NIH, CDC, and FDA Parent SBIR (R43/R44) Clinical Trial Optional: PA-27-100

NIH, CDC, and FDA Parent SBIR (R43/R44) Clinical Trial Optional: PA-27-100

The NIH, CDC, and FDA Small Business Innovation Research (SBIR) Parent Notice of Funding Opportunity PA-27-100 funds eligible U.S. small business concerns (SBCs) to carry out research and development intended to produce commercial products. The notice is open, and the next published standard receipt date is January 5, 2027. The announcement also lists April 5, 2027 as a later receipt date and April 6, 2027 as its expiration date. The September 5, 2026 receipt date has passed; it is not the current submission target.

This is a multi-agency parent announcement, not a promise that every institute or center will fund every subject area. Applicants need to match a product concept to a participating NIH institute, CDC office, or FDA center and confirm that the chosen component accepts the proposed work. The current source is the revised full announcement linked above. Read it together with any applicable NIH policy notices and the SBIR/STTR application guide before preparing forms.

Quick reference

The published date table marks the standard dates with an asterisk. The notice states that when a submission date falls on a weekend or federal holiday, the deadline automatically extends to the next business day. It also says no late applications will be accepted. Start well before the listed date so there is time to correct validation errors and complete institutional sign-off.

What the program supports

PA-27-100 supports company-led R&D for a commercial product. Phase I is intended to establish technical merit and feasibility. Phase II continues development toward commercialization. Under this SBIR announcement, the small business should carry out the majority of the research or analytical work, and the PD/PI should be primarily employed by the company. Research partners and consultants can contribute within the program’s phase-specific limits.

The notice accepts applications using the R43 and R44 activity codes. It provides Phase I and Phase II routes, plus two routes identified for NIH: Direct to Phase II and Fast-Track. Direct to Phase II is for a company with evidence of technical merit and feasibility that has not received a Phase I SBIR or STTR award for that project. A Fast-Track application presents Phase I and Phase II together for review. Check component-specific participation and instructions before choosing one of these routes; the options are not interchangeable in every agency context.

This is a product-development mechanism. A strong submission explains the unmet need, the product or service to be developed, the technical uncertainty to be resolved, and how the proposed work leads to a usable product. The application should make clear why the selected agency component is a fit. A broad health or technology theme on its own does not establish mission relevance.

If the project depends on a formal collaboration with a nonprofit research institution, such as a university, the notice directs applicants to consider the companion STTR announcement PA-27-102. STTR has a different collaboration structure and allows the PD/PI to be primarily employed by either the business or the nonprofit research partner. Both SBIR and STTR awards go to the small business.

Eligibility and company structure

Only U.S. small business concerns may apply. The notice evaluates the SBC at the time of award and specifies that the organization must be for-profit, have a U.S. place of business, and operate primarily in the United States or make a significant contribution to the U.S. economy through taxes or use of American products, materials, or labor. It lists eligible legal forms, including a proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, with an additional foreign-participation limit for joint ventures.

Ownership requirements are more detailed than a simple “U.S.-based company” test. The notice describes qualifying majority ownership by U.S. citizens or permanent resident aliens, certain eligible entities, tribes and related organizations, and a route for majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms subject to limits on any single firm’s ownership. Applicants should assess the full ownership and control rules in the eligibility section rather than relying on a short summary. Majority-owned investment firms also have a required SBIR certification attachment; other applicants should not attach that certification.

The company must perform the required share of the work. The notice says that, normally, the SBC performs at least two-thirds of the research or analytical effort in Phase I and at least one-half in Phase II. The corresponding share that may be performed through third-party consulting and contractual arrangements is generally limited to one-third in Phase I and one-half in Phase II. Deviations may be considered case by case and require written approval, so a proposal built around extensive outsourced work should be discussed with the program before submission.

At least one PD/PI must have primary employment with the SBC at the time of award and during the project. The PD/PI also needs an eRA Commons account linked to a valid ORCID ID. The notice allows multiple PDs/PIs, but at least one must meet the primary-employment requirement. Confirm the selected participating component’s interests and contact program staff early if the project, ownership structure, or employment arrangement is unusual.

Funding amounts and project duration

There is no single award amount for PA-27-100. The revised notice provides a component-by-component table of Phase I and Phase II budget levels. Examples include a $700,000 Phase I level and $2,500,000 Phase II level for NCI; $400,000 and $3,000,000 for NHLBI; and $700,000 and $3,000,000 for NIGMS. Other participating components list SBA guideline levels for one or both phases. These figures are the listed component budget levels, not a commitment to fund an application or a guaranteed award size.

Applicants proposing budgets above the Small Business Administration guideline levels are strongly encouraged to contact the participating component early. In every case, the request should be justified by the work plan, staffing, facilities, research costs, and proposed milestones. A large ceiling should not be treated as a target. Match the budget to the smallest credible set of experiments and development activities that can answer the project’s central question.

The notice says award periods normally may not exceed six months for Phase I or two years for Phase II. The proposed period should be reasonable for completing the work. Build milestones around technical questions and measurable evidence, such as analytical performance, prototype reliability, preclinical validation, manufacturing feasibility, or enrollment and endpoint targets for an applicable clinical trial.

Application timeline and submission

The notice lists these standard dates:

• January 5, 2027: next listed receipt date after the September 2026 cycle.
• April 5, 2027: later listed receipt date.
• April 6, 2027: expiration date for this announcement.

Applications are due by 5:00 p.m. in the applicant organization’s local time. The date table includes review and anticipated award timing for each cycle. Since a date may receive the next-business-day treatment when it falls on a weekend or federal holiday, check the notice and applicable NIH policy for the operative submission day. Do not rely on that rule as extra preparation time: the notice encourages early submission for corrections and states that late applications are not accepted.

Use one of the listed submission routes: NIH ASSIST; Grants.gov Workspace followed by eRA Commons tracking; or an institutional system-to-system solution that submits through Grants.gov and eRA Commons. Coordinate with the organization’s signing official and grants administrator, because registration, institutional approval, and final electronic validation are separate parts of a successful filing.

The organization needs active registrations before submission. The notice calls for SAM.gov registration and a Unique Entity Identifier, Grants.gov registration, and eRA Commons organizational and PD/PI accounts. The PD/PI’s Commons personal profile must be linked to ORCID. NIH notes that obtaining a Commons account can take up to two weeks, so complete these steps before the proposal is at the final editing stage. Recheck that the same UEI is used across registrations and in the application.

Application materials and compliance

Start with the SF424 (R&R) package and follow the SBIR/STTR application guide, the PA-27-100 instructions, page limits, and any current policy notices. The funding announcement’s instructions take precedence if they differ from the general guide. Use the package specific to PA-27-100 and confirm that the proposed activity code, phase, participating component, and requested budget are consistent across the forms and narrative.

The application should explain the product, need, market or intended users, technical aims, team, facilities, milestones, and a credible development path. The research plan should make its methods and decision points clear enough for peer reviewers to judge feasibility. Commercialization expectations vary by phase: the notice expressly says a Commercialization Plan is not allowed for a Phase I SBIR application. For Phase II and Fast-Track work, commercial prospects and the path beyond the SBIR project are important review considerations.

Two attachments merit particular attention:

• SBIR Application Certification: required for small businesses majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms. Follow the notice’s form and exact filename instructions. Companies outside this ownership category should not submit this certification.
• Regulatory Plan: required, with a two-page maximum, when the application proposes a clinical trial. The PDF must be named RegulatoryPlan.pdf. It should describe the regulatory pathway, trial-related requirements, milestones and timeline toward regulatory approval, and relevant discussions with regulatory authorities. Applications without a proposed clinical trial must not include this attachment.

Clinical trial applications also need the appropriate human-subjects and clinical-trials information in the application forms. A clinical study record or delayed-onset record may be required depending on the human-subjects answers and study plan. Do not treat the Regulatory Plan as a replacement for those forms; each item has a distinct purpose.

Before submission, check for correct attachment names, complete registrations, signatures, required institutional approvals, consistent budget totals, and successful validation in the submission systems. Applications that fail to follow the instructions can be delayed or not accepted for review. Keep time for corrections before the 5 p.m. cutoff rather than assuming that a file upload alone completes submission.

Review and award considerations

Peer reviewers assess the scientific and technical case alongside the company’s ability to execute and commercialize. The notice’s review criteria examine significance, investigators, innovation, approach, environment, and commercial potential. For Phase II applications, reviewers consider whether the work advances product development and whether feasibility and prior objectives provide a sound foundation. For clinical trials, the review also addresses trial design, recruitment and retention, safety and human-subject protections, data management, statistical analysis, and whether the Regulatory Plan is adequate.

The company should connect each aim to a product-development decision. State what result would support the next step, what result would cause a change in direction, and what evidence will be delivered by the end of the award. Include the business expertise and resources needed for the phase: the notice specifically asks about commercialization capacity for Phase I and for Phase II or Fast-Track applications. Product-market assumptions, regulatory barriers, reimbursement where relevant, competition, customer needs, and post-award financing should be grounded in evidence rather than aspiration.

An application can receive a strong scientific review and still not be funded. Award decisions depend on the participating component, available funds, program priorities, review results, and required pre-award checks. Applicants under consideration for an award may need to provide just-in-time information, including disclosures about foreign affiliations and relationships. The notice also contains security-related award restrictions, so review those provisions early if the company, owners, or covered individuals have relevant affiliations.

A practical preparation sequence

1. Choose the agency fit. Identify the NIH institute or center, CDC office, or FDA center whose mission and current priorities match the product. Contact program staff when fit, budget, or pathway is uncertain.
2. Choose the mechanism. Decide whether the evidence supports Phase I, Phase II, NIH Direct to Phase II, or NIH Fast-Track. If a formal nonprofit research partnership is central, compare the STTR route.
3. Audit eligibility. Document the company’s U.S. operations, legal form, ownership and control, employee roles, and planned division of research effort. Resolve questions before writing the final application.
4. Complete registrations. Confirm SAM.gov, UEI, Grants.gov, eRA Commons, signing official, PD/PI account, and ORCID linkage. Verify that account affiliations are correct.
5. Build a milestone-driven plan. Define the product, technical risks, experiments, data, decision criteria, timeline, and budget. Keep the proposed scope achievable within the phase’s duration and budget.
6. Prepare the correct attachments. Use the current application guide and PA-27-100 instructions. Add the ownership certification only when required; add the Regulatory Plan only for a proposed clinical trial.
7. Submit early and verify. Validate the package in the selected system, monitor eRA Commons for errors, correct issues, and secure institutional approval before the listed local-time cutoff.

Official sources

• PA-27-100 revised full announcement — controlling source for dates, eligibility, budgets, attachments, and submission requirements.
• NIH parent announcements — NIH listing of participating components and announcement expiration.
• NIH SBIR and STTR funding opportunities — NIH program listing for PA-27-100 and companion notices.
• NCI parent solicitation page — standard SBIR receipt dates and links to the current notice.
• NIH How to Apply — general application guidance; use the SBIR/STTR instructions and notice-specific requirements.

Frequently asked questions

Is the September receipt date still available?

No. September 5, 2026 is the first date in this cycle and has passed. The current next listed date is January 5, 2027, followed by April 5, 2027, subject to the notice’s weekend and federal-holiday rule.

Is there a single award amount?

No. Budget levels depend on the participating component and phase. The notice includes specified amounts for some components and SBA guideline levels for others. An applicant should confirm the relevant component’s rules and request a justified budget; the listed ceiling does not guarantee an award.

Can a university apply as the lead organization?

This is an SBIR opportunity for eligible U.S. small business concerns. The award goes to the SBC, which must perform the majority share of research or analytical effort. When a formal nonprofit research partnership is central, review the companion STTR opportunity.

Can the proposed work include a clinical trial?

Yes. Clinical trials are optional under the announcement. A trial application must include the required Regulatory Plan and the applicable human-subjects and clinical-trials information. The plan has a two-page maximum and a specified filename.

Is the announcement a historical reference?

No. PA-27-100 remains within its published open cycle as of this update. Its first listed date has passed, but later standard dates remain in the notice, so the page uses the next listed receipt date rather than archiving the opportunity.

Planning note

Treat PA-27-100 as a set of agency-specific entry points sharing one parent announcement. Before committing to a submission, verify the participating component’s current interest, review budget details for the intended phase, and make sure the company can meet ownership, registration, and work-share requirements. The most useful preparation is a coherent product-development case: a real need, a defined technical risk, an SBC-led plan, appropriate evidence for the selected phase, and a budget tied to milestones. The January receipt date is the next published opportunity to submit under this notice; the official full announcement remains the source for any updates and controlling instructions.