Overview
Title
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
Agencies
ELI5 AI
The FDA wants to know what people think about some new rules for keeping track of who makes blood products and certain medical devices. This helps them check the places where these things are made to make sure everything is safe.
Summary AI
The Food and Drug Administration (FDA) has announced an opportunity for the public to comment on a proposed information collection related to establishment registration and product listing requirements for manufacturers of human blood, blood products, and licensed devices. This notice, part of the Paperwork Reduction Act of 1995, allows 60 days for public input. Comments can be submitted electronically via the Federal eRulemaking Portal or by mail, with detailed instructions provided by the FDA. The purpose of this information collection is to aid the FDA in inspecting facilities and ensuring the safety of the nation's blood supply.
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 the information collection requirements pertaining to establishment registration and product listing for manufacturers of human blood and blood products and licensed devices.
Keywords AI
Sources
AnalysisAI
The document in question is an announcement from the Food and Drug Administration (FDA), a part of the Department of Health and Human Services, inviting public comment on a proposed information collection related to the registration and product listing for manufacturers of human blood, blood products, and licensed devices. This request for public input is based on the Paperwork Reduction Act of 1995, which necessitates federal agencies to publish notice whenever they propose collecting information from the public, to allow input within a 60-day period.
General Summary
The FDA's notice details the procedures through which comments can be submitted, either electronically or in written form, with a deadline set for April 19, 2021. The primary goal of this information collection is to assist the FDA in conducting facility inspections and ensuring the safety of the blood supply across the nation. The document specifies that this process assists in maintaining a regulatory framework that ensures the quality and safety of blood products.
Significant Issues or Concerns
A significant issue with the document is the complexity and possibly overwhelming nature of the submission instructions. Portions concerning electronic submissions and handling confidential submissions are complex, potentially hindering public participation due to misunderstandings or intimidation by the procedural demands.
Additionally, while the document notes an adjustment in the estimated burden based on data from 2019, it briefly mentions a slight increase in submissions without providing a detailed explanation. This could leave some readers questioning the relevance and significance of this increase in the broader context of regulatory affairs.
Public Impact
For the broader public, the document represents an opportunity for involvement in government processes affecting public health, albeit through a highly technical and potentially cumbersome mechanism. Because the subject matter touches on the safety and regulation of blood products, an area critical to public health, the implications are significant, particularly concerning consumer safety and confidence in medical products and services.
Stakeholder Impact
For specific stakeholders such as blood and plasma donor centers, blood banks, and other related organizations, the impact could be profound, as registering and updating product listings are crucial for ongoing compliance with FDA regulations. This document reflects the regulatory expectation placed on these establishments to stay current with their registrations, indicating a continued burden in terms of administrative demand.
On the positive side, clear and structured regulations can help ensure the safety of blood products, which directly benefits both consumers and healthcare providers by maintaining trust in the safety and efficacy of these essential health products.
In conclusion, while the document serves an essential role in regulatory procedures, its complexity may limit the potential for broad public engagement without additional efforts by the FDA to clarify and simplify the process.
Issues
• The document does not provide detailed information on the specific costs associated with the information collection activities, making it difficult to assess potential wasteful spending.
• There is no indication of specific organizations or individuals being favored in the document; however, the document lacks clarity on how the information might be utilized in specific scenarios which might indirectly benefit some parties.
• Some portions of the text, such as the description of electronic submissions and the procedures for confidential submissions, are complex and may be difficult for the general public to fully understand.
• The document could benefit from clearer language regarding the burden estimate adjustment explanation based on 2019 data, as it briefly notes a slight increase without further elaboration.
• The document is lengthy and includes numerous regulatory references (21 CFR and 44 U.S.C.) which may not be immediately accessible or understandable to all stakeholders without background knowledge.
• The instructions for submitting confidential information might be considered complex and could be simplified for better comprehension.