Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act April 2014
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineOffice of Regulatory AffairsCenter for Food Safety and Applied Nutrition
This guidance document provides updated information pertaining to the Food and Drug Administration’s (FDA) authority to access and copy records under sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is a revision of FDA’s November 2005 guidance entitled “Guidance for Industry and FDA Staff: Guidance for records access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.” FDA’s staff manuals, the Regulatory Procedures Manual (RPM) and Investigations Operations Manual (IOM), contain operational and procedural steps for FDA staff to follow for accessing records under sections 414 and 704 of the FD&C Act; therefore, that information has been removed from this guidance. Both the RPM and IOM are located on FDA’s website, www.fda.gov.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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:
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-2011-D-0674.