Agency Information Collection Activities; Proposals, Submissions, and Approvals
Federal Register: June 27, 2008 (Volume 73, Number 125)
Notices
Page 36537-36538
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr27jn08-63
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2008-N-0168
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records;
Electronic Signatures
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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.
DATES: Fax written comments on the collection of information by July 28, 2008.
ADDRESSES: 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: 202-395-6974, or e-mailed to baguilar@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.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY 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 agency-established 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 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.
Page 36538
The respondents will be businesses and other for-profit organizations, State or local governments, Federal agencies, and nonprofit institutions.
In the Federal Register of March 26, 2008 (73 FR 16017), FDA published a 60-day 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. E8-14659 Filed 6-26-08; 8:45 am
BILLING CODE 4160-01-S
