[Federal Register: January 4, 2005 (Volume 70, Number 2)]
[Notices]               
[Page 364-366]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja05-47]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0296]

 
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 
February 3, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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,

[[Page 365]]

OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, Rockville, MD 20857, 301-827-1472.

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.
    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, 360b, 360e) 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 the agency's 
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 July 22, 2004 (69 FR 43853), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                        No. of        Annual Frequency      Total Annual        Hours per
 21 CFR Section     Recordkeepers        per Record           Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
58.35(b)(7)                     300               60.25             18,075                  1             18,075
----------------------------------------------------------------------------------------------------------------
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 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 Record          Records          Recordkeeper        Total Hours
----------------------------------------------------------------------------------------------------------------
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            279,926
 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), (b),                  300              301.8             90,540                 .14             12,676
 and (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                   300                  5              1,500               11.8              17,700
 (b)
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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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[[Page 366]]


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                                                                                                    793,308
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\1\There are no capital costs or operating maintenance costs associated with this collection of information.


    Dated: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-28 Filed 1-3-05; 8:45 am]

BILLING CODE 4160-01-S