Opportunity Information: Apply for PAR 11 204
Apply for PAR 11 204
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Early Phase Clinical Trials for Blood Cell Therapies (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on Apr 20, 2011 and posted on Apr 20, 2011.
- Applicants must submit their applications by Jan 7, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Independent school districts County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses City or township governments Special district governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non U.S.) components of U.S. Organizations are not allowed.
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Opportunity Summary:
Early Phase Clinical Trials for Blood Cell Therapies (R01) (Funding Opportunity Number PAR-11-204) was a discretionary grant opportunity from the National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI). The program used the Research Project Grant (R01) mechanism to support early-stage clinical testing of innovative blood cell-based therapies. The central purpose was to fund clinical trials that move promising cell-therapy concepts into humans for the first time or test them in early development, specifically through first-in-human studies, Phase I trials, and Phase II trials. The scientific focus was on treatments for blood diseases and on approaches intended to improve outcomes of hematopoietic stem cell transplantation (HSCT), including strategies that could make transplants safer, more effective, or more broadly applicable.
This opportunity fell under the Health funding activity category and was associated with CFDA number 93.839 (Blood Diseases and Resources Research). The announcement emphasized evaluation of novel or innovative cell therapies, meaning the expectation was not basic discovery work alone, but clinical trial-ready interventions with a rationale and plan to assess safety, feasibility, and early signs of biological activity or clinical benefit in humans. The R01 format indicates investigator-initiated proposals, where applicants design the protocol and the overall clinical development approach, rather than responding to a narrowly specified government-designed trial.
In terms of who could apply, eligibility was broad across U.S.-based organizations and institutions. Eligible applicants included state and local governments (such as state governments, county governments, city or township governments, special district governments, and independent school districts), public and state-controlled institutions of higher education, private institutions of higher education, and a wide range of nonprofit organizations (including both 501(c)(3) nonprofits and certain nonprofits without 501(c)(3) status, other than institutions of higher education). Small businesses and for-profit organizations (other than small businesses) were also listed as eligible, along with public housing authorities/Indian housing authorities. Tribal entities were included in multiple forms, such as federally recognized Native American tribal governments and other Native American tribal organizations. The eligibility section also explicitly named categories of institutions and organizations often referenced in federal funding policy, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. At the same time, the program restricted applications to domestic entities: non-U.S. (foreign) organizations were not eligible to apply, and foreign components of U.S. organizations were not allowed under this FOA.
Administratively, the opportunity did not require cost sharing or matching funds, which typically means applicants were not expected to contribute a specific percentage of project costs from non-federal sources as a condition of the award. The FOA was posted and created on April 20, 2011. The original and current closing date was January 7, 2013, and the opportunity was archived on February 7, 2013, indicating it is no longer open for applications. Additional details and the full official announcement were provided through the NIH Grants Guide link (http://grants.nih.gov/grants/guide/pa-files/PAR-11-204.html). For access or technical issues, the listed contact route was the NIH Office of Extramural Research (OER) webmaster email (FBOWebmaster@OD.NIH.GOV), which is typically used for troubleshooting electronic access to the announcement rather than scientific or grants management questions.
Overall, PAR-11-204 was designed to help bridge the gap between promising blood cell therapy concepts and real-world patient testing by funding early clinical trials that assess new cellular interventions for blood disorders and for improving hematopoietic stem cell transplantation outcomes, with wide U.S. institutional eligibility and no matching requirement, during its active window from 2011 through early 2013.
FAQs: Early Phase Clinical Trials for Blood Cell Therapies (R01) (PAR-11-204)
What is PAR-11-204?
PAR-11-204 is a National Institutes of Health (NIH) funding opportunity titled "Early Phase Clinical Trials for Blood Cell Therapies (R01)." It was administered by the National Heart, Lung, and Blood Institute (NHLBI) and used the Research Project Grant (R01) mechanism.
What is the main purpose of this funding opportunity?
The program was designed to support early-stage clinical testing of innovative blood cell-based therapies. Its core goal was to help move promising cell-therapy concepts into human testing, including first-in-human studies, Phase I trials, and Phase II trials.
What types of clinical trials were supported?
The announcement focused on early clinical development, specifically first-in-human studies and Phase I and Phase II clinical trials intended to evaluate safety, feasibility, and early signs of biological activity or clinical benefit in humans.
What scientific areas did PAR-11-204 focus on?
The scientific focus was on treatments for blood diseases and on strategies to improve outcomes of hematopoietic stem cell transplantation (HSCT), including approaches intended to make transplants safer, more effective, or more broadly applicable.
Does the FOA emphasize basic research or clinical testing?
The FOA emphasized evaluation of novel or innovative cell therapies in humans. It set an expectation for clinical trial-ready interventions with a rationale and a plan to assess safety, feasibility, and early signals of biological activity or clinical benefit, rather than basic discovery work alone.
What does the R01 mechanism mean in this context?
The R01 mechanism indicates investigator-initiated research. Under this format, applicants propose and design the clinical protocol and overall clinical development approach, rather than participating in a narrowly specified, government-designed trial.
Which NIH Institute was responsible for this opportunity?
This opportunity was offered by NIH, specifically through the National Heart, Lung, and Blood Institute (NHLBI).
What is the funding activity category for this program?
The program was categorized under the Health funding activity category.
What CFDA number is associated with this opportunity?
The opportunity was associated with CFDA number 93.839, titled "Blood Diseases and Resources Research."
Who was eligible to apply?
Eligibility was broad for U.S.-based organizations. Eligible applicants included state and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (including 501(c)(3) nonprofits and certain nonprofits without 501(c)(3) status other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); public housing authorities/Indian housing authorities; tribal governments and tribal organizations; U.S. territories or possessions; regional organizations; and eligible federal agencies.
Were specific institution types explicitly included?
Yes. The eligibility language explicitly included institution categories commonly referenced in federal funding policy, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.
Could non-U.S. (foreign) organizations apply?
No. Applications were restricted to domestic entities. Non-U.S. (foreign) organizations were not eligible to apply.
Were foreign components of U.S. organizations allowed?
No. The FOA stated that foreign components of U.S. organizations were not allowed.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching funds, meaning applicants were not expected to contribute a specified portion of project costs from non-federal sources as a condition of the award.
When was the FOA posted?
The FOA was posted and created on April 20, 2011.
What was the application deadline?
The original and current closing date listed for the opportunity was January 7, 2013.
Is this funding opportunity still open?
No. The opportunity was archived on February 7, 2013, which indicates it is no longer open for applications.
Where can the official announcement be found?
The full official announcement was provided through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-204.html
Who should be contacted for access or technical issues related to the announcement?
For access or technical issues, the contact route listed was the NIH Office of Extramural Research (OER) webmaster email: FBOWebmaster@OD.NIH.GOV.
What kind of support was this program intended to provide overall?
Overall, PAR-11-204 was intended to bridge the gap between promising blood cell therapy concepts and real-world patient testing by funding early clinical trials of new cellular interventions for blood disorders and for improving HSCT outcomes.
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