[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Questions and Answers; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Use of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DATES: Submit either electronic or written comments on the draft
guidance by June 7, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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]
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