FR 2021-03254

The Federal Register document announced by the Food and Drug Administration (FDA) pertains to a routine update involving information collection oversight. Specifically, the FDA is informing the public about various information collections that have been recently approved by the Office of Management and Budget (OMB), a procedure mandated by the Paperwork Reduction Act of 1995. This process requires any collection of information by federal agencies to be reviewed and approved to ensure they are necessary and not overly burdensome for the public.

General Summary

The announcement by the FDA includes a list of information collections that have been examined and given the green light by the OMB. Each item in this list has a particular OMB control number and an expiration date that delineates the period for which the approval remains valid. The document reassures that the FDA will not conduct or compel responses to any information collection unless it has a valid OMB control number. This ensures transparency and accountability in governmental data gathering processes.

Significant Issues or Concerns

The document does not raise overt concerns or issues but rather serves as a reminder of legal compliance and procedural transparency. A notable point is the emphasis on the necessity of a valid OMB control number, which acts as a safeguard for individuals and organizations against unauthorized data collection attempts. However, some stakeholders may find the frequent updates and the need to locate OMB control numbers burdensome, particularly those frequently interacting with FDA data collection protocols.

Impact on the Public

For the general public, this document provides assurance that there are checks and balances in place regarding government data collection. Individuals can feel confident that any information submitted to the FDA is standardized and monitored, upholding a balance between necessary data collection and privacy concerns. The public can ascertain more details via the referenced online resources, enabling transparency and accessibility.

Impact on Specific Stakeholders

For stakeholders like pharmaceutical companies, researchers, and healthcare providers, this document represents standard regulatory notification. These entities are often required to submit data to the FDA and must, therefore, be diligent in ensuring compliance with any new collections marked by the control numbers. While the process may demand administrative attention, it also presents an assurance that the data they submit falls within a regulated framework, potentially reducing redundancy and increasing efficiency in governmental data requests.

In summary, the FDA’s notice reflects a standard procedural update that underscores regulatory compliance and reinforces the commitment to organizational transparency. While it may represent procedural complexity for some stakeholders, it ultimately serves the beneficial purpose of regulation and accountability in FDA data collection practices.