81 FR 30540 - Use of Electronic Health Record Data in Clinical Investigations; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 95 (May 17, 2016)

Page Range		30540-30541
FR Document		2016-11564

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Health Record Data in Clinical Investigations.'' The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on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.

Federal Register, Volume 81 Issue 95 (Tuesday, May 17, 2016)

[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Pages 30540-30541]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-11564]

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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Draft Guidance for Industry; Availability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.

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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the availability of a draft guidance for industry entitled ``Use of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 The draft
guidance is intended to assist sponsors, clinical investigators,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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 18, 2016.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

Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices 30541

regulated clinical investigations. In including capital costs or operating and Bethesda, MD 20892–9823, (240) 669–5082,
particular, the draft guidance provides maintenance costs, because sponsors Travis.Taylor@nih.gov.
recommendations on the following: (1) and others already have and are Name of Committee: National Institute of
Deciding whether and how to use EHRs experienced with using computer-based Allergy and Infectious Diseases, Special
as a source of data in clinical equipment and software necessary to be Emphasis Panel, Rapid Assessment of Zika
Virus (ZIKV) Complications (R21).
investigations; (2) using EHRs that are consistent with the draft guidance. Date: June 14, 2016.
interoperable with electronic systems Time: 12:00 p.m. to 7:00 p.m.
supporting clinical investigations; (3) III. Electronic Access
Agenda: To review and evaluate grant
ensuring the quality and the integrity of Persons with access to the Internet applications.
EHR data that are collected and used as may obtain the draft guidance at http:// Place: National Institutes of Health 3F100,
electronic source data in clinical www.fda.gov/Drugs/ 5601 Fishers Lane, Rockville, MD 20892
investigations; and (4) ensuring that the (Telephone Conference Call).
GuidanceCompliance
use of EHR data collected and used as Contact Person: Amir E. Zeituni, Ph.D.,
RegulatoryInformation/Guidances/ Scientific Review Officer, Scientific Review
electronic source data in clinical default.htm, http://www.fda.gov/ Program, Division of Extramural Activities
investigations meet FDA’s inspection, BiologicsBloodVaccines/ NIAID/NIH/DHHS, 5601 Fishers Lane, MSC–
recordkeeping, and record retention GuidanceCompliance 9834 Rockville, MD 20852, 301–496–2550,
requirements. In an effort to modernize RegulatoryInformation/Guidances/ amir.zeituni@nih.gov.
and streamline clinical investigations, default.htm, http://www.fda.gov/ (Catalogue of Federal Domestic Assistance
the goals of the draft guidance are to MedicalDevices/DeviceRegulation Program Nos. 93.855, Allergy, Immunology,
facilitate use of EHR data in clinical andGuidance/GuidanceDocuments/ and Transplantation Research; 93.856,
investigations and to promote the Microbiology and Infectious Diseases
default.htm, or http://
interoperability of EHRs and electronic Research, National Institutes of Health, HHS)
www.regulations.gov.
systems supporting the clinical Dated: May 11, 2016.
investigation. Dated: May 11, 2016.
This draft guidance is being issued Leslie Kux, Natasha M. Copeland,
consistent with FDA’s good guidance Associate Commissioner for Policy. Program Analyst, Office of Federal Advisory
Committee Policy.
practices regulation (21 CFR 10.115). [FR Doc. 2016–11564 Filed 5–16–16; 8:45 am]
The draft guidance, when finalized, will [FR Doc. 2016–11554 Filed 5–16–16; 8:45 am]
BILLING CODE 4164–01–P
represent the current thinking of FDA BILLING CODE 4140–01–P
on the use of EHR data in clinical
investigations. It does not establish any DEPARTMENT OF HEALTH AND
rights for any person and is not binding HUMAN SERVICES DEPARTMENT OF HEALTH AND
on FDA or the public. You can use an HUMAN SERVICES
alternative approach if it satisfies the National Institutes of Health
National Institutes of Health
requirements of the applicable statutes
and regulations. National Institute of Allergy and
Infectious Diseases; Notice of Closed Submission for OMB Review; 30-Day
II. Paperwork Reduction Act of 1995 Meetings Comment Request; National Institutes
of Health (NIH) Loan Repayment
This draft guidance refers to Programs; Office of the Director (OD)
collections of information that are Pursuant to section 10(d) of the
subject to review by the Office of Federal Advisory Committee Act, as Summary: Under the provisions of
Management and Budget (OMB) under amended (5 U.S.C. App.), notice is Section 3507(a)(1)(D) of the Paperwork
the Paperwork Reduction Act of 1995 hereby given of the following meetings. Reduction Act of 1995, the Division of
(44 U.S.C. 3501–3520). The draft The meetings will be closed to the Loan Repayment (DLR), the National
guidance pertains to sponsors, clinical public in accordance with the Institutes of Health (NIH), has submitted
investigators, contract research provisions set forth in sections to the Office of Management and Budget
organizations, IRBs, and other interested 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., (OMB) a request to review and approve
parties who use EHR systems as as amended. The contract proposals and the information collection listed below.
electronic source data in FDA-regulated the discussions could disclose This proposed information collection
clinical investigations and who send confidential trade secrets or commercial was previously published in the Federal
certain information to FDA or others or property such as patentable material, Register on February 19, 2016, and page
who keep certain records and make and personal information concerning numbers 8514–8516, and allowed 60
them available to FDA inspectors. The individuals associated with the contract days for public comment. No public
collections of information discussed in proposals, the disclosure of which comments were received. The purpose
the draft guidance are contained in our would constitute a clearly unwarranted of this notice is to allow an additional
investigational new drug regulations in invasion of personal privacy. 30 days for public comment. The NIH
part 312 (21 CFR part 312), approved Name of Committee: National Institute of may not conduct or sponsor, and the
under OMB control number 0910–0014, Allergy and Infectious Diseases, Special respondent is not required to respond
including §§ 312.58(a) and 312.62(b); Emphasis Panel, NIAID Peer Review Meeting. to, an information collection that has
investigational device exemption Date: June 9, 2016. been extended, revised, or implemented
regulations in § 812.140 (21 CFR Time: 1:00 p.m. to 5:00 p.m. on or after October 1, 1995, unless it
812.140) approved under OMB control Agenda: To review and evaluate contract
jstallworth on DSK7TPTVN1PROD with NOTICES

displays a currently valid OMB control
number 0910–0078; and electronic proposals. number.
records; electronic signatures Place: National Institutes of Health, Room Direct Comments to OMB: Written
3G61, 5601 Fishers Lane, Rockville, MD
regulations in 21 CFR part 11, approved 20892 (Telephone Conference Call).
comments and/or suggestions regarding
under OMB control number 0910–0303. Contact Person: Travis J Taylor, Ph.D., the item(s) contained in this notice,
The use of EHR systems as a source of Scientific Review Officer, Scientific Review especially regarding the estimated
data, as described in the draft guidance, Program, Division of Extramural Activities, public burden and associated response
would not result in any new costs, Room 3G62B 5601 Fishers Lane, MSC 9823, time, should be directed to the: Office

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Document Modified: 2018-02-07 15:05:28

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		81 FR 30540

81 FR 30540 - Use of Electronic Health Record Data in Clinical Investigations; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 95 (May 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration