Overview
Title
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
Agencies
ELI5 AI
The FDA wants to hear from people about a plan that asks tobacco companies to give them information so they can figure out how much money these companies should pay. People can share their thoughts by the end of June 2025.
Summary AI
The Food and Drug Administration (FDA) is seeking public comments on a proposed collection of information under the Paperwork Reduction Act. This initiative focuses on the requirements for domestic manufacturers and importers of tobacco products to submit data for calculating user fees. The FDA provides numerous ways for interested parties to submit their feedback, either electronically or via written submissions, by June 30, 2025. The notice also details changes in the estimated burden hours related to these submissions and highlights specific sections of the Federal Food, Drug, and Cosmetic Act that govern the collection of tobacco user fees.
Abstract
The Food and Drug Administration (FDA or Agency) 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 "Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products."
Keywords AI
Sources
AnalysisAI
The document from the Federal Register, issued by the Food and Drug Administration (FDA), seeks public input on a proposed information collection related to user fees for domestic manufacturers and importers of tobacco products. This initiative is part of the FDA's commitment to transparency and regulatory compliance under the Paperwork Reduction Act. The FDA requires these entities to submit data that are crucial for calculating the required user fees, which are mandated by the Federal Food, Drug, and Cosmetic Act. Public comments are invited until June 30, 2025, allowing stakeholders a 60-day window to contribute.
The document presents several issues that could affect its accessibility and clarity for the general public. Notably, it contains legal citations and jargon such as "21 CFR 1150.5" and "21 U.S.C. 387s," which may not be easily understood by individuals without a legal background. Such complexity can hinder public engagement and understanding, potentially limiting meaningful contributions from affected parties.
Moreover, there is some ambiguity around the reductions in the number of respondents required for compliance with certain Code of Federal Regulations (CFR) provisions. The lack of clear criteria or explanation could lead to confusion about the rationale behind these changes. The document assumes a level of familiarity with the Paperwork Reduction Act and the Federal Food, Drug, and Cosmetic Act, which may not be realistic for all readers. This assumption can further create barriers to understanding, particularly for individuals and businesses unfamiliar with federal regulations.
The estimated burden hours and number of respondents have shifted, but the document does not thoroughly explain these variations. Without a clear rationale, stakeholders may question the validity and reliability of these estimates, influencing trust and compliance with the proposed requirements.
For the general public, this document represents an opportunity to engage with federal regulatory processes, potentially influencing how tobacco user fees are calculated and implemented. However, the technical nature of the content could discourage wider participation, especially from individuals without specialized knowledge.
Specific stakeholders, such as tobacco manufacturers and importers, might be directly affected by these proposals. Positively, clearer and potentially streamlined processes could emerge from the feedback, improving operational efficiency. On the negative side, adjustments could also lead to increased responsibilities or costs if the requirements are deemed more burdensome than necessary.
In summary, while the document opens the floor for public engagement, its complex language and assumed familiarity with federal regulations could limit effective participation. Addressing these concerns in future communications could enhance the reach and effectiveness of such regulatory initiatives.
Issues
• The document uses complex language and legal references such as '21 CFR 1150.5' and '21 U.S.C. 387s', which may not be easily understandable to the general public.
• There is ambiguity in the section about reducing the number of respondents for certain CFR provisions, which might lead to confusion about the FDA's criteria and reasoning behind these decisions.
• The document assumes familiarity with the PRA and FD&C Act without providing sufficient explanation, making it less accessible to readers not familiar with those regulations.
• The rationale behind the variations in the estimated burden hours and number of respondents is not thoroughly explained, potentially leading to questions about the validity of these estimates.
• Instructions on how to submit comments with confidential information are detailed but could benefit from simplification to improve public understanding and compliance.