Document ID: FDA-2011-N-0076-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
Posted Date: 2017-06-19T04:00Z

[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27838-27840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12619]

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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 
(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 August 18, 2017.

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 August 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 18, 2017. 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.

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 ``Electronic Records; Electronic Signatures.'' 
Received

[[Page 27839]]

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.gpo.gov/fdsys/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, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
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 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

    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 electronically to FDA provided the Agency has stated its 
ability to electronically accept the records 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 for the collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of                       Average burden
                           21 CFR section                               Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (in hours)
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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.

[[Page 27840]]

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                  Average burden
                                     Number of       Number of     Total annual         per
         21 CFR section            recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
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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
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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: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12619 Filed 6-16-17; 8:45 am]
 BILLING CODE 4164-01-P