[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33755-33756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 invites 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 August 11, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
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 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, 360(b), 360(e)) 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

[[Page 33756]]

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.
    Part 58 requires testing facilities engaged in conducting 
toxicological studies to retain, and make available to regulatory 
officials, records regarding compliance with good laboratory practices. 
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 GLP's effectively. 
Further, they are essential for FDA to be able to determine a testing 
facility's compliance with the GLP regulations in part 58.
    Description of Respondents: The likely respondents collecting this 
information are contract laboratories, sponsors of FDA-regulated 
products, universities, or government agencies.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--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
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58.29(b); Personnel...........................             300           20              6,000  0.21 (13 minutes)                                  1,260
58.35(b)(1)-(b)(6) and (c); Quality assurance.             300          270.76          81,228  3.36                                             279,926
58.35(b)(7); Quality assurance................             300           60.25          18,075  1                                                 18,075
58.63(b) and (c); Maintenance and calibration              300           60             18,000  0.09 (5 minutes)                                   1,620
 of equipment.
58.81(a)-(c); SOPs............................             300          301.8           90,540  0.14 (8 minutes)                                  12,676
58.90(c) and (g); Animal care.................             300           62.7           18,810  0.13(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
58.185; Nonclinical laboratory study results..             300           60.25          18,075  27.65                                            499,774
58.195; Retention of records..................             300          251.5           75,450  3.9                                              294,255
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    Total.....................................  ..............  ..............  ..............  ........................................       1,311,157
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13787 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P