83 FR 34137 - Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 139 (July 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 139 (July 19, 2018)
| Page Range | 34137-34138 | |
| FR Document | 2018-15390 |
[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)] [Notices] [Pages 34137-34138] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15390] ----------------------------------------------------------------------- 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 The guidance finalizes the draft guidance issued in May 2016.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 [[Page 34138]] 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.thefederalregister.org/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 self-addressed 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, [email protected]; 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, [email protected]; 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, [email protected] or [email protected]. 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/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: July 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15390 Filed 7-18-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 34137
goal of 10 percent of eligible is voluntary, and there are no costs to recommendations for public health
households, ATSDR/NCEH will consent respondents other than their time. actions to reduce or eliminate harmful
and collect samples from approximately Public health professionals, levels of PFAS in the local environment.
15 households per EA or households environmental risk managers, and other These EAs are not intended to yield
annually (152*10/100*5). The average decision makers can use EA results to information about PFAS exposure that
time burden is estimated as 15 minutes make informed decisions about the will be generalized beyond the defined
per response, or 19 hours annually. sources and impact of PFAS boundaries of each investigation;
contamination in environmental media however, ATSDR/NCEH will use these
ATSDR estimates the total annualized within their own community and EA findings to inform a future national
time burden is 961 hours. Participation jurisdiction. The data will support their PFAS health study.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response hours
respondent (in hours)
Potential EA Heads-of-Households ... Household Eligibility Screener ......... 1,170 1 5/60 98
EA Adults ........................................... Exposure Questionnaire for Biologi- 1,440 1 30/60 720
cal and Environmental Testing
(Adults).
EA Parents ........................................ EA Questionnaire for Biological 264 1 15/60 66
Testing (Child).
EA Children ....................................... EA Questionnaire for Biological 191 1 15/60 48
Testing (Child).
EA Heads-of-Households .................. Household Recruitment Script for 117 1 5/60 10
Environmental Sampling.
Environmental Sample Collection 76 1 15/60 19
Form.
Total ........................................... .......................................................... ........................ ........................ ........................ 961
Jeffrey M. Zirger, The guidance finalizes the draft do not wish to be made available to the
Acting Chief, Information Collection Review guidance issued in May 2016. public, submit the comment as a
Office, Office of Scientific Integrity, Office DATES: The announcement of the written/paper submission and in the
of the Associate Director for Science, Office manner detailed (see ‘‘Written/Paper
guidance is published in the Federal
of the Director, Centers for Disease Control Submissions’’ and ‘‘Instructions’’).
and Prevention. Register on July 19, 2018.
[FR Doc. 2018–15437 Filed 7–18–18; 8:45 am] ADDRESSES: You may submit either Written/Paper Submissions
BILLING CODE 4163–18–P
electronic or written comments on Submit written/paper submissions as
Agency guidances at any time as follows:
follows: • Mail/Hand delivery/Courier (for
DEPARTMENT OF HEALTH AND Electronic Submissions written/paper submissions): Dockets
HUMAN SERVICES Management Staff (HFA–305), Food and
Submit electronic comments in the Drug Administration, 5630 Fishers
Food and Drug Administration following way: Lane, Rm. 1061, Rockville, MD 20852.
• Federal eRulemaking Portal: • For written/paper comments
[Docket No. FDA–2016–D–1224] https://www.regulations.gov. Follow the submitted to the Dockets Management
instructions for submitting comments. Staff, FDA will post your comment, as
Use of Electronic Health Record Data
Comments submitted electronically, well as any attachments, except for
in Clinical Investigations; Guidance for
including attachments, to https:// information submitted, marked and
Industry; Availability
www.regulations.gov will be posted to identified, as confidential, if submitted
AGENCY: Food and Drug Administration, the docket unchanged. Because your as detailed in ‘‘Instructions.’’
HHS. comment will be made public, you are Instructions: All submissions received
ACTION: Notice of availability. solely responsible for ensuring that your must include the Docket No. FDA–
comment does not include any 2016–D–1224 for ‘‘Use of Electronic
SUMMARY: The Food and Drug confidential information that you or a Health Record Data in Clinical
Administration (FDA or Agency) is third party may not wish to be posted, Investigations; Guidance for Industry;
announcing the availability of a final such as medical information, your or Availability.’’ Received comments will
guidance for industry entitled ‘‘Use of anyone else’s Social Security number, or be placed in the docket and, except for
Electronic Health Record Data in confidential business information, such those submitted as ‘‘Confidential
Clinical Investigations.’’ The guidance as a manufacturing process. Please note
sradovich on DSK3GMQ082PROD with NOTICES
Submissions,’’ publicly viewable at
provides recommendations for sponsors, that if you include your name, contact https://www.regulations.gov or at the
clinical investigators, contract research information, or other information that Dockets Management Staff office
organizations (CROs), institutional identifies you in the body of your between 9 a.m. and 4 p.m., Monday
review boards (IRBs), and other comments, that information will be through Friday.
interested parties on the use of posted on https://www.regulations.gov. • Confidential Submissions—To
electronic health record (EHR) data in • If you want to submit a comment submit a comment with confidential
FDA-regulated clinical investigations. with confidential information that you information that you do not wish to be
VerDate Sep<11>2014 17:34 Jul 18, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1](https://thefederalregister.org/doc/83_FR_34276/page/1.svg)
![34138 Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices
made publicly available, submit your the SUPPLEMENTARY INFORMATION section Investigations.’’ It does not establish any
comments only as a written/paper for electronic access to the guidance rights for any person and is not binding
submission. You should submit two document. on FDA or the public. You can use an
copies total. One copy will include the FOR FURTHER INFORMATION CONTACT: alternative approach if it satisfies the
information you claim to be confidential Cheryl Grandinetti, Center for Drug requirements of the applicable statutes
with a heading or cover note that states Evaluation and Research, Food and and regulations. This guidance is not
‘‘THIS DOCUMENT CONTAINS Drug Administration, 10903 New subject to Executive Order 12866.
CONFIDENTIAL INFORMATION.’’ The Hampshire Ave., Bldg. 51, Rm. 3348,
Agency will review this copy, including II. Paperwork Reduction Act of 1995
Silver Spring, MD 20993–0002, 301–
the claimed confidential information, in 796–2500, cheryl.grandinetti@
its consideration of comments. The This guidance refers to previously
fda.hhs.gov; Stephen Ripley, Center for approved collections of information
second copy, which will have the Biologics Evaluation and Research,
claimed confidential information found in FDA regulations. These
Food and Drug Administration, 10903 collections of information are subject to
redacted/blacked out, will be available
New Hampshire Ave., Bldg. 71, Rm. review by the Office of Management and
for public viewing and posted on
7301, Silver Spring, MD 20993–0002, Budget (OMB) under the Paperwork
https://www.regulations.gov. Submit
240–402–7911, ocod@fda.hhs.gov; or Reduction Act of 1995 (44 U.S.C. 3501–
both copies to the Dockets Management
Bakul Patel, Center for Devices and 3520). The guidance pertains to
Staff. If you do not wish your name and
Radiological Health, Food and Drug sponsors, clinical investigators, CROs,
contact information to be made publicly
Administration, 10903 New Hampshire IRBs, and other interested parties who
available, you can provide this
Ave., Bldg. 66, Rm. 5458, Silver Spring, use EHR data as electronic source data
information on the cover sheet and not
MD 20993–0002, 1–800–638–2041 or
in the body of your comments and you in FDA-regulated clinical investigations
must identify this information as 301–796–5528, bakul.patel@fda.hhs.gov
and who send certain information to
‘‘confidential.’’ Any information marked or DigitalHealth@fda.hhs.gov.
FDA or others or who keep certain
as ‘‘confidential’’ will not be disclosed SUPPLEMENTARY INFORMATION:
records and make them available to FDA
except in accordance with 21 CFR 10.20 I. Background inspectors. The collections of
and other applicable disclosure law. For information in 21 CFR part 11 have been
more information about FDA’s posting FDA is announcing the availability of
a guidance for industry entitled ‘‘Use of approved under OMB control number
of comments to public dockets, see 80 0910–0303; the collections of
FR 56469, September 18, 2015, or access Electronic Health Record Data in
Clinical Investigations.’’ The guidance is information in 21 CFR part 50 have been
the information at: https://www.gpo.gov/ approved under OMB control number
fdsys/pkg/FR-2015-09-18/pdf/2015- intended to assist sponsors, clinical
investigators, CROs, IRBs, and other 0910–0755; the collections of
23389.pdf. information in 21 CFR part 312 have
Docket: For access to the docket to interested parties on the use of EHR data
read background documents or the in FDA-regulated clinical investigations. been approved under OMB control
electronic and written/paper comments In an effort to modernize and streamline number 0910–0014; and the collections
received, go to https:// clinical investigations, the goals of the of information in 21 CFR 812.140 have
www.regulations.gov and insert the guidance are to facilitate the use of EHR been approved under OMB control
docket number, found in brackets in the data in clinical investigations and to number 0910–0078. The use of EHRs as
heading of this document, into the promote the interoperability of EHR and a source of data, as described in the
‘‘Search’’ box and follow the prompts EDC systems. guidance, would not result in any new
and/or go to the Dockets Management In the Federal Register of May 17, costs, including capital costs or
Staff, 5630 Fishers Lane, Rm. 1061, 2016 (81 FR 30540), FDA announced the operating and maintenance costs,
Rockville, MD 20852. availability of the draft guidance. FDA because sponsors and others already
You may submit comments on any received numerous comments on the have experience and are experienced
guidance at any time (see 21 CFR draft guidance, and those comments with using computer-based equipment
10.115(g)(5)). were considered as the guidance was and software necessary to be consistent
Submit written requests for single finalized. A summary of changes with the guidance.
copies of the guidance to the Division of includes clarifying the following: (1)
Drug Information, Center for Drug The types of clinical investigations III. Electronic Access
Evaluation and Research, Food and using EHR data as source data that fall
Drug Administration, 10001 New under the scope of the guidance; (2) Persons with access to the internet
Hampshire Ave., Hillandale Building, recommendations on the use of EHR may obtain the guidance at https://
4th Floor, Silver Spring, MD 20993– and EDC systems that are interoperable www.fda.gov/Drugs/Guidance
0002; or the Office of Communication, or fully integrated; (3) recommendations ComplianceRegulatoryInformation/
Outreach and Development, Center for on the use of certified and noncertified Guidances/default.htm, https://
Biologics Evaluation and Research EHR technology; (4) how electronic www.fda.gov/BiologicsBloodVaccines/
(CBER), Food and Drug Administration, source data principles apply to EHR GuidanceComplianceRegulatory
10903 New Hampshire Ave., Bldg. 71, data used as source data; and (5) Information/Guidances/default.htm,
Rm. 3128, Silver Spring, MD 20993– inspection, recordkeeping, and record https://www.fda.gov/MedicalDevices/
0002; or the Office of the Center retention requirements. This guidance DeviceRegulationandGuidance/
Director, Guidance and Policy GuidanceDocuments/default.htm, or
sradovich on DSK3GMQ082PROD with NOTICES
finalizes the draft guidance issued in
Development, Center for Devices and May 2016. https://www.regulations.gov.
Radiological Health, Food and Drug This guidance is being issued Dated: July 13, 2018.
Administration, 10903 New Hampshire consistent with FDA’s good guidance
Leslie Kux,
Ave., Bldg. 66, Rm. 5431, Silver Spring, practices regulation (21 CFR 10.115).
MD 20993–0002. Send one self- The guidance represents the current Associate Commissioner for Policy.
addressed adhesive label to assist the thinking of FDA on ‘‘Use of Electronic [FR Doc. 2018–15390 Filed 7–18–18; 8:45 am]
office in processing your requests. See Health Record Data in Clinical BILLING CODE 4164–01–P
VerDate Sep<11>2014 17:34 Jul 18, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 9990 E:\FR\FM\19JYN1.SGM 19JYN1](https://thefederalregister.org/doc/83_FR_34276/page/2.svg)
Document Created: 2018-07-19 01:34:38
Document Modified: 2018-07-19 01:34:38
| 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 | The announcement of the guidance is published in the Federal Register on July 19, 2018. | |
| 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, [email protected]; 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, [email protected]; 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, [email protected] or [email protected] | |
| FR Citation | 83 FR 34137 |
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