
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19054-19056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08304]


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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) 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 June 26, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2011-N-0075 for ``Good Laboratory Practice Regulations for 
Nonclinical Studies.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov/ or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets 
Management. 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''

[[Page 19055]]

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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

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, 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 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 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 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.
    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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              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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[[Page 19056]]

 
    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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                                                                                 Average burden
                                   Number of       Number of     Total annual          per
        21 CFR Section           recordkeepers    records per       records       recordkeeping     Total hours
                                                 recordkeeper                      (in hours)
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58.29(b); Personnel...........             300              20           6,000  0.21 (13                   1,260
                                                                                 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  0.09 (5 minutes)           1,620
 and calibration 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                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           251.5          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 plus 
786,308 equals 1,304,157). The hours per response estimates are based 
on our experience with similar programs and information received from 
industry.

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08304 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P


