Agency Information Collection Activities; Proposals, Submissions, and Approvals
Federal Register: June 27, 2008 (Volume 73, Number 125)
Notices
Page 36531-36533
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr27jn08-60
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2008-N-0154
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.
DATES: Fax written comments on the collection of information by July 28, 2008.
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: 202-395-6974, or e-mailed to baguilar@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: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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.
Page 36532
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, 360(b), 360(e)) 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 the following information: (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 March 12, 2008 (73 FR 13240), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
No. of
Annual Frequency
Total Annual
Hours per 21 CFR Section
Respondents
per Response
Responses
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.
Table 2.--Estimated Annual Recordkeeping Burden\1\
No. of
Annual Frequency
Total Annual
Hours per 21 CFR Section
Recordkeepers
per Recordkeeping
Records
Record
Total Hours
58.29(b)
300
20
6,000
.21
1,260
58.35(b)(1)
300
270.76
81,228
3.36
272,926 through (b)(6) and (c)
58.63(b) and (c)
300
60
18,000
.09
1,620
58.81(a) through
300
301.8
90,540
.14
12,676
(c)
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
786,308
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Page 36533
Dated: June 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
FR Doc. E8-14535 Filed 6-26-08; 8:45 am
BILLING CODE 4160-01-S
