Notice2023-11211
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry; Availability
Primary source
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Published
May 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers." This guidance represents FDA's current thinking on the use of whole slide images during good laboratory practice (GLP)-compliant toxicology studies. Documentation practices during generation, use, and retention of whole slide images have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA's recommendations concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with the GLP regulations. This guidance finalizes the draft guidance of the same title issued on April 8, 2022.
Full Text
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<title>Federal Register, Volume 88 Issue 101 (Thursday, May 25, 2023)</title>
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[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33893-33895]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11211]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1268]
Use of Whole Slide Imaging 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 ``Use of
Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and
Answers.'' This guidance represents FDA's current thinking on the use
of whole slide images during good laboratory practice (GLP)-compliant
toxicology studies. Documentation practices during generation, use, and
retention of whole slide images have not been clearly defined and vary
among nonclinical testing facilities. This question-and-answer document
is intended to clarify FDA's recommendations concerning the management,
documentation, and use of whole slide images in histopathology
assessment and/or pathology peer review for nonclinical studies
conducted in compliance with the GLP regulations. This guidance
finalizes the draft guidance of the same title issued on April 8, 2022.
DATES: The announcement of the guidance is published in the Federal
Register on May 25, 2023.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets
[[Page 33894]]
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
<bullet> 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-2021-D-1268 for ``Use of Whole Slide Imaging 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 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 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; Diane Maloney, 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 Device Evaluation, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2220, 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 Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., Rm. 4A012, College Park, MD
20740, 240-402-1757; Hans Rosenfeldt, Office of Science, Center for
Tobacco Products, Food and Drug Administration, 11785 Beltsville Dr.,
Calverton Tower, Rm. 5322, Beltsville, MD 20705, 301-796-2202; Eric S.
Myskowski, Office of Bioresearch Monitoring Operations, Office of
Regulatory Affairs, Food and Drug Administration, Resident Post--
Maplewood, 15 Sunnen Dr., Maplewood, MO 63143, 612-758-7187.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Use of Whole Slide Imaging in Nonclinical Toxicology
Studies: Questions and Answers.'' The histopathological assessment of
tissue samples is one of the key activities conducted during GLP-
compliant nonclinical laboratory studies. Commonly, the
histopathological assessment includes an initial evaluation of glass
histology slides by the study pathologist and a subsequent review
(referred to as pathology peer review) by a second pathologist, group
of pathologists, or Pathology Working Group. The current regulations
(21 CFR part 58) include general requirements for histopathology
evaluation (e.g., standard operating procedures), but the use of whole
slide images in lieu of glass slides is not expressly addressed. This
guidance provides information to sponsors and nonclinical laboratories
regarding the management, documentation, and use of whole slide images
during histopathology assessment and/or pathology peer review performed
for GLP-compliant nonclinical toxicology studies using non-human
specimens. The guidance does not cover the use of whole slide imaging
for clinical applications.
When whole slide images are used in lieu of glass slides as part of
a nonclinical study conducted in compliance with the GLP regulations,
adequate documentation is critical. Documentation practices during
whole slide imaging generation and use have not been clearly defined
and vary among nonclinical testing facilities. Use of whole slide
images in casual consultations, opinion exchanges, and mentoring among
pathologists are not covered by this guidance document.
This guidance finalizes the draft guidance entitled ``Use of Whole
Slide Imaging in Nonclinical Toxicology Studies: Questions and
Answers'' issued on April 8, 2022 (87 FR 20872). FDA considered
comments received on the draft guidance as the guidance was finalized.
This revision includes editorial changes to improve the clarity of the
document.
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 ``Use of Whole Slide Imaging 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.
[[Page 33895]]
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 pertaining to good laboratory practice
for non-clinical laboratory studies have been approved under OMB
control number 0910-0119. The collections of information in 21 CFR part
11 pertaining to electronic records and signatures have been approved
under OMB control number 0910-0303.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: May 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11211 Filed 5-24-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 25, 2023.
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