Reporting and Recordkeeping for Electronic Products - General Requirements

ICR 201706-0910-005

OMB: 0910-0025

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2017-06-12
ICR Details
0910-0025 201706-0910-005
Historical Active 201311-0910-008
HHS/FDA CDRH
Reporting and Recordkeeping for Electronic Products - General Requirements
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 07/17/2017
Retrieve Notice of Action (NOA) 06/15/2017
  Inventory as of this Action Requested Previously Approved
07/31/2020 36 Months From Approved
22,995 0 0
471,994 0 0
0 0 0

To protect the public from unnecessary exposure to radiation from electronic products, FDA must collect certain information from manufacturers and dealers/distributors about electronic products they sell or install. This ICR collects information from electronic product and x-ray manufacturers, importers, and assemblers. These respondents report and maintain information related to the identification of, location of, operational characteristics of, quality assurance programs for, and problem identification and correction of electronic products. The data reported to the Food and Drug Administration (FDA) and the records maintained are used by FDA and industry to make decisions and take actions that protect the public from radiation hazards presented by electronic products. The information collections are either specifically called for in legislation or were developed to aid FDA in performing its obligations under legislation.

US Code: 21 USC 360 Name of Law: null
  
None

Not associated with rulemaking

  81 FR 79030 11/10/2016
82 FR 26937 06/12/2017
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 22,995 0 0 0 22,995 0
Annual Time Burden (Hours) 471,994 0 0 0 471,994 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The number of respondents/responses per respondent for each IC has been adjusted to reflect updated Agency data. The burden estimates are based on data from the CDRH Center Tracking System and the CARS business objects system. We believe the current burden estimates are improved due to enhanced IT systems and staff training.

$3,209,160
No
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.
06/15/2017


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