Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 60203-60204 [2017-27255]
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
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methods for demonstrating OINDP
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Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27279 Filed 12–18–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0075]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good Laboratory
Practice Regulations for Nonclinical
Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Fax written comments on the
collection of information by January 18,
2018.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0119. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
Good Laboratory Practice Regulations
for Nonclinical Studies—21 CFR Part
58
OMB Control Number 0910–0119—
Extension
Sections 409, 505, 512, and 515 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 348, 355, 360b, and 360e) and
related statutes require manufacturers of
food additives, human drugs and
biological products, animal drugs, and
medical devices to demonstrate the
safety and utility of their product by
submitting applications to FDA for
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60203
research or marketing permits. Such
applications contain, among other
important items, full reports of all
studies done to demonstrate product
safety in man and/or other animals. In
order to ensure adequate quality control
for these studies and to provide an
adequate degree of consumer protection,
the Agency issued good laboratory
practice (GLP) regulations for
nonclinical laboratory studies in part 58
(21 CFR part 58). The regulations
specify minimum standards for the
proper conduct of safety testing and
contain sections on facilities, personnel,
equipment, standard operating
procedures (SOPs), test and control
articles, quality assurance, protocol and
conduct of a safety study, records and
reports, and laboratory disqualification.
Part 58 requires testing facilities
engaged in conducting toxicological
studies to retain, and make available to
regulatory officials, records regarding
compliance with GLPs. Records are
maintained on file at each testing
facility and examined there periodically
by FDA inspectors. The GLP regulations
require that, for each nonclinical
laboratory study, a final report be
prepared that documents the results of
quality assurance unit inspections, test
and control article characterization,
testing of mixtures of test and control
articles with carriers, and an overall
interpretation of nonclinical laboratory
studies. The GLP regulations also
require written records pertaining to: (1)
Personnel job descriptions and
summaries of training and experience;
(2) master schedules, protocols and
amendments thereto, inspection reports,
and SOPs; (3) equipment inspection,
maintenance, calibration, and testing
records; (4) documentation of feed and
water analyses, and animal treatments;
(5) test article accountability records;
and (6) study documentation and raw
data.
Recordkeeping is necessary to
document the conduct of nonclinical
laboratory studies of FDA-regulated
products to ensure the quality and
integrity of the resulting final study
report on which a regulatory decision
may be based. Written SOPs and records
of actions taken are essential for testing
facilities to implement GLPs effectively.
Further, they are essential for FDA to be
able to determine a testing facility’s
compliance with the GLP regulations in
part 58.
In a notice of proposed rulemaking
published in the Federal Register of
August 24, 2016 (81 FR 58342), we
proposed changes in our GLP
regulations, including some of those
listed in tables 1 and 2 of this
document. The document included
E:\FR\FM\19DEN1.SGM
19DEN1
60204
Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
revised burden estimates for the
proposed changes and solicited public
comment. In response to requests, the
comment period was extended to
January 21, 2017 (81 FR 75351, October
31, 2016). In the interim, FDA is seeking
an extension of OMB approval for the
In the Federal Register of April 25,
2017 (82 FR 19054), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received no comments.
FDA estimates the burden of this
collection of information as follows:
current regulations so that we can
continue to collect information while
the proposal is pending.
Description of Respondents: The
likely respondents collecting this
information are contract laboratories,
sponsors of FDA-regulated products,
universities, or government agencies.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/activity
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 maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section/activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
(in hours)
Total hours
58.29(b); Personnel .................................................
58.35(b)(1)–(6), and (c); Quality assurance unit .....
58.63(b) and (c); Maintenance and calibration of
equipment.
58.81(a)–(c); SOPs ..................................................
58.90(c) and (g); Animal care ..................................
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
20
270.76
60
6,000
81,228
18,000
.21 (13 minutes) ........
3.36 ...........................
.09 (5 minutes) ..........
1,260
272,926
1,620
300
300
300
301.8
62.7
5
90,540
18,810
1,500
.14 (8 minutes) ..........
.13 (8 minutes) ..........
11.8 ...........................
12,676
2,445
17,700
300
300
300
300
1
15.33
15.38
251.5
300
4,599
4,614
75,450
4.25 ...........................
6.8 .............................
32.7 ...........................
3.9 .............................
1,275
31,273
150,878
294,255
Total ..................................................................
........................
........................
........................
....................................
786,308
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The annual burden for the
information collection requirements in
these regulations is estimated at
1,304,157 burden hours (517,849 +
786,308 = 1,304,157). The hours per
response estimates are based on our
experience with similar programs and
information received from industry.
Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27255 Filed 12–18–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6535]
Standards Development and the Use of
Standards in Regulatory Submissions
Reviewed in the Center for Biologics
Evaluation and Research; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Standards
Development and the Use of Standards
in Regulatory Submissions Reviewed in
the Center for Biologics Evaluation and
Research; Draft Guidance for Industry
and Food and Drug Administration
Staff.’’ The draft guidance document
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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17:47 Dec 18, 2017
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recognizes the value of standards and
encourages the use of appropriate
standards to facilitate the evaluation of
products regulated by the Center for
Biologics Evaluation and Research
(CBER). The guidance describes CBER’s
recommendations on the use of
standards in product development and
the use of such standards in CBER’s
managed review process. The draft
guidance does not endorse the activities
of specific Standards Development
Organizations or recommend specific
standards for use in regulatory
submissions.
DATES: Submit either electronic or
written comments on the draft guidance
by March 19, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\19DEN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60203-60204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27255]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0075]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory
Practice Regulations for Nonclinical Studies
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: Fax written comments on the collection of information by January
18, 2018.
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 0910-0119.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
Good Laboratory Practice Regulations for Nonclinical Studies--21 CFR
Part 58
OMB Control Number 0910-0119--Extension
Sections 409, 505, 512, and 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348, 355, 360b, and 360e) and related statutes
require manufacturers of food additives, human drugs and biological
products, animal drugs, and medical devices to demonstrate the safety
and utility of their product by submitting applications to FDA for
research or marketing permits. Such applications contain, among other
important items, full reports of all studies done to demonstrate
product safety in man and/or other animals. In order to ensure adequate
quality control for these studies and to provide an adequate degree of
consumer protection, the Agency issued good laboratory practice (GLP)
regulations for nonclinical laboratory studies in part 58 (21 CFR part
58). The regulations specify minimum standards for the proper conduct
of safety testing and contain sections on facilities, personnel,
equipment, standard operating procedures (SOPs), test and control
articles, quality assurance, protocol and conduct of a safety study,
records and reports, and laboratory disqualification.
Part 58 requires testing facilities engaged in conducting
toxicological studies to retain, and make available to regulatory
officials, records regarding compliance with GLPs. Records are
maintained on file at each testing facility and examined there
periodically by FDA inspectors. The GLP regulations require that, for
each nonclinical laboratory study, a final report be prepared that
documents the results of quality assurance unit inspections, test and
control article characterization, testing of mixtures of test and
control articles with carriers, and an overall interpretation of
nonclinical laboratory studies. The GLP regulations also require
written records pertaining to: (1) Personnel job descriptions and
summaries of training and experience; (2) master schedules, protocols
and amendments thereto, inspection reports, and SOPs; (3) equipment
inspection, maintenance, calibration, and testing records; (4)
documentation of feed and water analyses, and animal treatments; (5)
test article accountability records; and (6) study documentation and
raw data.
Recordkeeping is necessary to document the conduct of nonclinical
laboratory studies of FDA-regulated products to ensure the quality and
integrity of the resulting final study report on which a regulatory
decision may be based. Written SOPs and records of actions taken are
essential for testing facilities to implement GLPs effectively.
Further, they are essential for FDA to be able to determine a testing
facility's compliance with the GLP regulations in part 58.
In a notice of proposed rulemaking published in the Federal
Register of August 24, 2016 (81 FR 58342), we proposed changes in our
GLP regulations, including some of those listed in tables 1 and 2 of
this document. The document included
[[Page 60204]]
revised burden estimates for the proposed changes and solicited public
comment. In response to requests, the comment period was extended to
January 21, 2017 (81 FR 75351, October 31, 2016). In the interim, FDA
is seeking an extension of OMB approval for the current regulations so
that we can continue to collect information while the proposal is
pending.
Description of Respondents: The likely respondents collecting this
information are contract laboratories, sponsors of FDA-regulated
products, universities, or government agencies.
In the Federal Register of April 25, 2017 (82 FR 19054), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received no comments.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
58.35(b)(7); Quality assurance 300 60.25 18,075 1 18,075
unit...........................
58.185; Reporting of nonclinical 300 60.25 18,075 27.65 499,774
laboratory study results.......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 517,849
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of records per Total annual Average burden per recordkeeping (in Total hours
recordkeepers recordkeeper records hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b); Personnel......................... 300 20 6,000 .21 (13 minutes).......................... 1,260
58.35(b)(1)-(6), and (c); Quality assurance 300 270.76 81,228 3.36...................................... 272,926
unit.
58.63(b) and (c); Maintenance and 300 60 18,000 .09 (5 minutes)........................... 1,620
calibration of equipment.
58.81(a)-(c); SOPs.......................... 300 301.8 90,540 .14 (8 minutes)........................... 12,676
58.90(c) and (g); Animal care............... 300 62.7 18,810 .13 (8 minutes)........................... 2,445
58.105(a) and (b); Test and control article 300 5 1,500 11.8...................................... 17,700
characterization.
58.107(d); Test and control article handling 300 1 300 4.25...................................... 1,275
58.113(a); Mixtures of articles with 300 15.33 4,599 6.8....................................... 31,273
carriers.
58.120; Protocol............................ 300 15.38 4,614 32.7...................................... 150,878
58.195; Retention of records................ 300 251.5 75,450 3.9....................................... 294,255
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 786,308
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The annual burden for the information collection requirements in
these regulations is estimated at 1,304,157 burden hours (517,849 +
786,308 = 1,304,157). The hours per response estimates are based on our
experience with similar programs and information received from
industry.
Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27255 Filed 12-18-17; 8:45 am]
BILLING CODE 4164-01-P
