[Federal Register Volume 64, Number 190 (Friday, October 1, 1999)]
[Notices]
[Pages 53392-53393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25491]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4166]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Electronic Records; Electronic Signature

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 comments on the collection of information by 
November 30, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (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 Information 
Resources Management (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: (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

[[Page 53393]]

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--Part 11 (21 CFR Part 11) 
(OMB Control Number 0910-0303)-Extension

     The Food and Drug Administration (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 (Secs.  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
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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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
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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                               2,250               1           2,250              20          45,000
11.30                               2,250               1           2,250              20          45,000
11.50                               4,500               1           4,500              20          90,000
11.300                              4,500               1           4,500              20          90,000
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: September 24, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-25491 Filed 9-30-99; 8:45 am]
BILLING CODE 4160-01-F