Agency information collection activities; proposals, submissions, and approvals,

[Federal Register: January 4, 2005 (Volume 70, Number 2)]

[Notices]

[Page 364-366]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr04ja05-47]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0296]

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 February 3, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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,

[[Page 365]]

OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, rm. 4B-41, Rockville, MD 20857, 301-827-1472.

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 (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, 360b, 360e) 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: (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 the agency's 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 July 22, 2004 (69 FR 43853), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1.--Estimated Annual Reporting Burden\1\

No. of

Annual Frequency Total Annual

Hours per 21 CFR Section Recordkeepers

per Record

Records

Recordkeeper 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 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 Record

Records

Recordkeeper

Total Hours

58.29(b)

300

20

6,000

.21

1,260

58.35(b)(1)

300

270.76

81,228

3.36

279,926 through (b)(6) and (c)

58.63(b) and (c)

300

60

18,000

.09

1,620

58.81(a), (b),

300

301.8

90,540

.14

12,676 and (c)

58.90(c) and (g)

300

62.7

18,810

.13

2,445

58.105(a) and

300

5

1,500

11.8

17,700 (b)

58.107(d)

300

1

300

4.25

1,275

58.113(a)

300

15.33

4,599

6.8

31,273

[[Page 366]]

58.120

300

15.38

4,614

32.7

150,878

58.195

300

251.5

75,450

3.9

294,255

Total

793,308

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

Dated: December 28, 2004. Jeffrey Shuren, Assistant Commissioner for Policy.

[FR Doc. 05-28 Filed 1-3-05; 8:45 am]

BILLING CODE 4160-01-S

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