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# FDA Defers New Drug Manufacturing Reporting Deadline
- URL: https://www.fdaweb.com/fda-defers-new-drug-manufacturing-reporting-deadline/
- Published: 2022-02-17T12:00:00.000Z
- Updated: 2026-09-14T17:33:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151189

FDA is backpedaling on new requirements for annual drug manufacturing reporting that were mandated by the CARES Act to help the agency get a handle on potential drug shortages. Last October, FDA announced the availability of a “NextGen Portal” for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should use the portal to submit annual reports as required under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, FDA said at the time.

The agency also released two related guidances to assist registrants. The [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-amount-listed-drugs-and-biological-products-under-section-510j3-federal-food-drug-and?ref=fdaweb.com) *Reporting* *Amount* *of* *Listed* *Drugs* *and* *Biological* *Products* *Under* *Section* *510(j)(3)* *of the FD&C Act Guidance for Industry* describes the process that should be used for reporting by each person who registers with FDA. The [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-amount-listed-drugs-and-biological-products-technical-conformance-guide?ref=fdaweb.com) *Reporting* *Amount* *of* *Listed* *Drugs* *and* *Biological* *Products Technical Conformance Guide* describes **1)** how first-time users can access FDA’s CDER NextGen 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.

The agency now says it is considering comments submitted by industry and that the 2/15 recommended reporting date for 2020 data is not a requirement. “We are carefully reviewing all issues raised by stakeholder comments to the docket, including regarding the recommended reporting timeframes,” an [FDA notice](https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-shortage-mitigation-efforts?ref=fdaweb.com) says. “We will consider updating the draft guidance's recommended timeframes for reporting, as appropriate, along with other issues raised by such stakeholder feedback.”

In an earlier comment [letter](https://downloads.regulations.gov/FDA-2021-D-1031-0021/attachment%5F1.pdf?ref=fdaweb.com), Pharmaceutical Research and Manufacturers of America said the reporting would be “exceedingly burdensome.” It noted that drug company data collection practices vary from product to product and company to company, and because of this variability in manufacturers’ data collection practices, “it is anticipated that implementing the 510(j)(3) reporting requirements will be exceedingly burdensome, particularly for complex supply chains. Therefore, to ensure that FDA and manufacturer resources are focused on those issues most critical to public health, PhRMA encourages FDA to take a phased approach to the implementation of these reporting requirements, to describe how the agency intends to use the reported data to mitigate against drug shortages, and to focus the agency’s limited resources on the optimization of existing quality oversight tools and initiatives that will have the greatest impact in enabling FDA and manufacturers to prevent and mitigate drug shortages.” Additional specific comments were provided by the [Biotechnology Innovation Organization](https://downloads.regulations.gov/FDA-2021-D-1031-0012/attachment%5F1.pdf?ref=fdaweb.com) and [Pfizer](https://downloads.regulations.gov/FDA-2021-D-1031-0016/attachment%5F1.pdf?ref=fdaweb.com)