20872 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 

Similarly, the total hours associated 

with the Title VI, Part C, application is 

375. 

Dated: April 4, 2022. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2022–07507 Filed 4–7–22; 8:45 am] 

BILLING CODE 4154–01–P 

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. 

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 nonhuman 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-andanswer 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written comments on the draft guidance 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draft guidance before it begins work on 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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 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/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1158] 

Cybersecurity in Medical Devices: 

Quality System Considerations and 

Content of Premarket Submissions; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Cybersecurity in 

Medical Devices: Quality System 

Considerations and Content of 

Premarket Submissions.’’ As more 

medical devices are becoming 

interconnected, cybersecurity threats 

have become more numerous, more 

frequent, more severe, and more 

clinically impactful. As a result, 

ensuring medical device safety and 

effective includes adequate medical 

device cybersecurity, as well as its 

security as part of the larger system. In 

2018, FDA proposed updates to the final 

guidance, ‘‘Content of Premarket 

Submissions for Management of 

Cybersecurity in Medical Devices,’’ and 

issued a draft guidance of the same 

name. This draft guidance replaces the 

2018 draft guidance. This draft guidance 

is intended to further emphasize the 

importance of ensuring that devices are 

designed securely, are designed to be 

capable of mitigating emerging 

cybersecurity risks throughout the Total 

Product Life Cycle, and to clearly 

outline FDA’s recommendations for 

premarket submission content to 

address cybersecurity concerns. This 

draft guidance is not final nor is it for 

implementation at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 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 


jspears on DSK121TN23PROD with NOTICES1