Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 34137 

goal of 10 percent of eligible 

households, ATSDR/NCEH will consent 

and collect samples from approximately 

15 households per EA or households 

annually (152*10/100*5). The average 

time burden is estimated as 15 minutes 

per response, or 19 hours annually. 

ATSDR estimates the total annualized 

time burden is 961 hours. Participation 

is voluntary, and there are no costs to 

respondents other than their time. 

Public health professionals, 

environmental risk managers, and other 

decision makers can use EA results to 

make informed decisions about the 

sources and impact of PFAS 

contamination in environmental media 

within their own community and 

jurisdiction. The data will support their 

recommendations for public health 

actions to reduce or eliminate harmful 

levels of PFAS in the local environment. 

These EAs are not intended to yield 

information about PFAS exposure that 

will be generalized beyond the defined 

boundaries of each investigation; 

however, ATSDR/NCEH will use these 

EA findings to inform a future national 

PFAS health study. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Potential EA Heads-of-Households ... Household Eligibility Screener ......... 1,170 1 5/60 98 

EA Adults ........................................... Exposure Questionnaire for Biological and Environmental Testing 

(Adults).

1,440 1 30/60 720 

EA Parents ........................................ EA Questionnaire for Biological 

Testing (Child).

264 1 15/60 66 

EA Children ....................................... EA Questionnaire for Biological 

Testing (Child).

191 1 15/60 48 

EA Heads-of-Households .................. Household Recruitment Script for 

Environmental Sampling.

117 1 5/60 10 

Environmental Sample Collection 

Form.

76 1 15/60 19 

Total ........................................... .......................................................... ........................ ........................ ........................ 961 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–15437 Filed 7–18–18; 8:45 am] 

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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; 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 final 

guidance for industry entitled ‘‘Use of 

Electronic Health Record Data in 

Clinical Investigations.’’ The guidance 

provides recommendations for sponsors, 

clinical investigators, contract research 

organizations (CROs), institutional 

review boards (IRBs), and other 

interested parties on the use of 

electronic health record (EHR) data in 

FDA-regulated clinical investigations. 

The guidance finalizes the draft 

guidance issued in May 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 19, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 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– 

2016–D–1224 for ‘‘Use of Electronic 

Health Record Data in Clinical 

Investigations; 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 office 

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 


sradovich on DSK3GMQ082PROD with NOTICES
34138 Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the 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 

(CBER), 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 selfaddressed adhesive label to assist the 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the 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, cheryl.grandinetti@

fda.hhs.gov; 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, ocod@fda.hhs.gov; or 

Bakul Patel, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5458, Silver Spring, 

MD 20993–0002, 1–800–638–2041 or 

301–796–5528, bakul.patel@fda.hhs.gov 

or DigitalHealth@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Use of 

Electronic Health Record Data in 

Clinical Investigations.’’ The guidance is 

intended to assist sponsors, clinical 

investigators, CROs, IRBs, and other 

interested parties on the use of EHR data 

in FDA-regulated clinical investigations. 

In an effort to modernize and streamline 

clinical investigations, the goals of the 

guidance are to facilitate the use of EHR 

data in clinical investigations and to 

promote the interoperability of EHR and 

EDC systems. 

In the Federal Register of May 17, 

2016 (81 FR 30540), FDA announced the 

availability of the draft guidance. FDA 

received numerous comments on the 

draft guidance, and those comments 

were considered as the guidance was 

finalized. A summary of changes 

includes clarifying the following: (1) 

The types of clinical investigations 

using EHR data as source data that fall 

under the scope of the guidance; (2) 

recommendations on the use of EHR 

and EDC systems that are interoperable 

or fully integrated; (3) recommendations 

on the use of certified and noncertified 

EHR technology; (4) how electronic 

source data principles apply to EHR 

data used as source data; and (5) 

inspection, recordkeeping, and record 

retention requirements. This guidance 

finalizes the draft guidance issued in 

May 2016. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Use of Electronic 

Health Record 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. This guidance is not 

subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA 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). The guidance pertains to 

sponsors, clinical investigators, CROs, 

IRBs, and other interested parties who 

use EHR data 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 in 21 CFR part 11 have been 

approved under OMB control number 

0910–0303; the collections of 

information in 21 CFR part 50 have been 

approved under OMB control number 

0910–0755; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; and the collections 

of information in 21 CFR 812.140 have 

been approved under OMB control 

number 0910–0078. The use of EHRs as 

a source of data, as described in the 

guidance, would not result in any new 

costs, including capital costs or 

operating and maintenance costs, 

because sponsors and others already 

have experience and are experienced 

with using computer-based equipment 

and software necessary to be consistent 

with the guidance. 

III. Electronic Access 

Persons with access to the internet 

may obtain the 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: July 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15390 Filed 7–18–18; 8:45 am] 

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