Overview
Title
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine
Agencies
ELI5 AI
The FDA wants to hear people's thoughts on how to resolve disagreements about animal-related products, like pet medicines, made by experts. They're trying to make sure the rules are clear so everyone knows how these arguments are handled.
Summary AI
The Food and Drug Administration (FDA) is seeking public feedback on a proposed information collection regarding dispute resolution procedures related to scientific decisions about products overseen by the Center for Veterinary Medicine. This effort is in line with the Paperwork Reduction Act of 1995. The FDA is specifically focusing on how disputes involving technical expertise and scientific controversies between product sponsors and the FDA are handled. Comments can be submitted online until March 24, 2021, and the guidance aims to clarify how existing regulations will be applied to internal reviews of agency decisions.
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Keywords AI
Sources
AnalysisAI
The Federal Register document issued by the Food and Drug Administration (FDA) informs the public about a proposed information collection related to the dispute resolution procedures for scientific decisions on products overseen by the Center for Veterinary Medicine (CVM). This action aligns with the requirements of the Paperwork Reduction Act of 1995, which aims to minimize the paperwork burdens on the public. The document solicits public feedback on the collection of information, with comments due by March 24, 2021.
General Summary
The FDA is focusing on processes that handle disagreements involving technical expertise and scientific controversies related to products regulated by the CVM. This involves guidance detailed in the Center for Veterinary Medicine Guidance for Industry #79, which provides a framework for addressing scientific disputes. The notice published in the Federal Register provides details for stakeholders—such as sponsors, applicants, or manufacturers of animal drugs—on how to request a review of a scientific disagreement if initial discussions do not resolve their concerns.
Significant Issues and Concerns
One notable issue with the document is its use of technical language, which may be challenging for individuals without a background in regulatory affairs or veterinary medicine to fully understand. Additionally, the process for submitting comments appears complex and may unintentionally deter public participation. It involves navigating through multiple online platforms and documents, possibly creating a barrier for some individuals.
Another concern is that the document reports no comments were received from a 60-day notice previously published, which may indicate low engagement or awareness among the public. This could be seen as a potential drawback in the effectiveness of the notice or the outreach efforts.
Impact on the Public
The document is part of an effort by the FDA to ensure transparency and provide clear pathways for resolving scientific disagreements, which can ultimately contribute to the safety and efficacy of veterinary products on the market. By structuring a formal mechanism for dispute resolution, the community involved in veterinary medicine and its stakeholders can have a clearer understanding of how decisions are made and reviewed within the FDA.
Impact on Specific Stakeholders
For sponsors, applicants, or manufacturers involved in the veterinary field, this document outlines a vital process for contesting decisions that impact their products. Having these procedures in place allows them to engage with the FDA in a structured manner, potentially ensuring fair consideration of their scientific evidence and arguments.
However, the complexity involved in this process might be a hurdle, especially for smaller companies or individuals unfamiliar with regulatory nuances. These stakeholders may require additional resources or support to navigate the procedures effectively.
In conclusion, the document serves as an important step towards establishing structured communication between the FDA and entities regulated by the CVM. By inviting public feedback, the FDA shows a commitment to refining its processes, although it must ensure that the channels for this engagement are accessible to all levels of stakeholders.
Issues
• The document contains technical language and references to regulations (21 CFR 10.75, Guidance for Industry #79) that may be difficult for the general public to understand without expertise in regulatory affairs or veterinary medicine.
• There is a reference to a 60-day notice in the Federal Register from August 18, 2020, where no comments were received. This might suggest low public engagement or awareness regarding the collection of information, which could be a point of concern.
• The procedural instructions for submitting comments are complex and require navigating through multiple platforms and documents, which may discourage public participation.
• The estimated burden error mentioned in the document was corrected but not detailed in the content, which might lead to confusion about what the original error was.
• The document does not provide any information or context on the potential impact (positive or negative) of the dispute resolution procedures, which could be important for stakeholders to understand.