Electronic Submission of Medical Device Registration and Listing

ICR 201904-0910-010

OMB: 0910-0625

Federal Form Document

ICR Details
0910-0625 201904-0910-010
Active 201603-0910-006
HHS/FDA CDRH
Electronic Submission of Medical Device Registration and Listing
Extension without change of a currently approved collection   No
Regular
Approved without change 06/17/2019
Retrieve Notice of Action (NOA) 05/21/2019
  Inventory as of this Action Requested Previously Approved
06/30/2022 36 Months From Approved 06/30/2019
186,230 0 180,585
93,798 0 99,470
0 0 0

This information collection request covers the reporting and recordkeeping provisions associated with FDA's implementation of sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which require that device establishment registrations and listings under section 21 U.S.C. 360(p) (including the submission of updated information) be submitted to the Secretary by electronic means, unless the Secretary grants a request for waiver of the requirement because the use of electronic means is not reasonable for the person requesting the waiver.

US Code: 21 USC 510(j)(2) Name of Law: null
   US Code: 21 USC 510(p) Name of Law: null
   US Code: 21 USC 510(b) Name of Law: null
  
None

Not associated with rulemaking

  83 FR 62583 12/04/2018
84 FR 20138 05/08/2019
No

  Total Approved 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 186,230 180,585 0 0 5,645 0
Annual Time Burden (Hours) 93,798 99,470 0 0 -5,672 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The following adjustments resulted in a 5,672-hour decrease to the overall total hour burden estimate for this ICR. -We adjusted the number of respondents based on updated registration and listing data. -In the reporting burden table, we corrected the table footnotes to accurately indicate whether the IC is a one-time or reoccurring burden. -We also adjusted some of the IC descriptions in the table for increased clarity. -We updated our estimate of Hours per Response for “807.22(a) Initial Registration & Listing” (+0.5 hours), “807.22(b)(1) Annual Registration” (-0.25 hours), and “807.22(b)(3) Annual Update of Listing Information” (-0.25 hours). Based on our review of the program, we believe these changes to the burden estimate will more accurately reflect the current preparation time for these ICs.

$540,610
No
    Yes
    No
No
No
No
Uncollected
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.
05/21/2019


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