[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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