Description
In response to this RFI, respondents should submit a detailed statement that addresses their radiation dosimetry capabilities for nonclinical animal models and microphysiological systems (MPS). Where applicable, respondents should include the following information: Details about the radiation facility used for the respondents’ nonclinical radiation research, including the type of radiation source, calibration methods (including independent assessment of calibration and frequency of calibration), and maintenance procedures for the radiation source Experience with different animal species of nonclinical models in radiation research, whether real-time dosimetry is used while animals are irradiated, and whether or how energies are confirmed prior to irradiating the animals. Experience with radiation of MPS, whether real-time dosimetry is used, and whether or how energies are confirmed prior to irradiation, with or without continuous flow through the system. Methods used to establish consistent and accurate dosimetry exposures and field homogeneity for nonclinical radiation studies Key personnel capabilities, such as an on-site radiation physicist, in ensuring the facility is consistent with accepted dosimetry standards In addition to a capabilities statement, respondents are encouraged to provide information regarding their capabilities and expertise on the following topics: Variance in dosimetry measurements: Dose uniformity is critical to interpreting data collected from nonclinical models across multiple studies. Dosimetry measurements with < 5% variance from expected radiation dose is considered standard; variance at or near 1% is ideal. BARDA is interested in respondents’ methods to measure and verify the variance of their radiation source, as well as methods used to reduce variance. Tissue-mimicking phantoms: BARDA is interested in information about the process of fabricating and characterizing tissue-mimicking phantoms for dosimetry verification for multiple species, particularly for minipig and rabbit models. In addition to phantoms, BARDA is interested in respondents’ experience with other dosimetry tools, whether off-the-shelf or custom-designed, that could be used in a dosimetry harmonization effort across multiple institutions. If your institution has substantial dosimetry expertise and capabilities, experience with nonclinical models, and is interested in working with BARDA in developing standardized dosimetry guidelines for use across the BARDA portfolio, please provide the following information: Organization name, address, email address, website address, telephone number, and size and type of ownership for the organization. Current Government Contracts and Schedules or Other Relevant Government Wide Acquisition Contracts (GWAC) or schedule contracts such as GSA. Response statements tailored to addressing the particulars of this effort as outlined above, with appropriate documentation supporting claims of organizational and staff capability.