[Federal Register Volume 63, Number 186 (Friday, September 25, 1998)]
[Pages 51357-51359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25641]



Food and Drug Administration
[Docket No. 98N-0335]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 (the PRA).

DATES: Submit written comments on the collection of information by 
October 26, 1998.
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: 
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 section 3507 of the

[[Page 51358]]

PRA (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 
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 (the 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 (SOP's), 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 SOP's; (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 the 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 on-site audits of records and reports, during its inspections 
of testing laboratories, to verify reliability of results submitted in 
    In the Federal Register of June 10, 1998 (63 FR 31786), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.
    FDA estimates the burden of this collection of information as 

                                  Table 1.--Estimated Annual Reporting Burden1
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
58.35(b)(7)                           400              60.25       24,100               1          24,100
58.185                                400              60.25       24,100              27.65      666,400
Total burden hours                                                                                690,500
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

                                Table 2.--Estimated Annual Recordkeeping Burden1
       21 CFR Section             No. of       Frequency per   Total Annual      Hours per        Total Hours
                               Recordkeepers   Recordkeeping      Records      Recordkeeper
58.29(b)                          400              20           8,000                .21            1,700
58.35(b)(1) to (b)(6) and
 (c)                              400             270.76      108,400               3.36          363,900
58.63(b) and (c)                  400              60          24,000                .09            2,200
58.81(a) to (c)                   400             301.8       120,000                .14           16,800
58.90(c) and (g)                  400              62.7        25,000                .13            3,200
58.105(a) and (b)                 400               5           2,000              11.8            23,600
58.107(d)                         400               1             400               4.25            1,700
58.113(a)                         400              15.33        6,132               6.8            41,700
58.120                            400              15.38        6,160              32.7           201,200
58.195                            400             251.5       100,000               3.9           392,400
Total                                                                                           1,048,400
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

[[Page 51359]]

    Dated: September 17, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-25641 Filed 9-24-98; 8:45 am]