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Grant Analysis

Purpose & Target

This grant supports exploratory/developmental research studies focused on understanding, preventing, or treating Guillain Barre Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It targets a wide range of organizations with research capabilities. - Explicit identification of target recipient type and size: All types of organizations, including higher education institutions, non-profits, for-profits (including small businesses), and various government entities. - MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Health/Medical Research, Neuroscience, Autoimmune Diseases) - Geographic scope and any location requirements: Global, as non-U.S. entities are eligible to apply. - Key filtering criteria for initial grant screening: Focus on GBS/CIDP research, 'Clinical Trial Not Allowed' (R21 activity code), and specific research component requirements (models, biospecimens, or data). - Grant frequency and program context: This is a new funding opportunity, part of the NIH R21 Exploratory/Developmental Research Grant program, with multiple application due dates until its expiration in October 2025.

Financial Structure

Total estimated funding available: $3,000,000 for approximately 7 awards.
Maximum award budget for direct costs: Combined budget for the two-year project period may not exceed $275,000.
Annual direct cost limitation: No more than $200,000 may be requested in any single year.
Project period: The total project period may not exceed 2 years.
Matching fund requirements: This funding opportunity does not require cost sharing.
Financial reporting: Recipients must submit the Research Performance Progress Report (RPPR) annually and financial statements. A final RPPR, invention statement, and expenditure data are required for closeout.
Audit requirements: Awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR Part 200).

Eligibility Requirements

Organization Type & Status

Organizations eligible include: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (with/without 501(c)(3) IRS Status), For-Profit Organizations (Small Businesses, Other than Small Businesses), Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments), Federal Governments (Eligible Agencies, U.S. Territory or Possession), Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations.
Non-domestic (non-U.S.) entities (Foreign Organizations) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are also eligible.

Registration & Certification

Applicant organizations must complete and maintain active registrations with: System for Award Management (SAM) (requires annual renewal), Unique Entity Identifier (UEI) (assigned via SAM.gov), eRA Commons, and Grants.gov. These must be completed prior to application submission. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must have an eRA Commons account and affiliate it with the applicant organization. If the PD/PI is also the Signing Official, they need two distinct eRA Commons accounts.

Research Scope & Requirements

Applications must not propose clinical trials.
Non-responsive applications will be administratively withdrawn without review. This includes:
Applications proposing to characterize infectious agents associated with GBS without additional studies of cellular and/or humoral immune responses in peripheral nerves.
Studies that do not include at least one of the following: an animal model of GBS or CIDP; a cellular model of GBS or CIDP that includes peripheral nerve-relevant neurons and/or Schwann cells; biospecimens or data from GBS or CIDP patients.

Application Process

Application Deadlines & Submission

Open Date (Earliest Submission Date): February 03, 2025.
Application Due Dates: March 03, 2025 and October 03, 2025. All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date: October 04, 2025.
Submission Method: Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Early submission is encouraged to allow time for corrections.
Letters of Intent are optional but encouraged, with contents including descriptive title, PD/PI contact, key personnel, institutions, and funding opportunity number.

Required Documentation & Materials

Standard application forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget forms: R&R or Modular Budget, R&R Subaward Budget.
Specific NIH forms: PHS 398 Cover Page Supplement, PHS 398 Research Plan.
Research Plan specifics: Must include a Resource Sharing Plan and a Data Management and Sharing Plan (if generating scientific data).
Human Subjects: If human subjects are involved, include the PHS Human Subjects and Clinical Trials Information form (Clinical Trials are Not Allowed for this RFA).
Appendix: Only limited appendix materials are allowed (e.g., blank questionnaires/surveys).

Review & Award Timeline

Scientific Merit Review: Anticipated July 2025 (for March 2025 applications) or March 2026 (for October 2025 applications).
Advisory Council Review: Anticipated October 2025 (for March 2025 applications) or May 2026 (for October 2025 applications).
Earliest Start Date: Anticipated December 2025 (for March 2025 applications) or July 2026 (for October 2025 applications).
Post-Review: PD/PIs can access their Summary Statement via eRA Commons after review.

Post-Award Requirements & Compliance

Annual Reporting: Research Performance Progress Reports (RPPR) and financial statements are required annually.
Closeout Reporting: A final RPPR, invention statement, and expenditure data (Federal Financial Report) are required for closeout.
Data Management & Sharing: Recipients must adhere to their approved Data Management and Sharing Plan.
Mandatory Disclosure: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Evaluation Criteria

The evaluation process considers the scientific and technical merit of the proposed project. Overall Impact Score Reviewers will assign an overall impact score reflecting the likelihood of the project to have a sustained, powerful influence on the research field(s) involved. This score is based on the following scored criteria and additional review considerations. Scored Review Criteria (Factors 1, 2, and 3 will each receive a separate score):

Factor 1. Importance of the Research (Significance and Innovation): Evaluates the project's potential to advance the field and its novelty.
Factor 2. Rigor and Feasibility (Approach): Assesses the soundness of the research design, methods, and analyses; considers potential problems and alternative strategies; evaluates plans for ensuring robust and unbiased results.
Factor 3. Expertise and Resources (Investigator(s) and Environment): Reviews the qualifications of the Project Director(s)/Principal Investigator(s) and other key personnel, and the adequacy of the institutional environment and available resources.

Additional Review Criteria (considered for overall impact, but not separately scored):

Protections for Human Subjects: Assessment of the adequacy of plans for the protection of human subjects.
Vertebrate Animals: Evaluation of the use of live vertebrate animals, including justification for their use, appropriateness of species, measures to minimize discomfort, and justification for euthanasia methods.
Biohazards: Assessment of specific materials or procedures that are hazardous to research personnel and/or the environment, and the adequacy of proposed protections.
Resubmissions/Renewals/Revisions: Evaluation of previous applications, progress made, or appropriateness of scope expansion as applicable.

Additional Review Considerations (considered, but not scored):

Authentication of Key Biological and/or Chemical Resources: Brief plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Evaluation of whether the budget and requested period are justified and reasonable in relation to the proposed research.

Funding Decisions Funding decisions are based on: - Scientific and technical merit as determined by peer review. - Availability of funds. - Relevance of the proposed project to program priorities.

Compliance & Special Requirements

Regulatory & Legal Compliance

All awards are subject to the NIH Grants Policy Statement, the Public Health Service Act (Sections 301 and 405), and Federal Regulations (42 CFR Part 52 and 2 CFR Part 200).
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Health IT requirements: If award funding involves implementing, acquiring, or upgrading health IT, it must meet standards in 45 CFR part 170, Subpart B, and if for eligible clinicians, certified under the ONC Health IT Certification Program.

Data & Security

Data Management and Sharing Plan: Required for all applications generating scientific data, regardless of direct costs requested.
Cybersecurity: Recipients with ongoing access to HHS information or operational technology systems, or handling PII/PHI from HHS, must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical & Research Standards

Human Subjects: Research involving human subjects must ensure inclusion across the lifespan unless scientifically or ethically justified for exclusion. Plans for participant diversity (socioeconomic status, geographic distribution) should be considered for GBS/CIDP patient populations.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for protocols involving human subjects.
Vertebrate Animals: Research involving vertebrate animals must adhere to specific guidelines regarding procedures, justification, minimization of discomfort, and euthanasia methods.
Biohazards: Adequate protection must be proposed for specific hazardous materials or procedures.

Special Considerations

'Clinical Trial Not Allowed': This is a foundational constraint of the R21 activity code for this NOFO.
Non-responsive applications: Applications that do not meet specific requirements regarding immune response studies for GBS or do not include required animal models, cellular models, or patient biospecimens/data will be administratively withdrawn.
Strategic alignment: Potential for co-funding from the Office of Autoimmune Disease Research (OADR) if the proposed work aligns with OADR portfolio interest and the NIH-Wide Strategic Plan for the Health of Women.

Grant Details