[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49381-49383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17711]


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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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (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 electronic or written comments on the collection 
of information by October 13, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 13, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

[[Page 49382]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0076 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Electronic Records; Electronic 
Signatures.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3521), 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

    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 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

[[Page 49383]]

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 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).
    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  burden
        21 CFR section            Number of        record per     Total annual         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: August 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17711 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P


