Opportunity Information: Apply for PA 06 363
Apply for PA 06 363
- The National Institutes of Health in the education employment, labor and training health income security and social services sector is offering a public funding opportunity titled "NIH Clinical Trial Planning Grant Program (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.209 Contraception and Infertility Research Loan Repayment Program 93.213 Research and Training in Complementary and Integrative Health 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs 93.846 Arthritis, Musculoskeletal and Skin Diseases Research 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research 93.866 Aging Research.
- This funding opportunity was created on Dec 5, 2008 and posted on Apr 20, 2006.
- Applicants must submit their applications by Multiple Receipt Dates See Link to Full Announcement for details.. (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 $100,000.00 in funding.
- Eligible applicants include: County governments Others (see text field entitled Additional Information on Eligibility for clarification) State governments Public and State controlled institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Private institutions of higher education.
- Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply. Faith based or community based organizations can apply.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The NIH Clinical Trial Planning Grant Program (R34) is a one-year grant opportunity meant to help investigators get a Phase III clinical trial fully prepared and ready to launch. The central idea is to fund the nuts-and-bolts planning work that has to be in place before a large, definitive trial can responsibly begin. Rather than paying for the trial itself, the R34 is designed to support the structured planning activities that reduce risk, improve trial quality, and make sure the study is operationally realistic.
This FOA emphasizes concrete trial start-up development tasks. Applicants can use the award to assemble and organize the research team, clarify roles and responsibilities, and put the management and oversight structure in place. It also supports building or refining critical infrastructure such as data management systems, study monitoring plans, and operational workflows. Another major focus is recruitment planning: defining recruitment strategies, identifying study sites or populations, and working through the practical steps needed to enroll participants effectively and ethically. A key expected product is a finalized clinical trial protocol along with other essential study documents, often organized into a manual of operations and procedures (sometimes called a manual of procedures), which spells out how the trial will be conducted consistently across staff and sites.
Just as important is what the R34 is not meant to do. The announcement makes it clear that this planning grant is not intended for collecting preliminary data and is not a mechanism for pilot studies used to justify the rationale for the clinical trial. In other words, NIH is treating this as support for planning a Phase III trial when the scientific premise is already in place, and the remaining need is to finalize the design and operational plan to execute the trial at scale.
Applications submitted under this FOA are investigator-initiated and will be assigned to NIH Institutes and Centers using standard Public Health Service referral guidelines, along with alignment to specific program interests. Prospective applicants are encouraged to review participating Institutes and Centers and their special research interests, since fit with an Institute or Center can affect where the application is assigned and how it is reviewed within NIH program priorities. The mechanism used is the NIH R34 Clinical Trial Planning Grant.
Funding is limited and time-bounded. The total project period is one year, and applicants may request up to $100,000 in direct costs for that one-year period. The FOA also notes that award size and number of awards can vary depending on application quality, proposed scope, duration, and costs, but the stated ceiling is $100,000 direct costs. Renewal applications are not permitted, meaning this is a one-time planning award rather than a multi-year or renewable mechanism.
Eligibility is broad and includes for-profit and nonprofit organizations as well as public or private institutions such as universities, colleges, hospitals, and laboratories. Government entities are eligible at multiple levels, including state and local units and eligible federal agencies. The FOA also explicitly allows applications from domestic and foreign institutions and organizations, and it includes faith-based and community-based organizations. Tribal governments (federally recognized and otherwise) and tribally designated organizations are also eligible.
For leadership eligibility, any individual with the appropriate skills, knowledge, and resources to carry out the proposed planning work may serve as Project Director/Principal Investigator (PD/PI), working through their institution to apply. NIH continues to encourage applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities. Applicants may submit more than one application as long as each application is scientifically distinct.
Administrative details in the source listing indicate the opportunity is a discretionary grant program from the National Institutes of Health, with multiple receipt dates (rather than a single deadline) referenced in the full announcement. The FOA is identified as PA 06-363, and it is associated with several CFDA numbers spanning different NIH research areas (for example, aging research, child health and human development, neurosciences, arthritis and musculoskeletal diseases, alcohol research, drug abuse, and communication disorders), reflecting that multiple NIH components may participate depending on topic and fit.
In practical terms, a competitive R34 application is typically one that shows the Phase III trial concept is mature and justified, then lays out a clear one-year plan to finish the trial blueprint: finalize the protocol, lock down procedures, create the operational manual, establish data and safety oversight approaches, and produce realistic recruitment and management plans that would enable a subsequent full-scale clinical trial to proceed efficiently and with strong quality control.
NIH Clinical Trial Planning Grant Program (R34) FAQ
What is the NIH Clinical Trial Planning Grant Program (R34)?
The NIH Clinical Trial Planning Grant Program (R34) is a one-year grant mechanism designed to support the detailed planning work needed to prepare a Phase III clinical trial so it is ready to launch. It focuses on practical start-up and operational development tasks rather than funding the trial itself.
What is the main purpose of this R34 opportunity?
The purpose is to fund the nuts-and-bolts planning activities that must be completed before a large, definitive Phase III clinical trial can responsibly begin. The goal is to reduce risk, improve trial quality, and ensure the study is operationally realistic.
How long is the project period for this R34?
The total project period is limited to one year.
How much funding can an applicant request?
Applicants may request up to $100,000 in direct costs for the one-year project period. The FOA notes that award size and number of awards may vary depending on factors such as application quality, scope, duration, and costs, but the stated ceiling is $100,000 in direct costs.
Does this R34 pay for running the Phase III clinical trial?
No. This R34 is intended to support planning and start-up development activities so the Phase III trial is ready to launch, but it is not designed to fund the conduct of the full trial itself.
What kinds of activities does the R34 support?
This FOA emphasizes concrete trial start-up and development tasks, such as organizing the research team, defining roles and responsibilities, establishing management and oversight structures, developing or refining data management systems, creating study monitoring plans, and building operational workflows.
Does the R34 support recruitment planning?
Yes. Recruitment planning is a major focus, including defining recruitment strategies, identifying study sites or target populations, and working through practical steps needed to enroll participants effectively and ethically.
What deliverables or products are expected from an R34 planning award?
A key expected product is a finalized clinical trial protocol. The FOA also emphasizes development of essential study documents, often organized into a manual of operations and procedures (also called a manual of procedures), describing how the trial will be conducted consistently across staff and sites.
Is creating a manual of operations/procedures part of the intended scope?
Yes. The FOA highlights the importance of producing essential study documents, commonly assembled into a manual of operations and procedures, to standardize how the trial will run across personnel and locations.
Can R34 funds be used to collect preliminary data?
No. The FOA states that this planning grant is not intended for collecting preliminary data.
Is the R34 a mechanism to run a pilot study to justify the Phase III trial?
No. The FOA is explicit that the R34 is not a mechanism for pilot studies used to justify the rationale for the clinical trial. NIH treats this as planning support when the scientific premise is already in place.
What trial phase is this R34 intended to support?
This R34 is intended to prepare a Phase III clinical trial for launch by funding the planning activities needed to finalize design and operational readiness.
Are applications investigator-initiated?
Yes. Applications submitted under this FOA are investigator-initiated.
How are applications assigned within NIH?
Applications are assigned to NIH Institutes and Centers using standard Public Health Service referral guidelines, along with alignment to specific program interests.
Why does Institute/Center fit matter for this FOA?
The FOA encourages applicants to review participating Institutes and Centers and their special research interests, because fit with an Institute or Center can affect where an application is assigned and how it is reviewed within NIH program priorities.
What is the FOA identification number?
The FOA is identified as PA 06-363.
Is this a discretionary grant program and which agency is offering it?
Yes. The listing describes it as a discretionary grant program from the National Institutes of Health (NIH).
Are there multiple receipt dates or a single deadline?
The source listing indicates there are multiple receipt dates referenced in the full announcement rather than a single deadline.
Are renewal applications allowed?
No. Renewal applications are not permitted, meaning this is a one-time planning award rather than a renewable, multi-year mechanism.
Which organizations are eligible to apply?
Eligibility is broad and includes for-profit and nonprofit organizations, as well as public or private institutions such as universities, colleges, hospitals, and laboratories.
Are government entities eligible?
Yes. Government entities are eligible at multiple levels, including state and local units and eligible federal agencies.
Can foreign institutions or organizations apply?
Yes. The FOA explicitly allows applications from domestic and foreign institutions and organizations.
Are faith-based and community-based organizations eligible?
Yes. The FOA includes faith-based and community-based organizations as eligible applicants.
Are Tribal governments and tribally designated organizations eligible?
Yes. Tribal governments (federally recognized and otherwise) and tribally designated organizations are explicitly included as eligible.
Who can serve as the Project Director/Principal Investigator (PD/PI)?
Any individual with the appropriate skills, knowledge, and resources to carry out the proposed planning work may serve as PD/PI, applying through their institution.
Does NIH encourage applications from underrepresented groups?
Yes. NIH encourages applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities.
Can an applicant submit more than one application under this FOA?
Yes. Applicants may submit more than one application as long as each application is scientifically distinct.
What makes an R34 application competitive based on this description?
A competitive application typically shows that the Phase III trial concept is mature and justified, and provides a clear one-year plan to finalize the trial blueprint. This includes finalizing the protocol, locking down procedures, creating the operational manual, establishing data and safety oversight approaches, and producing realistic recruitment and management plans so the subsequent full-scale trial can proceed efficiently with strong quality control.
Why does NIH fund a planning grant instead of only funding the full trial?
Based on the FOA description, the R34 is meant to support structured planning activities that reduce risk and improve trial quality by ensuring that critical operational and oversight elements are in place before a large Phase III study begins.
What NIH research areas might this FOA cover?
The FOA is associated with several CFDA numbers spanning different NIH research areas (for example, aging research, child health and human development, neurosciences, arthritis and musculoskeletal diseases, alcohol research, drug abuse, and communication disorders). This reflects that multiple NIH components may participate depending on topic and fit.
Browse more opportunities from the same category: Education Employment, Labor and Training Health Income Security and Social Services
Next opportunity: Cell Lineage and Developmental Studies in Hearing and Balance (R21)
Previous opportunity: Planning Grants For Translational Research For The Prevention And Control Of Diabetes And Obesity (R34)
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 PA 06 363
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PA 06 363) also looked into and applied for these:
| Funding Opportunity |
|---|
| NIH Clinical Trial Planning Grant Program (R34) Apply for PA 09 186 Funding Number: PA 09 186 Agency: National Institutes of Health Category: Education Employment, Labor and Training Health Income Security and Social Services Funding Amount: $100,000 |
| Mentored Research Scientist Development Award (Parent K01) Apply for PA 11 190 Funding Number: PA 11 190 Agency: National Institutes of Health Category: Education Employment, Labor and Training Health Income Security and Social Services Funding Amount: Case Dependent |
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 "PA 06 363", 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.