83 FR 8882 - E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonisation; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 41 (March 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 41 (March 1, 2018)
| Page Range | 8882-8883 | |
| FR Document | 2018-04154 |
[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)] [Notices] [Pages 8882-8883] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04154] [[Page 8882]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0719] E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonisation; 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 guidance entitled ``E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1).'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance amends the guidance entitled ``E6 Good Clinical Practice: Consolidated Guidance (E6(R1))'' to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The guidance is intended to improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results. DATES: The announcement of the guidance is published in the Federal Register on March 1, 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-2018-D-0719 for ``E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1).'' 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 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 this guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), 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. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, 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. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548. SUPPLEMENTARY INFORMATION: I. Background In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH [[Page 8883]] meetings designed to enhance harmonization, and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was established to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association. The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance. In the Federal Register of September 29, 2015 (80 FR 58492), FDA published a notice announcing the availability of a draft guidance entitled ``E6(R2) Good Clinical Practice.'' The notice gave interested persons an opportunity to submit comments on the ``ADDENDUM'' text added to ICH E6(R1) by November 30, 2015. After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Assembly and endorsed by the regulatory agencies in November 2016. The guidance discusses approaches to clinical trial design, conduct, oversight, recording, and reporting as well as updated standards regarding electronic records and essential documents. This guidance includes additions to ICH E6(R1) that are identified as ``ADDENDUM'' and are marked with vertical lines on both sides of the text. The additions to ICH E6(R1) are intended to encourage implementation of the described approaches and processes to improve clinical trial quality and efficiency while maintaining human subject protection and reliability of trial results. Evolutions in technology and risk management processes offer new opportunities to increase clinical trial efficiency, in part by focusing on trial activities essential to ensuring human subject protection and the reliability of trial results. For example, the guidance recommends sponsors implement a system to manage quality throughout clinical trials and recommends sponsors develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The guidance provides additional detail regarding recommendations for use of electronic records and essential documents. The final guidance includes clarifications and additional detail on topics including, for example, validation of computerized systems and centralized monitoring. 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 ``E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1).'' 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 guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (21 U.S.C. 3501-3520). The collections of information in this guidance were approved under 0910- 0843. This guidance also refers to previously approved collections of information found in FDA regulations. The collections of information found in 21 CFR part 11 have been approved under OMB control number 0910-0303; the collections of information found in 21 CFR part 56 have been approved under OMB control numbers 0910-0755; the collections of information found in 21 CFR part 312 have been approved under OMB control numbers 0910-0014 and 0910-0733; the collections of information found in 21 CFR part 314 have been approved under OMB control number 0910-0001; and the collections of information found in 21 CFR part 601 have been approved under OMB control number 0910-0338. III. Electronic Access Persons with access to the internet may obtain the document at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: February 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04154 Filed 2-28-18; 8:45 am] BILLING CODE 4164-01-P
![8882 Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
DEPARTMENT OF HEALTH AND comments, that information will be FR 56469, September 18, 2015, or access
HUMAN SERVICES posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Food and Drug Administration with confidential information that you 23389.pdf.
[Docket No. FDA–2018–D–0719]
do not wish to be made available to the Docket: For access to the docket to
public, submit the comment as a read background documents or the
E6(R2) Good Clinical Practice: written/paper submission and in the electronic and written/paper comments
Integrated Addendum to E6(R1); manner detailed (see ‘‘Written/Paper received, go to https://
International Council for Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Harmonisation; Guidance for Industry; Written/Paper Submissions docket number, found in brackets in the
Availability heading of this document, into the
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, follows: and/or go to the Dockets Management
HHS. • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061,
ACTION: Notice of availability. written/paper submissions): Dockets Rockville, MD 20852.
Management Staff (HFA–305), Food and You may submit comments on any
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
Administration (FDA or Agency) is guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)).
announcing the availability of a • For written/paper comments Submit written requests for single
guidance entitled ‘‘E6(R2) Good Clinical submitted to the Dockets Management
Practice: Integrated Addendum to copies of this guidance to the Division
Staff, FDA will post your comment, as
E6(R1).’’ The guidance was prepared of Drug Information, Center for Drug
well as any attachments, except for
under the auspices of the International Evaluation and Research (CDER), Food
information submitted, marked and
Council for Harmonisation (ICH), and Drug Administration, 10001 New
identified, as confidential, if submitted
formerly the International Conference Hampshire Ave., Hillandale Building,
as detailed in ‘‘Instructions.’’
on Harmonisation. The guidance Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
amends the guidance entitled ‘‘E6 Good must include the Docket No. FDA– 0002, or the Office of Communication,
Clinical Practice: Consolidated 2018–D–0719 for ‘‘E6(R2) Good Clinical Outreach and Development, Center for
Guidance (E6(R1))’’ to encourage Practice: Integrated Addendum to Biologics Evaluation and Research
implementation of improved and more E6(R1).’’ Received comments will be (CBER), Food and Drug Administration,
efficient approaches to clinical trial placed in the docket and, except for 10903 New Hampshire Ave., Bldg. 71,
design, conduct, oversight, recording, those submitted as ‘‘Confidential Rm. 3128, Silver Spring, MD 20993–
and reporting, and also updates Submissions,’’ publicly viewable at 0002. Send one self-addressed adhesive
standards regarding electronic records https://www.regulations.gov or at the label to assist that office in processing
and essential documents. The guidance Dockets Management Staff between 9 your requests. The guidance may also be
is intended to improve clinical trial a.m. and 4 p.m., Monday through obtained by mail by calling CBER at 1–
quality and efficiency, while Friday. 800–835–4709 or 240–402–8010. See
maintaining human subject protection • Confidential Submissions—To the SUPPLEMENTARY INFORMATION section
and reliability of trial results. submit a comment with confidential for electronic access to the guidance
information that you do not wish to be document.
DATES: The announcement of the
guidance is published in the Federal made publicly available, submit your FOR FURTHER INFORMATION CONTACT:
Register on March 1, 2018. comments only as a written/paper Regarding the guidance: Dianne
ADDRESSES: You may submit either submission. You should submit two Paraoan, Center for Drug Evaluation and
electronic or written comments on copies total. One copy will include the Research, Food and Drug
Agency guidances at any time as information you claim to be confidential Administration, 10903 New Hampshire
follows: with a heading or cover note that states Ave., Bldg. 51, Rm. 3326, Silver Spring,
‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 301–796–2500; or
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The Stephen Ripley, Center for Biologics
Submit electronic comments in the Agency will review this copy, including Evaluation and Research, Food and
following way: the claimed confidential information, in Drug Administration, 10903 New
• Federal eRulemaking Portal: its consideration of comments. The Hampshire Ave., Bldg. 71, Rm. 7301,
https://www.regulations.gov. Follow the second copy, which will have the Silver Spring, MD 20993–0002, 240–
instructions for submitting comments. claimed confidential information 402–7911.
Comments submitted electronically, redacted/blacked out, will be available Regarding the ICH: Amanda Roache,
including attachments, to https:// for public viewing and posted on Center for Drug Evaluation and
www.regulations.gov will be posted to https://www.regulations.gov. Submit Research, Food and Drug
the docket unchanged. Because your both copies to the Dockets Management Administration, 10903 New Hampshire
comment will be made public, you are Staff. If you do not wish your name and Ave., Bldg. 51, Rm. 1176, Silver Spring,
solely responsible for ensuring that your contact information to be made publicly MD 20993–0002, 301–796–4548.
comment does not include any available, you can provide this SUPPLEMENTARY INFORMATION:
confidential information that you or a information on the cover sheet and not
third party may not wish to be posted, in the body of your comments and you I. Background
amozie on DSK30RV082PROD with NOTICES
such as medical information, your or must identify this information as In recent years, regulatory authorities
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked and industry associations from around
confidential business information, such as ‘‘confidential’’ will not be disclosed the world have participated in many
as a manufacturing process. Please note except in accordance with 21 CFR 10.20 important initiatives to promote
that if you include your name, contact and other applicable disclosure law. For international harmonization of
information, or other information that more information about FDA’s posting regulatory requirements under the ICH.
identifies you in the body of your of comments to public dockets, see 80 FDA has participated in several ICH
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![Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices 8883
meetings designed to enhance guidance includes additions to ICH 21 CFR part 601 have been approved
harmonization, and FDA is committed E6(R1) that are identified as under OMB control number 0910–0338.
to seeking scientifically based ‘‘ADDENDUM’’ and are marked with
III. Electronic Access
harmonized technical procedures for vertical lines on both sides of the text.
pharmaceutical development. One of The additions to ICH E6(R1) are Persons with access to the internet
the goals of harmonization is to identify intended to encourage implementation may obtain the document at https://
and then reduce differences in technical of the described approaches and www.regulations.gov, https://
requirements for drug development processes to improve clinical trial www.fda.gov/Drugs/Guidance
among regulatory agencies. quality and efficiency while ComplianceRegulatoryInformation/
ICH was established to provide an maintaining human subject protection Guidances/default.htm, or https://
opportunity for harmonization and reliability of trial results. Evolutions www.fda.gov/BiologicsBloodVaccines/
initiatives to be developed with input in technology and risk management GuidanceComplianceRegulatory
from both regulatory and industry processes offer new opportunities to Information/Guidances/default.htm.
representatives. FDA also seeks input increase clinical trial efficiency, in part Dated: February 23, 2018.
from consumer representatives and by focusing on trial activities essential Leslie Kux,
others. ICH is concerned with to ensuring human subject protection
harmonization of technical Associate Commissioner for Policy.
and the reliability of trial results. For
requirements for the registration of example, the guidance recommends [FR Doc. 2018–04154 Filed 2–28–18; 8:45 am]
pharmaceutical products for human use sponsors implement a system to manage BILLING CODE 4164–01–P
among regulators around the world. The quality throughout clinical trials and
six founding members of the ICH are the recommends sponsors develop a
European Commission; the European systematic, prioritized, risk-based DEPARTMENT OF HEALTH AND
Federation of Pharmaceutical Industries approach to monitoring clinical trials. HUMAN SERVICES
Associations; FDA; the Japanese The guidance provides additional detail Food and Drug Administration
Ministry of Health, Labour, and Welfare; regarding recommendations for use of
the Japanese Pharmaceutical electronic records and essential [Docket No. FDA–2017–N–5925]
Manufacturers Association; and the documents. The final guidance includes
Pharmaceutical Research and clarifications and additional detail on Susceptibility Test Interpretive Criteria
Manufacturers of America. The topics including, for example, Recognized and Listed on the
Standing Members of the ICH validation of computerized systems and Susceptibility Test Interpretive Web
Association include Health Canada and centralized monitoring. Page; Reopening of a Public Docket;
Swissmedic. Any party eligible as a This guidance is being issued Request for Comments
Member in accordance with the ICH consistent with FDA’s good guidance AGENCY: Food and Drug Administration,
Articles of Association can apply for practices regulation (21 CFR 10.115). HHS.
membership in writing to the ICH The guidance represents the current
Secretariat. The ICH Secretariat, which thinking of FDA on ‘‘E6(R2) Good ACTION: Notice; reopening of a public
coordinates the preparation of Clinical Practice: Integrated Addendum docket; request for comments.
documentation, operates as an to E6(R1).’’ It does not establish any SUMMARY: The Food and Drug
international nonprofit organization and rights for any person and is not binding Administration (FDA or the Agency) is
is funded by the Members of the ICH on FDA or the public. You can use an reopening a docket for public comment
Association. alternative approach if it satisfies the on the susceptibility test interpretive
The ICH Assembly is the overarching requirements of the applicable statutes criteria for antibacterial and antifungal
body of the Association and includes and regulations. drugs provided by FDA on its
representatives from each of the ICH
II. Paperwork Reduction Act of 1995 Susceptibility Test Interpretive Criteria
members and observers. The Assembly
This guidance contains information web page (Interpretive Criteria web
is responsible for the endorsement of
collection provisions that are subject to page) established on December 13, 2017.
draft guidelines and adoption of final
review by the Office of Management and On the Interpretive Criteria web page,
guidelines. FDA publishes ICH
Budget (OMB) under the Paperwork FDA recognizes, in whole or in part,
guidelines as FDA guidance.
In the Federal Register of September Reduction Act of 1995 (21 U.S.C. 3501– susceptibility test interpretive criteria
29, 2015 (80 FR 58492), FDA published 3520). The collections of information in standards established by Standard
a notice announcing the availability of this guidance were approved under Development Organizations (SDOs) and
a draft guidance entitled ‘‘E6(R2) Good 0910–0843. This guidance also refers to lists other susceptibility test interpretive
Clinical Practice.’’ The notice gave previously approved collections of criteria identified by FDA outside of the
interested persons an opportunity to information found in FDA regulations. SDO process.
submit comments on the The collections of information found in DATES: This notice is published in the
‘‘ADDENDUM’’ text added to ICH 21 CFR part 11 have been approved Federal Register on March 1, 2018.
E6(R1) by November 30, 2015. under OMB control number 0910–0303; ADDRESSES: You may submit either
After consideration of the comments the collections of information found in electronic or written comments and
received and revisions to the guidance, 21 CFR part 56 have been approved information as follows:
a final draft of the guidance was under OMB control numbers 0910–
0755; the collections of information Electronic Submissions
submitted to the ICH Assembly and
amozie on DSK30RV082PROD with NOTICES
endorsed by the regulatory agencies in found in 21 CFR part 312 have been Submit electronic comments in the
November 2016. approved under OMB control numbers following way:
The guidance discusses approaches to 0910–0014 and 0910–0733; the • Federal eRulemaking Portal:
clinical trial design, conduct, oversight, collections of information found in 21 https://www.regulations.gov. Follow the
recording, and reporting as well as CFR part 314 have been approved under instructions for submitting comments.
updated standards regarding electronic OMB control number 0910–0001; and Comments submitted electronically,
records and essential documents. This the collections of information found in including attachments, to https://
VerDate Sep<11>2014 17:26 Feb 28, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\01MRN1.SGM 01MRN1](https://thefederalregister.org/doc/83_FR_8923/page/2.svg)
Document Created: 2018-02-28 23:58:32
Document Modified: 2018-02-28 23:58:32
| 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 March 1, 2018. | |
| Contact | Regarding the guidance: Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, 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. | |
| FR Citation | 83 FR 8882 |
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