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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0303
ICR Reference No:
201409-0910-018
Status:
Historical Active
Previous ICR Reference No:
201107-0910-009
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Electronic Records: Electronic Signatures
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
12/23/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/15/2014
Terms of Clearance:
This submission better accounts for the burden associated with these provisions, which are unchanged.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2017
36 Months From Approved
12/31/2014
Responses
18,500
0
4,500
Time Burden (Hours)
284,500
0
284,500
Cost Burden (Dollars)
0
0
0
Abstract:
FDA regulations in part 11 (21 CFR Part 11) provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. Records and reports may be submitted to FDA electronically provided the Agency has stated its ability to accept the records electronically in an Agency-established public docket, and other requirements of part 11 are met.
Authorizing Statute(s):
US Code:
21 USC 301
Name of Law: Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
79 FR 17551
03/28/2014
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 59775
10/03/2014
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Closed for Open Systems - 11.30
Controls for Closed Systems - 11.10
Controls for Identification Codes/Passwords - 11.300
General Requirements - 11.100
Signature Manifestation - 11.50
ICR Summary of Burden
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
4,500
0
0
14,000
0
Annual Time Burden (Hours)
284,500
284,500
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The change in burden hours is a result of updated data on the number of submissions received by FDA.
Annual Cost to Federal Government:
$87,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
10/15/2014
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