75600 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 

supportive services to seniors and their 

caregivers in an integrated system of 

long-term care. Information gathered 

through the Assessment and Evaluation 

of the Title VI Programs will inform 

ACL and its partners, other Federal 

agencies and administrators, current 

grantees, policymakers, and the field 

about ways to improve service delivery 

for elders and their caregivers and 

helping them to remain in their homes 

for as long as possible. For example, 

information gathered through the 

evaluation will be used to identify gaps 

and challenges in service delivery, as 

well as areas of further need. 

Without this assessment and 

evaluation, Federal and local officials 

will not be able to determine whether 

the Title VI Programs are having the 

intended impact on AI/AN/NH elders 

and whether the grantees are meeting 

the individual goals of the programs. 

The new proposed data collection with 

further allow ACL to understand how 

successful the training and technical 

assistance provided to Title VI 

evaluation grantees was for their 

practice of data collection and use. 

Comments in Response to the 60-Day 

Federal Register Notice 

A notice published in the Federal 

Register 88 FR 56633 on August 18, 

2023. There were no public comments 

received during the 60-day FRN. 

Estimated Program Burden: 

ESTIMATED PROGRAM BURDEN

Respondent type Form name 

Number of 

annual 

respondents 

Number of 

responses per 

respondent 

Average burden 

(in hours) 

per response 

Annual burden 

hours 

Program director ........... Program staff follow-up interview guide ............. 12 1 1 12 

Dated: October 30, 2023. 

Alison Barkoff, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the duties of the Administrator 

and the Assistant Secretary for Aging. 

[FR Doc. 2023–24255 Filed 11–2–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4372] 

Enforcement Policy for Clinical 

Electronic Thermometers; 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, Agency, or we) is 

announcing the availability of a final 

guidance entitled ‘‘Enforcement Policy 

for Clinical Electronic Thermometers.’’ 

This guidance applies to clinical 

electronic thermometers, which are 

regulated as class II devices. This 

guidance has been implemented 

without prior comment, but it remains 

subject to comment in accordance with 

the Agency’s good guidance practices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 3, 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: 

• 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– 

2023–N–4372 for ‘‘Enforcement Policy 

for Clinical Electronic Thermometers.’’ 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 75601 

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 § 10.115(g)(5) 

(21 CFR 10.115(g)(5))). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Enforcement Policy 

for Clinical Electronic Thermometers’’ 

to the Office of Policy, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

David Wolloscheck, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2416, Silver Spring, 

MD 20993–0002, 301–796–1480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance entitled ‘‘Enforcement 

Policy for Clinical Electronic 

Thermometers.’’ During the Coronavirus 

Disease 2019 (COVID–19) public health 

emergency (PHE), FDA issued certain 

enforcement policies for non-invasive 

remote monitoring devices and clinical 

electronic thermometers. The policies 

regarding the modification of previously 

FDA-cleared clinical electronic 

thermometers within product code FLL 

were originally included in FDA’s 

guidance ‘‘Enforcement Policy for NonInvasive Remote Monitoring Devices 

Used to Support Patient Monitoring 

During the Coronavirus Disease 2019 

(COVID–19) Public Health Emergency’’ 

first issued in March 2020, and 

subsequently revised in June 2020, 

October 2020, and March 2023. The 

policies regarding the distribution and 

use of clinical electronic thermometers 

not previously cleared under section 

510(k) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360(k)) were outlined in FDA’s guidance 

‘‘Enforcement Policy for Clinical 

Electronic Thermometers During the 

Coronavirus Disease 2019 (COVID–19) 

Public Health Emergency’’ issued in 

April 2020 and revised in March 2023. 

At the time, FDA stated that the 

policies described in these guidances 

were intended to remain in effect only 

for the duration of the PHE related to 

COVID–19 declared by the Secretary of 

Health and Human Services in 

accordance with section 319 of the 

Public Health Service Act (42 U.S.C. 

247d). On March 13, 2023, FDA 

announced in the Federal Register 

notice ‘‘Guidance Documents Related to 

Coronavirus Disease 2019 (COVID–19)’’ 

(88 FR 15417) that these guidance 

documents were being revised to 

continue in effect for 180 days after the 

expiration of the COVID–19 PHE 

declaration, and that, during that time, 

FDA would further revise these 

guidances, among others. Consistent 

with what we said in the Federal 

Register notice of March 13, 2023, FDA 

has revised and consolidated the 

policies that apply to clinical electronic 

thermometers in this guidance. 

Elsewhere in this issue of the Federal 

Register, FDA is proposing to exempt 

certain clinical electronic 

thermometers—specifically clinical 

thermometers without telethermography 

or continuous temperature measurement 

functions—from premarket notification 

requirements under section 510(m) of 

the FD&C Act (see the Federal Register 

document ‘‘Medical Devices; 

Exemptions from Premarket 

Notification: Class II Devices; Clinical 

Electronic Thermometers; Request for 

Comments’’). FDA intends to withdraw 

this guidance after any final exemption 

document has been published in the 

Federal Register. 

The policies outlined in this guidance 

are organized by clinical thermometer 

type. The guidance describes 

enforcement policies that are intended 

to help foster compliance with certain 

applicable legal requirements for these 

devices. 

The enforcement policies in this 

guidance apply to clinical electronic 

thermometers, which are regulated as 

class II devices under 21 CFR 880.2910, 

product code FLL. These devices 

include both contact and non-contact 

clinical electronic thermometers. This 

guidance supersedes ‘‘Enforcement 

Policy for Clinical Electronic 

Thermometers During the Coronavirus 

Disease 2019 (COVID–19) Public Health 

Emergency’’ issued in April 2020 and 

updated in March 2023. 

This guidance is being implemented 

without prior public comment because 

FDA has determined that prior public 

participation for this guidance is not 

feasible or appropriate (see section 

701(h)(1)(C) of the FD&C Act (21 U.S.C. 

371(h)(1)(C)) and § 10.115(g)(2)). FDA 

has determined that this guidance 

document presents a less burdensome 

policy that is consistent with public 

health. Although this policy is being 

implemented immediately without prior 

comment, it remains subject to comment 

in accordance with FDA’s good 

guidance practices regulation 

(§ 10.115(g)(3)(D)). FDA will consider all 

comments received and revise the 

guidance document as appropriate. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the current thinking 

of FDA on ‘‘Enforcement Policy for 

Clinical Electronic Thermometers.’’ 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. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov or https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Enforcement Policy 

for Clinical Electronic Thermometers’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number GUI00020021 

and complete title to identify the 

guidance you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in the following table have 

been approved by OMB: 


lotter on DSK11XQN23PROD with NOTICES1
75602 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket notification ................................................................. 0910–0120 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-Submissions and Early Payor Feedback Request Programs 

for Medical Devices.

0910–0756 

800, 801, 809, and 830 .............................................................. Medical Device Labeling Requirements; Unique Device Identification.0910–0485 

806 .............................................................................................. Medical Devices; Reports of Corrections and Removals .......... 0910–0359 

807, subparts A through D ......................................................... Medical Device Registration and Listing .................................... 0910–0625 

820 .............................................................................................. Current Good Manufacturing Practice, Quality Systems ........... 0910–0073 

Dated: October 31, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24291 Filed 11–2–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4372] 

Medical Devices; Exemptions From 

Premarket Notification: Class II 

Devices; Clinical Electronic 

Thermometers; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

identified certain class II clinical 

electronic thermometers that, when 

finalized, will be exempt from 

premarket notification requirements, 

subject to certain limitations. FDA is 

publishing this notice of that 

determination and requesting public 

comment in accordance with the 

procedures established by the 21st 

Century Cures Act. FDA will review any 

comments submitted within the 60-day 

comment period and will consider 

whether any modifications should be 

made to the exemption for certain 

clinical electronic thermometers prior to 

publication of its final determination in 

the Federal Register. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by January 2, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 2, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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– 

2023–N–4372 for ‘‘Medical Devices; 

Exemptions from Premarket 

Notification: Class II Devices; Clinical 

Electronic Thermometers; Request for 

Comments.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Madhusoodana Nambiar, Center for 

Devices and Radiological Health, Food 


lotter on DSK11XQN23PROD with NOTICES1