Opportunity Information: Apply for RFA FD 18 021
The Assuring Radiation Protection (U18) opportunity (RFA-FD-18-021) is a fiscal year 2018 cooperative agreement announced by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health (CDRH). The purpose is to strengthen and coordinate national radiation protection efforts by aligning Federal, State, and Tribal actions to better protect the public from radiation risks. This award is explicitly described as a single-source application that FDA intended to accept and consider only from the Conference of Radiation Control Program Directors, Inc. (CRCPD), reflecting CRCPD's long-standing role as a national coordinating forum for radiation control program leaders. The grant sits under CFDA 93.103 and is supported by FDA authority under Section 532 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ii) to maintain a comprehensive radiation control program, with general grants authority under Section 301 of the Public Health Service Act (42 U.S.C. 241). The funding opportunity was posted March 23, 2018, closed June 4, 2018, anticipated one award, and listed an award ceiling of $400,000.
At its core, the cooperative agreement is meant to keep Federal and State radiation programs working in sync as radiation technologies, medical practices, industrial uses, and security needs evolve. FDA frames this as a continuation of coordination mechanisms in place since 1968, when FDA began facilitating collaboration with agencies such as the Nuclear Regulatory Commission (NRC) and the Environmental Protection Agency (EPA), among others. The rationale is practical: radiation protection responsibilities are spread across different jurisdictions and agencies, so a structured forum helps avoid duplicated work, helps states share solutions, and allows limited resources to be used more efficiently. The notice also includes broad public health expectations consistent with Public Health Service policy, such as encouraging smoke-free workplaces and aligning with Healthy People 2010 health promotion objectives, which are standard grant-related policy statements rather than technical requirements of the radiation program itself.
The work described for CRCPD is wide-ranging and organized around a few proven coordination tools. One major mechanism is the use of committees and working groups made up primarily of representatives from State radiation control programs, with Federal participants serving as liaisons or advisors. These groups study specific radiation health and safety problems, draft recommendations, and pass them through a central management board before recommendations are relayed to relevant Federal, State, and Tribal entities. Another centerpiece is the planning and execution of a large annual meeting that typically runs about four days and draws roughly 350 participants. This meeting is intended to share study results, run workshops to define emerging issues, and hold clinics or demonstrations of practical radiological health techniques and systems. Beyond meetings, the agreement emphasizes ongoing education and outreach, including training courses and distribution of materials to help state programs and the public understand radiation exposure issues and effective mitigation strategies.
Programmatically, the cooperative agreement aims to coordinate Federal, State, and Tribal activities so that present and future radiation control problems are addressed with consistent approaches, shared data, and usable guidance. CRCPD is expected to recruit and organize state participation on committees, manage those committees, and facilitate consensus-based solutions across a wide spectrum of radiation topics. The announcement highlights three broad technical areas of interest. First is the application of x-rays in the healing arts, with attention to diagnostic radiology practices such as radiography, fluoroscopy, and computed tomography. Here, the work includes practice guidelines, quality assurance procedures, and evaluating patient exposures. A concrete deliverable embedded in this area is the expectation that the recipient will conduct surveys of a representative sample of medical x-ray facilities performing a specific diagnostic procedure, with the targeted procedures defined ahead of time and rotated over time so that exposure and practice trends can be monitored.
The second area covers medical and non-medical uses of ionizing radiation, and it also extends to non-ionizing radiation applications (the notice distinguishes these categories). The emphasis is on identifying issues and developing coordinated approaches not just for healthcare settings but also for broader uses where radiation may present occupational, consumer, or environmental concerns. The third area focuses on controlling and mitigating radiation exposure from all sources, which is where many cross-jurisdictional challenges show up. Examples named in the notice include responding to radiation accidents or incidents, evaluating whether state radiation control programs are adequate, overseeing radiation laboratory capabilities, and addressing residual radioactivity after decontamination and decommissioning of nuclear facilities. It also points to policy- and implementation-heavy topics, such as whether to delegate authority for Federal standards related to radionuclides regulated as hazardous air pollutants, and implementation of the Indoor Radon Abatement Act. CRCPD is additionally expected to review and comment on matters tied to radiological emergency preparedness and homeland security, reinforcing that the program is not only about routine regulation but also about readiness for high-impact events.
A significant, recurring deliverable under this cooperative agreement is the maintenance and updating of the Suggested State Regulations for the Control of Radiation (SSRCR). These are consensus-based model regulations intended to help states promote greater uniformity in how radiation hazards are managed across the country. The SSRCR scope is broad and includes low-level radioactive waste, radioactive contamination, radioactive materials regulation, radon, and x-rays in the healing arts. The agreement expects CRCPD to provide leadership to refresh prior guidance documents and keep SSRCR current as technologies, best practices, and Federal standards change. Importantly, the notice also expects CRCPD to create and operate a structured process for deciding when updates are needed, how to prioritize them, and when to develop entirely new SSRCR components, rather than relying on ad hoc revisions.
From an operations standpoint, the award anticipates substantial governance and coordination workload. CRCPD is told to plan for oversight and management of roughly 45 committees, and in some cases to provide representatives to certain Federal radiation committees. While voting membership on CRCPD committees is limited to state members, the model explicitly allows non-state and Federal representatives to participate as advisors. Those advisors help ensure recommendations align with Federal policies and regulations and may also serve as investigators, collaborators, or technical resources depending on the topic. The notice also leaves room for "special projects" that can be initiated as needs arise, with potential focus areas including radiation issues in the environment, healthcare, industry, and consumer products.
The annual meeting and related training requirements are described in fairly practical terms. CRCPD must handle the full administrative workload of the meeting, consult stakeholders to set priorities for the agenda, and use general sessions and workshops to surface new problems and share techniques and systems that could be adopted broadly. When a new issue emerges as a shared concern, it can be assigned to a task force or committee of experts for follow-on work. A specific dissemination requirement is that meeting proceedings be posted on the recipient's website for limited distribution to member states and relevant Federal personnel. Training is expected to be held in conjunction with the meeting, and FDA may also request CRCPD to provide instructors for other Federal training courses with radiological content outside the annual meeting cycle.
Finally, the opportunity includes an information access and technology component. CRCPD is expected to maintain a website that supports information sharing for states and other interested parties, with FDA project staff and designated Federal personnel granted full access to all materials relevant to the work supported by FDA and other contributing agencies. The site is expected to be reviewed and updated regularly, and the notice calls out the need for real expertise in website maintenance and security, signaling that information integrity and controlled access are considered part of successful program execution.
In short, this single-award U18 cooperative agreement is less about funding a single research project and more about sustaining the national coordination infrastructure for radiation protection: keeping expert committees operating, updating model state regulations, collecting and sharing practical data (including patient exposure-related surveys for medical x-ray procedures), delivering training, and convening a major annual meeting that helps Federal, State, and Tribal partners respond consistently to both routine and emerging radiation health and safety challenges.Apply for RFA FD 18 021
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Assuring Radiation Protection (U18)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Mar 23, 2018.
- Applicants must submit their applications by Jun 04, 2018. (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 $400,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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| Funding Opportunity |
|---|
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216 Funding Number: PAR 19 216 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
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