2020-16036. 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 ...

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, [e-mail].

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 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; International Council for Harmonisation; integrated addendum to ICH E6(R1)	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
Section 5. Quality Management (including sections 5.0.1 to 5.0.7)—Developing a Quality Management System	1,457	1	1,457	60	87,420
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; International Council for Harmonisation; integrated addendum to ICH E6(R1)	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Section 5.0.7. Risk Reporting—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	1,457	4.6	6,702	3	20,106
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; International Council for Harmonisation; integrated addendum to ICH E6(R1)	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
Section 5. Quality Management (including sections 5.0.1 to 5.0.7)—Developing a Quality Management System	423	1	423	60	25,380
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; International Council for Harmonisation; integrated addendum to ICH E6(R1)	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Section 5.0.7. Risk Reporting—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	423	1.56	660	3	1,980
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 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.