[Federal Register Volume 68, Number 141 (Wednesday, July 23, 2003)]
[Notices]
[Pages 43531-43532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0084]


Agency Information Collection Activities; Submission for OMB 
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: Submit written comments on the collection of information by 
August 22, 2003.

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 L. 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 
No. 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 that 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.
    The respondents will be businesses and other for-profit 
organizations, state or local governments, Federal agencies, and 
nonprofit institutions.
    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.


                               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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[[Page 43532]]

 
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.

    In the Federal Register of March 26, 2003 (68 FR 14663), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. Three comments were received. All three were 
submitted to the docket in error. One was a comment meant for the part 
11 scope and application draft guidance. One was an opinion on medical 
device approvals. The last comment was questions from an individual 
related to electronic records.

    Dated: July 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18690 Filed 7-22-03; 8:45 am]
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