Document ID: FDA-2015-D-3327-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; E6(R2) Good
Clinical Practice; International Council for Harmonisation
Posted Date: 2017-07-18T04:00Z

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32847-32848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14999]

[[Page 32847]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3327]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; E6(R2) Good Clinical 
Practice; International Council for Harmonisation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
17, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``E6(R2) Good Clinical Practice; International Council for 
Harmonisation.'' Also include the FDA docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733; 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance on E6(R2) Good Clinical Practice; International Council for 
Harmonisation

OMB Control Number 0910--NEW

    This information collection request supports Agency guidance 
entitled ``E6(R2) Good Clinical Practice'' (ICH E6(R2)), which was 
prepared under the auspices of the International Council for 
Harmonisation (ICH), formerly the International Conference on 
Harmonisation. ICH E6(R2) amends the ICH guidance entitled ``E6 Good 
Clinical Practice: Consolidated Guidance'' (issued in April 1996) to 
encourage implementation of improved and more-efficient approaches to 
clinical trial design, conduct, oversight, recording, and reporting 
that are intended to increase clinical trial quality and efficiency 
while continuing to ensure human subject protection and reliability of 
trial results. Standards regarding electronic records and essential 
documents intended to increase clinical trial quality and efficiency 
have also been updated. The guidance includes additions to ICH E6(R1) 
that are identified as ``ADDENDUM'' and are marked with vertical lines 
on both sides of the text.
    In table 1, we estimate that approximately 1,457 sponsors of 
clinical trials of human drugs will develop approximately 1,457 quality 
management systems per year (as described in ICH E6(R2) in section 5.0, 
including sections 5.0.1 to 5.0.7). We further estimate that it will 
take sponsors approximately 60 hours to develop and implement each 
quality management system, totaling 87,420 hours annually. The 
estimated number of sponsors who will develop a quality management 
system, as described in ICH E6(R2), is based on the number of annual 
investigational new drug applications (INDs) and new drug applications 
(NDAs) submitted to the Center for Drug Evaluation and Research. The 
estimated number of hours it will take to develop a quality management 
system is based on FDA interactions with sponsors about activities that 
support drug development plans.
    In table 2, we estimate that approximately 1,457 sponsors of 
clinical trials of human drugs will describe the quality management 
approach implemented in a clinical trial and summarize important 
deviations from the predefined quality tolerance limits and remedial 
actions taken in the clinical study report (as described in section 
5.0.7 of ICH E6(R2)). We further estimate that sponsors will submit 
approximately 4.6 responses per respondent and that it will take 
sponsors 3 hours to complete this reporting task, totaling 20,107 
reporting hours annually. These estimates are based on FDA's past 
experiences with INDs and NDAs.
    In table 3, we estimate that approximately 218 sponsors of clinical 
trials of biological products will develop approximately 218 quality 
management systems per year (as described in ICH E6(R2) in section 5.0, 
including sections 5.0.1 to 5.0.7). We further estimate that it will 
take sponsors approximately 60 hours to develop and implement each 
quality management system, totaling 13,080 hours annually. The 
estimated number of sponsors who will develop a quality management 
system, as described in ICH E6(R2), is based on the number of annual 
INDs and biologics license application (BLAs) submitted to the Center 
for Biologics Evaluation and Research. The estimated number of hours it 
will take to develop a quality management system is based on FDA 
interactions with sponsors about activities that support drug 
development plans.
    In table 4, we estimate that approximately 218 sponsors of clinical 
trials of biological products will describe the quality management 
approach implemented in a clinical trial and summarize important 
deviations from the predefined quality tolerance limits and remedial 
actions taken in a clinical study report (as described in section 5.0.7 
of ICH E6(R2)). We further estimate that sponsors will submit 
approximately 3.69 responses per respondent and that it will take 
sponsors 3 hours to complete this reporting task, totaling 2,413 
reporting hours annually. As described previously, these estimates are 
based on past experiences with INDs and BLAs submitted to the Agency.
    In the Federal Register of May 31, 2016 (81 FR 34345), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the proposed 
collection of information.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 32848]]

                       Table 1--Estimated Annual Recordkeeping Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
 E6(R2) Good clinical practice;
    International Council for        Number of       Number of     Total annual   Average burden
   Harmonisation; guidance for     recordkeepers    records per       records           per         Total hours
            industry                               recordkeeper                    recordkeeping
----------------------------------------------------------------------------------------------------------------
Section 5.0--Quality Management            1,457               1           1,457              60          87,420
 (including sections 5.0.1 to
 5.0.7)--Developing a Quality
 Management System..............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                         Table 2--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
 E6(R2) Good clinical practice;
    International Council for        Number of       Number of     Total annual   Average burden
   Harmonisation; guidance for      respondents    responses per     responses     per response     Total hours
            industry                                respondent
----------------------------------------------------------------------------------------------------------------
Section 5.0.7--Risk Reporting--            1,457             4.6           6,702               3          20,107
 Describing the Quality
 Management Approach Implemented
 in a Clinical Trial and
 Summarizing Important
 Deviations From the Predefined
 Quality Tolerance Limits and
 Remedial Actions Taken in the
 Clinical Study Report..........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                        Table 3--Estimated Annual Recordkeeping Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
 E6(R2) Good clinical practice;
    International Council for        Number of       Number of     Total annual   Average burden
   Harmonisation; guidance for     recordkeepers    records per       records           per         Total hours
            industry                               recordkeeper                    recordkeeping
----------------------------------------------------------------------------------------------------------------
Section 5.0--Quality Management              218               1             218              60          13,080
 (including 5.0.1 to 5.0.7)--
 Developing a Quality Management
 System.........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                          Table 4--Estimated Annual Reporting Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
 E6(R2) Good clinical practice;
    International Council for        Number of       Number of     Total annual   Average burden
   Harmonisation; guidance for       responses     responses per     responses     per response     Total hours
            industry                                respondent
----------------------------------------------------------------------------------------------------------------
Section 5.0.7--Risk Reporting--              218            3.69             804               3           2,413
 Describing the Quality
 Management Approach Implemented
 in a Clinical Trial and
 Summarizing Important
 Deviations From the Predefined
 Quality Tolerance Limits and
 Remedial Actions Taken in the
 Clinical Study Report..........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14999 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P