Electronic Records: Electronic Signatures

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 10-15-14.doc Supporting Statement A	2014-10-15

IC Document Collections

IC ID	Document Title	Status
5871	General Requirements - 11.100	Modified
213244	Controls for Identification Codes/Passwords - 11.300	New
213243	Signature Manifestation - 11.50	New
213242	Closed for Open Systems - 11.30	New
213241	Controls for Closed Systems - 11.10	New

ICR Details

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
	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

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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.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
General Requirements - 11.100
Controls for Closed Systems - 11.10
Closed for Open Systems - 11.30
Signature Manifestation - 11.50
Controls for Identification Codes/Passwords - 11.300

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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.

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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

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Common Form ICR:  No

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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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