[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44900-44902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16095]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1671]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Good Laboratory Practice for Non-Clinical 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, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection provisions of 
FDA's good laboratory practice (GLP) regulations for nonclinical 
laboratory studies.

DATES: Submit either electronic or written comments on the collection 
of information by September 22, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 22, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 22, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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

[[Page 44901]]

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-2020-N-1671 for ``Good Laboratory Practice (GLP) for Non-Clinical 
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, including 
each proposed extension of an existing 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 
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 (GLP) for Non-Clinical 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 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 44902]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
           21 CFR part               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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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.......
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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
           21 CFR part               Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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58.29(b); Personnel.............             300              20           6,000             .21           1,260
                                                                                    (13 minutes)
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           1,620
 and calibration of equipment...                                                     (5 minutes)
58.81(a)-(c); SOPs..............             300          301.80          90,540             .14          12,676
                                                                                     (8 minutes)
58.90(c) and (g); Animal care...             300           62.70          18,810             .13           2,445
                                                                                     (8 minutes)
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 articles              300           15.33           4,599             6.8          31,273
 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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: July 20, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16095 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-P