[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82906-82907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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, 
<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
----------------------------------------------------------------------------------------------------------------
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........................
                                 -------------------------------------------------------------------------------
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                              ----------------------------------------------------------------------------------------------------------
    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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