Shortages Data Collection

ICR 202104-0910-015

OMB: 0910-0491

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-05-25
IC Document Collections
ICR Details
0910-0491 202104-0910-015
Received in OIRA 202011-0910-005
HHS/FDA CDRH
Shortages Data Collection
Revision of a currently approved collection   No
Regular 05/26/2021
  Requested Previously Approved
36 Months From Approved 05/31/2021
18,800 9,145
5,200 2,481
0 0

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.

US Code: 21 USC 393(d)(2) Name of Law: Food, Drug, and Cosmetic Act
  
US Code: 21 USC 356c Name of Law: FFDCA

Not associated with rulemaking

  86 FR 10972 02/23/2021
86 FR 28116 05/25/2021
No

2
IC Title Form No. Form Name
Notification under 506J
Shortages Data Collection System

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 18,800 9,145 0 0 9,655 0
Annual Time Burden (Hours) 5,200 2,481 0 0 2,719 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects changes and adjustments. We have revised the information collection to include voluntary collection elements and provisions related to the CARES Act. This results in an adjustment of an additional 2,719 hours and 9,655 responses annually.

$1,393,010
No
    Yes
    No
No
No
No
Yes
Amber Sanford 301 796-8867 [email protected]

  No

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.
05/26/2021


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