Electronic Submission of Medical Device Registration and Listing

ICR 201208-0910-003

OMB: 0910-0625

Federal Form Document

ICR Details
0910-0625 201208-0910-003
Historical Active 201201-0910-005
HHS/FDA
Electronic Submission of Medical Device Registration and Listing
Revision of a currently approved collection   No
Regular
Approved with change 03/25/2013
Retrieve Notice of Action (NOA) 08/06/2012
Following this approval, FDA will discontinue OMB control number 0910-0387, which covers paper-based registration & listing.
  Inventory as of this Action Requested Previously Approved
03/31/2016 36 Months From Approved 06/30/2015
180,585 0 121,343
99,470 0 72,625
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

0910-AF88 Final or interim final rulemaking 77 FR 45927 08/02/2012

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 180,585 121,343 0 59,242 0 0
Annual Time Burden (Hours) 99,470 72,625 0 26,845 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
There is a program change due to an associated final rule. FDA attributes the increase in burden hours to the more accurate estimates from FURLS and the increase in burden from requiring (1) initial importers to identify manufacturers by product, (2) foreign manufacturers identifying their importers, and (3) contract manufacturers and sterilizers that do not put their devices into commercial distribution to register and list.

$208,000
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  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.
08/06/2012


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