and IP: Recipients accessing PATH Study Biospecimens must adhere to separate agreements regarding data sharing and intellectual property to balance timely sharing with IP protection.
Project Period: Maximum project period is 5 years.

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field(s), considering the following criteria. Scored Review Criteria

Significance:
How the proposed use of biospecimens relates to PATH Study objectives and informs scientific community, public health policy, and/or tobacco regulation.
How the project improves scientific knowledge and technical capability for tobacco control/regulatory science.
How the study aims utilize the unique nature of the PATH Study design and biospecimens.
Adequacy of justification for requesting specific biospecimens and why other sources are not appropriate.
How adequately the research uses questionnaire and biomarker data associated with biospecimens.
Investigator(s):
Qualifications and experience of PD(s)/PI(s), collaborators, and other researchers.
Strength of expertise and experience of individuals conducting data analyses.
Innovation:
Whether the application challenges and shifts current research paradigms in tobacco science related to manufacture, distribution, and marketing of tobacco products.
How outcomes provide new information to develop the knowledge base for informing public health related to tobacco products.
Approach:
Soundness of overall strategy, methodology, and analyses to accomplish specific aims.
Plans to address weaknesses in prior research rigor.
Strategies to ensure a robust and unbiased approach.
Plans for potential problems, alternative strategies, and benchmarks.
Adequacy of variables selected to define participant groups.
Justification for types, numbers, and volumes of biospecimens.
Validation of proposed assays for requested biospecimen types; provision of preliminary and validation data.
Justification for chosen assay if multiple are available.
Adequacy of the laboratory quality control plan.
For non-pilot/exploratory studies, provision of power calculations and effect sizes, and appropriateness for scientific aims.
Detail and adequacy of the statistical analysis plan, including addressing statistical issues (measurement error, multiple comparison testing, bias, interactions, data adjustments).
Protection of Human Subjects: Plans for protecting human subjects from research risks and inclusion/exclusion criteria.
Timeline: Realism, organization, and completeness of the proposed timeline, demonstrating understanding of project steps.

Additional Review Considerations (Not Scored)

Select Agent Research: Assessment of select agent use, registration, monitoring, biosafety, biocontainment, and security.
Resource Sharing Plans: Reasonableness of sharing plans for model organisms or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the proposed budget and project period.

Compliance & Special Requirements

Regulatory Compliance

Human Subjects Research: Applicants must consult their local IRB to determine if proposed research constitutes human subjects research or is exempt. Documentation of IRB's determination is required if the application is approved. Note: Use of de-identified biospecimens from the PATH Study does not meet the NIH definition of human subjects research. If combined with other human subjects data, consult IRB.
Data Protection and Privacy: Adherence to NIH Data Management and Sharing Policy (effective for due dates on or after January 25, 2023).

Technical & Research Requirements

Clinical Trials: Explicitly not allowed.
Research Scope: Projects must be consistent with PATH Study objectives and/or tobacco regulatory science research priorities. Studies expanding knowledge of tobacco use/related health outcomes also considered but may have lower priority.
Technical Documentation: Detailed methodology, assay information (numbers/types/volumes of biospecimens, volume justification, multiplex assay approaches preferred, methodologies/instrumentation, analyte stability, assay validation, assay performance, QC plan, lab competency, preliminary data), power calculations, detailed statistical analysis plan required.

Special Considerations

Nature of Award: This is a resource access award (X01), not a traditional grant providing monetary funds. The value is in gaining access to unique biospecimens and data from a large, longitudinal study.
Strategic Alignment: Highly aligned with the FDA's regulatory activities under the Family Smoking Prevention and Tobacco Control Act.
Unique Resource: The PATH Study provides a nationally representative sample of tobacco users and non-users, with longitudinal data and biospecimens (urine, serum, plasma, genomic DNA), which is a unique resource for tobacco regulatory science.
Risk Management: Applicants must present potential problems, alternative strategies, and benchmarks for success in their approach section.
Intellectual Property: Data sharing and IP policies apply post-access, ensuring a balance between maximizing timely data sharing and IP protection.

Grant Details