Opportunity Information: Apply for RFA HL 11 009
Apply for RFA HL 11 009
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Planning Grants for Pivotal Clinical Trials in Hemoglobinopathies (R34)" 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 8, 2010 and posted on Apr 8, 2010.
- Applicants must submit their applications by Sep 14, 2010. (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 $450,000.00 in funding.
- Eligible applicants include: Public and State controlled institutions of higher education Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments For profit organizations other than small businesses Small businesses Independent school districts Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Private institutions of higher education Native American tribal governments (Federally recognized) State 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
Planning Grants for Pivotal Clinical Trials in Hemoglobinopathies (R34) is a National Heart, Lung, and Blood Institute (NHLBI) funding opportunity under the National Institutes of Health (NIH) that focuses on helping research teams get high-quality, Phase II and Phase III clinical trials in major hemoglobin disorders ready to launch. The central idea is not to pay for running a full pivotal trial right away, but to fund the critical planning, preparatory work, and targeted preliminary studies needed to design a strong, feasible, and scientifically defensible clinical trial in sickle cell disease (SCD) and the thalassemias. In practical terms, the program supports efforts that answer key design questions that can make or break a later trial, such as refining eligibility criteria, selecting and validating endpoints, confirming recruitment feasibility, standardizing procedures across sites, and resolving operational or statistical uncertainties before large amounts of money and patient participation are committed.
This opportunity uses the NIH R34 Clinical Trial Planning Grant mechanism. R34 awards are commonly used to support activities that sit between early-stage research and an actual multi-site clinical trial. For this specific announcement, the goal is to develop studies and planning products that directly enable robust pivotal trials. Typical deliverables for an R34 planning grant often include an implementable clinical protocol, a detailed manual of operations, a data and safety monitoring approach, a recruitment and retention plan, a finalized statistical analysis plan, and readiness steps such as site selection and harmonized data collection tools. The emphasis is on producing a trial design that is realistic, ethically sound, and statistically powered to answer an important clinical question in hemoglobinopathies.
The funding information indicates NHLBI intended to commit up to $4.65 million in total costs over three years for this initiative. For fiscal year 2011, NHLBI anticipated awarding up to $1.55 million to support about six applications, although actual awards depended on available funds and the quality of applications received. The listed award ceiling is $450,000, which signals that budgets were expected to be moderate and focused on planning activities rather than full-scale trial implementation.
Eligibility is broad and includes many types of organizations that can credibly carry out clinical trial planning work. Eligible applicants include public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and various levels of government (state, county, city/township, special district governments), as well as independent school districts and public housing authorities/Indian housing authorities. The announcement also explicitly references additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribal organizations (including federally recognized tribal governments), regional organizations, faith-based or community-based organizations, eligible federal agencies, and U.S. territories or possessions. There is no cost sharing or matching requirement, meaning applicants were not required to provide matching funds as a condition of receiving the grant.
Administratively, this is a discretionary grant opportunity in the health area, tied to CFDA 93.839 (Blood Diseases and Resources Research). The funding opportunity number is RFA-HL-11-009. It was posted on April 8, 2010, with an original and current closing date of September 14, 2010, and an archive date of October 15, 2010, indicating that the competition is historical rather than currently open. The full announcement was made available through the NIH grants guide, and contact support for access or linking issues was directed to the NIH Office of Extramural Research (OER) webmaster.
Overall, the opportunity is best understood as targeted support for teams that are close to being ready for a pivotal SCD or thalassemia clinical trial but still need to settle the crucial scientific and logistical details. By funding that planning phase, NHLBI aimed to improve the quality, feasibility, and eventual impact of later Phase II/III trials in these high-need blood disorders.
Frequently Asked Questions (FAQs)
What is the "Planning Grants for Pivotal Clinical Trials in Hemoglobinopathies (R34)" opportunity?
It is a National Heart, Lung, and Blood Institute (NHLBI) funding opportunity under the National Institutes of Health (NIH) that supports clinical trial planning work for major hemoglobin disorders. The focus is on getting high-quality Phase II and Phase III (pivotal) clinical trials in sickle cell disease (SCD) and the thalassemias ready to launch by funding planning, preparation, and targeted preliminary studies.
What is the main purpose of this R34 planning grant?
The purpose is to fund the critical planning and preparatory work needed to design a strong, feasible, and scientifically defensible pivotal trial. This program is not intended to pay for running the full pivotal trial; instead, it supports activities that settle key design and operational questions before major resources and patient participation are committed.
Which diseases or conditions are targeted by this opportunity?
This opportunity targets major hemoglobin disorders, specifically sickle cell disease (SCD) and the thalassemias.
What trial phases does this opportunity aim to enable?
The opportunity is intended to enable robust Phase II and Phase III clinical trials by supporting planning and preparatory work that makes those pivotal studies feasible and well-designed.
Does this grant pay for conducting the full clinical trial?
No. The central idea is not to fund the execution of a full pivotal trial right away. It funds planning activities and targeted preliminary studies intended to directly support a later Phase II/III trial.
What kinds of planning activities are supported?
Supported activities include efforts to answer key trial design questions and resolve uncertainties that can affect the success of a later pivotal trial. Examples described in the opportunity include refining eligibility criteria, selecting and validating endpoints, confirming recruitment feasibility, standardizing procedures across sites, and resolving operational or statistical uncertainties.
What are examples of typical deliverables for an R34 clinical trial planning grant in this program?
Typical deliverables often include an implementable clinical protocol, a detailed manual of operations, a data and safety monitoring approach, a recruitment and retention plan, a finalized statistical analysis plan, and readiness steps such as site selection and harmonized data collection tools.
What does "R34 Clinical Trial Planning Grant" mean in this context?
R34 is an NIH grant mechanism commonly used to support work that sits between early-stage research and an actual multi-site clinical trial. For this announcement, it is used to develop studies and planning products that directly enable strong pivotal clinical trials in hemoglobinopathies.
How much funding was NHLBI planning to commit overall?
NHLBI intended to commit up to $4.65 million in total costs over three years for this initiative.
How many awards were anticipated and at what funding level?
For fiscal year 2011, NHLBI anticipated awarding up to $1.55 million to support about six applications, depending on available funds and the quality of applications received.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $450,000, suggesting budgets were expected to be moderate and focused on planning rather than full-scale trial implementation.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement, meaning applicants were not required to provide matching funds as a condition of receiving the grant.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and various government entities (state, county, city/township, and special district governments), as well as independent school districts and public housing authorities/Indian housing authorities.
Are minority-serving institutions and tribal organizations included in the eligibility list?
Yes. The opportunity explicitly references eligible applicants 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 tribal organizations including federally recognized tribal governments.
Are faith-based or community-based organizations eligible?
Yes. The eligibility list explicitly includes faith-based or community-based organizations.
Are U.S. territories or possessions eligible to apply?
Yes. The announcement explicitly references U.S. territories or possessions as eligible applicants.
What is the funding opportunity number for this announcement?
The funding opportunity number is RFA-HL-11-009.
What is the CFDA number and program area associated with this opportunity?
The opportunity is tied to CFDA 93.839, titled Blood Diseases and Resources Research.
What agency is offering this grant?
This is an NIH opportunity offered through the National Heart, Lung, and Blood Institute (NHLBI).
When was this opportunity posted and when did it close?
It was posted on April 8, 2010. The original and current closing date listed is September 14, 2010, with an archive date of October 15, 2010.
Is this funding opportunity currently open?
Based on the listed closing date (September 14, 2010) and archive date (October 15, 2010), this competition is historical rather than currently open.
Where was the full announcement made available?
The full announcement was made available through the NIH grants guide.
Who was the listed contact for access or linking issues?
For access or linking issues, the opportunity directed users to contact the NIH Office of Extramural Research (OER) webmaster.
What type of grant is this described as administratively?
It is described as a discretionary grant opportunity in the health area.
What kind of teams is this opportunity designed to support?
It is intended for teams that are close to being ready for a pivotal sickle cell disease or thalassemia trial, but still need to resolve crucial scientific, statistical, and logistical details to produce a realistic, ethically sound, and well-powered trial design.
Browse more opportunities from the same category: Health
Next opportunity: Effective Strategies to Reduce Motor Vehicle Injuries Among American Indians/Alaska Natives
Previous opportunity: ROSES 2010 Heliophysics Theory
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA HL 11 009
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (RFA HL 11 009) also looked into and applied for these:
| Funding Opportunity |
|---|
| Effective Strategies to Reduce Motor Vehicle Injuries Among American Indians/Alaska Natives Apply for CDC RFA CE10 1001 Funding Number: CDC RFA CE10 1001 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $70,000 |
| Integrating HIV Care and Treatment within the Network of Facilities Offering TB Treatment and Providing Technical Assistance to the Ministry of Health Toward Strengthening the National TB/HIV System in Haiti Under the President s Emergency Plan for A Apply for CDC RFA PS10 1011 Funding Number: CDC RFA PS10 1011 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: Case Dependent |
| Health Careers Opportunity Program Apply for HRSA 10 119 Funding Number: HRSA 10 119 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Cooperative Agreements for the National Suicide Prevention Lifeline Crisis Center Follow Up Apply for SM 10 014 Funding Number: SM 10 014 Agency: Substance Abuse Mental Health Services Adminis. Category: Health Funding Amount: $60,000 |
| The NEI Mentored Clinical Scientist Development Program Award (K12) Apply for PAR 10 166 Funding Number: PAR 10 166 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Fetal Alcohol Spectrum Disorders Apply for HRSA 10 034 Funding Number: HRSA 10 034 Agency: Health Resources and Services Administration Category: Health Funding Amount: $478,000 |
| Knowledge Synthesis Center for Evaluating Genomic Application in Practice and Prevention (U18) Apply for RFA GD 10 001 Funding Number: RFA GD 10 001 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $500,000 |
| FY10 Announcement of Availability of Funds for Adolescent Family Life (AFL) Demonstration Projects Apply for PA APH 10 001 Funding Number: PA APH 10 001 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $600,000 |
| Ryan White Part B Supplemental Apply for HRSA 10 165 Funding Number: HRSA 10 165 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Future Competitive Procurement for Regional HIV Prevention Program in Central America and Mexico Apply for RFA 596 10 000001 Funding Number: RFA 596 10 000001 Agency: El Salvador USAID San Salvador Category: Health Funding Amount: $30,000,000 |
| Development and Dissemination of Evidence Based Clinical Care Guidelines for Muscular Dystrophies Apply for CDC RFA DD10 1012 Funding Number: CDC RFA DD10 1012 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $350,000 |
| Addressing Syndemics Through Program Collaboration and Service Integration (PCSI) Apply for CDC RFA PS10 10175 Funding Number: CDC RFA PS10 10175 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $400,000 |
| Nurse Faculty Loan Program Apply for HRSA 10 142 Funding Number: HRSA 10 142 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Tribal Management Grant Program Apply for HHS 2011 IHS TMD 0001 Funding Number: HHS 2011 IHS TMD 0001 Agency: Indian Health Service Category: Health Funding Amount: $100,000 |
| Grants to Support the Historically Black Colleges and Universities Health Serv Apply for CMS 1I0 10 011 Funding Number: CMS 1I0 10 011 Agency: Centers for Medicare Medicaid Services Category: Health Funding Amount: $100,000 |
| Grants to Support the Hispanic Health Services Research Grant Program Apply for CMS 1H0 10 011 Funding Number: CMS 1H0 10 011 Agency: Centers for Medicare Medicaid Services Category: Health Funding Amount: $100,000 |
| AHRQ Small Research Grant Program (R03) Apply for PAR 10 168 Funding Number: PAR 10 168 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: $100,000 |
| Institutional Training for a Dental and Craniofacial Research Workforce (T90/R90) Apply for PAR 10 170 Funding Number: PAR 10 170 Agency: National Institutes of Health Category: Health Funding Amount: $800,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Training for a Dental and Craniofacial Research Workforce (T32) Apply for PAR 10 171 Funding Number: PAR 10 171 Agency: National Institutes of Health Category: Health Funding Amount: $800,000 |
| Preparedness and Emergency Response Learning Centers (PERLC) Apply for CDC RFA TP10 1001 Funding Number: CDC RFA TP10 1001 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $905,987 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA HL 11 009", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.