[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.
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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,
[email protected].
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
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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]
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