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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Veterinary Medicine
FDA is issuing this Technical Conformance Guide (guide) to assist registrants of drug establishments (or their authorized agents) in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This guide supplements the draft guidance for industry Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (October 2021). The guide describes 1) how first-time users can access FDA’s CDER NextGen Portal (the portal) to submit these reports, 2) the different methods for submitting the reports through the portal, and 3) the data elements to be included in the reports.
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-2017-D-6821.