[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.
                                                --------------------------------------------------------------------------------------------------------
    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
                                                --------------------------------------------------------------------------------------------------------
    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]
BILLING CODE 4164-01-P