Document ID: FDA-2011-N-0076-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic Records; Electronic Signature
Posted Date: 2011-02-16T05:00Z

[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9024-9025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3465]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0076]

Agency Information Collection Activities; Proposed Collection; 
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 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 either electronic or written comments on the collection 
of information by April 18, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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 these topics: (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 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--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 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 the following 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

[[Page 9025]]

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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                                                      Annual
         21 CFR section              Number 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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    Total.......................  ..............  ..............  ..............  ..............           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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                                                      Annual
         21 CFR section              Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
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11.10...........................           2,500               1           2,500              20          50,000
11.30...........................           2,500               1           2,500              20          50,000
11.50...........................           4,500               1           4,500              20          90,000
11.300..........................           4,500               1           4,500              20          90,000
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    Total.......................  ..............  ..............  ..............  ..............         280,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a 
Governmentwide, electronic docket management system. Electronic 
submissions will be accepted by FDA through FDMS only.

    Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3465 Filed 2-15-11; 8:45 am]
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