[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]
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