Document ID: FDA-2011-N-0076-0013
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Electronic
Records; Electronic Signatures
Posted Date: 2020-12-01T05:00Z

[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Notices]
[Pages 77223-77224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26487]

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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.

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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: Submit written comments (including recommendations) on the 
collection of information by December 31, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 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, 301-796-5733, 
PRAStaff@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--21 CFR Part 11

OMB Control Number 0910-0303--Extension

    This information collection supports FDA regulations in part 11 (21 
CFR part 11), which govern 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 us electronically 
provided that we have 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 Sec. Sec.  11.10, 11.30, 11.50, and 
11.300 (21 CFR 11.10, 11.30, 11.50, and 11.300) require the following 
standard operating procedures to ensure 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 to us in writing 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. We 
anticipate that 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.
    To assist respondents with the information collection we have 
developed the guidance document entitled ``Guidance for Industry: Part 
11, Electronic Records; Electronic Signatures--Scope and Application,'' 
available on our website at https://www.fda.gov/media/75414/download. 
While we do not believe the guidance creates any attendant burden, it 
describes the Agency's thinking regarding persons who, in fulfillment 
of a requirement in a statute or another part of FDA's regulations to 
maintain records or submit information to FDA, have chosen to maintain 
the records or submit designated information electronically and, as a 
result, have become subject to part 11. Part 11 applies to records in 
electronic form that are created, modified, maintained, archived, 
retrieved, or transmitted under any records requirements set forth in 
Agency regulations. Part 11 also

[[Page 77224]]

applies to electronic records submitted to the Agency under the Federal 
Food, Drug, and Cosmetic Act and the Public Health Service Act, even if 
such records are not specifically identified in Agency regulations 
(Sec.  11.1).
    In the Federal Register of August 13, 2020 (85 FR 49381), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but was not 
responsive to the information collection topics solicited.
    We estimate 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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Sec.   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.

                                Table 2--Estimated Annual Recordkeeping Burden 1
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                                                     Number of                        Average
         21 CFR section              Number of      record per     Total annual     burden per      Total hours
                                   recordkeepers   recordkeepers      records      recordkeeping
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Sec.   11.10....................           2,500               1           2,500              20          50,000
Sec.   11.30....................           2,500               1           2,500              20          50,000
Sec.   11.50....................           4,500               1           4,500              20          90,000
Sec.   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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26487 Filed 11-30-20; 8:45 am]
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