[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Notices]
[Pages 20872-20873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07511]


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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Questions and Answers; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Use of 
Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and 
Answers.'' When final, this guidance will represent FDA's current 
thinking on the use of whole slide images during good laboratory 
practice (GLP)-compliant toxicology studies using non-human specimens. 
When whole slide images are used as part of a nonclinical study 
conducted in compliance with the GLP regulations, adequate 
documentation is critical. 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.

DATES: Submit either electronic or written comments on the draft 
guidance by June 7, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-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 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 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 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 draft 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 Device Evaluation, Center for Devices 
and

[[Page 20873]]

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, 
Division of Operational Policy, Office of Regulatory Affairs, Food and 
Drug Administration, District Office--Minneapolis, 250 Marquette Ave., 
Minneapolis, MN 55401, 612-758-7187.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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 
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 specifically 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.
    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. This question-and-answer 
document is intended to clarify FDA's recommendations concerning the 
management, documentation, and use of whole slide imaging in 
histopathology assessment and/or pathology peer review for nonclinical 
studies conducted in compliance with the GLP regulations. Use of whole 
slide images in casual consultations, opinion exchanges, and mentoring 
among pathologists are not covered by this guidance document.
    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 ``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.

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 regarding the good laboratory practice 
requirements for nonclinical laboratory studies have been approved 
under OMB control number 0910-0119.

III. Electronic Access

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

    Dated: April 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07511 Filed 4-7-22; 8:45 am]
BILLING CODE 4164-01-P