[Federal Register Volume 70, Number 24 (Monday, February 7, 2005)]
[Notices]
[Pages 6447-6448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0045]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
provisions relating to FDA's electronic records and electronic 
signatures.

DATES: Submit written or electronic comments on the collection of 
information by April 8, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 
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 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 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:

[[Page 6448]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                      Annual Frequency        Total Annual
                21 CFR Section                  No. of Respondents      per Response           Responses         Hours per 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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                                                   Annual
       21 CFR Section             No. of        Frequency of     Total Annual      Hours per       Total Hours
                              Recordkeepers    Recordkeeping       Records        Recordkeeper
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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: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2298 Filed 2-4-05; 8:45 am]
BILLING CODE 4160-01-S