Overview
Title
Information Collection: NRC Form 483, “Registration Certificate-In Vitro Testing with Byproduct Material Under General License”
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The NRC wants to keep collecting forms from doctors and labs who use special materials for tests, to make sure they can use them safely. They are asking for ideas on this plan until February 11, 2021.
Summary AI
The U.S. Nuclear Regulatory Commission (NRC) has requested a renewal of an information collection with the Office of Management and Budget (OMB) for NRC Form 483, titled "Registration Certificate—In Vitro Testing with Byproduct Material Under General License." This renewal affects physicians, veterinarians, clinical laboratories, and hospitals that need a general license to use certain byproduct materials for in vitro testing. The NRC is accepting comments on this proposal until February 11, 2021 and encourages electronic submissions through the Federal Rulemaking website. The information collected helps ensure that license holders are authorized to handle specific materials, contributing to safety and regulatory compliance.
Abstract
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, NRC Form 483, "Registration Certificate--In Vitro Testing with Byproduct Material Under General License."
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Summary of the Document
This document is a notice from the U.S. Nuclear Regulatory Commission (NRC) regarding the renewal request for NRC Form 483. This form, titled "Registration Certificate—In Vitro Testing with Byproduct Material Under General License," is necessary for certain medical professionals and facilities. It allows physicians, veterinarians, clinical laboratories, and hospitals to legally use certain byproduct materials in in vitro testing under a general license. The NRC intends for this renewal to streamline the regulatory process and ensure that all license holders are authorized to handle these materials appropriately, thereby maintaining safety and compliance. The NRC invites public comments on the proposal until February 11, 2021, via their Federal Rulemaking website.
Issues and Concerns
Several issues within the document might confuse those unfamiliar with NRC processes. Primarily, there is a lack of clarity regarding what constitutes a 'byproduct material,' potentially leaving individuals unsure about the materials covered by the license.
Moreover, terms like "validated copy of the NRC Form 483" are repeatedly mentioned without explicating what validation involves or who is tasked with performing this validation.
The statement that "comments received after this date will be considered if it is practical to do so" leaves room for ambiguity, as it does not specify the criteria or decision-making process for considering late responses.
By not providing concrete examples of "certain small quantities of byproduct material," the document fails to explicitly define the limits of the license, potentially causing stakeholders uncertainty about what applications and materials are applicable under this form.
Additionally, while the document provides an estimate of 1.12 hours to comply with the information collection requirements, this may seem excessively precise and likely subject to variability across different entities or cases.
The phrasing "not involving the internal or external administration of the byproduct material or the radiation therefrom to human beings or animals" appears unnecessarily complex, which might confuse readers.
The process for obtaining the NRC Form 483 is not thoroughly outlined, particularly any steps or notifications required beyond submitting the form itself.
Lastly, the directive to report changes in writing within 30 days lacks specificity, as it does not mention acceptable methods or formats for submission.
Impact on the Public
For the general public, this document mainly serves as a procedural update, dovetailing with ongoing regulatory practices intended to ensure safety in the handling of certain radioactive materials. The emphasis on public comments reflects the NRC's interest in maintaining transparency and accountability.
Impact on Specific Stakeholders
For specific stakeholders such as physicians, veterinarians, clinical laboratories, and hospitals, this document could have practical implications. Positively, it ensures access to necessary materials for testing, reinforcing their ability to provide essential services. However, the nuanced procedural requirements and lack of clear guidance could pose compliance challenges, possibly leading to administrative delays or misunderstandings.
Furthermore, these stakeholders may bear the burden of navigating complex regulatory language and processes to secure the necessary authorizations, underscoring the importance of clear and accessible information from the NRC.
Issues
• The document refers to the NRC Form 483 and its use but does not clarify what a 'byproduct material' is, potentially leading to confusion for those unfamiliar with NRC terminology.
• The document mentions a 'validated copy of the NRC Form 483' multiple times without explaining what validation entails or who is responsible for it.
• The text notes that 'comments received after this date will be considered if it is practical to do so,' which is vague and leaves uncertainty about the criteria or process for consideration of late comments.
• No specific examples are given of the 'certain small quantities of byproduct material' referenced in the document, leaving the scope of what can be licensed under this form unclear.
• The estimated time for compliance is mentioned as '1.12 hours,' which seems unrealistically precise and might not reflect practical variations across different respondents.
• The phrase 'not involving the internal or external administration of the byproduct material or the radiation therefrom to human beings or animals' is complex and could be simplified for better understanding.
• The process for obtaining NRC Form 483 is not clearly detailed, especially concerning any preliminary steps or notifications required beyond the form submission.
• There is no specific guidance on how changes should be 'reported in writing to the NRC within 30 days,' lacking details on acceptable formats or channels.