Opportunity Information: Apply for PAR 14 346
Apply for PAR 14 346
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34)" 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.
- This funding opportunity was created on Sep 19, 2014 and posted on Sep 19, 2014.
- Applicants must submit their applications by Sep 7, 2017. (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 $150,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Special district governments County governments State 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 Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34) (Funding Opportunity Number PAR-14-346) is a National Institutes of Health discretionary grant designed to fund the up-front planning work needed before launching a full clinical trial or a biomarker clinical validation study in oral health and related conditions (CFDA 93.121, Oral Diseases and Disorders Research). The central goal is to help research teams build a complete, well-justified, operationally sound study package that can move smoothly into a subsequent trial or validation phase. Instead of paying for the trial itself, this R34 supports the structured development of the trial or validation study blueprint so that the later, larger application is more rigorous, feasible, and ready to implement.
The activities supported under this planning grant focus on producing the core documents and infrastructure that a future clinical study requires. This includes drafting a full clinical protocol and, when applicable, preparing a Clinical Investigators Brochure (or an equivalent document). It also covers the practical systems that make a study run correctly and safely, such as tools and plans for data management and quality control, along with safety monitoring and operational oversight plans. Applicants are expected to think through recruitment and retention in a realistic way, and to use the R34 period to develop detailed strategies for enrolling and keeping participants in the future study. The FOA also emphasizes building out the study team and producing other essential operational documents, including a draft Manual of Procedures that spells out how study activities will be carried out consistently across staff and, if relevant, across sites.
Just as important as what the R34 funds is what it does not fund. This planning grant is not meant for collecting preliminary efficacy data for an intervention, whether clinical or preclinical, and it is not intended to support prospective data collection to strengthen the scientific rationale for doing the study in the first place. In other words, it is not a mechanism for running a small proof-of-concept efficacy trial. The FOA draws a clear line between planning and hypothesis-testing: the R34 is there to design and prepare, not to generate early efficacy outcomes that would ordinarily belong in a different type of award. That said, the announcement notes one limited allowance: teams may evaluate a potential subject population to see whether participants are likely to be eligible for the future clinical trial or biomarker validation study. This kind of feasibility assessment is permitted but not required, and it is framed as eligibility evaluation rather than efficacy testing.
The FOA also distinguishes between biomedical trials/validation studies and certain behavioral and social intervention projects. For behavioral and social interventions, planning may sometimes include pilot testing of the intervention during the R34 period. However, those projects are directed to a separate funding opportunity (PAR-14-342) rather than this one. This is meant to ensure that applicants use the correct mechanism depending on whether the planning phase includes piloting behavioral/social intervention components.
From an administrative standpoint, this opportunity was posted on September 19, 2014, with an original and final closing date of September 7, 2017, and an archive date of October 8, 2017. The award ceiling listed is $150,000, and there is no cost-sharing or matching requirement. While the opportunity itself is archived, the structure provides a clear example of what NIDCR expects when it supports clinical study planning: a strong emphasis on protocol readiness, operational detail, safety and oversight, data and quality systems, and practical recruitment/retention planning, all aimed at positioning the project for a subsequent, fully powered clinical trial or biomarker clinical validation study application.
Eligibility is broad and includes many organization types across the public, private, nonprofit, and governmental spectrum. Eligible applicants include for-profit entities (other than small businesses), small businesses, nonprofits with and without 501(c)(3) status (other than institutions of higher education), public and private institutions of higher education, and a range of government bodies (state, county, city or township, special district governments, and independent school districts). It also includes public housing authorities/Indian housing authorities and multiple tribal entities, including federally recognized tribal governments and other Native American tribal organizations. The announcement explicitly includes a variety of institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, as well as eligible federal agencies and faith-based or community-based organizations. Importantly, non-U.S. entities are eligible: foreign organizations and foreign institutions may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement.
For further details, the FOA points applicants to the NIH grants page for PAR-14-346 and provides NIH Office of Extramural Research contact points for technical issues accessing the announcement.
Frequently Asked Questions (FAQ)
What is the NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34) (PAR-14-346)?
PAR-14-346 is a National Institutes of Health (NIH) discretionary funding opportunity from the National Institute of Dental and Craniofacial Research (NIDCR) that supports the up-front planning work needed before launching a full clinical trial or a biomarker clinical validation study in oral health and related conditions.
What is the main purpose of this R34 planning grant?
The central goal is to help research teams develop a complete, well-justified, operationally sound study package (a detailed blueprint) so a later, larger clinical trial or biomarker clinical validation study application is more rigorous, feasible, and ready to implement.
Does this award pay for the clinical trial or biomarker validation study itself?
No. This R34 is intended to fund structured planning and preparation, not the conduct of the full clinical trial or the full biomarker clinical validation study.
What kinds of planning activities does the R34 support?
Supported activities focus on producing the core documents and operational infrastructure required for a future clinical study. Examples described in the opportunity include developing a full clinical protocol, preparing a Clinical Investigators Brochure (or equivalent when applicable), and establishing practical systems and plans for running the study correctly and safely.
Is writing a full clinical protocol part of what this grant supports?
Yes. Drafting a full clinical protocol is specifically identified as a key deliverable supported by this planning grant.
What is a Clinical Investigators Brochure, and is it required?
The opportunity notes that the R34 can support preparing a Clinical Investigators Brochure (or an equivalent document) when applicable. The text does not state that it is always required in every case, but it is included as a planning activity when relevant to the proposed study.
Does the R34 support data management and quality control planning?
Yes. The announcement highlights tools and plans for data management and quality control as part of the practical systems a future study needs.
Are safety monitoring and operational oversight plans part of the expected planning work?
Yes. Safety monitoring and operational oversight planning are specifically called out as important components of the planning package.
Does the FOA emphasize recruitment and retention planning?
Yes. Applicants are expected to develop realistic, detailed strategies for recruiting and retaining participants for the future clinical trial or biomarker validation study.
Does this R34 support development of a Manual of Procedures (MOP)?
Yes. The FOA describes producing essential operational documents, including a draft Manual of Procedures, to ensure study activities are carried out consistently across staff and, if relevant, across sites.
Can the R34 be used to collect preliminary efficacy data for an intervention?
No. The opportunity explicitly states the R34 is not meant for collecting preliminary efficacy data, whether clinical or preclinical, and it is not intended to support prospective data collection to strengthen the scientific rationale for doing the study.
Is this R34 intended for a small proof-of-concept efficacy trial?
No. The FOA draws a clear line between planning and hypothesis-testing and states this mechanism is not for running a small proof-of-concept efficacy trial.
Can any prospective data collection be done during the R34 period?
The FOA generally states the R34 is not intended to support prospective data collection to strengthen scientific rationale or to generate efficacy outcomes. It does note a limited allowance related to evaluating a potential subject population for likely eligibility (a feasibility-style eligibility evaluation), which is permitted but not required.
What feasibility work is allowed under this R34?
The announcement allows (but does not require) evaluating a potential subject population to assess whether participants are likely to be eligible for the future clinical trial or biomarker clinical validation study. This is described as eligibility evaluation rather than efficacy testing.
How does this FOA treat behavioral and social intervention projects?
The FOA distinguishes this planning grant from certain behavioral and social intervention projects where planning may include pilot testing of the intervention during the R34 period. Those projects are directed to a separate funding opportunity, PAR-14-342, rather than PAR-14-346.
If a project includes pilot testing of a behavioral or social intervention during the planning phase, should PAR-14-346 be used?
Based on the text provided, behavioral and social intervention projects that include pilot testing during the R34 planning period are directed to PAR-14-342, not PAR-14-346.
What is the CFDA number and program area associated with this opportunity?
The CFDA listed is 93.121, Oral Diseases and Disorders Research.
What is the award ceiling for this opportunity?
The award ceiling listed is $150,000.
Is cost-sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
When was this funding opportunity posted, and what were the closing dates?
It was posted on September 19, 2014. The original and final closing date listed is September 7, 2017. The archive date is October 8, 2017.
Is this funding opportunity currently open?
No. The opportunity is described as archived, with an archive date of October 8, 2017.
What types of organizations are eligible to apply?
Eligibility is broad and includes many organization types across public, private, nonprofit, and governmental sectors. Examples listed include for-profit entities (other than small businesses), small businesses, nonprofits with and without 501(c)(3) status (other than institutions of higher education), public and private institutions of higher education, and a wide range of government bodies.
Which government entities are listed as eligible applicants?
The opportunity lists state governments, county governments, city or township governments, special district governments, independent school districts, and eligible federal agencies.
Are tribal entities eligible to apply?
Yes. The eligibility list includes federally recognized tribal governments and other Native American tribal organizations, and it also references tribally controlled colleges and universities.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are explicitly included in the eligible applicant types.
Are minority-serving institutions explicitly included?
Yes. The announcement explicitly includes multiple institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed as eligible.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The announcement states that foreign organizations and foreign institutions may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement.
Where can applicants find additional official details about PAR-14-346?
The FOA points applicants to the NIH grants page for PAR-14-346 for further details.
Who is listed for help with technical issues accessing the announcement?
The FOA provides NIH Office of Extramural Research contact points for technical issues related to accessing the announcement.
What does NIDCR appear to expect from a strong planning application under this model?
Based on the description, NIDCR emphasizes protocol readiness, operational detail, safety and oversight planning, data and quality systems, and practical recruitment and retention planning, all aimed at positioning the project for a subsequent fully powered clinical trial or biomarker clinical validation study application.
Browse more opportunities from the same category: Health
Next opportunity: Strengthening and Enhancing National HIV/AIDS Prevention, Diagnosis, Care, Treatment,
Previous opportunity: NIDCR Behavioral or Social Intervention Clinical Trial Planning Grant (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 PAR 14 346
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 14 346) also looked into and applied for these:
| Funding Opportunity |
|---|
| Strengthening and Enhancing National HIV/AIDS Prevention, Diagnosis, Care, Treatment, Apply for CDC RFA PS10 1009 I Funding Number: CDC RFA PS10 1009 I Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: Case Dependent |
| Building Genetics and Genomic Knowledge about Dental, Oral, and Craniofacial Diseases and Disorders (R01) Apply for PA 14 347 Funding Number: PA 14 347 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Supporting Implementation of Sustainable Blood Safety Activities in the Republic of Kenya under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH15 1545 Funding Number: CDC RFA GH15 1545 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $3,000,000 |
| Achieving and Sustaining TB/HIV Collaborative Activities in Cambodia under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH15 1507 Funding Number: CDC RFA GH15 1507 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $300,000 |
| Increasing Capacity of the Dominican Republic Ministry of Health in the Areas of Blood Safety, Monitoring and Evaluation, Epidemiology, and Health Information Systems under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH15 1518 Funding Number: CDC RFA GH15 1518 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $1,631,500 |
| Supporting Implementation of the National HIV and AIDS Strategic Plan (NSP) through Improving Coverage and Quality of HIV and AIDS Services and Strengthening Health Systems in Malawi under the President Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH15 1553 Funding Number: CDC RFA GH15 1553 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $8,000,000 |
| Support the Mandate of the Ministry of Health and Social Welfare in the United Republic of Tanzania to Improve the Quality, Responsiveness, Accessibility and Sustainability of the National Health Laboratory Services (NHLS) under the Presidents Emerge Apply for CDC RFA GH15 1587 Funding Number: CDC RFA GH15 1587 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $1,040,000 |
| Establishment of a Strategic Partnership to Strengthen the Council of Ministries of Health of Central America (COMISCA) in the Central America Region under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH15 1509 Funding Number: CDC RFA GH15 1509 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $418,824 |
| Service Area Competition Additional Areas (SAC AA) Baltimore, MD Gonzales, TX Los Angeles, CA and Minneapolis, MN Apply for HRSA 15 128 Funding Number: HRSA 15 128 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Nuclear Organization and Function Interdisciplinary Consortium (NOFIC)(U54) Apply for RFA RM 14 006 Funding Number: RFA RM 14 006 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Nucleomics Tools (U01) Apply for RFA RM 14 007 Funding Number: RFA RM 14 007 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Study of Nuclear Bodies and Compartments (U01) Apply for RFA RM 14 008 Funding Number: RFA RM 14 008 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| 4D Nucleome Imaging Tools (U01) Apply for RFA RM 14 009 Funding Number: RFA RM 14 009 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| 4D Nucleome Network Organizational Hub (U01) Apply for RFA RM 14 010 Funding Number: RFA RM 14 010 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| 4D Nucleome Network Data Coordination and Integration Center (U01) Apply for RFA RM 14 011 Funding Number: RFA RM 14 011 Agency: National Institutes of Health Category: Health Funding Amount: $2,500,000 |
| Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34) Apply for PAR 14 348 Funding Number: PAR 14 348 Agency: National Institutes of Health Category: Health Funding Amount: $100,000 |
| Model Organisms Screening Center for the Undiagnosed Diseases Network (UDN) (U54) Apply for RFA RM 14 016 Funding Number: RFA RM 14 016 Agency: National Institutes of Health Category: Health Funding Amount: $1,000,000 |
| NEI Institutional Mentored Physician Scientist Award (K12) Apply for PAR 14 352 Funding Number: PAR 14 352 Agency: National Institutes of Health Category: Health Funding Amount: $1,125,000 |
| Facile Methods and Technologies for Synthesis of Biomedically Relevant Carbohydrates (U01) Apply for RFA RM 14 015 Funding Number: RFA RM 14 015 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Novel and Innovative Tools to Facilitate Identification, Tracking, Manipulation, and Analysis of Glycans and their Functions (R21) Apply for RFA RM 14 014 Funding Number: RFA RM 14 014 Agency: National Institutes of Health Category: Health Funding Amount: $400,000 |
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 "PAR 14 346", 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.