[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57935-57936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22986]


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

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.

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

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 (PRA).

DATES: Fax written comments on the collection of information by October 
27, 2014.

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 emailed to [email protected]. 
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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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, 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 for nonclinical laboratory studies in part 58 (21 CFR part 
58). 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.
    Part 58 requires testing facilities engaged in conducting 
toxicological studies to retain, and make available to regulatory 
officials, records regarding compliance with GLPs. Records are 
maintained on file at each testing facility and examined there 
periodically by FDA inspectors. The GLP regulations

[[Page 57936]]

require that, for each nonclinical laboratory study, a final report be 
prepared that documents 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 require written records pertaining to: (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.
    Recordkeeping is necessary to document the conduct of nonclincial 
laboratory studies of FDA-regulated products to ensure the quality and 
integrity of the resulting final study report on which a regulatory 
decision may be based. Written SOPs and records of actions taken are 
essential for testing facilities to implement GLPs effectively. 
Further, they are essential for FDA to be able to determine a testing 
facility's compliance with the GLP regulations in part 58.
    Description of Respondents: The likely respondents collecting this 
information are contract laboratories, sponsors of FDA-regulated 
products, universities, or government agencies.
    In the Federal Register of June 12, 2014 (79 FR 33755), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received. On its own 
initiative, however, the Agency is now including two burden tables 
rather than only the one included in its 60-day notice. While this does 
not change the Agency's burden estimate, FDA believes that 
distinguishing between reporting elements and recordkeeping elements 
more clearly reflects the requirements associated with this information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                      21 CFR section                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.35(b)(7); Quality assurance unit......................                300              60.25             18,075                  1             18,075
58.185; Reporting of nonclinical laboratory study results                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.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of      Number of records     Total annual      Average burden
                      21 CFR Section                         recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b); Personnel......................................                300                 20              6,000  0.21 (13 minutes)              1,260
58.35(b)(1)-(b)(6) and (c); Quality assurance unit.......                300             270.76             81,228               3.36            272,926
58.63(b) and (c); Maintenance and calibration of                         300                 60             18,000    .09 (5 minutes)              1,620
 equipment...............................................
58.81(a)-(c); SOPs.......................................                300              301.8             90,540   0.14 (8 minutes)             12,676
58.90(c) and (g); Animal care............................                300               62.7             18,810   0.13 (8 minutes)              2,445
58.105(a) and (b); Test and control article                              300                  5              1,500               11.8             17,700
 characterization........................................
58.107(d); Test and control article handling.............                300                  1                300               4.25              1,275
58.113(a); Mixtures of articles with carriers............                300              15.33              4,599                6.8             31,273
58.120; Protocol.........................................                300              15.38              4,614               32.7            150,878
58.195; Retention of records.............................                300              251.5             75,450                3.9            294,255
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................            786,308
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22986 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P