Document ID: FDA-2016-D-1224-0001
Agency: fda
Document Type: Notice
Title: Use of Electronic Health Record Data in Clinical Investigations; Draft
Guidance for Industry; Availability
Posted Date: 2016-05-17T04:00Z

[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Pages 30540-30541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11564]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1224]

Use of Electronic Health Record Data in Clinical Investigations; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice 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the availability of a draft guidance for industry entitled ``Use of 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 Health Record Data in Clinical Investigations.'' The draft 
guidance is intended to assist sponsors, clinical investigators, 
contract research organizations, institutional review boards (IRBs), 
and other interested parties on the use of electronic health record 
(EHR) data in FDA-regulated clinical investigations.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 18, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 deliveryCourier (for written/paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-D-1224 for ``Use of Electronic Health Record Data in Clinical 
Investigations; Draft Guidance for Industry; Availability.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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; 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; 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 Health Record Data in Clinical 
Investigations.'' The draft guidance is intended to assist sponsors, 
clinical investigators, contract research organizations, IRBs, and 
other interested parties on the use of EHR data in FDA-

[[Page 30541]]

regulated clinical investigations. In particular, the draft guidance 
provides recommendations on the following: (1) Deciding whether and how 
to use EHRs as a source of data in clinical investigations; (2) using 
EHRs that are interoperable with electronic systems supporting clinical 
investigations; (3) ensuring the quality and the integrity of EHR data 
that are collected and used as electronic source data in clinical 
investigations; and (4) ensuring that the use of EHR data collected and 
used as electronic source data in clinical investigations meet FDA's 
inspection, recordkeeping, and record retention requirements. In an 
effort to modernize and streamline clinical investigations, the goals 
of the draft guidance are to facilitate use of EHR data in clinical 
investigations and to promote the interoperability of EHRs and 
electronic systems supporting the clinical investigation.
    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 EHR 
data in clinical investigations. 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 the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to collections of information that 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). The draft 
guidance pertains to sponsors, clinical investigators, contract 
research organizations, IRBs, and other interested parties who use EHR 
systems as electronic source data 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 discussed in the draft guidance are 
contained in our investigational new drug regulations in part 312 (21 
CFR part 312), approved under OMB control number 0910-0014, including 
Sec. Sec.  312.58(a) and 312.62(b); investigational device exemption 
regulations in Sec.  812.140 (21 CFR 812.140) approved under OMB 
control number 0910-0078; and electronic records; electronic signatures 
regulations in 21 CFR part 11, approved under OMB control number 0910-
0303. The use of EHR systems as a source of data, 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 and are experienced with 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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: May 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11564 Filed 5-16-16; 8:45 am]
 BILLING CODE 4164-01-P