Overview
Title
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
Agencies
ELI5 AI
The FDA wants to collect information about how people use certain animal medicines in ways they are not originally meant for. They need help figuring out how to check that these medicines are safe, and they're asking people to share their thoughts by February 12, 2021.
Summary AI
The Food and Drug Administration (FDA) is notifying the public about a proposed collection of information related to the extralabel use of drugs in animals that has been submitted to the Office of Management and Budget (OMB) for review. This request is part of the Paperwork Reduction Act of 1995 process. The proposal involves the FDA's ability to set safety levels for drug residues and require methods to detect them. Public comments on this collection of information can be submitted until February 12, 2021.
Abstract
The Food and Drug Administration (FDA 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 document in question is a notice from the Food and Drug Administration (FDA) concerning the collection of information related to the use of drugs in animals beyond their originally intended use, a practice known as "extralabel drug use." This information has been submitted to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act of 1995. The FDA is essentially looking to gather data on the necessity of developing analytical methods to detect drug residues that could pose a risk to public health.
General Summary
The FDA is responsible for ensuring the safety of drugs used in animals, which could potentially affect humans. The notice is part of a process that allows the use of approved drugs on animals in a way that was not initially intended, under specific conditions. It lays out FDA's capability to establish safety levels for drug residues in animal products and to require methods to identify these residues. Public input is invited on how to conduct this information collection, with a deadline for comments set for February 12, 2021.
Significant Issues and Concerns
A notable issue in the document is the assumption that drug sponsors will voluntarily develop the necessary analytical methodologies. There is no clear recourse mentioned if sponsors are unwilling, leaving potential gaps in executing safety measures. Additionally, terms such as "reasonable probability" and "risk to public health" are not explicitly defined, allowing for broad interpretation that could vary case-by-case. The lack of detailed criteria or parameters is potentially problematic, raising concerns about consistent application and interpretation.
Potential Impact on the Public
Broadly speaking, the move towards regulating drug residues in animals serves to protect public health by ensuring that any risks from consuming animal products with drug residues are minimized. This focus on safety could reassure consumers about the integrity of the food supply. However, if the costs for developing such methodologies are transferred in any way to the end consumer, there could be economic implications in terms of higher prices for animal products.
Impact on Specific Stakeholders
This notice could positively affect stakeholders such as animal health advocates by providing a framework to safeguard against potential risks of drug residues. Conversely, it may pose challenges for pharmaceutical companies, who might bear the costs of developing and implementing these analytical methods. Additionally, veterinarians and farmers could face increased regulatory scrutiny, potentially complicating their use of extralabel drugs.
In conclusion, while the FDA's actions as outlined in this document aim to enhance public health safety protocols related to animal drug residue, the underlying issues highlight the need for transparency and clarity, particularly in how these measures will be executed and funded. The outcome of this proposal will ultimately depend on the responses received during the public comment period and the subsequent actions taken by the FDA and OMB.
Issues
• The document does not specify the potential costs associated with the development of analytical methodology for detecting drug residues, which could lead to concerns about wasteful spending if the costs are high and the benefits are not clearly articulated.
• The document assumes that the sponsor of the drug will be willing to develop the method in most cases, but it does not specify what happens if a sponsor is unwilling to develop it, leading to potential ambiguity in execution of methodology development.
• There is no clear explanation of what happens after analytical methodology is developed, such as how the analytical results will be used or verified, which could be considered unclear or incomplete.
• The document mentions "reasonable probability" and "risk to public health" but does not define these terms or outline criteria used to evaluate them, which might lead to ambiguous interpretation.
• The document states that a third party may be involved in method development but does not describe the oversight or selection criteria for third parties, potentially leading to favoritism or unclear accountability.
• The document references a comment received during the public notice period that was not responsive but does not elaborate on why it was not responsive, which could be seen as lacking transparency.