[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Notices]
[Pages 21396-21398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10623]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0176]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Good Laboratory Practices (GLP) Regulations for 
Nonclinical Laboratory Studies

<BD>AGENCY: <RM>Food and Drug Administration, HHS.

[[Page 21397]]


<BD>ACTION: <RM>Notice.

-----------------------------------------------------------------------

<BD>SUMMARY: <RM>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 
<CS>Federal Register <RM>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 GLP for 
Nonclinical Laboratory Studies regulations.

<BD>DATES:  <RM>Submit written or electronic comments on the collection 
of information by June 29, 2001.

<BD>ADDRESSES: <RM>Submit electronic comments on the collection of 
information via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Submit written comments on the 
collection of information to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. All comments should be identified with the docket number 
found in brackets in the heading of this document.

<BD>FOR FURTHER INFORMATION CONTACT: <RM>JonnaLynn P. Capezzuto, Office 
of Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

<BD>SUPPLEMENTARY INFORMATION: <RM>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 <CS>Federal Register <RM>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: (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.

Good Laboratory Practices (GLP) Regulations for Nonclinical 
Laboratory 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, and 360e) 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. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     <CS>Table 1.--Estimated Annual Reporting Burden\1\<RM>
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Annual Frequency        Total Annual
              21 CFR Section                 No. of Respondents       per Response            Responses        Hours per Response        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
                                                                                                                                   ---------------------
Total                                                                                                                                  517,849
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 21398]]


                                                   <CS>Table 2.--Estimated Annual Recordkeeping Burden\1\<RM>
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     No. of       Annual Frequency per                              Hours per
                21 CFR Section                    Recordkeepers       Recordkeeping     Total Annual Records      Recordkeeper           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b)                                             300                  20                 6,000                      .21              1,260
58.35(b)(1) through (b)(6) and (c)                   300                 270.56             81,228                     3.36            279,926
58.63(b) and (c)                                     300                  60                18,000                      .09              1,620
58.81(a) through (c)                                 300                 301.8              90,540                      .14             12,676
58.90(c) and (g)                                     300                  62.7              18,810                      .13              2,445
58.105(a) and (b)                                    300                   5                 1,500                    11.8              17,700
58.107(d)                                            300                   1                   300                     4.25              1,275
58.113(a)                                            300                  15.33              4,599                     6.8              31,273
58.120                                               300                  15.38              4,614                    32.7             150,878
58.195                                               300                 251.5              75,450                     3.9             294,255
                                                                                                                                   ---------------------
Total                                                                                                                                  793,308
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 24, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-10623 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S