[Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
[Notices]
[Pages 33660-33661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16178]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 92N-0251]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by July
21, 1997.
[[Page 33661]]
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503,
Attention: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1471.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance:
Title: Electronic Records; Electronic Signatures--21 CFR Part 11
Description: 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 in place of
paper records. The regulations will become effective on August 20,
1997. 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. 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.
Description of Respondents: Businesses and other for-profit
organizations, State or local governments, Federal agencies, and
nonprofit institutions.
Most of the burden created by the information collection provisions
of this final rule will be a one-time burden associated with the
creation of standard operating procedures, validation, and
certification. The agency anticipates that the use of electronic media
will result in a substantial net reduction in the paperwork burden
associated with maintaining FDA-required records.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden
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Frequency per Hours per
21 CFR Section Recordkeeper Recordkeeper Total Hours
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11.10 50 40 2,000
11.30 50 40 2,000
11.50 50 40 2,000
11.300 50 40 2,000
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Total Recordkeeping
Burden Hours 8,000
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There are no capital costs or operating and maintenance costs associated
with this collection of information.
Table 2.--Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Hours per
Respondents Response Response
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11.100 1,000 1 1,000
Total Reporting Burden
Hours 1,000
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There are no capital costs or operating and maintenance costs associated
with this information collection.
Dated: June 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-16178 Filed 6-19-97; 8:45 am]
BILLING CODE 4160-01-F