[Federal Register Volume 84, Number 148 (Thursday, August 1, 2019)]
[Notices]
[Pages 37646-37648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16361]


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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Questions and Answers; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Pathology 
Peer Review in Nonclinical Toxicology Studies: Questions and Answers.'' 
This draft guidance represents FDA's current thinking on the management 
and conduct of pathology peer review performed during good laboratory 
practice (GLP)-

[[Page 37647]]

compliant toxicology studies. When pathology peer review occurs as part 
of a nonclinical laboratory 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. This question-and-answer 
(Q&A) draft guidance is intended to clarify FDA's recommendations 
concerning the management, conduct, and documentation of pathology peer 
review.

DATES: Submit either electronic or written comments on the draft 
guidance by September 30, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 
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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft 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 the 
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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Tahseen Mirza, Center for Drug 
Evaluation and Research, Office of Study Integrity and Surveillance, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 
5330, Silver Spring, MD 20993, 301-796-7645; or Stephen Ripley, Office 
of the Center Director, 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; or Judy Davis, Office of 
Device Evaluation, 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; or Hilary Hoffman, Center for 
Veterinary Medicine, Office of New Animal Drug Evaluation, Food and 
Drug Administration, 7500 Standish Place, Rm. 389, Rockville, MD, 
20855, 240-402-8406; or Yuquang Wang, Center for Food Safety and 
Nutrition, Office of the Center Director, Food and Drug Administration, 
5001 Campus Drive, Rm. 4A035, College Park, MD, 20740, 240-402-1757; or 
Kimberly Benson, Center for Tobacco Products, Office of Science, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, 
Silver Spring, MD 20993, 301-796-1327.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Pathology Peer Review in Nonclinical Toxicology Studies: 
Questions and Answers.'' This draft 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

[[Page 37648]]

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 reviewing 
pathologist has a particular expertise with a class of compounds. When 
pathology peer review occurs as part of a nonclinical laboratory study 
conducted in compliance with 21 CFR part 58 (GLP regulations), it 
should be well-documented in the study records. However, documentation 
practices during pathology peer review have not been clearly defined 
and vary among nonclinical testing facilities.
    The GLP regulations include general requirements for histopathology 
evaluation (for example, it requires that standard operating procedures 
be established to cover histopathology), and pathology peer review can 
be valuable to the histopathology evaluation during a GLP study even 
though it is not specifically addressed in the GLP regulations. This 
Q&A draft guidance is intended to clarify FDA's recommendations 
concerning the management and conduct of pathology peer review when 
performed during GLP-compliant toxicology studies.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. This 
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
following collections of information regarding GLP-compliant toxicology 
studies have been approved under OMB control number 0910-0119:
     Sec.  58.29 related to personnel who conduct nonclinical 
laboratory studies;
     Sec.  58.35 for preparing quality control units;
     Sec.  58.81 for preparing and maintaining standard 
operating procedures for testing facilities; pathology peer review 
should be planned, conducted, documented, and reported in accordance 
with established procedure;
     Sec.  Sec.  58.120, 58.185, and 58.190 for preparing a 
final report for each study, including a protocol and any changes to 
the protocol and for maintaining documentation, protocols, and final 
reports generated from nonclinical laboratory studies.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: July 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16361 Filed 7-31-19; 8:45 am]
 BILLING CODE 4164-01-P