[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)] [Notices] [Pages 41503-41504] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2011-17736] [[Page 41503]] ----------------------------------------------------------------------- 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. 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 [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: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7651, [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, 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of records Total annual Average burden 21 CFR Section recordkeepers per recordkeeper records per recordkeeping Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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