[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Notices]
[Pages 31786-31788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15409]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0335]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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
(the 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
[[Page 31787]]
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the Good Laboratory Practice
(GLP) for Nonclinical Laboratory Studies regulations.
DATES: Submit written comments on the collection of information by
August 10, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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: 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 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 listed below. With respect to the
following collection of information, FDA invites comments on: (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.
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 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 (21
U.S.C. 348, 355, 360b, and 360e). 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 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.
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 690,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 31788]]
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) through (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) through (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.
Dated: June 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15409 Filed 6-9-98; 8:45 am]
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