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), 44902-44904 [2020-16036]
Download as PDF
<![CDATA[
44902
Federal Register / Vol. 85, No. 143 / Friday, July 24, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR part
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
58.35(b)(7); Quality assurance unit .....................................
58.185; Reporting of nonclinical laboratory study results ...
300
300
60.25
60.25
18,075
18,075
1
27.65
18,075
499,774
Total ..............................................................................
........................
........................
........................
........................
517,849
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part
Total annual
records
58.29(b); Personnel .............................................................
300
20
6,000
58.35(b)(1)–(6), and (c); Quality assurance unit .................
58.63(b) and (c); Maintenance and calibration of equipment ..................................................................................
300
270.76
81,228
300
60
18,000
58.81(a)–(c); SOPs ..............................................................
300
301.80
90,540
58.90(c) and (g); Animal care ..............................................
300
62.70
18,810
58.105(a) and (b); Test and control article characterization
58.107(d); Test and control article handling ........................
58.113(a); Mixtures of articles with carriers ........................
58.120; Protocol ...................................................................
58.195; Retention of records ...............................................
300
300
300
300
300
5
1
15.33
15.38
251.50
Total ..............................................................................
........................
........................
1 There
Dated: July 20, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–16095 Filed 7–23–20; 8:45 am]
BILLING CODE 4164–01–P
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:
Average
burden per
recordkeeping
.21
(13 minutes)
3.36
Total hours
1,260
272,926
1,500
300
4,599
4,614
75,450
.09
(5 minutes)
.14
(8 minutes)
.13
(8 minutes)
11.8
4.25
6.8
32.7
3.9
1,620
17,700
1,275
31,273
150,878
294,255
........................
........................
786,308
12,676
2,445
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
jbell on DSKJLSW7X2PROD with NOTICES
Number of
records per
recordkeeper
Notice.
VerDate Sep<11>2014
20:45 Jul 23, 2020
Jkt 250001
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.
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\24JYN1.SGM
24JYN1
44903
Federal Register / Vol. 85, No. 143 / Friday, July 24, 2020 / Notices
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-fdaguidance-documents/e6r2-good-clinicalpractice-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
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
20:45 Jul 23, 2020
Jkt 250001
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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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
E:\FR\FM\24JYN1.SGM
24JYN1
44904
Federal Register / Vol. 85, No. 143 / Friday, July 24, 2020 / Notices
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
jbell on DSKJLSW7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4829]
Jin Su Park: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
20:45 Jul 23, 2020
Jkt 250001
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring Jin
Su Park for a period of 10 years from
importing or offering for import any
drug into the United States. FDA bases
this order on a finding that Mr. Park was
convicted of one felony count under
Federal law for Importing Merchandise
Contrary to Law, Causing an Act to be
Done and of one felony count of
introducing Misbranded Drugs into
Interstate Commerce, causing an Act to
be Done. The factual basis supporting
both of Mr. Park’s convictions, as
described below, is conduct relating to
the importation into the United States of
a drug or controlled substance. Mr. Park
was given notice of the proposed
debarment and was given an
opportunity to request a hearing to show
why he should not be debarred. As of
January 19, 2019 (30 days after receipt
of the notice), Mr. Park had not
responded. Mr. Park’s failure to respond
and request a hearing constitutes a
waiver of his right to a hearing
concerning this matter.
DATES: This order is applicable July 24,
2020.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of
Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240 402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
debarment of an individual from
importing or offering for import any
drug into the United States if the FDA
finds, as required by section 306(b)(3)(C)
of the FD&C Act, that the individual has
been convicted of a felony for conduct
relating to the importation into the
United States of any drug or controlled
substance.
On March 25, 2019, Mr. Park was
convicted, as defined in section
306(l)(1)(B) of the FD&C Act, in the
United States District Court for the
Central District of California, when the
court accepted his plea of guilty and
entered judgment against him for the
felony offenses of Importing
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Merchandise Contrary to Law, Causing
an Act to be Done in violation of 18
U.S.C. 545, 2(b) and of Introducing
Misbranded Drugs into Interstate
Commerce, causing an Act to be Done
in violation of 21 U.S.C. 331(a), 352, and
333(a)(2) (sections 301(a), 502, and
303(a)(2) of the FD&C Act).
The FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for these convictions is as
follows: As contained in the Plea
Agreement, filed on February 7, 2019,
Mr. Park did, no later than 2015, begin
providing minor assistance to his longtime friend ‘‘J.L.’’ who owned and
operated several companies that
manufactured and distributed
misbranded male sexual enhancement
pills across the United States. In
February 2017, J.L.’s operation was shut
down after the FDA and Department of
Homeland Security executed a search
warrant at J.L.’s pill business as part of
an investigation into J.L.’s smuggling of
Tadalafil into the United States from
China. Mr. Park knew that J.L. had been
unlawfully selling misbranded pills
containing Tadalafil and other active
pharmaceutical ingredients smuggled
from China. Mr. Park took
approximately 14,000 male sexual
enhancement pills, all containing
undisclosed Tadalafil, from J.L.’s
business, and stored them at Mr. Park’s
home. Mr. Park then set up a new
company, RNG Global Management and
Trading Group, Inc. (RNG). Mr. Park
repackaged the 14,000 pills with new
labeling that failed to disclose the
presence of Tadalafil and he
commenced selling the misbranded pills
to various customers throughout the
United States.
Furthermore, in April 2018, Mr. Park
ordered, and subsequently paid for, five
kilograms of Dapoxetine and five
kilograms of Rhodiola rosea from
suppliers in China. Mr. Park had the
Chinese supplier ship five kilograms of
Dapoxetine to him, through a Korean
intermediary, in a parcel mislabeled as
containing, ‘‘Glass Colour Sample (Zinc
Sulfide)’’ to a commercial mailbox Mr.
Park controlled in Michigan. Mr. Park
subsequently had the same Chinese
supplier ship to his Michigan mailbox
the five kilograms of Rhodiola rosea,
through the same Korean intermediary,
in a parcel mislabeled as containing,
‘‘Glass Colour (Zinc Sulfide) Sample.’’
Mr. Park intended to use both the
Dapoxetine and Rhodiola rosea in the
male sexual enhancement pills he
would sell.
As a result of this conviction, FDA
sent Mr. Park by certified mail on
December 16, 2019, a notice proposing
E:\FR\FM\24JYN1.SGM
24JYN1
]]>Agencies
[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
