Source: https://www.federalregister.gov/documents/2014/03/28/2014-06918/agency-information-collection-activities-proposed-collection-comment-request-electronic-records
Timestamp: 2017-08-22 07:39:53
Document Index: 29221194

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

Submit either written or electronic comments on the collection of information by May 27, 2014.
17551-17552 (2 pages)
FDA-2011-N-0076
Electronic Records; Electronic Signatures—(OMB Control Number 0910-0303)—Extension
https://www.federalregister.gov/d/2014-06918 https://www.federalregister.gov/d/2014-06918
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or Start Printed Page 17552provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information listed set forth in this document.
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. Under these regulations, 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 that the other requirements of part 11 are met.
The recordkeeping provisions in 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.
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 are businesses and other for-profit organizations, State or local governments, Federal Agencies, and nonprofit institutions.
11.100—General Requirements 4,500 1 4,500 1 4,500
11.10—Controls for closed systems 2,500 1 2,500 20 50,000
11.30—Controls for open systems 2,500 1 2,500 20 50,000
11.50—Signature manifestations 4,500 1 4,500 20 90,000
11.300—Controls for identification codes/passwords 4,500 1 4,500 20 90,000
[FR Doc. 2014-06918 Filed 3-27-14; 8:45 am]