75604 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 

to devices that are appropriately tested 

in accordance with specific FDArecognized standards (as outlined in the 

limitations) and excludes clinical 

electronic thermometers with 

telethermographic and continuous 

temperature measurement functions. 

Most contact and non-contact clinical 

electronic thermometers that are 

appropriately tested in accordance with 

specific FDA-recognized standards are 

well-understood devices; however, FDA 

considers premarket notification 

requirements for clinical thermometers 

with telethermographic and continuous 

temperature measurement functions to 

be necessary to provide a reasonable 

assurance of safety and effectiveness 

because such thermometers include 

newer technology that may require 

additional testing beyond that specified 

in FDA-recognized standards and have 

additional biocompatibility, 

interoperability, electromagnetic 

compatibility, electrical safety, and 

sterility considerations compared to 

clinical electronic thermometers 

without these types of functions. 

IV. Class II Device 

FDA is identifying the following class 

II device that, if finalized, would no 

longer require premarket notification 

under section 510(k) of the FD&C Act, 

subject to the general limitations to the 

exemptions found in § 880.9: 

TABLE 1—CLASS II DEVICES

21 CFR 

section Device description Product code Partial exemption limitation 

880.2910 ...... Clinical electronic thermometer .......... FLL ......... Exemption is limited to the following: 

1. Device is not a clinical thermometer with telethermography functions; 

2. Device is not a clinical thermometer with continuous temperature measurement functions; and 

3. Appropriate analysis and testing (such as outlined in the currently FDArecognized editions of ISO 80601–2–56 Medical electrical equipment— 

Part 2–56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement, or 

ASTM E1965 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature, or ASTM E1112 Standard 

Specification for Electronic Thermometer for Intermittent Determination of 

Patient Temperature, or ASTM E1104 Standard Specification for Clinical 

Thermometer Probe Covers and Sheaths) must validate specifications 

and performance of the device. 

FDA will assign new product codes to 

clinical electronic thermometers with 

telethermography functions and those 

with continuous temperature 

measurement functions in order to 

ensure that these devices can be 

identified distinctly from devices that 

will be exempt subject to the partial 

limitations under the existing product 

code (i.e., exempt and non-exempt 

devices within a device type will have 

different product codes). 

V. Reference 

The following reference is on display 

in the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA Guidance, ‘‘Procedures for Class II 

Device Exemptions from Premarket 

Notification, Guidance for Industry and 

CDRH Staff,’’ February 19, 1998, available at 

https://www.fda.gov/media/72685/download. 

Dated: October 31, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24290 Filed 11–2–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Standardized Work Plan 

Form for Use With Applications to the 

Bureau of Health Workforce Research 

and Training Grants and Cooperative 

Agreements OMB No. 0906–0049— 

Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than December 4, 

2023. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Standardized Work Plan (SWP) Form for 

Use with Applications to the Bureau of 

Health Workforce (BHW) Research and 

Training Grants and Cooperative 

Agreements OMB No. 0906–0049— 

Extension 

Abstract: HRSA’s BHW requires 

applicants for training and research 

grants and cooperative agreements to 

submit work plans via the SWP form. 


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Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 75605 

Information in the SWP describes the 

timeframes and progress required 

during the grant period of performance 

to address each of the needs detailed in 

the Purpose and Need section of the 

application, as required in the Notice of 

Funding Opportunity announcement. 

Applicants use the SWP form when they 

submit their proposals, and award 

recipients and Project Officers use the 

SWP information to assist in monitoring 

progress once HRSA makes the awards. 

After awards are made, recipients 

complete a Quarterly Progress Update 

(QPU) to provide information to BHW 

on a quarterly basis on each activity 

listed in the SWP. 

A 60-day notice published in the 

Federal Register on August 25, 2023, 

vol. 88, No. 164; pp. 58284–85. There 

were no public comments. 

Need and Proposed Use of the 

Information: Information collected by 

the SWP form and QPUs standardizes 

and streamlines the data used by HRSA 

in reviewing applications and 

monitoring awardees. The form asks 

applicants to provide a description of 

the activities or steps the applicant will 

take to achieve each of the objectives 

proposed during the entire period of 

performance. The current standardized 

format and data submission by 

applicants increases efficiency in 

reviewing, awarding, and monitoring 

each project. 

The QPU is completed via HRSA’s 

Electronic Handbook system and 

prompts recipients to report on progress 

of activities that were submitted using 

the SWP in the original application. The 

QPU automatically populates activities 

from the recipient’s SWP form on a 

quarterly basis. For each activity listed 

in the submitted SWP for any particular 

quarter within the project period, 

recipients select and submit a single 

selection response for each activity 

status from a pull-down menu with five 

options: Activity is on Schedule, 

Activity is Complete, Timing is off 

track, Activity will be missed if action 

is not taken, and Activity cannot be 

achieved. Information provided is 

utilized by the program staff to regularly 

assess overall progress of program 

requirements and analyze data in order 

to monitor award recipient compliance 

and track progress against proposed 

targets and goals. Information gathered 

allows an improved and more efficient 

method for identifying whether projects’ 

goals are being advanced or achieved, as 

set forth in 45 CFR 75.342. Program staff 

also use information provided over the 

period of performance to see emerging 

trends and to assess whether an award 

recipient requires technical assistance to 

address challenges that the award 

recipient may be experiencing with the 

implementation of the project. Seeking 

OMB extension approval comports with 

the regulatory requirement imposed by 

45 CFR 75.206(a), Paperwork clearances. 

Likely Respondents: Respondents are 

applicants for, and recipients of, BHW’s 

research and training grants and 

cooperative agreements. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

Standardized Work Plan (SWP) .......................................... 1,000 1 1,000 1.00 1,000 

Quarterly Progress Update (QPU) Form ............................. 1,000 4 4,000 .10 400 

Total .............................................................................. 1 1,000 ........................ 5,000 ........................ 1,400 

1The 1,000 SWP respondents reflects the number of new grant applications submitted annually. The 1,000 QPU respondents reflects the current volume of funded, active grants. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–24273 Filed 11–2–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Advancing 

Therapeutics II. 

Date: November 14, 2023. 

Time: 11:00 a.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Lystranne Alysia Maynard 

Smith, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Bethesda, MD 20892, 301–402–4809, 

lystranne.maynard-smith@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 30, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–24277 Filed 11–2–23; 8:45 am] 

BILLING CODE 4140–01–P 


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