Opportunity Information: Apply for PA 08 142

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pharmacologic Agents and Drugs for Mental Disorders (SBIR R43/R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants.
  • This funding opportunity was created on Jan 26, 2009 and posted on Apr 10, 2008.
  • Applicants must submit their applications by May 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses.
  • Other Eligible Applicants include the following 1. 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. 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 can be no more than 49 percent participation by business entities in the joint venture 3. At least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for profit business concern that is at least 51 owned and controlled by another for profit business concern that is at least 51 owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States (except in the case of a joint venture) 4. Has, including its affiliates, not more than 500 employees and meets 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.
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Opportunity Summary:

The Pharmacologic Agents and Drugs for Mental Disorders (SBIR R43/R44) opportunity (Funding Opportunity Number PA 08 142) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant program focused on advancing medication-based approaches for mental disorders. The main aim is to support small businesses that are developing novel pharmacologic agents for brain and mental health research, including projects that directly pursue the discovery of new drugs. The scope is broad enough to cover early discovery work as well as more applied development efforts, and it also explicitly invites proposals that evaluate the effectiveness of new intervention approaches when those interventions are tied to the program's goals.

A key feature of the FOA is that it is not limited only to brand-new molecules. It also encourages applications that take existing, promising compounds and move them to the next stage of drug discovery and development. In practice, that means a small business could propose work such as lead optimization, formulation improvements, additional preclinical pharmacology, proof-of-concept studies, or other development steps that strengthen the scientific and commercial case for a mental health therapeutic candidate. In parallel, the FOA signals interest in studies that assess how well novel interventions work, which can include carefully designed effectiveness-oriented work, provided it fits within the SBIR framework and the underlying pharmacologic and mental-disorder focus of the announcement.

The program uses the SBIR grant mechanisms R43 and R44, which correspond to Phase I and Phase II SBIR awards, and it also accepts Fast Track applications that combine Phase I and Phase II in a single, continuous application path. As with many NIH opportunities, the number of awards and total dollars ultimately depend on the availability of funds and the strength of the applications received, meaning there is no fixed award count stated in advance. Awards are made competitively, and the final portfolio is driven by scientific merit, feasibility, and alignment with the FOA's objectives.

Budget and timing are structured around SBIR phases, but this FOA provides expanded limits compared with the typical SBIR defaults. Under normal SBIR guidelines referenced in the announcement, Phase I awards generally do not exceed $100,000 total costs over about 6 months, and Phase II awards generally do not exceed $750,000 total costs over about 2 years. For this specific FOA, applicants may request substantially higher budgets and longer time frames: Phase I budgets up to $350,000 total costs per year for as long as two years, and Phase II budgets up to $600,000 total costs per year for as long as three years. This expanded ceiling is important for drug discovery and early development work, where chemistry, pharmacology, toxicology, and translational studies can be more expensive and time-intensive than typical early-stage feasibility projects.

Eligibility is limited to United States small business concerns (SBCs) that meet SBIR requirements at the time of award for both Phase I and Phase II. The FOA reiterates the core SBIR eligibility standards: the business must be organized for profit with a place of business in the United States and must 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. The entity can take common legal forms (for example, LLC, corporation, partnership, sole proprietorship), and joint ventures are allowed with restrictions, including no more than 49 percent participation by other business entities. Ownership and control must meet SBIR rules, generally requiring at least 51 percent U.S. citizen or permanent resident ownership and control (with specific allowances for certain structures as described in the solicitation), and the company (including affiliates) must have no more than 500 employees in line with SBA size standards (13 C.F.R. Part 121) and NIH SBIR policy on affiliation.

The principal investigator rules follow standard SBIR expectations: the Project Director/Principal Investigator (PD/PI) must be primarily employed by the small business, meaning more than 50 percent employment with the SBC at the time of award and for the duration of the project. The FOA notes that individuals with the appropriate expertise and resources are invited to apply through their organizations, and it emphasizes NIH's ongoing encouragement for participation by individuals from underrepresented racial and ethnic groups and individuals with disabilities. The announcement also allows multiple PDs/PIs, enabling team-based leadership when a project benefits from shared responsibility across scientific, clinical, and development domains.

From an application management standpoint, a small business may submit more than one application as long as each submission is scientifically distinct. Resubmissions are permitted, but they must include an Introduction that directly addresses the critiques raised in the prior peer review summary statement. The FOA is categorized as a discretionary grant opportunity in the health area, tied to CFDA 93.242 (Mental Health Research Grants), and it does not require cost sharing or matching.

Administrative details included in the source information indicate the FOA was posted April 10, 2008, with an original and current closing date listed as May 7, 2011, and an archive date of June 7, 2011, meaning the specific announcement as written is historical rather than currently open. The sponsoring agency is NIH, and the full archived announcement was available through the NIH Grants Guide link provided in the notice. For access or technical issues related to the announcement, the contact listed is the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@od.nih.gov).

FAQs: Pharmacologic Agents and Drugs for Mental Disorders (SBIR R43/R44) - PA 08 142

What is the PA 08 142 funding opportunity?

PA 08 142 is an NIH Small Business Innovation Research (SBIR) funding opportunity titled "Pharmacologic Agents and Drugs for Mental Disorders (SBIR R43/R44)." It supports small businesses working on medication-based approaches for mental disorders, including projects focused on discovering and developing pharmacologic agents for brain and mental health research.

Which NIH grant mechanisms are used in this program?

The opportunity uses SBIR grant mechanisms R43 (Phase I) and R44 (Phase II). It also accepts Fast Track applications that combine Phase I and Phase II into a single application pathway.

What types of projects does this FOA support?

The scope is broad and can include early discovery as well as more applied development work for mental health therapeutics. It explicitly includes projects that directly pursue discovery of new drugs and also invites proposals that evaluate the effectiveness of new intervention approaches when those interventions align with the FOA's pharmacologic and mental-disorder focus.

Does the FOA only fund brand-new molecules?

No. The FOA encourages applications that advance existing promising compounds to the next stage of drug discovery and development, not just brand-new molecules.

What are examples of activities that could fit under advancing an existing compound?

Examples described include lead optimization, formulation improvements, additional preclinical pharmacology, proof-of-concept studies, and other development steps that strengthen the scientific and commercial rationale for a therapeutic candidate addressing mental disorders.

Can applicants propose effectiveness-oriented studies?

Yes. The FOA signals interest in studies that assess how well novel interventions work, as long as the work fits the SBIR framework and remains tied to pharmacologic agents and mental disorders as described in the announcement.

How many awards will NIH make under this FOA?

No fixed number of awards is stated. The number of awards and total funding depend on the availability of funds and the quality of applications received.

How are applications selected for funding?

Awards are made competitively. The final set of funded projects is driven by scientific merit, feasibility, and alignment with the FOA's objectives.

What are the typical SBIR budget guidelines referenced in the FOA?

Under the normal SBIR guidelines referenced in the announcement, Phase I awards generally do not exceed $100,000 total costs over about 6 months, and Phase II awards generally do not exceed $750,000 total costs over about 2 years.

Does this FOA allow larger budgets or longer project periods than typical SBIR limits?

Yes. This FOA provides expanded limits beyond the typical SBIR defaults, reflecting the higher cost and time demands of drug discovery and early development.

What are the expanded Phase I budget and duration limits under this FOA?

Applicants may request up to $350,000 total costs per year for Phase I, for as long as two years.

What are the expanded Phase II budget and duration limits under this FOA?

Applicants may request up to $600,000 total costs per year for Phase II, for as long as three years.

Who is eligible to apply?

Eligibility is limited to U.S. small business concerns (SBCs) that meet SBIR requirements at the time of award for both Phase I and Phase II.

What basic business characteristics are required for SBIR eligibility under this FOA?

The business must be organized for profit, have a place of business in the United States, and operate primarily in the United States or make a significant contribution to the U.S. economy through taxes or through the use of American products, materials, or labor.

What legal entity types are allowed to apply?

The FOA indicates that eligible entities can include common for-profit legal forms such as an LLC, corporation, partnership, or sole proprietorship.

Are joint ventures allowed?

Yes, joint ventures are allowed with restrictions, including that participation by other business entities cannot exceed 49 percent.

What ownership and control rules apply?

The FOA reiterates SBIR ownership and control expectations, generally requiring at least 51 percent U.S. citizen or permanent resident ownership and control, with certain allowances for specific structures as described in the solicitation.

Is there a company size (employee) limit?

Yes. The company, including affiliates, must have no more than 500 employees, consistent with SBA size standards (13 C.F.R. Part 121) and NIH SBIR policy on affiliation.

What employment requirement applies to the Project Director/Principal Investigator (PD/PI)?

The PD/PI must be primarily employed by the small business, meaning more than 50 percent employment with the SBC at the time of award and for the duration of the project.

Does the FOA allow multiple PDs/PIs?

Yes. The FOA allows multiple PDs/PIs, which can support team-based leadership when shared responsibility is beneficial across scientific, clinical, and development functions.

Can a small business submit more than one application?

Yes. A small business may submit more than one application as long as each application is scientifically distinct.

Are resubmissions permitted?

Yes. Resubmissions are permitted, but they must include an Introduction that directly addresses critiques from the prior peer review summary statement.

Is cost sharing or matching required?

No. The FOA states that it does not require cost sharing or matching.

What is the CFDA number associated with this opportunity?

The FOA is tied to CFDA 93.242, described as Mental Health Research Grants.

When was this FOA posted and what are the dates shown for closing and archiving?

The FOA was posted on April 10, 2008. The original and current closing date listed is May 7, 2011, and the archive date is June 7, 2011.

Is PA 08 142 currently open based on the information provided?

Based on the listed closing and archive dates, the announcement as written is historical and is not currently open.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

Who is listed as a contact for access or technical issues related to the announcement?

The contact listed for access or technical issues is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@od.nih.gov.

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