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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket ID: [Docket No. FDA-2008-N-0168]

NOTICE: NOTICES

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures

DATES: Fax written comments on the collection of information by July 28, 2008.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

SUMMARY: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

SUPPLEMENTAL INFORMATION

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Electronic Records; Electronic Signatures(OMB Control Number 0910 0303)Extension

The 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 agencyestablished public docket and that the other requirements of part 11 are met.

The recordkeeping provisions in part 11 (Sec. Sec. 11.10, 11.30, 11.50, and 11.300) require standard operating procedures to assure appropriate use of, and precautions for, systems using electronic records and signatures; (1) Sec. 11.10 specifies procedures and controls for persons who use closed systems to create, modify, maintain, or transmit electronic records; (2) Sec. 11.30 specifies procedures and controls for persons who use open systems to create, modify, maintain, or transmit electronic records; (3) Sec. 11.50 specifies procedures and controls for persons who use electronic signatures; and (4) Sec. 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 (Sec. 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 onetime 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.

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The respondents will be businesses and other forprofit organizations, State or local governments, Federal agencies, and nonprofit institutions.

In the Federal Register of March 26, 2008 (73 FR 16017), FDA published a 60day notice requesting public comment on the information collection provisions. No comments were received.
Table 1.Estimated Annual Reporting Burden\1\ No. of Annual Frequency Total Annual Hours per 21 CFR Section Respondents per Response Responses Response Total Hours 11.100 4,500 1 4,500 1 4,500 \1\There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2.Estimated Annual Recordkeeping Burden\1\ No. of Annual Frequency Total Annual 21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours 11.10 2,500 1 2,500 20 50,000 11.30 2,500 1 2,500 20 50,000 11.50 4,500 1 4,500 20 90,000 11.300 4,500 1 4,500 20 90,000 Total 280,000 \1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: June 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E814659 Filed 62608; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Elizabeth Berbakos, Office of the Chief Information Officer (HFA250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3018271482.