Overview
Title
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files
Agencies
ELI5 AI
The FDA wants to know what people think about new rules for animal medicines and how to organize their paperwork. They are asking for ideas on how to make these tasks easier and better, and people have until the end of February 2025 to share their thoughts.
Summary AI
The Food and Drug Administration (FDA) is opening the floor for public comments about a new collection of information related to animal drugs and veterinary master files. This initiative is part of the Paperwork Reduction Act, requiring federal notices about such collections and giving the public 60 days to comment. The FDA aims to gather insights on whether the information collection is necessary, its accuracy, and how to minimize the efforts needed from participants. Interested parties can submit their comments electronically or in written form by February 28, 2025.
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information associated with new animal drug applications and veterinary master files.
Keywords AI
Sources
AnalysisAI
The document in question is an official notice from the Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services. It invites public commentary on an upcoming collection of information concerning new animal drugs and veterinary master files. This public consultation period, lasting 60 days, is mandated by the Paperwork Reduction Act, which requires federal agencies to seek public input on proposed information collection activities. While the technical nature of this document may serve to ensure a comprehensive consultation, it inevitably presents challenges for a broad audience.
General Summary
The document provides the public an opportunity to comment on the FDA's proposed methods for collecting information associated with applications for animal drugs and veterinary master files. The FDA seeks feedback on the necessity and accuracy of the proposed information collection, as well as strategies to streamline it. The public is invited to submit comments electronically or via written submissions by February 28, 2025.
Significant Issues and Concerns
Several areas within the document present potential challenges for understanding due to technical jargon and procedural details:
Complex Language and Terminology: Terms such as "OMB Control Number," "21 CFR 514," and "FD&C Act" can be unfamiliar to those outside legal or regulatory fields, potentially alienating lay readers.
Confidentiality Ambiguities: The process for confidential or public submissions is detailed but could benefit from clearer explanations, especially concerning what qualifies as confidential information and how it is safeguarded.
Regulatory References: Citations of specific legal provisions without contextual explanation make it difficult for readers not versed in legal jargon to fully grasp the document’s implications.
Impact on the General Public
For the general public, particularly those involved with animal health and pharmaceutical industries, this document marks an important chance to influence how new animal drug-related information is collected and managed. The complexities of the document may limit engagement to those with prior knowledge or vested interests, limiting the potential breadth of public participation.
Impact on Specific Stakeholders
Animal Pharmaceutical Industry: For professionals developing or manufacturing new animal drugs, the document outlines critical procedural updates that could streamline drug approval processes and foster greater regulatory transparency.
Regulatory and Legal Experts: These stakeholders will have to navigate the technical language to assess how proposed changes align with existing laws, possibly influencing policy compliance strategies.
Pet Owners and Farmers: Indirectly affected, these groups might benefit from improved drug safety and efficacy resulting from enhanced regulatory oversight and a more refined approval process driven by public and industry feedback.
Overall, while the document serves an essential regulatory function, elevated by its requirement under the Paperwork Reduction Act, its accessibility to general audiences might be hampered by technical legal language and complex submission processes. This complexity underscores the need for clear, accessible communication from regulatory bodies to ensure effective public engagement and oversight.
Issues
• The document includes terminology and references that might be complex and difficult for general public understanding, such as mentions of 'OMB Control Number,' '21 CFR 514,' and 'FD&C Act.'
• There is potential ambiguity regarding the confidentiality of submissions, especially concerning what constitutes 'confidential information' and how it is protected.
• The process for submitting comments, especially the distinction between public and confidential submissions, might benefit from clearer guidelines or simpler language to help stakeholders understand their options and responsibilities.
• The document references multiple forms and guidance documents like 'Form FDA 356v' and 'FDA Guidance #152,' which are mentioned with URLs for access. Users unfamiliar with these documents might find this information necessary but insufficiently explained.
• There are references to specific sections of regulations (e.g., '21 U.S.C. 360b' or '21 CFR 558.5(i)') without explanations, making it difficult for those not familiar with legal texts to understand their implications.
• The estimated burden numbers and calculations for respondents might seem opaque to readers without context or expertise in regulatory processes.
• The document mentions a decrease in overall burden hours but an increase in responses without providing detailed context, which could appear contradictory or confusing.