[Federal Register: July 23, 2003 (Volume 68, Number 141)]
[Notices]
[Page 43531-43532]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy03-58]
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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]
BILLING CODE 4160-01-S