Electronic Records: Electronic Signatures

Forms and Documents

Document Name	Status
Part 11 guidance.pdf Supplementary Document	2011-10-28
0303 Electronic Signatures SS.doc Supporting Statement A	2011-10-26

IC Document Collections

IC ID	Document Title	Status
5871	Electronic Records: Electronic Signatures	Modified

ICR Details

OMB Control No: 0910-0303	ICR Reference No: 201107-0910-009
Status: Historical Active	Previous ICR Reference No: 200807-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Electronic Records: Electronic Signatures
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/31/2011
	Date Received in OIRA: 07/19/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2014	36 Months From Approved	10/31/2011
Responses	4,500	0	4,500
Time Burden (Hours)	284,500	0	270,000
Cost Burden (Dollars)	0	0	0

---

Abstract: 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.

---

Authorizing Statute(s): US Code: 21 USC 301 Name of Law: U.S.C.
  

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:
	76 FR 9024	02/16/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 40378	07/08/2011
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 1

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

---

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	4,500	4,500	0	0	0	0
Annual Time Burden (Hours)	284,500	270,000	0	14,500	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: No

Burden Reduction Due to:

Short Statement: The burden for this collection of information is expected to increase by 4,500 reporting hours, and 10,000 recordkeeping hours, due to the addition of certification reporting under section 11.100 and an expected increase in the number of recordkeepers (250) for closed and open systems under sections 11.10 and 11.30. This is a total increase of 14,500 burden hours. These additions to burden were based on the actual number of certifications received and consultations among FDA staff familiar with the types of SOPs needed to meet the requirements of this collection.

---

Annual Cost to Federal Government: $58,000

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

---

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: 07/19/2011

---