[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Notices]
[Pages 77219-77220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26502]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1671]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory
Practice for Nonclinical Laboratory Studies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 December 31, 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 0910-0119. 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.
Good Laboratory Practice for Nonclinical Laboratory 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,
[[Page 77220]]
and include information collection provisions.
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.
In the Federal Register of July 24, 2020 (85 FR 44900), FDA
published a 60-day notice requesting public comment on the proposed
collection of information.
One comment was received that encouraged implementation of
automated collection methods and analytical software to evaluate
results. FDA appreciates this comment and continually seek ways to
employ efficient collection methods using our limited resources. The
comment suggested no revision to our burden estimate.
FDA estimates the burden of this information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR part Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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58.35(b)(7); Quality assurance unit............ 300 60.25 18,075 1..................................... 18,075
58.185; Reporting of nonclinical laboratory 300 60.25 18,075 27.65................................. 499,774
study results.
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Total...................................... .............. ............... .............. ...................................... 517,849
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR part Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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58.29(b); Personnel............................ 300 20 6,000 .21 (13 minutes)....................... 1,260
58.35(b)(1)-(6) and (c); Quality assurance unit 300 270.76 81,228 3.36................................... 272,926
58.63(b) and (c); Maintenance and calibration 300 60 18,000 .09 (5 minutes)........................ 1,620
of equipment.
58.81(a)-(c); SOPs............................. 300 301.80 90,540 .14 (8 minutes)........................ 12,676
58.90(c) and (g); Animal care.................. 300 62.70 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 carriers.. 300 15.33 4,599 6.8.................................... 31,273
58.120; Protocol............................... 300 15.38 4,614 32.7................................... 150,878
58.195; Retention of records................... 300 251.50 75,450 3.9.................................... 294,255
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Total...................................... .............. .............. .............. ....................................... 786,308
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\1\ There 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, FDA has made no adjustments to our burden
estimate.
Dated: November 24, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26502 Filed 11-30-20; 8:45 am]
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