[Federal Register Volume 66, Number 140 (Friday, July 20, 2001)]
[Notices]
[Pages 37977-37978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18130]



[[Page 37977]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0176]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Good Laboratory Practices (GLP) Regulations 
for Nonclinical Laboratory Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below 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 on the collection of information by 
August 20, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 Practices (GLP) Regulations 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 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: (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.
    In the Federal Register of April 30, 2001 (66 FR 21396), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                             Annual Frequency    Total Annual       Hours per
     21 CFR Section       No. of Responses     per Response        Responses        Response        Total Hours
----------------------------------------------------------------------------------------------------------------
58.35(b)(7)                    300                 60.25         18,075                1           18,075
58.185                         300                 60.25         18,075               27.65       499,774
                                                                                                 ---------------
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 per   Total Annual      Hours per
      21 CFR Section         Recordkeepers      Recordkeeping         Records      Recordkeeper     Total Hours
----------------------------------------------------------------------------------------------------------------
58.29(b)                        300                 20              6,000                .21        1,260
58.35(b)(1) through (b)(6)      300                270.76          81,228               3.36      279,926
 and (c)
58.63(b) and (c)                300                 60             18,000                .09        1,620
58.81(a) through (c)            300                301.8           90,540                .14       12,676
58.90(c) and (g)                300                 62.7           18,810                .13        2,445
58.105(a) and (b)               300                  5              1,500              11.8        17,700
58.107(d)                       300                  1                300               4.25        1,275

[[Page 37978]]

 
58.113(a)                       300                 15.33           4,599               6.8        31,273
58.120                          300                 15.38           4,614              32.7       150,878
58.195                          300                251.5           75,450               3.9       294,255
                                                                                                 ---------------
Total                                                                                             793,308
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 12, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-18130 Filed 7-19-01; 8:45 am]
BILLING CODE 4160-01-S