Electronic Records: Electronic Signatures

ICR 201711-0910-010

OMB: 0910-0303

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-11-29
IC Document Collections
ICR Details
0910-0303 201711-0910-010
Active 201409-0910-018
HHS/FDA CDER
Electronic Records: Electronic Signatures
Extension without change of a currently approved collection   No
Regular
Approved without change 01/31/2018
Retrieve Notice of Action (NOA) 11/29/2017
  Inventory as of this Action Requested Previously Approved
01/31/2021 36 Months From Approved 01/31/2018
18,500 0 18,500
284,500 0 284,500
0 0 0

This information collection supports Food and Drug Administration (FDA) regulations. Specifically, the regulations found at 21 CFR Part 11: Electronic Records; Electronic Signatures provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures serving to legally bind subsequent electronic submissions and verify electronic records. Under the regulations, records and reports may be submitted to FDA electronically, with certain provisions.

US Code: 21 USC 301 et seq. Name of Law: Federal Food Drug and Cosmetic Act
  
None

Not associated with rulemaking

  82 FR 27838 06/19/2017
82 FR 56035 11/27/2017
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 18,500 18,500 0 0 0 0
Annual Time Burden (Hours) 284,500 284,500 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$161,112
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
11/29/2017


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