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OMB Control No: 0910-0491	ICR Reference No: 202011-0910-005
Status: Historical Active	Previous ICR Reference No: 202001-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Shortages Data Collection
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Emergency	Approval Requested By: 11/20/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/24/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/18/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	6 Months From Approved	02/28/2023
Responses	9,145	0	780
Time Burden (Hours)	2,481	0	390
Cost Burden (Dollars)	0	0	0

Abstract: 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.

Emergency Justfication: 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.

Authorizing Statute(s): US Code: 21 USC 393(d)(2) Name of Law: Food, Drug, and Cosmetic Act

Citations for New Statutory Requirements: US Code: 21 USC 356c Name of Law: FFDCA

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Notification under 506J
Shortages Data Collection System

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	9,145	780	8,365
Annual Time Burden (Hours)	2,481	390	2,091
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

Annual Cost to Federal Government: $810,915

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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