[Federal Register: May 11, 2005 (Volume 70, Number 90)]
[Notices]
[Page 24818-24819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11my05-59]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0045]
Agency Information Collection Activities; Submission for Office
of Management and Budget 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: Fax written comments on the collection of information by June
10, 2005.
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 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 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
provisions (Sec. 11.100) require 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 are businesses and other for-profit organizations,
State or local governments, Federal agencies, and nonprofit
institutions.
In the Federal Register of February 7, 2005 (70 FR 6447), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
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.
[[Page 24819]]
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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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: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9370 Filed 5-10-05; 8:45 am]
BILLING CODE 4160-01-S