82 FR 32847 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; E6(R2) Good Clinical Practice; International Council for Harmonisation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 136 (July 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 136 (July 18, 2017)
| Page Range | 32847-32848 | |
| FR Document | 2017-14999 |
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)] [Notices] [Pages 32847-32848] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14999] [[Page 32847]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [email protected]. 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; [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 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
![Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 32847
DEPARTMENT OF HEALTH AND ‘‘E6(R2) Good Clinical Practice’’ (ICH respondent and that it will take
HUMAN SERVICES E6(R2)), which was prepared under the sponsors 3 hours to complete this
auspices of the International Council for reporting task, totaling 20,107 reporting
Food and Drug Administration Harmonisation (ICH), formerly the hours annually. These estimates are
[Docket No. FDA–2015–D–3327] International Conference on based on FDA’s past experiences with
Harmonisation. ICH E6(R2) amends the INDs and NDAs.
Agency Information Collection ICH guidance entitled ‘‘E6 Good Clinical
In table 3, we estimate that
Activities; Submission for Office of Practice: Consolidated Guidance’’
(issued in April 1996) to encourage approximately 218 sponsors of clinical
Management and Budget Review;
implementation of improved and more- trials of biological products will develop
Comment Request; E6(R2) Good
Clinical Practice; International Council efficient approaches to clinical trial approximately 218 quality management
for Harmonisation design, conduct, oversight, recording, systems per year (as described in ICH
and reporting that are intended to E6(R2) in section 5.0, including sections
AGENCY: Food and Drug Administration, increase clinical trial quality and 5.0.1 to 5.0.7). We further estimate that
HHS. efficiency while continuing to ensure it will take sponsors approximately 60
ACTION: Notice. human subject protection and reliability hours to develop and implement each
SUMMARY: The Food and Drug of trial results. Standards regarding quality management system, totaling
Administration (FDA, the Agency, or electronic records and essential 13,080 hours annually. The estimated
we) is announcing that a proposed documents intended to increase clinical number of sponsors who will develop a
collection of information has been trial quality and efficiency have also quality management system, as
submitted to the Office of Management been updated. The guidance includes described in ICH E6(R2), is based on the
and Budget (OMB) for review and additions to ICH E6(R1) that are number of annual INDs and biologics
clearance under the Paperwork identified as ‘‘ADDENDUM’’ and are license application (BLAs) submitted to
Reduction Act of 1995. marked with vertical lines on both sides the Center for Biologics Evaluation and
DATES: Fax written comments on the of the text. Research. The estimated number of
collection of information by August 17, In table 1, we estimate that hours it will take to develop a quality
2017. approximately 1,457 sponsors of clinical management system is based on FDA
trials of human drugs will develop interactions with sponsors about
ADDRESSES: To ensure that comments on
approximately 1,457 quality activities that support drug
the information collection are received,
management systems per year (as development plans.
OMB recommends that written
described in ICH E6(R2) in section 5.0,
comments be faxed to the Office of In table 4, we estimate that
Information and Regulatory Affairs, including sections 5.0.1 to 5.0.7). We
further estimate that it will take approximately 218 sponsors of clinical
OMB, Attn: FDA Desk Officer, FAX: trials of biological products will
202–395–7285, or emailed to oira_ sponsors approximately 60 hours to
develop and implement each quality describe the quality management
submission@omb.eop.gov. All
management system, totaling 87,420 approach implemented in a clinical trial
comments should be identified with the
hours annually. The estimated number and summarize important deviations
OMB control number 0910–NEW and
title ‘‘E6(R2) Good Clinical Practice; of sponsors who will develop a quality from the predefined quality tolerance
International Council for management system, as described in limits and remedial actions taken in a
Harmonisation.’’ Also include the FDA ICH E6(R2), is based on the number of clinical study report (as described in
docket number found in brackets in the annual investigational new drug section 5.0.7 of ICH E6(R2)). We further
heading of this document. applications (INDs) and new drug estimate that sponsors will submit
applications (NDAs) submitted to the approximately 3.69 responses per
FOR FURTHER INFORMATION CONTACT:
Center for Drug Evaluation and respondent and that it will take
Domini Bean, Office of Operations,
Food and Drug Administration, Three Research. The estimated number of sponsors 3 hours to complete this
White Flint North, 10A63, 11601 hours it will take to develop a quality reporting task, totaling 2,413 reporting
Landsdown St., North Bethesda, MD management system is based on FDA hours annually. As described
20852, 301–796–5733; PRAStaff@ interactions with sponsors about previously, these estimates are based on
fda.hhs.gov. activities that support drug past experiences with INDs and BLAs
development plans.
SUPPLEMENTARY INFORMATION: In submitted to the Agency.
In table 2, we estimate that
compliance with 44 U.S.C. 3507, FDA approximately 1,457 sponsors of clinical In the Federal Register of May 31,
has submitted the following proposed trials of human drugs will describe the 2016 (81 FR 34345), FDA published a
collection of information to OMB for quality management approach 60-day notice requesting public
review and clearance. implemented in a clinical trial and comment on the proposed collection of
Guidance on E6(R2) Good Clinical summarize important deviations from information. No comments were
Practice; International Council for the predefined quality tolerance limits received on the proposed collection of
Harmonisation and remedial actions taken in the information.
clinical study report (as described in FDA estimates the burden of this
OMB Control Number 0910—NEW section 5.0.7 of ICH E6(R2)). We further collection of information as follows:
This information collection request estimate that sponsors will submit
sradovich on DSK3GMQ082PROD with NOTICES
supports Agency guidance entitled approximately 4.6 responses per
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![32848 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1
Number of Average
E6(R2) Good clinical practice; International Council for Number of Total annual
records per burden per Total hours
Harmonisation; guidance for industry recordkeepers records
recordkeeper recordkeeping
Section 5.0—Quality Management (including sections
5.0.1 to 5.0.7)—Developing a Quality Management Sys-
tem .................................................................................... 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
Number of Average
E6(R2) Good clinical practice; International Council for Number of Total annual
responses per burden per Total hours
Harmonisation; guidance for industry respondents responses
respondent response
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 Ac-
tions Taken in the Clinical Study Report ......................... 1,457 4.6 6,702 3 20,107
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
Number of Average
E6(R2) Good clinical practice; International Council for Number of Total annual
records per burden per Total hours
Harmonisation; guidance for industry recordkeepers records
recordkeeper recordkeeping
Section 5.0—Quality Management (including 5.0.1 to
5.0.7)—Developing a Quality Management System ........ 218 1 218 60 13,080
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
Number of Average
E6(R2) Good clinical practice; International Council for Number of Total annual
responses per burden per Total hours
Harmonisation; guidance for industry responses responses
respondent response
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 Ac-
tions Taken in the Clinical Study Report ......................... 218 3.69 804 3 2,413
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 12, 2017. ACTION: Notice. include the FDA docket number found
Anna K. Abram, in brackets in the heading of this
Deputy Commissioner for Policy, Planning, SUMMARY: The Food and Drug document.
Legislation, and Analysis. Administration (FDA) is announcing
[FR Doc. 2017–14999 Filed 7–17–17; 8:45 am] that a proposed collection of FOR FURTHER INFORMATION CONTACT: Ila
BILLING CODE 4164–01–P
information has been submitted to the S. Mizrachi, Office of Operations, Food
Office of Management and Budget and Drug Administration, Three White
(OMB) for review and clearance under Flint North, 10A63, 11601 Landsdown
DEPARTMENT OF HEALTH AND the Paperwork Reduction Act of 1995. St., North Bethesda, MD 20852, 301–
HUMAN SERVICES DATES: Fax written comments on the 796–7726, PRAStaff@fda.hhs.gov.
collection of information by August 17, SUPPLEMENTARY INFORMATION: In
Food and Drug Administration 2017. compliance with 44 U.S.C. 3507, FDA
[Docket No. FDA–2010–N–0601] ADDRESSES: To ensure that comments on has submitted the following proposed
the information collection are received, collection of information to OMB for
Agency Information Collection
OMB recommends that written
sradovich on DSK3GMQ082PROD with NOTICES
Activities; Submission for Office of review and clearance.
comments be faxed to the Office of
Management and Budget Review;
Information and Regulatory Affairs,
Comment Request; Current Good
OMB, Attn: FDA Desk Officer, FAX:
Manufacturing Practice Regulations for
202–395–7285, or emailed to oira_
Medicated Feeds
submission@omb.eop.gov. All
AGENCY: Food and Drug Administration, comments should be identified with the
HHS. OMB control number 0910–0152. Also
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Document Created: 2018-10-24 11:24:25
Document Modified: 2018-10-24 11:24:25
| 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. | |
| Dates | Fax written comments on the collection of information by August 17, 2017. | |
| 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; [email protected] | |
| FR Citation | 82 FR 32847 |
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