[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53492-53494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. FDA-2023-N-2894]


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on information collection applicable to the Good 
Laboratory Practice Requirements for Nonclinical Laboratory Studies 
established in Agency regulations.

DATES: Either electronic or written comments on the collection of 
information must be submitted by October 10, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 10, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-2894 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Good Laboratory Practice 
Requirements for Nonclinical Laboratory Studies.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical

[[Page 53493]]

utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Good Laboratory Practice Requirements for Nonclinical Laboratory 
Studies--21 CFR Part 58

OMB Control No. 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.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of
                                                  Number of    responses      Total       Average
                  21 CFR part                    respondents      per         annual     burden per  Total hours
                                                               respondent   responses     response
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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                     Average burden
          21 CFR part              Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
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58.29(b); Personnel...........             300              20           6,000  .21 (13 mins.)..           1,260
58.35(b)(1)-(6), and (c);                  300          270.76          81,228  3.36............         272,926
 Quality assurance unit.
58.63(b) and (c); Maintenance              300              60          18,000  .09 (5 mins.)...           1,620
 and calibration of equipment.
58.81(a)-(c); SOPs............             300          301.80          90,540  .14 (8 mins.)...          12,676
58.90(c) and (g); Animal care.             300           62.70          18,810  .13 (8 mins.)...           2,445
58.105(a) and (b); Test and                300               5           1,500  11.8............          17,700
 control article
 characterization.
58.107(d); Test and control                300               1             300  4.25............           1,275
 article handling.
58.113(a); Mixtures of                     300           15.33           4,599  6.8.............          31,273
 articles with carriers.
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.


[[Page 53494]]

    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: August 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16925 Filed 8-7-23; 8:45 am]
BILLING CODE 4164-01-P