Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11-Questions and Answers; Draft Guidance for Industry; Availability, 28277-28279 [2017-12811]
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Proposed Rules
using the procedures found in 14 CFR 39.19.
In accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
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(2) Contacting the Manufacturer: For any
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116, Transport Airplane Directorate, FAA; or
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Information Collection Clearance Officer,
AES–200.
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
(o) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA AD
2017–0004, dated January 9, 2017, for related
information. This MCAI may be found in the
AD docket on the Internet at https://
www.regulations.gov by searching for and
locating Docket No. FAA–2016–9386.
(2) For more information about this AD,
contact Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM–116,
Transport Airplane Directorate, FAA, 1601
Lind Avenue SW., Renton, WA 98057–3356;
telephone 425–227–1112; fax 425–227–1149.
(3) For service information identified in
this AD, contact Airbus Defense and Space
Services/Engineering Support, Avenida de
´
Aragon 404, 28022 Madrid, Spain; telephone
+34 91 585 55 84; fax +34 91 585 31 27; email
MTA.TechnicalService@airbus.com.; Internet
https://www.eads.net You may view this
service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the
availability of this material at the FAA, call
425–227–1221.
VerDate Sep<11>2014
17:44 Jun 20, 2017
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Issued in Renton, Washington, on June 12,
2017.
Dionne Palermo,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2017–12630 Filed 6–20–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11, 312, and 812
[Docket No. FDA–2017–D–1105]
Use of Electronic Records and
Electronic Signatures in Clinical
Investigations Under Part 11—
Questions and Answers; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
Proposed rule; notification of
availability.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Use of
Electronic Records and Electronic
Signatures in Clinical Investigations
under our regulations—Questions and
Answers.’’ The draft guidance provides
guidance to sponsors, clinical
investigators, institutional review
boards (IRBs), contract research
organizations (CROs), and other
interested parties on the use of
electronic records and electronic
signatures under our regulations in
clinical investigations of medical
products. The draft guidance expands
upon recommendations in the guidance
for industry entitled ‘‘Part 11, Electronic
Records; Electronic Signatures—Scope
and Application’’ issued in August 2003
(referred to as the 2003 part 11
guidance) for recommendations that
pertain to FDA-regulated clinical
investigations conducted under our
regulations.
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 21,
2017.
DATES:
ADDRESSES:
You may submit comments
as follows:
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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–
2017–D–1105 for ‘‘Use of Electronic
Records and Electronic Signatures in
Clinical Investigations Under 21 CFR
Part 11—Questions and Answers; Draft
Guidance for Industry; Availability.’’
Received comments 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
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Proposed Rules
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/201523389.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.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002; or
the Office of the Center Director,
Guidance and Policy Development,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Cheryl Grandinetti, Center for Drug
Evaluation and Research, Food and
VerDate Sep<11>2014
17:44 Jun 20, 2017
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Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3348,
Silver Spring, MD 20993–0002, 301–
796–2500; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911; or Irfan Khan, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3563,
Silver Spring, MD 20993–0002, 301–
796–7100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Use of Electronic Records and
Electronic Signatures in Clinical
Investigations under 21 CFR Part 11—
Questions and Answers.’’ The draft
guidance provides guidance to sponsors,
clinical investigators, IRBs, CROs, and
other interested parties on the use of
electronic records and electronic
signatures under part 11 in clinical
investigations of medical products. The
draft guidance thus expands upon
recommendations in the 2003 part 11
guidance for recommendations that
pertain to FDA-regulated clinical
investigations conducted under parts
312 and 812 and is limited to the scope
and application of part 11 requirements
to such clinical investigations.
Since 2003, advances in electronic
technology have expanded the uses and
capabilities of electronic systems in
clinical investigations. In addition,
electronic systems and technologies are
used and managed in novel ways,
services are shared or contracted
between organizations in new ways, and
electronic data flow between parties is
more efficient and more prevalent. The
standards and capabilities of electronic
systems have improved, and features—
such as audit trails, automated date-andtime stamps, appropriate validation, and
the ability to generate copies and retain
records—are standard components of
many electronic systems.
FDA’s overall approach to the 2003
part 11 guidance was to provide a
narrow and practical interpretation of
part 11 requirements. FDA continues to
support and promote such a narrow and
practical interpretation in the draft
guidance, including our intent to
exercise enforcement discretion
regarding specific part 11 provisions for
validation, audit trails, record retention,
and record copying. FDA reminds
sponsors, however, that records must
still be maintained or submitted in
accordance with the underlying
predicate rules, and the Agency can take
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Fmt 4702
Sfmt 4702
regulatory action for noncompliance
with such predicate rules. In addition,
FDA continues to encourage sponsors
and other regulated entities to use a
risk-based approach, as introduced in
the 2003 part 11 guidance and further
described in the draft guidance, when
deciding to validate electronic systems,
implement audit trails, or archive
required records for clinical
investigations. The draft guidance
clarifies and expands upon
recommendations for applying and
implementing part 11 requirements, as
appropriate, in the current environment
of electronic systems used in clinical
investigations.
The draft guidance discusses the
following: (1) Procedures that may be
followed to help ensure that electronic
records and electronic signatures meet
FDA requirements and are considered to
be trustworthy, reliable, and generally
equivalent to paper records and
handwritten signatures executed on
paper, and (2) the use of a risk-based
approach when deciding to validate
electronic systems, implement audit
trails for electronic records, and archive
records that are pertinent to clinical
investigations conducted under parts
312 and 812.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the use of electronic records and
electronic signatures for FDA-regulated
clinical investigations conducted under
parts 312 and 812. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of applicable statutes
and regulations. This is not a significant
regulatory action subject to Executive
Order 12866.
II. Paperwork Reduction Act
This draft guidance refers to
previously approved collections of
information that are found in
regulations. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). This
draft guidance pertains to sponsors,
clinical investigators, IRBs, CROs, and
other interested parties who use
electronic records, electronic signatures,
and electronic systems in FDA-regulated
clinical investigations and who send
certain information to FDA or others or
who keep certain records and make
them available to FDA inspectors. The
collections of information in part 11
have been approved under OMB control
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Proposed Rules
number 0910–0303; the collections of
information in part 312, including
§§ 312.41, 312.57, 312.58, 312.62, and
312.120, have been approved under
OMB control number 0910–0014; and
the collections of information in
§ 812.140 have been approved under
OMB control number 0910–0078. The
use of electronic records, electronic
signatures, and electronic systems (as
described in the draft guidance) would
not result in any new costs, including
capital costs or operating and
maintenance costs because sponsors and
others already have experience using
computer-based equipment and
software necessary to be consistent with
the draft guidance.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm, or
https://www.regulations.gov.
Dated: June 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–12811 Filed 6–20–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 3285
[Docket No. FR–6023–N–01]
Interpretative Bulletin for Model
Manufactured Home Installation
Standards Foundation Requirements
in Freezing Temperature Areas Under
24 CFR 3285.312(b)
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Notice of proposed installation
Interpretative Bulletin I–1–17.
AGENCY:
The purpose of this proposed
Interpretative Bulletin (IB) is to provide
guidance for designing and installing
manufactured home foundations in
areas subject to freezing temperatures
with seasonal ground freezing, in
accordance with the Model
Manufactured Home Installation
Standards, wherever soil conditions are
susceptible to frost heave. Specifically,
this guidance is being provided for
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
17:44 Jun 20, 2017
Jkt 241001
designing and installing manufactured
home foundation systems in areas
where frost susceptible seasonally
frozen ground conditions are
encountered and when footings do not
extend below the frost depth at the site.
These types of foundation systems
include monolithic slab systems, ‘‘frostprotected shallow foundations’’
(FPSF)—insulated foundations, and
alternative foundation systems that
include foundation variations termed by
industry as frost free footing systems or
frost free foundations (FFF). Guidance is
also being provided in this
interpretative bulletin for installing
manufactured home foundations, when
non-frost susceptible soil conditions are
available at the site to protect
foundations against the effects of frost
heave.
DATES: Comment Due Date: August 21,
2017.
ADDRESSES: Interested persons are
invited to submit comments regarding
this Interpretative Bulletin to the
Regulations Division, Office of General
Counsel, Department of Housing and
Urban Development, 451 Seventh Street
SW., Washington, DC 20410–0500.
Room 10276, Washington, DC 20410–
0500. Communications must refer to the
above docket number and title. There
are two methods for submitting public
comments. All submissions must refer
to the above docket number and title.
1. Submission of Comments by Mail.
Comments may be submitted by mail to
the Regulations Division, Office of
General Counsel, Department of
Housing and Urban Development, 451
7th Street SW., Room 10276,
Washington, DC 20410–0500.
2. Electronic Submission of
Comments. Interested persons may
submit comments electronically through
the Federal eRulemaking Portal at
www.regulations.gov. HUD strongly
encourages commenters to submit
comments electronically. Electronic
submission of comments allows the
commenter maximum time to prepare
and submit a comment, ensures timely
receipt by HUD, and enables HUD to
make them immediately available to the
public. Comments submitted
electronically through the
www.regulations.gov Web site can be
viewed by other commenters and
interested members of the public.
Commenters should follow the
instructions provided on that site to
submit comments electronically.
Note: To receive consideration as public
comments, comments must be submitted
through one of the two methods specified
above. Again, all submissions must refer to
the docket number and title of the rule.
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28279
No Facsimile Comments. Facsimile
(FAX) comments are not acceptable.
Public Inspection of Public
Comments. All properly submitted
comments and communications
submitted to HUD will be available for
public inspection and copying between
8 a.m. and 5 p.m. weekdays at the above
address. Due to security measures at the
HUD Headquarters building, an advance
appointment to review the public
comments must be scheduled by calling
the Regulations Division at 202–708–
3055 (this is not a toll-free number).
Individuals with speech or hearing
impairments may access this number
through TTY by calling the Federal
Information Relay Service at 800–877–
8339. Copies of all comments submitted
are available for inspection and
downloading at www.regulations.gov.
FOR FURTHER INFORMATION, CONTACT:
Pamela Beck Danner, Administrator,
Office of Manufactured Housing
Programs, Office of Housing,
Department of Housing and Urban
Development, 451 Seventh Street SW.,
Washington, DC 20410; telephone (202)
708–6409 (this is not a toll-free
number). Persons with hearing or
speech impairments may access this
number via TTY by calling the toll free
Federal Relay Service at 1–800–877–
8389.
SUPPLEMENTARY INFORMATION:
I. Background
The National Manufactured Housing
Construction and Safety Standards Act
of 1974 (42 U.S.C. 5401–5426) (the Act)
as amended in 2000 authorizes the
Department to establish Model
Manufactured Home Installation
Standards (Installation Standards) and
establish an installation program to
enforce those Installation Standards.
The Installation Standards are at 24 CFR
part 3285, and installation in freezing
temperature areas is covered at
§ 3285.312(b). Section 604(a)(3) of the
Act as amended in 2000 also created the
Manufactured Housing Consensus
Committee (MHCC). Section 604(b)(3) of
the Act directs HUD to provide the
MHCC with an opportunity to review
any HUD proposed Interpretative
Bulletin and to provide written
comments to the Department for a
period of up to 120 days.
Frost-protected shallow foundations
have been successfully used both
domestically and internationally in
residential and commercial applications
for over 50 years as a means to avoid
deeper and more costly foundation
systems. However, as a result of recent
problems and inquiries related to the
proper design, use, and installation of
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Agencies
[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Proposed Rules]
[Pages 28277-28279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12811]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11, 312, and 812
[Docket No. FDA-2017-D-1105]
Use of Electronic Records and Electronic Signatures in Clinical
Investigations Under Part 11--Questions and Answers; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Use of
Electronic Records and Electronic Signatures in Clinical Investigations
under our regulations--Questions and Answers.'' The draft guidance
provides guidance to sponsors, clinical investigators, institutional
review boards (IRBs), contract research organizations (CROs), and other
interested parties on the use of electronic records and electronic
signatures under our regulations in clinical investigations of medical
products. The draft guidance expands upon recommendations in the
guidance for industry entitled ``Part 11, Electronic Records;
Electronic Signatures--Scope and Application'' issued in August 2003
(referred to as the 2003 part 11 guidance) for recommendations that
pertain to FDA-regulated clinical investigations conducted under our
regulations.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 21, 2017.
ADDRESSES: You may submit comments as follows:
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-2017-D-1105 for ``Use of Electronic Records and Electronic
Signatures in Clinical Investigations Under 21 CFR Part 11--Questions
and Answers; Draft Guidance for Industry; Availability.'' Received
comments 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
[[Page 28278]]
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.
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Cheryl Grandinetti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301-
796-2500; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Irfan
Khan, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3563, Silver
Spring, MD 20993-0002, 301-796-7100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Use of Electronic Records and Electronic Signatures in
Clinical Investigations under 21 CFR Part 11--Questions and Answers.''
The draft guidance provides guidance to sponsors, clinical
investigators, IRBs, CROs, and other interested parties on the use of
electronic records and electronic signatures under part 11 in clinical
investigations of medical products. The draft guidance thus expands
upon recommendations in the 2003 part 11 guidance for recommendations
that pertain to FDA-regulated clinical investigations conducted under
parts 312 and 812 and is limited to the scope and application of part
11 requirements to such clinical investigations.
Since 2003, advances in electronic technology have expanded the
uses and capabilities of electronic systems in clinical investigations.
In addition, electronic systems and technologies are used and managed
in novel ways, services are shared or contracted between organizations
in new ways, and electronic data flow between parties is more efficient
and more prevalent. The standards and capabilities of electronic
systems have improved, and features--such as audit trails, automated
date-and-time stamps, appropriate validation, and the ability to
generate copies and retain records--are standard components of many
electronic systems.
FDA's overall approach to the 2003 part 11 guidance was to provide
a narrow and practical interpretation of part 11 requirements. FDA
continues to support and promote such a narrow and practical
interpretation in the draft guidance, including our intent to exercise
enforcement discretion regarding specific part 11 provisions for
validation, audit trails, record retention, and record copying. FDA
reminds sponsors, however, that records must still be maintained or
submitted in accordance with the underlying predicate rules, and the
Agency can take regulatory action for noncompliance with such predicate
rules. In addition, FDA continues to encourage sponsors and other
regulated entities to use a risk-based approach, as introduced in the
2003 part 11 guidance and further described in the draft guidance, when
deciding to validate electronic systems, implement audit trails, or
archive required records for clinical investigations. The draft
guidance clarifies and expands upon recommendations for applying and
implementing part 11 requirements, as appropriate, in the current
environment of electronic systems used in clinical investigations.
The draft guidance discusses the following: (1) Procedures that may
be followed to help ensure that electronic records and electronic
signatures meet FDA requirements and are considered to be trustworthy,
reliable, and generally equivalent to paper records and handwritten
signatures executed on paper, and (2) the use of a risk-based approach
when deciding to validate electronic systems, implement audit trails
for electronic records, and archive records that are pertinent to
clinical investigations conducted under parts 312 and 812.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the use of
electronic records and electronic signatures for FDA-regulated clinical
investigations conducted under parts 312 and 812. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of
applicable statutes and regulations. This is not a significant
regulatory action subject to Executive Order 12866.
II. Paperwork Reduction Act
This draft guidance refers to previously approved collections of
information that are found in regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). This draft guidance pertains to sponsors, clinical
investigators, IRBs, CROs, and other interested parties who use
electronic records, electronic signatures, and electronic systems in
FDA-regulated clinical investigations and who send certain information
to FDA or others or who keep certain records and make them available to
FDA inspectors. The collections of information in part 11 have been
approved under OMB control
[[Page 28279]]
number 0910-0303; the collections of information in part 312, including
Sec. Sec. 312.41, 312.57, 312.58, 312.62, and 312.120, have been
approved under OMB control number 0910-0014; and the collections of
information in Sec. 812.140 have been approved under OMB control
number 0910-0078. The use of electronic records, electronic signatures,
and electronic systems (as described in the draft guidance) would not
result in any new costs, including capital costs or operating and
maintenance costs because sponsors and others already have experience
using computer-based equipment and software necessary to be consistent
with the draft guidance.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.
Dated: June 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-12811 Filed 6-20-17; 8:45 am]
BILLING CODE 4164-01-P