[Federal Register Volume 70, Number 90 (Wednesday, May 11, 2005)]
[Notices]
[Pages 24818-24819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0045]


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 June 
10, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (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--(21 CFR Part 11) (OMB 
Control Number 0910-0303)--Extension

    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 our 
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 (SOPs) to 
assure appropriate use of, and precautions for, systems using 
electronic records and signatures: (1) Section 11.10 specifies 
procedures and controls for persons who use closed systems to create, 
modify, maintain, or transmit electronic records; (2) section 11.30 
specifies procedures and controls for persons who use open systems to 
create, modify, maintain, or transmit electronic records; (3) section 
11.50 specifies procedures and controls for persons who use electronic 
signatures; and (4) section 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 
provisions (Sec.  11.100) require 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 SOPs, 
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.
    In the Federal Register of February 7, 2005 (70 FR 6447), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 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.


[[Page 24819]]


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers     of Recordkeeping       Records          Recordkeeper       Total Hours
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11.10                          2,500                  1              2,500                 20             45,000
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11.30                          2,500                  1              2,500                 20             45,000
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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                                                                                                    270,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9370 Filed 5-10-05; 8:45 am]
BILLING CODE 4160-01-S