🧪FDA Notice
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
Summary
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 information collection associated with implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The proposed collection of information for Clinical Laboratory Improvement Amendments (CLIA) involves compliance and regulatory requirements affecting laboratory testing facilities. These become critical for businesses involved in diagnostic device manufacturing and testing, creating financial implications due to associated costs and burdens outlined in the text.