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 waiver’s 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