[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44902-44904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16036]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-D-3327 and FDA-2018-D-0719]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on E6(R2) Good Clinical Practice; International Council for 
Harmonisation; Integrated Addendum to International Council for 
Harmonisation E6(R1)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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: Submit written comments (including recommendations) on the 
collection of information by August 24, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0843. 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, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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 for Industry on E6(R2) Good Clinical Practice; International 
Council for Harmonisation; Integrated Addendum to ICH E6(R1)

OMB Control Number 0910-0843--Extension

    This information collection request supports recommendations found 
in the Agency guidance entitled ``E6(R2) Good Clinical Practice; 
Integrated Addendum to ICH E6(R1)'' (ICH E6(R2)). The guidance was 
originally prepared under the auspices of the International Council for 
Harmonisation (ICH) (formerly the International Conference on 
Harmonisation); it amends the ICH guidance for industry entitled ``E6 
Good Clinical Practice: Consolidated Guidance'' (issued in April 1996). 
The guidance is intended to facilitate implementation of improved and 
more efficient approaches to clinical trial design, including conduct, 
oversight, recording, and reporting. This is intended to increase 
clinical trial quality and efficiency while continuing

[[Page 44903]]

to ensure human subject protection and reliability of trial results. 
Included in the guidance are additions identified as ``ADDENDUM'' and 
marked with vertical lines on both sides of the text.
    Standards regarding electronic records and essential documents 
intended to increase clinical trial quality and efficiency have also 
been updated. The guidance is available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1.
    In the Federal Register of September 5, 2019 (84 FR 46742), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                            Table 1--Estimated Annual Recordkeeping Burden for Human Drugs 1
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      Guidance for industry on E6(R2) good clinical practice;                            Number of                      Average  burden
  International Council for Harmonisation; integrated  addendum to      Number of       records per      Total annual         per          Total hours
                             ICH E6(R1)                               recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 5. Quality Management (including sections 5.0.1 to 5.0.7)--           1,457                1            1,457               60           87,420
 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Guidance for industry on E6(R2) good clinical practice;                            Number of
  International Council for Harmonisation; integrated  addendum to      Number of      responses per     Total annual   Average  burden    Total hours
                             ICH E6(R1)                                respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 5.0.7. Risk Reporting--Describing the Quality Management              1,457              4.6            6,702                3           20,106
 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Guidance for industry on E6(R2) good clinical practice;                            Number of                      Average  burden
  International Council for Harmonisation; integrated  addendum to      Number of       records per      Total annual         per          Total hours
                             ICH E6(R1)                               recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 5. Quality Management (including sections 5.0.1 to 5.0.7)--             423                1              423               60           25,380
 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Guidance for industry on E6(R2) good clinical practice;                            Number of
  International Council for Harmonisation; integrated  addendum to      Number of      responses per     Total annual   Average  burden    Total hours
                             ICH E6(R1)                                respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 5.0.7. Risk Reporting--Describing the Quality Management                423             1.56              660                3            1,980
 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.

    In table 1, we estimate 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 assume it will take respondents 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 FDA's Center for Drug Evaluation and 
Research. The estimated number of hours we assume it takes to develop a 
quality management system is based on informal interactions with 
industry about activities that support drug development plans.
    In table 2, we estimate 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 20,106 reporting hours annually. These 
estimates are based on our past experiences with INDs and NDAs.
    In table 3, we estimate 423 sponsors of clinical trials of 
biological products will develop 423 quality management systems per 
year (as described in ICH

[[Page 44904]]

E6(R2) in section 5.0, including sections 5.0.1 to 5.0.7). We assume it 
will take respondents 60 hours to develop and implement each quality 
management system, totaling 25,380 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 applications (BLAs) submitted to FDA's Center for Biologics 
Evaluation and Research. The estimated number of hours we assume it 
takes to develop a quality management system is based on informal 
interactions with industry about activities that support drug 
development plans.
    In table 4, we estimate 423 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 660 responses 
per respondent and that it will take sponsors 3 hours to complete this 
reporting task, totaling 1,980 reporting hours annually. As described 
previously, these estimates are based on past experiences with INDs and 
BLAs submitted to FDA.
    Although our estimated burden for the information collection 
reflects an overall decrease of 433 hours, we have increased the 
estimate by 861 records. We are making this adjustment based on an 
increase in the number of submissions we received over the last few 
years. We have also finalized the guidance since last OMB review, 
consistent with our good guidance practices regulation, which provide 
for public comment at any time, announcing its availability in the 
Federal Register of March 1, 2018 (83 FR 8882).

    Dated: July 20, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16036 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-P