Document ID: FDA-2011-N-0076-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic Records; Electronic Signatures
Posted Date: 2011-07-08T04:00Z

[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40378-40379]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17155]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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.

-----------------------------------------------------------------------

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 August 
8, 2011.

ADDRESSES: 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: FDA Desk Officer, 
Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0303. 
Also include the FDA 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: 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--(OMB Control Number 0910-
0303)--Revision

    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 (21 CFR 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.
    In the Federal Register of February 16, 2011 (76 FR 9024), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 40379]]

information. FDA received one comment which was related to the 
Paperwork Reduction Act burden associated with this collection of 
information.
    The comment indicated that table 2 in the 60-day notice was not 
clear if it represented burden for all respondents, or just one 
respondent. In addition, the commenter noted that if table 2 
represented the estimated burden for all respondents, that they did not 
agree with the accuracy of FDA's estimate, as the table appears to 
assume that each respondent creates one SOP per each 21 CFR section 
listed. The commenter felt that this assumption is not correct for 
large companies, who could possibly have several thousand systems, each 
requiring their own SOPs. If this were the case, the recordkeeping 
burden in Table 2 would be severely understated.
    FDA's response is to note that the recordkeeping burden in table 2 
is an estimate of both large and small firms, and the burden 
represented in the table is an average of the burden for all forms. In 
addition, the recordkeeping requirements ask each respondent to this 
collection maintain a set of SOPs which could help the company and FDA 
in the future determine the methodology the company employed in its 
systems to ensure that the electronic signatures for its employees on 
documents submitted to the FDA were valid, if needed. Over the years, 
FDA developed this recordkeeping burden by listening to feedback from 
its staff and external stakeholders, and feels that the burden 
adequately represents the average burden a firm might expend to 
complete the recordkeeping requirements for this collection.
    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\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
         21 CFR section             respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
11,100..........................           4,500               1           4,500               1           4,500
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
         21 CFR section            recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         280,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17155 Filed 7-7-11; 8:45 am]
BILLING CODE 4160-01-P