
[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Pages 17551-17552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06918]


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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 requirements governing the 
acceptance of electronic records and electronic signatures.

DATES: Submit either written or electronic comments on the collection 
of information by May 27, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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

[[Page 17552]]

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 listed 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--(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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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11.100--General Requirements.......................................           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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                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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11.10--Controls for closed                 2,500               1           2,500              20          50,000
 systems........................
11.30--Controls for open systems           2,500               1           2,500              20          50,000
11.50--Signature manifestations.           4,500               1           4,500              20          90,000
11.300--Controls for                       4,500               1           4,500              20          90,000
 identification codes/passwords.
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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.


    Dated: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06918 Filed 3-27-14; 8:45 am]
BILLING CODE 4160-01-P


