[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]
BILLING CODE 4160-01-F