[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60203-60204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0075]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Good Laboratory 
Practice Regulations for Nonclinical Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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: Fax written comments on the collection of information by January 
18, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0119. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 Regulations for Nonclinical 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.
    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.
    Recordkeeping is necessary to document the conduct of nonclinical 
laboratory studies of FDA-regulated products to ensure the quality and 
integrity of the resulting final study report on which a regulatory 
decision may be based. Written SOPs and records of actions taken are 
essential for testing facilities to implement GLPs effectively. 
Further, they are essential for FDA to be able to determine a testing 
facility's compliance with the GLP regulations in part 58.
    In a notice of proposed rulemaking published in the Federal 
Register of August 24, 2016 (81 FR 58342), we proposed changes in our 
GLP regulations, including some of those listed in tables 1 and 2 of 
this document. The document included

[[Page 60204]]

revised burden estimates for the proposed changes and solicited public 
comment. In response to requests, the comment period was extended to 
January 21, 2017 (81 FR 75351, October 31, 2016). In the interim, FDA 
is seeking an extension of OMB approval for the current regulations so 
that we can continue to collect information while the proposal is 
pending.
    Description of Respondents: The likely respondents collecting this 
information are contract laboratories, sponsors of FDA-regulated 
products, universities, or government agencies.
    In the Federal Register of April 25, 2017 (82 FR 19054), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received no comments.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
     21 CFR section/activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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 maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                 Number of
           21 CFR section/activity               Number of      records per    Total annual     Average burden  per recordkeeping  (in      Total hours
                                               recordkeepers   recordkeeper       records                       hours)
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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              300          270.76          81,228  3.36......................................         272,926
 unit.
58.63(b) and (c); Maintenance and                        300              60          18,000  .09 (5 minutes)...........................           1,620
 calibration of equipment.
58.81(a)-(c); SOPs..........................             300           301.8          90,540  .14 (8 minutes)...........................          12,676
58.90(c) and (g); Animal care...............             300            62.7          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                     300           15.33           4,599  6.8.......................................          31,273
 carriers.
58.120; Protocol............................             300           15.38           4,614  32.7......................................         150,878
58.195; Retention of records................             300           251.5          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.

    The annual burden for the information collection requirements in 
these regulations is estimated at 1,304,157 burden hours (517,849 + 
786,308 = 1,304,157). The hours per response estimates are based on our 
experience with similar programs and information received from 
industry.

    Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27255 Filed 12-18-17; 8:45 am]
 BILLING CODE 4164-01-P