Notice2023-26044
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, we, or the 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.
Full Text
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<title>Federal Register, Volume 88 Issue 226 (Monday, November 27, 2023)</title>
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[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82906-82907]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26044]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2894]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory
Practice Requirements for Nonclinical Laboratory Studies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, we, or the 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 27, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#b0e0e2f1e3c4d1d6d6f0d6d4d19ed8d8c39ed7dfc6"><span class="__cf_email__" data-cfemail="b3e3e1f2e0c7d2d5d5f3d5d7d29ddbdbc09dd4dcc5">[email protected]</span></a>.
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 Requirements 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, 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.
Description of Respondents: Respondents to the collection of
information are sponsors of nonclinical laboratory studies that support
or are intended to support applications for research or marketing
permits for products regulated by FDA.
In the Federal Register of August 8, 2023 (88 FR 53492), we
published a 60-day notice soliciting comment on the proposed collection
of information. One comment was received underscoring the critical
nature of language translations in information exchange between
international communities but did not suggest any modifications to our
burden estimates.
We estimate the burden of this collection of information as
follows:
[[Page 82907]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Sec. 58.35(b)(7); Quality 300 60.25 18,075 1 18,075
assurance unit.................
Sec. 58.185; Reporting of 300 60.25 18,075 27.65 499,774
nonclinical laboratory 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 section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Sec. 58.29(b); Personnel................... 300 20 6,000 .21 (13 minutes)......................... 1,260
Sec. 58.35(b)(1)-(6), and (c); Quality 300 270.76 81,228 3.36..................................... 272,926
assurance unit.
Sec. 58.63(b) and (c); Maintenance and 300 60 18,000 .09 (5 minutes).......................... 1,620
calibration of equipment.
Sec. 58.81(a)-(c); SOPs.................... 300 301.80 90,540 .14 (8 minutes).......................... 12,676
Sec. 58.90(c) and (g); Animal care......... 300 62.70 18,810 .13 (8 minutes).......................... 2,445
Sec. 58.105(a) and (b); Test and control 300 5 1,500 11.8..................................... 17,700
article characterization.
Sec. 58.107(d); Test and control article 300 1 300 4.25..................................... 1,275
handling.
Sec. 58.113(a); Mixtures of articles with 300 15.33 4,599 6.8...................................... 31,273
carriers.
Sec. 58.120; Protocol...................... 300 15.38 4,614 32.7..................................... 150,878
Sec. 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 an evaluation of the information collection, we are
retaining the currently approved estimates. Our assumptions made
regarding the time needed for the respective activities is based on our
experience with the information collection and informal communications
with respondents.
Dated: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26044 Filed 11-24-23; 8:45 am]
BILLING CODE 4164-01-P
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