Guidance for Food and Drug Administration Field Offices on “Regulatory Procedures Manual, Chapter 9, Subchapter, ‘Import for Export’”; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for FDA Field Offices entitled "Regulatory Procedures Manual, Chapter 9, Subchapter, `Import for Export'." This final guidance is a revision of the FDA Office of Regulatory Affairs' Regulatory Procedures Manual, Chapter 9, "Import Operations/Actions," Subchapter, "Import for Export," to provide guidance to the FDA Field Offices regarding the handling of products offered for import into the United States under section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act (the act). The revision is necessary because of the enactment of section 322 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188, signed into law on June 12, 2002. Section 322 amends section 801(d)(3) of the act and is effective September 9, 2002.