[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Notices]
[Page 36531-36533]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn08-60]
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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 baguilar@omb.eop.gov. 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