Electronic Records: Electronic Signatures

ICR 200505-0910-002

OMB: 0910-0303

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5871
Migrated
ICR Details
0910-0303 200505-0910-002
Historical Active 200307-0910-005
HHS/FDA
Electronic Records: Electronic Signatures
Extension without change of a currently approved collection   No
Regular
Approved without change 07/13/2005
Retrieve Notice of Action (NOA) 05/12/2005
  Inventory as of this Action Requested Previously Approved
07/31/2008 07/31/2008 07/31/2005
4,500 0 4,500
270,000 0 270,000
0 0 0

This regulation requires/specifies (1) Procedures and controls for persons who use closed or open systems to create, modify, maintain, or transmit electronic records, (2) procedures and controls for persons who use electronic signatures, (3) controls to ensure the security and integrity of electronic signatures based upon use of identification codes in combination with passwords. Some or all of the procedures and controls will need to be incorporated in written standard operating procedures. Ths use of electronic records as well as their submission to FDA is voluntary.

None
None


No

1
IC Title Form No. Form Name
Electronic Records: Electronic Signatures

  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 4,500 4,500 0 0 0 0
Annual Time Burden (Hours) 270,000 270,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
05/12/2005


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