[Federal Register Volume 63, Number 186 (Friday, September 25, 1998)]
[Notices]
[Pages 51357-51359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25641]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 (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
applications.
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
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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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
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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 Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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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
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[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]
BILLING CODE 4160-01-F
