Opportunity Information: Apply for PAR 16 114
Apply for PAR 16 114
- The HHS-NIH11 in the health, income security and social services sector is offering a public funding opportunity titled "Spermatogenic Stem Cell Culture Systems to Preserve and Restore Reproductive Capacity in Males (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
- This funding opportunity was created on Feb 25, 2016 and posted on Feb 25, 2016.
- Applicants must submit their applications by Jun 05, 2018. (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 $300,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The grant opportunity titled "Spermatogenic Stem Cell Culture Systems to Preserve and Restore Reproductive Capacity in Males (R01)" (Funding Opportunity Number PAR 16-114) is a U.S. National Institutes of Health (NIH) research project grant solicitation aimed at advancing the science of spermatogenic stem cells (SSCs). SSCs are the foundational cell population in the testes that sustain sperm production over a male's lifetime. The central public health motivation behind this announcement is fertility preservation and fertility restoration, particularly for males whose reproductive capacity is threatened or damaged by disease or its treatment. By strengthening the underlying biology and technical toolkit around SSCs, the program is trying to improve the odds that couples can ultimately have genetically related children without relying on conventional assisted reproductive technologies such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
A major emphasis of the FOA is the development of reliable, long-term culture systems that can maintain SSCs and enable their expansion over extended periods. In practical terms, this means creating or improving laboratory methods that keep SSCs viable, stable, and functional outside the body, while also allowing researchers to increase the number of cells available for downstream use. Long-term culture and expansion are often a bottleneck in translating stem-cell-based fertility approaches into real-world clinical options, because SSCs can be difficult to sustain and may lose key properties if culture conditions are not carefully optimized. Applications responsive to this program would generally be expected to tackle challenges like maintaining SSC "stemness," preserving genetic and epigenetic integrity during prolonged culture, controlling differentiation, and establishing reproducible protocols that could eventually support translational pathways.
Another key research area highlighted in the announcement involves developing methods to remove malignant (cancer) cells from SSC cultures, especially in situations where an individual has undergone chemotherapy and/or radiation. This speaks directly to a well-known safety concern in fertility preservation for cancer patients: if SSCs are collected and later reintroduced or used in some restorative approach, any contaminating tumor cells could pose a serious risk of reintroducing disease. The FOA encourages research aimed at selectively eliminating malignant contamination while preserving the SSC population and its capacity to regenerate spermatogenesis. This could include strategies such as improved cell sorting, molecular targeting, selective culture conditions, or other decontamination and validation techniques, provided they can demonstrate meaningful improvements in safety and effectiveness.
The FOA also notes the value of SSCs derived from adult human males as tools for drug development and toxicity testing. Animal models, while essential, do not always mirror human reproductive biology closely enough to predict how drugs and environmental exposures will affect human spermatogenesis. Better human SSC systems could therefore serve as more predictive platforms for screening compounds, understanding reproductive toxicology, and studying mechanisms of germ cell damage or protection in a human-relevant context. In that sense, the opportunity is not limited to fertility restoration alone; it also supports broader biomedical applications where accurate human testicular biology models are needed.
From an administrative standpoint, this is an NIH R01 funding mechanism under the U.S. Department of Health and Human Services, with the agency listed as HHS-NIH. It falls under the Health, Income Security and Social Services activity category and is associated with CFDA number 93.865. The opportunity was posted and created on February 25, 2016, with an original and current closing date of June 5, 2018. The listed award ceiling is $300,000 (as provided in the source data). Eligibility is broad and includes a wide range of applicant organizations such as state, local, and tribal governments; public and private institutions of higher education; nonprofits (including 501(c)(3) and non-501(c)(3) entities); for-profit organizations (other than small businesses); small businesses; and other eligible applicants as further defined in the full announcement.
Overall, the program is best understood as a targeted push to overcome the scientific and technical barriers that currently limit SSC-based strategies for preserving and restoring male fertility. By prioritizing long-term SSC culture and expansion, methods to prevent cancer cell carryover, and human-relevant SSC applications for drug and toxicity testing, the FOA aims to move the field toward safer, more effective, and more clinically meaningful options for men whose fertility is at risk.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Spermatogenic Stem Cell Culture Systems to Preserve and Restore Reproductive Capacity in Males (R01)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR 16-114.
Which agency is offering this grant?
This is a U.S. National Institutes of Health (NIH) funding opportunity under the U.S. Department of Health and Human Services (HHS-NIH).
What type of grant mechanism is being used?
The funding mechanism is an NIH R01 (Research Project Grant).
What is the public health motivation behind this FOA?
The central motivation is to preserve and restore male fertility, especially for males whose reproductive capacity is threatened or harmed by disease or medical treatments (such as chemotherapy and radiation). The FOA aims to strengthen the biology and technical toolkit around spermatogenic stem cells (SSCs) to support fertility preservation and fertility restoration.
What are spermatogenic stem cells (SSCs)?
SSCs are the foundational stem cell population in the testes that sustains sperm production over a male's lifetime. Because they are responsible for ongoing spermatogenesis, SSCs are a key focus for fertility preservation and restoration research.
What kinds of projects are emphasized as responsive to this FOA?
Projects are expected to advance the science and technical methods needed to work with SSCs, with a major emphasis on developing reliable long-term culture systems that maintain SSC viability and function while enabling SSC expansion over extended periods.
What does "long-term culture systems" mean in this context?
It refers to laboratory methods that can keep SSCs alive, stable, and functional outside the body for long durations, while allowing researchers to increase the number of SSCs available for downstream applications.
Why is SSC long-term culture and expansion considered a bottleneck?
SSCs can be difficult to sustain outside the body, and they may lose important properties if culture conditions are not carefully optimized. Long-term maintenance and expansion are often limiting steps in turning SSC-based concepts into practical, real-world clinical options.
What scientific challenges does the FOA expect applicants to address for SSC culture?
Examples of challenges highlighted include maintaining SSC "stemness," preserving genetic and epigenetic integrity during prolonged culture, controlling differentiation, and developing reproducible protocols that could ultimately support translational pathways.
Does this FOA include safety-related research for cancer patients?
Yes. A key area is developing methods to remove malignant (cancer) cells from SSC cultures, particularly relevant when SSCs may come from individuals exposed to chemotherapy and/or radiation.
Why is removing malignant cells from SSC cultures important?
A major safety concern in fertility preservation for cancer patients is the risk of reintroducing disease if tumor cells contaminate SSC cultures that might later be used for reintroduction or restorative approaches. The FOA encourages strategies that can eliminate malignant contamination while preserving SSC function.
What types of approaches to remove malignant cells are mentioned?
The FOA points to approaches such as improved cell sorting, molecular targeting, selective culture conditions, and other decontamination and validation techniques, as long as they demonstrate meaningful improvements in safety and effectiveness.
Is the FOA only about fertility restoration?
No. While fertility preservation and restoration are central, the FOA also highlights the value of SSC systems (including those derived from adult human males) as tools for drug development and toxicity testing.
How can human SSCs support drug development and toxicity testing?
Animal models do not always predict human reproductive biology accurately. Improved human SSC systems could provide more predictive platforms to screen compounds, study reproductive toxicology, and investigate mechanisms of germ cell damage or protection in a human-relevant context.
What conventional assisted reproductive technologies does the FOA mention as alternatives it hopes to reduce reliance on?
The FOA references conventional assisted reproductive technologies such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), and it frames SSC advances as a path that could help couples have genetically related children without relying on those approaches.
What is the activity category associated with this opportunity?
The opportunity is listed under the "Health, Income Security and Social Services" activity category.
What CFDA number is associated with this grant?
The associated CFDA number is 93.865.
When was this opportunity posted?
The opportunity was posted (and created) on February 25, 2016.
What is the closing date for this opportunity?
The original and current closing date listed is June 5, 2018.
What is the maximum award amount (award ceiling) listed?
The listed award ceiling is $300,000 (as provided in the source data).
Who is eligible to apply?
Eligibility is broad and includes state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; and other eligible applicants as further defined in the full announcement.
Are small businesses eligible?
Yes. Small businesses are explicitly included in the eligibility list.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible separately.
Are nonprofit organizations eligible?
Yes. Both 501(c)(3) and non-501(c)(3) nonprofit organizations are included.
Are government entities eligible?
Yes. State, local, and tribal governments are included among eligible applicants.
What is the overall goal of the program described in this FOA?
The program is a targeted effort to overcome scientific and technical barriers that limit SSC-based strategies for preserving and restoring male fertility. It prioritizes long-term SSC culture and expansion, methods to prevent cancer cell carryover, and human-relevant SSC applications for drug and toxicity testing, aiming to move toward safer, more effective, and clinically meaningful options.
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