2017-27255. 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 January 18, 2018.

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: [phone], or emailed to [e-mail]. 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:

Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [e-mail].

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 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 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 nonclinical 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.

In a notice of proposed rulemaking published in the Federal Register of August 24, 2016 (81 FR 58342), we proposed changes in our GLP regulations, including some of those listed in tables 1 and 2 of this document. The document included revised burden estimates for the proposed changes and solicited public comment. In response to requests, the comment period was extended to January 21, 2017 (81 FR 75351, October 31, 2016). In the interim, FDA is seeking an extension of OMB approval for the current regulations so that we can continue to collect information while the proposal is pending.

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 April 25, 2017 (82 FR 19054), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received no comments.

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

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section/activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
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 maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden ¹

21 CFR section/activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping (in hours)	Total hours
58.29(b); Personnel	300	20	6,000	.21 (13 minutes)	1,260
58.35(b)(1)-(6), and (c); Quality assurance unit	300	270.76	81,228	3.36	272,926
58.63(b) and (c); Maintenance and calibration of equipment	300	60	18,000	.09 (5 minutes)	1,620
58.81(a)-(c); SOPs	300	301.8	90,540	.14 (8 minutes)	12,676
58.90(c) and (g); Animal care	300	62.7	18,810	.13 (8 minutes)	2,445
58.105(a) and (b); Test and control article characterization	300	5	1,500	11.8	17,700
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.

The annual burden for the information collection requirements in these regulations is estimated at 1,304,157 burden hours (517,849 + 786,308 = 1,304,157). The hours per response estimates are based on our experience with similar programs and information received from industry.

Dated: December 13, 2017.

Leslie Kux,

Associate Commissioner for Policy.