85 FR 231 pgs. 77219-77220 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice for Nonclinical Laboratory Studies
Type: NOTICEVolume: 85Number: 231Pages: 77219 - 77220
Pages: 77219, 77220Docket number: [Docket No. FDA–2020–N–1671]
FR document: [FR Doc. 2020–26502 Filed 11–30–20; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1671]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice for Nonclinical Laboratory Studies
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) 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:
Submit written comments (including recommendations) on the collection of information by December 31, 2020.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. The OMB control number for this information collection is 0910-0119. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
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 for Nonclinical Laboratory Studies-21 CFR Part 58
OMB Control Number 0910-0119-Extension
[top] 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.
In the Federal Register of July 24, 2020 (85 FR 44900), FDA published a 60-day notice requesting public comment on the proposed collection of information.
One comment was received that encouraged implementation of automated collection methods and analytical software to evaluate results. FDA appreciates this comment and continually seek ways to employ efficient collection methods using our limited resources. The comment suggested no revision to our burden estimate.
FDA estimates the burden of this information collection as follows:
| 21 CFR part | 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 and maintenance costs associated with this collection of information. | |||||
| 21 CFR part | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | 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 | 301.80 | 90,540 | .14 (8 minutes) | 12,676 |
| 58.90(c) and (g); Animal care | 300 | 62.70 | 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 | 251.50 | 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. | |||||
Based on a review of the information collection since our last request for OMB approval, FDA has made no adjustments to our burden estimate.
Dated: November 24, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26502 Filed 11-30-20; 8:45 am]
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