[Federal Register Volume 69, Number 140 (Thursday, July 22, 2004)]
[Notices]
[Pages 43853-43855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16629]


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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://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