[Federal Register: July 22, 2004 (Volume 69, Number 140)]
[Notices]
[Page 43853-43855]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy04-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0296]
Agency Information Collection Activities; Proposed Collection;
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 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
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 or electronic comments on the collection of
information by September 20, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, rm. 1061, Rockville, MD 20852.
All comments should be identified with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs, (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
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 collection of information, including
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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
[[Page 43854]]
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: (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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency of Total Annual
21 CFR Section No. of Respondents Response Responses Hours per 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 1.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency Total Annual Hours per
21 CFR Section No. of Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
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58.29(b) 300 20 6,000 .21 1,260
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58.35(b)(1) through (b)(6) and (c) 300 270.76 81,228 3.36 279,926
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58.63(b) and (c) 300 60 18,000 .09 1,620
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58.81(a), (b), and (c) 300 301.8 90,540 .14 12,676
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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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[[Page 43855]]
58.195 300 251.5 75,450 3.9 294,255
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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 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16629 Filed 7-21-04; 8:45 am]
BILLING CODE 4160-01-S