82 FR 56035 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Signatures

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 226 (November 27, 2017)

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.

[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56035-56036]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25453]


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

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 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 
December 27, 2017.

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 emailed to [email protected]. 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7729, 
[email protected].

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--Extension

    This information collection supports FDA regulations; specifically, 
in part 11 (21 CFR part 11), which sets forth 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.
    In the Federal Register of June 19, 2017 (82 FR 27838), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the information collection topics solicited in the 
notice. However, one comment was received regarding a related Agency 
draft guidance entitled, ``Use of Electronic Records and Electronic 
Signatures in Clinical Investigations Under 21 CFR part 11--Questions 
and Answers,'' and the comment has been directed to the appropriate 
Agency components for consideration.
    We therefore estimate the burden of this collection of information 
as follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                           21 CFR section                               Number of      responses per     Total annual    per  response     Total hours
                                                                       respondents       respondent       responses        (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.100.............................................................           4,500                1            4,500                1            4,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 56036]]


                                Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
         21 CFR section             respondents    responses per     responses     response (in     Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
11.10...........................           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: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25453 Filed 11-24-17; 8:45 am]
 BILLING CODE 4164-01-P