Opportunity Information: Apply for PA 08 043

  • The National Institutes of Health in the education food and nutrition health income security and social services sector is offering a public funding opportunity titled "Human Pluripotent Stem Cell (hPSC) Research Using Non Embryonic Sources (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research 93.173 Research Related to Deafness and Communication Disorders 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs 93.389 National Center for Research Resources 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research 93.846 Arthritis, Musculoskeletal and Skin Diseases Research 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.855 Allergy, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research 93.859 Biomedical Research and Research Training 93.865 Child Health and Human Development Extramural Research 93.866 Aging Research 93.867 Vision Research.
  • This funding opportunity was created on Dec 5, 2008 and posted on Dec 13, 2007.
  • Applicants must submit their applications by Jan 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Public and State controlled institutions of higher education Special district governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education County governments Independent school districts.
  • Foreign institutions are eligible to apply.
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Opportunity Summary:

The Human Pluripotent Stem Cell (hPSC) Research Using Non Embryonic Sources (R01) opportunity (Funding Opportunity Number PA-08-043) is an NIH-wide program announcement designed to expand and accelerate research on human pluripotent stem cells that do not come from embryos. The core idea is to support studies that isolate, derive, produce, and test stem cells capable of generating all, or nearly all, of the body s cell types, while meeting a strict ethical constraint: the cells must be derived without creating a human embryo for research purposes and without destroying, discarding, or harming a human embryo. This initiative directly responds to Executive Order 13435, issued June 20, 2007, which directed the Department of Health and Human Services to conduct and support precisely this kind of non-embryonic pluripotent stem cell research because of its potential to improve understanding of disease and contribute to new treatments.

The announcement uses the NIH Research Project Grant (R01) mechanism, which is typically intended for more mature, hypothesis-driven projects with a well-developed research plan, appropriate preliminary data when relevant, and a scope that justifies a full research project grant. NIH also noted that this R01 opportunity runs in parallel with a separate but scientifically identical announcement using the R21 mechanism (PA-08-044), which is generally aimed at earlier-stage or higher-risk exploratory and developmental work. In practical terms, applicants with a more established body of preliminary findings and a larger, more comprehensive project would usually look to the R01, while applicants pursuing proof-of-concept or early feasibility studies might consider the R21 companion announcement.

The research scope is broad and NIH-wide, meaning multiple NIH institutes and centers can support projects under this umbrella so long as they fit the scientific goals and comply with the non-embryonic sourcing requirement. The listed CFDA program areas span many biomedical fields, including (among others) cardiovascular, lung, blood, diabetes and kidney diseases, neurological disorders, mental health, allergy and immunology, infectious diseases, aging, vision, child health and development, oral health, and communication disorders. That breadth signals that NIH was looking for pluripotent stem cell approaches that could apply across disease areas, from basic biology of pluripotency and differentiation to translational research that builds disease models, screens therapies, or advances regenerative strategies, provided the stem cells originate from non-embryonic sources consistent with the Executive Order.

Funding levels and the number of awards were not guaranteed in advance. Instead, NIH stated that awards would depend on the availability of funds and the number of meritorious applications received. This is a common NIH posture for program announcements, emphasizing that strong scientific and technical review outcomes, programmatic priorities, and budget realities will determine how many projects are ultimately supported.

Eligibility was expansive. A wide range of domestic applicant types could apply, including public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit organizations (including small businesses), independent school districts, various levels of government (state, county, city or township), special district governments, public housing authorities or Indian housing authorities, and eligible Native American tribal organizations and governments. Importantly, foreign institutions were also eligible to apply, which indicates NIH was open to supporting qualified international research efforts aligned with the FOA s requirements and NIH policies.

Key administrative details place the opportunity in the 2007 to 2011 timeframe. The opportunity was posted December 13, 2007, with an original and current closing date of January 7, 2011, and an archive date of February 7, 2011. The sponsoring agency is the National Institutes of Health, and the FOA is categorized as discretionary grant funding. For applicants needing the official full text, NIH provided the FOA page through its grants guide (PA-08-043) and directed technical access questions to the NIH Office of Extramural Research (OER) webmaster contact listed in the announcement.

In plain terms, this FOA aimed to grow a portfolio of rigorous, full-scale R01 research projects that could push pluripotent stem cell science forward without relying on embryonic sources, aligning federal support with the ethical and policy boundaries specified in Executive Order 13435 while still pursuing the medical promise of pluripotent stem cells for understanding and treating disease.

FAQs: Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources (R01) - PA-08-043

What is this funding opportunity?

This is an NIH-wide Program Announcement for the Research Project Grant (R01) mechanism titled "Human Pluripotent Stem Cell (hPSC) Research Using Non Embryonic Sources (R01)." The Funding Opportunity Number is PA-08-043.

What is the main goal of PA-08-043?

The goal is to expand and accelerate research on human pluripotent stem cells that do not come from embryos. The FOA supports research to isolate, derive, produce, and test pluripotent stem cells that can generate all, or nearly all, of the body's cell types, while complying with strict non-embryonic sourcing requirements.

What ethical constraint does the FOA require for stem cell sources?

The pluripotent stem cells must be derived without creating a human embryo for research purposes and without destroying, discarding, or harming a human embryo.

What policy or directive does this FOA respond to?

This initiative directly responds to Executive Order 13435 (issued June 20, 2007), which directed the Department of Health and Human Services to conduct and support non-embryonic pluripotent stem cell research due to its potential to improve understanding of disease and contribute to new treatments.

What grant mechanism does PA-08-043 use?

PA-08-043 uses the NIH Research Project Grant (R01) mechanism, typically intended for more mature, hypothesis-driven projects with a well-developed research plan and appropriate preliminary data when relevant.

Is there a companion funding opportunity related to this FOA?

Yes. NIH noted this R01 opportunity runs in parallel with a separate, scientifically identical announcement using the R21 mechanism: PA-08-044.

How should an applicant decide between the R01 (PA-08-043) and the R21 (PA-08-044)?

Based on the description provided, applicants with a more established body of preliminary findings and a larger, more comprehensive project would usually look to the R01. Applicants pursuing proof-of-concept or early feasibility studies might consider the R21 companion announcement.

Is this FOA limited to a specific NIH institute or disease area?

No. The FOA is NIH-wide and the scope is broad. Multiple NIH institutes and centers may support projects under this umbrella as long as the research fits the scientific goals and complies with the non-embryonic sourcing requirement.

What types of research topics are within scope?

The FOA supports studies to isolate, derive, produce, and test non-embryonic human pluripotent stem cells. The scope includes work ranging from basic biology of pluripotency and differentiation to translational research such as building disease models, screening therapies, or advancing regenerative strategies, as long as the stem cell sources meet the non-embryonic requirement.

Which biomedical program areas are associated with this opportunity?

The listed CFDA program areas span many biomedical fields, including cardiovascular, lung, and blood; diabetes and kidney diseases; neurological disorders; mental health; allergy and immunology; infectious diseases; aging; vision; child health and development; oral health; and communication disorders, among others.

Who is eligible to apply?

Eligibility is expansive and includes a wide range of domestic applicant types such as public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit organizations (including small businesses), independent school districts, and various levels of government (state, county, city or township), as well as special district governments, public housing authorities or Indian housing authorities, and eligible Native American tribal organizations and governments.

Are foreign institutions eligible to apply?

Yes. Foreign institutions are eligible to apply, indicating NIH openness to supporting qualified international research efforts aligned with the FOA requirements and NIH policies.

How much funding is available and how many awards will be made?

Funding levels and the number of awards were not guaranteed in advance. NIH stated that awards would depend on the availability of funds and the number of meritorious applications received.

What factors influence whether awards are made?

Based on the announcement description, awards depend on available funds and the number of meritorious applications received, which implies that scientific/technical review outcomes, programmatic priorities, and budget availability affect final award decisions.

When was this funding opportunity posted?

The opportunity was posted on December 13, 2007.

What were the closing dates for this FOA?

The original and current closing date listed was January 7, 2011.

When was the FOA archived?

The archive date listed was February 7, 2011.

Who is the sponsoring agency?

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

How is this funding categorized?

The FOA is categorized as discretionary grant funding.

Where can applicants find the official full text of the FOA?

Applicants were directed to the NIH grants guide FOA page for PA-08-043 to access the official full text.

Who should be contacted for technical access questions about the FOA page?

For technical access questions, the announcement directed users to the NIH Office of Extramural Research (OER) webmaster contact listed in the FOA.

In practical terms, what kind of projects did NIH want to fund through this FOA?

NIH aimed to build a portfolio of rigorous, full-scale R01 research projects that advance pluripotent stem cell science without relying on embryonic sources, aligning federal support with the ethical and policy boundaries described in Executive Order 13435 while pursuing the medical promise of pluripotent stem cells for understanding and treating disease.

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