FR 2021-03532

Summary of the Document

The document from the Food and Drug Administration (FDA) announces an extension of the public comment period for a concept paper titled "Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed." Initially, this comment period was set to conclude on April 12, 2021, following the paper's publication on January 11, 2021. However, in response to requests for more time, the deadline has been extended to June 11, 2021. This extension allows stakeholders an additional 60 days to submit their feedback, either electronically or in paper form.

Significant Issues and Concerns

One notable issue with the document is the lack of clarity regarding the FDA's criteria for setting or extending comment periods. There is no explanation given as to why the original 90 days were deemed insufficient or why an additional 60 days is considered adequate. This lack of transparency could lead to ambiguity and concerns about the fairness or standards applied in decision-making.

Moreover, the instructions for submitting comments, particularly confidential information, involve multiple intricate steps. For some respondents, especially those unfamiliar with such processes, this could be confusing and deter participation. While the document provides detailed guidance on submission formats and marking confidential submissions, it may benefit from simplification or further clarification to minimize misunderstandings.

The assurance that confidential information will not be disclosed except under specific laws might not fully clarify how these laws affect submissions, potentially causing uncertainty among commenters about the security of their sensitive information.

Impact on the Public Broadly

For the general public, this document represents an opportunity to participate in the regulatory process by providing input on a significant issue—the use of antimicrobial drugs in animal feed. While the extension allows more time for input, the complexity of the submission process might deter participation from individuals without specialized knowledge or legal assistance. Hence, there may be limited public engagement from broader communities unless adequately informed and supported.

Impact on Specific Stakeholders

For specific stakeholders, such as farmers, veterinarians, and pharmaceutical companies involved in livestock operations, the extension provides additional time to craft comprehensive responses. These stakeholders may appreciate the opportunity to voice their perspectives and concerns, which could directly influence the FDA's approach to the regulation of antimicrobial drug usage.

However, the detailed and challenging nature of the comment submission process might still discourage participation from smaller operations or those without extensive legal resources, potentially skewing feedback towards larger entities that can navigate these requirements more easily.

Overall, while the document represents a vital step in involving stakeholders in policy development concerning public health and food safety, it highlights challenges in accessibility and transparency that the FDA might address to ensure broad and equitable participation.