Source: https://www.federalregister.gov/documents/2011/07/08/2011-17155/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2017-08-24 08:45:58
Document Index: 85161664

Matched Legal Cases: ['art 11', 'art 11', '§\u200911', '§\u200911', '§\u200911', '§\u200911', '§\u200911', '§\u200911']

40378-40379 (2 pages)
Electronic Records; Electronic Signatures—(OMB Control Number 0910-0303)—Revision
https://www.federalregister.gov/d/2011-17155 https://www.federalregister.gov/d/2011-17155
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0303. Also include the FDA docket number found in brackets in the heading of this document.
The recordkeeping provisions in part 11 (21 CFR part 11) (§§ 11.10, 11.30, 11.50, and 11.300) require the following standard operating procedures to assure appropriate use of, and precautions for, systems using electronic records and signatures: (1) § 11.10 specifies procedures and controls for persons who use closed systems to create, modify, maintain, or transmit electronic records; (2) § 11.30 specifies procedures and controls for persons who use open systems to create, modify, maintain, or transmit electronic records; (3) § 11.50 specifies procedures and controls for persons who use electronic signatures; and (4) § 11.300 specifies controls to ensure the security and integrity of electronic signatures based upon use of identification codes in combination with passwords. The reporting provision (§ 11.100) requires persons to certify in writing to FDA that they will regard electronic signatures used in their systems as the legally binding equivalent of traditional handwritten signatures.
In the Federal Register of February 16, 2011 (76 FR 9024), FDA published a 60-day notice requesting public comment on the proposed collection of Start Printed Page 40379information. FDA received one comment which was related to the Paperwork Reduction Act burden associated with this collection of information.
The comment indicated that table 2 in the 60-day notice was not clear if it represented burden for all respondents, or just one respondent. In addition, the commenter noted that if table 2 represented the estimated burden for all respondents, that they did not agree with the accuracy of FDA's estimate, as the table appears to assume that each respondent creates one SOP per each 21 CFR section listed. The commenter felt that this assumption is not correct for large companies, who could possibly have several thousand systems, each requiring their own SOPs. If this were the case, the recordkeeping burden in Table 2 would be severely understated.
FDA's response is to note that the recordkeeping burden in table 2 is an estimate of both large and small firms, and the burden represented in the table is an average of the burden for all forms. In addition, the recordkeeping requirements ask each respondent to this collection maintain a set of SOPs which could help the company and FDA in the future determine the methodology the company employed in its systems to ensure that the electronic signatures for its employees on documents submitted to the FDA were valid, if needed. Over the years, FDA developed this recordkeeping burden by listening to feedback from its staff and external stakeholders, and feels that the burden adequately represents the average burden a firm might expend to complete the recordkeeping requirements for this collection.
The burden created by the information collection provision of this regulation is a one-time burden associated with the creation of standard operating procedures, validation, and certification. The Agency anticipates the use of electronic media will substantially reduce the paperwork burden associated with maintaining FDA required records. The respondents will be businesses and other for-profit organizations, State or local governments, Federal Agencies, and nonprofit institutions.
11,100 4,500 1 4,500 1 4,500
[FR Doc. 2011-17155 Filed 7-7-11; 8:45 am]