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GUIDANCE DOCUMENT

Release of ORA Laboratory Analytical Results to the Responsible Party Guidance for Food and Drug Administration Staff March 2019

Final

Release of ORA Laboratory Analytical Results to the Responsible Party

Docket Number:
FDA-2019-D-1163
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs
Center for Tobacco Products
Center for Devices and Radiological Health

This document provides guidance for FDA staff regarding the release of final and, in some circumstances, preliminary Office of Regulatory Affairs (ORA) laboratory analytical results to the responsible party. This policy applies to samples collected during FDA regulatory activities and analyzed in ORA laboratories.  It applies to FDA personnel assigned to deliver and discuss ORA laboratory analytical results with the responsible party. The policy does not require the responsible party to file a Freedom of Information Act (FOIA) request for the records.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1163.