Document ID: FDA-2008-N-0168-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures
Posted Date: 2008-06-27T04:00Z

[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]                         

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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.

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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\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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11.100                                                              4,500                     1              4,500                  1              4,500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
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11.10                                                               2,500                     1              2,500                 20             50,000
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11.30                                                               2,500                     1              2,500                 20             50,000
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11.50                                                               4,500                     1              4,500                 20             90,000
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11.300                                                              4,500                     1              4,500                 20             90,000
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Total                                                                                                                                            280,000
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\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