Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 9025 

substantially reduce the paperwork 

burden associated with maintaining 

FDA required records. 

The respondents will be businesses 

and other for-profit organizations, State 

or local governments, Federal Agencies, 

and nonprofit institutions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

11.100 .................................................................................. 4,500 1 4,500 1 4,500 

Total .............................................................................. ........................ ........................ ........................ ........................ 4,500 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

11.10 .................................................................................... 2,500 1 2,500 20 50,000 

11.30 .................................................................................... 2,500 1 2,500 20 50,000 

11.50 .................................................................................... 4,500 1 4,500 20 90,000 

11.300 .................................................................................. 4,500 1 4,500 20 90,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 280,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Governmentwide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

Dated: February 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3465 Filed 2–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0075] 

Agency Information Collection 

Activities; Proposed Collection; 

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 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 Federal Register 

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 good laboratory practice (GLP) for 

nonclinical laboratory studies 

regulations. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 18, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (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. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 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 

Federal Register 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 these topics: (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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

9026 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 

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, 360(b), 360(e)) 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 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. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

58.29(b) ...................................................................... 300 20 6,000 0.21 1,260 

58.35(b)(1)–(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)–(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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Governmentwide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

Dated: February 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3464 Filed 2–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

mstockstill on DSKH9S0YB1PROD with NOTICES