Opportunity Information: Apply for PA 06 036
Apply for PA 06 036
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "NIDA Phase II Small Business Innovation Research (SBIR R44) Competing Renewal Awards" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279 Drug Abuse and Addiction Research Programs.
- This funding opportunity was created on Jan 26, 2009 and posted on Dec 8, 2005.
- Applicants must submit their applications by Multiple Receipt Dates See Link to Full Announcement for details.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- Eligible applicants include: Small businesses Others (see text field entitled Additional Information on Eligibility for clarification).
- Foreign institutions are not eligible to apply. Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of award for both Phase I and Phase II SBIR awards, meets all of the following criteria 1. Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the U.S. economy, and is organized for profit. 2. Is at least 51 owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, 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 re sident aliens, in the United States. 3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in Title 13 Code of Federal Regulations (CFR) Part 121. Business concerns are generally considered to be 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. Control can be exercised through common ownership, common management, and contractual relationships. The term affiliates is defined in greater detail in 13 CFR 121.103. The term number of employees is defined in 13 CFR 121.106 Small Business Size Regulations. A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtaine d at http://sba.gov/size, or by contacting the Small Business Administ rations (SBA) Government Contracting Area Office or Office of Size Standards.
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Opportunity Summary:
The NIDA Phase II Small Business Innovation Research (SBIR) R44 Competing Renewal Awards opportunity (Funding Opportunity Number PA 06-036) is a discretionary NIH grant program aimed at helping qualified US small businesses push promising addiction-treatment medications into more advanced stages of development. The focus is specifically on pharmacological treatment agents intended for drug abuse, nicotine dependence, and related substance use disorders. Rather than supporting brand-new Phase II projects, this announcement targets the next step after a successful Phase II effort by inviting competing renewal applications (previously called competing continuations). In practical terms, it is meant for companies that already received a Phase II SBIR award and now need additional support to further mature the same compound or treatment candidate through key drug discovery and development milestones.
The core purpose of the FOA is to accelerate the advanced development of existing, promising compounds that address addiction and dependence. Projects are expected to build directly on prior Phase II SBIR results and move the therapeutic candidate closer to real-world clinical or commercial readiness. While the announcement text in your source summary does not list every allowable activity, the intent is clearly positioned around later-stage, higher-readiness work in the drug development pipeline, where additional funding can help a small business complete critical experiments, refine the candidate, and strengthen the overall data package needed for subsequent development decisions.
Eligibility is limited to US small business concerns (SBCs) meeting SBIR requirements, and foreign institutions are explicitly not eligible to apply. To qualify as an SBC at the time of award for both Phase I and Phase II SBIR awards, the business must be independently owned and operated, organized for profit, not dominant in its field, and have a place of business in the United States while operating primarily in the United States or making a significant contribution to the US economy. Ownership and control must generally be at least 51 percent held by one or more individuals who are US citizens or permanent resident aliens; alternatively, for SBIR purposes, the applicant can be 51 percent owned and controlled by another for-profit business that itself is 51 percent owned and controlled by US citizens or permanent residents. The company must also meet the SBIR size standard of no more than an average of 500 employees over the preceding 12 months (including affiliates) and comply with the relevant SBA and federal definitions of affiliation and employee counts described in 13 CFR Part 121, including the affiliation rules in 13 CFR 121.103 and employee-number rules in 13 CFR 121.106. The FOA notes that a small business may be structured as a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, as long as it meets the SBA size and control requirements.
From an administrative standpoint, the award instrument is a grant, and the activity category is listed under education and health, with CFDA number 93.279 (Drug Abuse and Addiction Research Programs). The program does not require cost sharing or matching. The posted date is December 8, 2005, with a later creation date listed as January 26, 2009, and the announcement ultimately archived on October 2, 2009. The award ceiling shown in the source data is $750,000. Application due dates are described as multiple receipt dates, with applicants directed to the full announcement for the specific schedule and instructions.
The sponsoring agency is the National Institutes of Health, and the program is associated with NIDA through the SBIR mechanism and addiction-treatment focus. For full details, applicants were directed to the official FOA page at http://grants.nih.gov/grants/guide/pa-files/PA-06-036.html, and NIH support contacts were provided for technical access or linking issues via the NIH Office of Extramural Research (OER) webmaster.
Frequently Asked Questions (FAQs)
What is the NIDA Phase II SBIR R44 Competing Renewal Awards opportunity (PA-06-036)?
This opportunity is a discretionary NIH grant program associated with NIDA that supports qualifying US small businesses seeking additional funding to advance a promising addiction-treatment medication beyond the work completed under a prior Phase II SBIR award. It is specifically for R44 Phase II SBIR competing renewal applications (previously called competing continuations).
What is the main purpose of this funding opportunity?
The purpose is to accelerate advanced development of existing, promising pharmacological treatment agents for addiction and dependence by funding the next step after a successful Phase II SBIR effort. Projects are expected to build directly on prior Phase II SBIR results and move the same therapeutic candidate closer to clinical or commercial readiness.
Is this funding for brand-new Phase II SBIR projects?
No. This announcement is aimed at competing renewal applications following a successful Phase II SBIR award, supporting additional development of the same compound or treatment candidate rather than launching an entirely new Phase II project.
What kinds of therapeutic products are targeted by this FOA?
The focus is on pharmacological treatment agents intended for drug abuse, nicotine dependence, and related substance use disorders.
Who is eligible to apply?
Eligibility is limited to US small business concerns (SBCs) that meet SBIR requirements and that have already received a Phase II SBIR award for the project being advanced. The business must meet SBIR ownership, control, size, and US-location/economic contribution requirements at the time of award.
Are foreign institutions eligible to apply?
No. Foreign institutions are explicitly not eligible to apply under this opportunity.
What SBIR small business requirements are referenced for eligibility?
To qualify as an SBC at the time of award (for both Phase I and Phase II SBIR awards), the business must be independently owned and operated, organized for profit, not dominant in its field, and have a place of business in the United States while operating primarily in the United States or making a significant contribution to the US economy.
What are the ownership and control requirements?
Ownership and control must generally be at least 51 percent held by one or more individuals who are US citizens or permanent resident aliens. Alternatively, the applicant may be 51 percent owned and controlled by another for-profit business that is itself 51 percent owned and controlled by US citizens or permanent residents.
What is the employee size limit for eligibility?
The company must meet the SBIR size standard of no more than an average of 500 employees over the preceding 12 months, including affiliates.
Do affiliation rules apply when counting employees?
Yes. The opportunity references SBA and federal definitions of affiliation and employee counts described in 13 CFR Part 121, including affiliation rules in 13 CFR 121.103 and employee-number rules in 13 CFR 121.106.
What legal business structures can qualify as an SBC for this FOA?
The FOA notes that a small business may be structured as a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, as long as it meets SBA size and control requirements.
What is the award instrument for this opportunity?
The award instrument is a grant.
What is the general activity category for this program?
The activity category is listed under education and health.
What is the CFDA number associated with this opportunity?
The CFDA number is 93.279 (Drug Abuse and Addiction Research Programs).
Is cost sharing or matching required?
No. The program does not require cost sharing or matching.
What is the maximum (ceiling) award amount listed for this opportunity?
The award ceiling shown in the provided source data is $750,000.
When was this opportunity posted, and what is its archival status?
The posted date is December 8, 2005. A later creation date is listed as January 26, 2009. The announcement was ultimately archived on October 2, 2009.
When are applications due?
Application due dates are described as multiple receipt dates, with applicants directed to the full announcement for the specific schedule and instructions.
Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), and the program is associated with NIDA through the SBIR mechanism and addiction-treatment focus.
Where can applicants find the official FOA details?
Applicants were directed to the official FOA page at http://grants.nih.gov/grants/guide/pa-files/PA-06-036.html.
Who is listed as a support contact for technical access or linking issues?
NIH support contacts were provided for technical access or linking issues via the NIH Office of Extramural Research (OER) webmaster.
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