Overview
Title
Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Information for Participation in the Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
Agencies
ELI5 AI
The FDA wants people to tell them what they think about collecting info for a program where people get to learn and train with them. They're asking everyone to share their thoughts on this by March 9, 2021.
Summary AI
The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection for its Non-Employee Fellowship and Traineeship Programs. Under the Paperwork Reduction Act of 1995, federal agencies must allow a 60-day public comment period for such collections. The purpose is to evaluate the necessity and utility of the information collection, which involves forms for starting, administering, coordinating, and exiting the fellowship and traineeship programs. Comments can be submitted electronically or in written form by March 9, 2021.
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 "Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs."
Keywords AI
Sources
AnalysisAI
The document from the Federal Register presents a notice from the Food and Drug Administration (FDA) regarding a proposed collection of information related to its Non-Employee Fellowship and Traineeship Programs. The FDA is seeking public comments on this proposed collection to comply with the Paperwork Reduction Act of 1995, which mandates federal agencies to allow a 60-day period for public comment on such matters.
Summary of the Document
The notice outlines the various types of information the FDA plans to collect from participants in its fellowship and traineeship programs. This includes information necessary to initiate participation, manage the programs, coordinate training, and complete the exit process. The information spans from personal details and health insurance proof to emergency contacts and financial data for stipend payments. The FDA is requesting input from the public on the necessity and effectiveness of this data collection, aiming to ensure it is practical, efficient, and not overly burdensome.
Significant Issues and Concerns
Several aspects of the document raise potential issues:
Complex and Bureaucratic Language: The document's dense administrative language may be difficult for the general public to grasp fully. This complexity might deter meaningful participation in the commenting process.
Undefined Terms and Privacy Concerns: Terms like "confidential information" are not sufficiently defined, which could lead to inconsistencies in handling sensitive submissions. Additionally, the document lacks clear guidance on the privacy and security measures that will protect sensitive data, such as Social Security numbers and health insurance details.
Justification and Necessity: Some of the information requested, such as social history and travel preferences, lacks a clear justification. It remains opaque why such extensive personal details are crucial for the program's success.
Unclear Burden Estimate: The document does not elucidate an estimate of the burden placed on individuals participating in this information collection. The lack of explicit burden estimates leaves respondents unsure about the potential workload.
Broader Impact on the Public
The public's understanding and engagement with this document could be limited due to its complexity and lack of clarity on several fronts. Individuals interested in participating in the FDA's fellowship and traineeship programs may find the requirements and processes cumbersome without a streamlined explanation. Clarity and simplification of the document could improve public participation and compliance.
Impact on Specific Stakeholders
For potential participants in the FDA's programs, the document represents both an opportunity and a challenge. On one hand, it outlines a structured pathway to engage with the FDA in scientific and policy-oriented training programs. On the other hand, the complex requirements and extensive data collection could discourage potential applicants, particularly those concerned about personal privacy and data security.
For the FDA, obtaining useful feedback through public comments offers a chance to refine and tailor this information collection process. If the agency considers and addresses concerns raised during the comment period, it could lead to enhanced program administration and participant satisfaction.
Overall, while this document serves the critical function of collecting input on program logistics and information handling, it would benefit from greater clarity and simplification to enhance understanding and engage broader public participation.
Issues
• The document contains a significant amount of administrative and bureaucratic language, which could be complex or difficult for some readers to understand.
• There is potential for ambiguities in defining terms like 'confidential information' which can lead to inconsistencies in how submissions are handled.
• Details about the necessity and practicality of collecting certain information, such as emergency contact information and travel preferences, are not clearly justified in the document.
• The burden estimate for the information collection process is not explicitly outlined, leaving the reader without an understanding of the potential workload for respondents.
• Descriptions of application processes and necessary documents, such as for travel and training requests, could be simplified to increase clarity and accessibility.
• The text refers to multiple forms and data collection without providing concrete examples or templates, which can make it difficult for applicants to understand what is expected.
• There is no discussion of data privacy and security precautions related to the collection and handling of sensitive information like Social Security numbers and health insurance details.
• The necessity and benefit of collecting extensive personal information such as relationship history and social history in an FDA Health Summary are not clearly explained.