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GUIDANCE DOCUMENT

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide Guidance for Industry February 2024

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center 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 This guide supplements the draft guidance for industry Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (October 2021).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.

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

 
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