Document ID: FDA-2011-N-0075-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Good Laboratory Practice Regulations for Nonclinical Studies
Posted Date: 2011-07-14T04:00Z

[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41503-41504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17736]

[[Page 41503]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0075]

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 August 
15, 2011.

ADDRESSES: 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, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0119. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
Juanmanuel.vilela@fda.hhs.gov.

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 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, 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 good laboratory practice (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.
    In the Federal Register of February 16, 2011 (76 FR 9025), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. 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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                                                                                    Number of
                       21 CFR Section                             Number of       responses per      Total annual      Average burden      Total hours
                                                                 respondents        respondent         responses        per response
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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
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of     Number of records    Total annual      Average burden
                       21 CFR Section                           recordkeepers    per recordkeeper       records      per recordkeeping     Total hours
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58.29(b)....................................................               300              20                6,000               0.21             1,260

[[Page 41504]]

 
58.35(b)(1) to (b)(6) and (c)...............................               300             270.76            81,228               3.36           272,926
58.63(b) and (c)............................................               300              60               18,000               0.09             1,620
58.81(a) to (c).............................................               300             301.8             90,540               0.14            12,676
58.90(c) and (g)............................................               300              62.7             18,810               0.13             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...................................................  ................  .................  ................  .................           786,308
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: July 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17736 Filed 7-13-11; 8:45 am]
BILLING CODE 4160-01-P