[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73300-73302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2330]


Pathology Peer Review in Nonclinical Toxicology Studies: 
Questions and Answers; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Pathology 
Peer Review in Nonclinical Toxicology Studies: Questions and Answers.'' 
This guidance represents FDA's current thinking on the management and 
conduct of pathology peer review performed during good laboratory 
practice (GLP)-compliant toxicology studies. This guidance finalizes 
the draft guidance ``Pathology Peer Review in Nonclinical Toxicology 
Studies: Questions and Answers'' issued on September 30, 2019. This 
revision includes editorial changes to improve the clarity of the 
document.

DATES: The announcement of the guidance is published in the Federal 
Register on December 27, 2021.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-2330 for ``Pathology Peer Review in Nonclinical Toxicology

[[Page 73301]]

Studies: Questions and Answers.'' Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or to Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tahseen Mirza, Office of Study 
Integrity and Surveillance, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 
2211, Silver Spring, MD 20993, 301-796-7645; Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911; Judy Davis, Office of Product Evaluation and Quality, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 1216, Silver Spring, MD 20993, 
301-796-6636; Hilary Hoffman, Office of New Animal Drug Evaluation, 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Pl., Rm. 389, Rockville, MD 20855, 240-402-8406; Yuguang Wang, 
Office of the Center Director, Center for Food Safety and Nutrition, 
Food and Drug Administration, 5001 Campus Dr., Rm. 4A035, College Park, 
MD 20740, 240-402-1757; Hans Rosenfeldt, Office of Science, Center for 
Tobacco Products, Food and Drug Administration, 11785 Beltsville Dr., 
Bldg. BELT1, Rm. 5322, Beltsville, MD 20705-3121, 301-796-2202; or Tony 
Taube, Division of Operational Policy, Office of Regulatory Affairs, 
12420 Parklawn Dr., Rm. 4044, Rockville, MD 20857 email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Pathology Peer Review in Nonclinical Toxicology Studies: 
Questions and Answers.'' This guidance represents FDA's current 
thinking on the management and conduct of pathology peer review 
performed during GLP-compliant toxicology studies.
    The histopathological assessment of tissue samples is one of the 
key activities performed during GLP-compliant toxicology studies. 
Commonly, histopathological assessment includes an initial read of 
tissue slides by the study pathologist and a subsequent review 
(referred to as pathology peer review) by a second pathologist. 
Pathology peer review may be particularly useful in situations where 
unique or unexpected findings are noted or when the peer-review 
pathologist has a particular expertise relevant to the study. When 
pathology peer review occurs as part of a nonclinical study conducted 
in compliance with GLP regulations, it should be well-documented. 
However, documentation practices during pathology peer review have not 
been clearly defined and vary among nonclinical testing facilities.
    Although the current regulations include general requirements for 
histopathology evaluation (for example, it requires that standard 
operating procedures be established to cover histopathology), pathology 
peer review is not specifically addressed in the current regulations. 
This Q&A document is intended to clarify FDA's recommendations 
concerning the management and conduct of pathology peer review 
performed during GLP-compliant toxicology studies.
    This guidance finalizes the draft guidance entitled ``Pathology 
Peer Review in Nonclinical Toxicology Studies: Questions and Answers'' 
issued on September 30, 2019 (84 FR 37646). FDA considered comments 
received on the draft guidance as the guidance was finalized. Editorial 
changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Pathology Peer Review in Nonclinical 
Toxicology Studies: Questions and Answers.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 58 (Good Laboratory Practice for Non-
Clinical Laboratory Studies) have been approved under OMB control 
number 0910-0119; and submission of information for FDA review under an 
investigational new drug application for human drug or

[[Page 73302]]

biologic products is approved under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28051 Filed 12-23-21; 8:45 am]
BILLING CODE 4164-01-P