FDA maintains a medical device database which allows FDA to identify locations and manufacturers of hard to locate medical devices in the context of a Federally-declared disaster/emergency, an official emergency preparedness exercise, or a potential public health risk posed by non-disaster-related device shortage. Because of the dynamic nature of the medical device industry, particularly with respect to specific product lines, manufacturing capabilities and raw material/subcomponent sourcing, it is necessary to update the data in the Emergency Shortages Data Collection System at regular intervals, but efforts are made to limit the frequency of outreach to a specific manufacturer to no more than every 4 months. The Emergency Shortages Data Collection System will only include those medical devices for which there will likely be high demand during a specific emergency/disaster, or for which there are sufficiently small numbers of manufacturers such that disruption of manufacture, or loss of one or more of these manufacturers would create a shortage.
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted on March 27, 2020. Section 3121 of the CARES Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 506J to the FD&C Act. Section 506J provides FDA with new authorities intended to help prevent or mitigate medical device shortages by requiring medical device manufacturers to inform FDA about changes in device manufacturing that could potentially lead to a device shortage. Apprised with that information, section 506J authorizes FDA to take several actions that may help to mitigate or avoid supply disruptions.
While FDA does have a waiver in place for certain collections during COVID-19, and while this waiver applies to guidance documents that relate to the COVID-19 pandemic public health emergency (PHE) response, recent discussions have raised questions regarding the waiverâs applicability to part of the collection in this guidance. Specifically, it was recently brought to our attention that the PRA waiver may not cover the mandatory collections under section 506J of the FD&C Act, but the waiver does cover voluntary collections related to section 506J.
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted on March 27, 2020. Section 3121 of the CARES Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 506J to the FD&C Act. Section 506J provides FDA with new authorities intended to help prevent or mitigate medical device shortages by requiring medical device manufacturers to inform FDA about changes in device manufacturing that could potentially lead to a device shortage. Apprised with that information, section 506J authorizes FDA to take several actions that may help to mitigate or avoid supply disruptions.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
0491 emergency request for FDCA sec. 506J PRA Memo 11-16-2020docx.docx
Shortages Data Collection System