Opportunity Information: Apply for PA 09 055
Apply for PA 09 055
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Tools for Germplasm Cryopreservation (SBIR) R43/R44" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.389 National Center for Research Resources.
- This funding opportunity was created on Dec 18, 2008 and posted on Dec 18, 2008.
- Applicants must submit their applications by Jan 7, 2012. (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 Only United States SBCs are eligible to submit SBIR applications. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 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 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 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) 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. Control can be exercised through common ownership, common management, and contractual relationships. The term affiliates is defined in greater detail in 13 C.F.R. 121.3 2(a). The term number of employees is defined in 13 C.F.R. 121.3 2(t). Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://sba.gov/size.
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Opportunity Summary:
Tools for Germplasm Cryopreservation (SBIR) R43/R44 (Funding Opportunity Number PA 09 055) is a National Institutes of Health (NIH) funding opportunity aimed at helping small businesses develop new and improved tools that make animal germplasm cryopreservation more effective, reliable, and safe. The program is grounded in a practical need: research repositories and resource centers increasingly depend on long-term storage of animal germplasm (such as sperm, oocytes, embryos, and related reproductive tissues) to preserve valuable strains, support biomedical research, and ensure that critical animal models remain available for future studies. This FOA is essentially looking for innovations that strengthen the infrastructure behind germplasm banking, from how samples are frozen and thawed, to how they are handled, tested, and protected from contamination or disease.
The scientific scope is focused on applied research and product-oriented development in several key areas. Applications are encouraged that propose advances in cryopreservation methods (for example, improved protocols that increase survival and post-thaw function), specialized reagents and formulations (such as new cryoprotectants or additives that reduce ice damage or toxicity), and enabling equipment (devices, instruments, or systems that improve standardization, throughput, consistency, or field usability). The FOA also highlights biosecurity and disease-related needs, including technologies for detecting disease agents in germplasm and approaches to address risks such as vertical transmission of disease (pathogens passed from parent to offspring through reproductive materials). Overall, the intent is to fund innovations that repositories and researchers can realistically use to build or expand secure, high-quality germplasm banks.
This opportunity uses the SBIR grant mechanisms R43/R44, meaning applicants can apply for Phase I, Phase II, or a Fast Track that links Phase I and Phase II in a single application path. Phase I is intended to support early-stage feasibility work and proof-of-concept research, while Phase II supports more advanced research and development toward a deployable tool or product. The FOA runs in parallel with a separate but scientifically identical announcement for STTR (PA 09 054; R41/R42), which is designed for projects built around a formal small business and research institution partnership. Applicants choosing SBIR should still be prepared to show strong scientific capability and a credible development plan suited to a small business setting.
Budget guidance follows typical SBIR norms for the time period described in the announcement, while also noting that these are guidelines rather than absolute caps. Phase I awards are described as normally not exceeding $100,000 in total costs for a project period normally not to exceed 6 months. Phase II awards are described as normally not exceeding $750,000 in total costs for a project period normally not to exceed 2 years. The FOA makes an important point that applicants should propose a budget and timeline that are reasonable and appropriate for the work proposed, since the statutory guidelines are not presented as hard ceilings in the text. The number of awards and total dollars ultimately issued depend on availability of funds and the quality and merit of applications received, rather than a fixed number of guaranteed awards.
Eligibility is limited to United States small business concerns (SBCs). The announcement spells out the core SBIR eligibility expectations: the business must be for-profit, have a place of business in the United States, and primarily operate in the United States (or otherwise make a significant contribution to the U.S. economy through taxes or use of American products, materials, or labor). It must have an acceptable legal form (such as LLC, corporation, partnership, sole proprietorship, and similar), meet ownership and control requirements (generally at least 51% owned and controlled by U.S. citizens or permanent residents, with additional details for certain structures like joint ventures), and have no more than 500 employees including affiliates. The FOA also references standard SBA affiliation principles and points applicants to the relevant federal regulations (13 C.F.R. Part 121) for definitions and details.
The FOA is also explicit about principal investigator requirements for SBIR. The Project Director/Principal Investigator (PD/PI) must have primary employment with the small business (more than 50% of their time) at the time of award and for the duration of the project. It also notes NIH’s standing encouragement for participation by individuals from underrepresented racial and ethnic groups and individuals with disabilities, emphasizing broad inclusion in the applicant pool. The announcement allows multiple PDs/PIs on an application, which can be useful for projects that combine expertise in cryobiology, veterinary or reproductive biology, engineering, device development, and disease detection.
From an application strategy standpoint, the FOA allows a small business to submit more than one application as long as each one is scientifically distinct. It also permits resubmissions, with the standard NIH expectation that a resubmitted application includes an Introduction that addresses the prior peer review critique (the Summary Statement). These features matter for companies building a platform technology where different species, sample types, or technology components might justify separate applications, or where a first submission needs refinement based on reviewer feedback.
Administrative details in the source information indicate this is a discretionary grant opportunity from NIH, associated with the National Center for Research Resources and CFDA number 93.389, with no cost-sharing or matching requirement. The opportunity was posted and created on December 18, 2008, and the original and current closing date listed is January 7, 2012, with an archive date of February 7, 2012. In other words, this specific announcement is historical and is no longer open, but it provides a clear template for the kind of SBIR projects NIH has sought in the cryopreservation and germplasm banking space. The full announcement is linked via NIH’s grants guide, and the contact listed for access or technical linking issues is the NIH Office of Extramural Research (OER) webmaster.
Frequently Asked Questions (FAQs): Tools for Germplasm Cryopreservation (SBIR) R43/R44 (PA 09 055)
What is this funding opportunity about?
This NIH Small Business Innovation Research (SBIR) opportunity supports small businesses developing new or improved tools that make animal germplasm cryopreservation more effective, reliable, and safe. The goal is to strengthen the practical infrastructure behind germplasm banking for biomedical research, including how reproductive samples are preserved, handled, tested, and protected from contamination or disease.
What types of biological materials are included under "animal germplasm" in this opportunity?
The scope includes animal reproductive materials such as sperm, oocytes, embryos, and related reproductive tissues that repositories and resource centers store long-term to preserve valuable strains and ensure availability of important animal models for future studies.
Why is NIH interested in funding germplasm cryopreservation tools?
Research repositories and resource centers increasingly depend on long-term storage of animal germplasm to preserve valuable strains, support biomedical research, and ensure critical animal models remain available. NIH is looking for innovations that improve the effectiveness and security of these germplasm banking efforts.
What is the scientific focus of the program?
The focus is applied research and product-oriented development. The intent is to fund innovations that repositories and researchers can realistically use to build or expand secure, high-quality germplasm banks.
What kinds of projects are encouraged?
Projects are encouraged in several areas, including: (1) improved cryopreservation methods and protocols that increase survival and post-thaw function; (2) specialized reagents and formulations such as new cryoprotectants or additives to reduce ice damage or toxicity; (3) enabling equipment, devices, instruments, or systems that improve standardization, throughput, consistency, or usability in the field; and (4) biosecurity and disease-related technologies, including detection of disease agents in germplasm and approaches that address risks like vertical transmission of disease.
Does the opportunity cover disease detection and biosecurity in addition to freezing and thawing?
Yes. The opportunity explicitly highlights biosecurity and disease-related needs, including technologies for detecting disease agents in germplasm and approaches to address risks such as vertical transmission of disease (pathogens passed from parent to offspring through reproductive materials).
What are the grant mechanisms used for this opportunity?
This opportunity uses the NIH SBIR grant mechanisms R43/R44. Applicants can apply for Phase I, Phase II, or Fast Track (which links Phase I and Phase II in a single application path).
What is the difference between Phase I and Phase II under this SBIR opportunity?
Phase I supports early-stage feasibility work and proof-of-concept research. Phase II supports more advanced research and development aimed at producing a deployable tool or product.
What is Fast Track in this context?
Fast Track is an application path that links Phase I and Phase II in a single combined submission, intended to streamline progression from feasibility to more advanced development for projects that are ready for that structure.
Is there a related STTR version of this opportunity?
Yes. This SBIR announcement runs in parallel with a separate but scientifically identical STTR announcement (PA 09 054; R41/R42). STTR is designed for projects built around a formal small business and research institution partnership.
If a company applies through SBIR, do they still need strong scientific capability?
Yes. The information indicates that applicants choosing SBIR should be prepared to show strong scientific capability and a credible development plan suited to a small business setting.
What are the typical budget and project period expectations for Phase I?
Phase I awards are described as normally not exceeding $100,000 in total costs for a project period normally not to exceed 6 months. The announcement notes these are guidelines rather than absolute caps.
What are the typical budget and project period expectations for Phase II?
Phase II awards are described as normally not exceeding $750,000 in total costs for a project period normally not to exceed 2 years. The announcement notes these are guidelines rather than absolute caps.
Are the budget amounts strict caps?
No. The text frames the budget figures as normal SBIR guidelines for the period and emphasizes that applicants should propose a budget and timeline that are reasonable and appropriate for the work proposed rather than treating the figures as hard ceilings.
How many awards will NIH make under this announcement?
The number of awards and total dollars depend on availability of funds and the quality and merit of applications received. The announcement does not state a fixed number of guaranteed awards.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs) that meet SBIR requirements, including being for-profit, having a place of business in the United States, and primarily operating in the United States (or otherwise making a significant contribution to the U.S. economy through taxes or use of American products, materials, or labor).
What legal forms of business are acceptable?
The small business must have an acceptable legal form such as an LLC, corporation, partnership, sole proprietorship, or similar entity type consistent with SBIR eligibility.
Are there size limits for the small business?
Yes. The business must have no more than 500 employees, including affiliates, consistent with SBIR rules and SBA affiliation principles.
What are the ownership and control requirements mentioned?
The information describes SBIR ownership and control expectations as generally at least 51% owned and controlled by U.S. citizens or permanent residents, with additional details applicable to certain business structures such as joint ventures.
Where are the detailed definitions for eligibility and affiliation found?
The announcement points applicants to federal regulations, including 13 C.F.R. Part 121, and references standard SBA affiliation principles for definitions and details.
What are the Principal Investigator (PD/PI) employment requirements for SBIR?
The Project Director/Principal Investigator (PD/PI) must have primary employment with the small business (more than 50% of their time) at the time of award and for the duration of the project.
Can an application have multiple PDs/PIs?
Yes. The announcement allows multiple PDs/PIs, which can be helpful for projects combining expertise across areas such as cryobiology, veterinary or reproductive biology, engineering, device development, and disease detection.
Does NIH encourage applications from underrepresented groups?
Yes. The information notes NIH encouragement for participation by individuals from underrepresented racial and ethnic groups and individuals with disabilities, emphasizing broad inclusion in the applicant pool.
Can a small business submit more than one application to this FOA?
Yes. A small business may submit more than one application as long as each application is scientifically distinct.
Are resubmissions allowed, and what is expected in a resubmission?
Resubmissions are permitted. The standard NIH expectation described is that a resubmitted application includes an Introduction addressing the prior peer review critique (the Summary Statement).
What is the administering agency and program type?
This is an NIH discretionary grant opportunity associated with the National Center for Research Resources.
Is cost-sharing or matching required?
No. The information states there is no cost-sharing or matching requirement.
What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.389.
Is this funding opportunity still open?
No. The administrative details indicate the original and current closing date listed is January 7, 2012, with an archive date of February 7, 2012. This indicates the specific announcement is historical and no longer open.
What are the key dates noted in the listing?
The opportunity was posted and created on December 18, 2008. The closing date listed is January 7, 2012, and the archive date is February 7, 2012.
Where was the full announcement made available?
The information states the full announcement is linked via the NIH grants guide.
Who is listed as the contact for access or technical linking issues?
The contact listed for access or technical linking issues is the NIH Office of Extramural Research (OER) webmaster.
What is the practical end goal NIH is trying to support with these awards?
The intent is to support tools and technologies that can be used by repositories and researchers to build or expand germplasm banks that are secure, high-quality, and practical to operate, including improved preservation outcomes and stronger safeguards against contamination and disease.
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