[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36531-36533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0154]


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 July 
28, 2008.

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: 202-395-6974, or e-mailed 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: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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.

[[Page 36532]]

Good Laboratory Practice (GLP) 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 statues 
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 the GLP regulations. 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.
    The GLP regulations contain requirements for the reporting of 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 contain recordkeeping requirements 
relating to the conduct of safety studies. Such records include the 
following information: (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.
    The information collected under GLP regulations is generally 
gathered by testing facilities routinely engaged in conducting 
toxicological studies and is used as part of an application for a 
research or marketing permit that is voluntarily submitted to FDA by 
persons desiring to market new products. The facilities that collect 
this information are typically operated by large entities, e.g., 
contract laboratories, sponsors of FDA-regulated products, 
universities, or Government agencies. Failure to include the 
information in a filing to FDA would mean that agency scientific 
experts could not make a valid determination of product safety. FDA 
receives, reviews, and approves hundreds of new product applications 
each year based on information received. The recordkeeping requirements 
are necessary to document the proper conduct of a safety study, to 
assure the quality and integrity of the resulting final report, and to 
provide adequate proof of the safety of regulated products. FDA 
conducts onsite audits of records and reports, during its inspections 
of testing laboratories, to verify reliability of results submitted in 
applications.
    The likely respondents collecting this information are contract 
laboratories, sponsors of FDA-regulated products, universities, or 
Government agencies.
    In the Federal Register of March 12, 2008 (73 FR 13240), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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58.35(b)(7)                                                           300                 60.25             18,075                  1             18,075
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58.185                                                                300                 60.25             18,075              27.65            499,774
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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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                          No. of        Annual Frequency      Total Annual       Hours per
  21 CFR Section      Recordkeepers     per Recordkeeping       Records            Record         Total Hours
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58.29(b)                          300                  20              6,000              .21              1,260
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58.35(b)(1)                       300              270.76             81,228             3.36            272,926
 through (b)(6)
 and (c)
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58.63(b) and (c)                  300                  60             18,000              .09              1,620
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58.81(a) through                  300               301.8             90,540              .14             12,676
 (c)
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58.90(c) and (g)                  300                62.7             18,810              .13              2,445
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58.105(a) and (b)                 300                   5              1,500             11.8             17,700
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58.107(d)                         300                   1                300             4.25              1,275
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58.113(a)                         300               15.33              4,599              6.8             31,273
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58.120                            300               15.38              4,614             32.7            150,878
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58.195                            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.



[[Page 36533]]

    Dated: June 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14535 Filed 6-26-08; 8:45 am]
BILLING CODE 4160-01-S