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, 75604-75605 [2023-24273]

Download as PDF 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 lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:02 Nov 02, 2023 Jkt 262001 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services. AGENCY: ACTION: Notice. 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. SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Comments on this ICR should be received no later than December 4, 2023. DATES: 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. ADDRESSES: E:\FR\FM\03NON1.SGM 03NON1 75605 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 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 Number of respondents Form name Number of responses per respondent Average burden per response (in hours) Total responses Total annual burden hours Standardized Work Plan (SWP) .......................................... Quarterly Progress Update (QPU) Form ............................. 1,000 1,000 1 4 1,000 4,000 1.00 .10 1,000 400 Total .............................................................................. 1 1,000 ........................ 5,000 ........................ 1,400 1 The 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. 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. [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 lotter on DSK11XQN23PROD with NOTICES1 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., VerDate Sep<11>2014 17:02 Nov 02, 2023 Jkt 262001 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 PO 00000 Frm 00069 Fmt 4703 Sfmt 9990 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 E:\FR\FM\03NON1.SGM 03NON1

Agencies

[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Notices]
[Pages 75604-75605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24273]


-----------------------------------------------------------------------

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 [email protected] 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.

[[Page 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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total annual
            Form name               respondents    responses per     responses     response  (in   burden hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Standardized Work Plan (SWP)....           1,000               1           1,000            1.00           1,000
Quarterly Progress Update (QPU)            1,000               4           4,000             .10             400
 Form...........................
                                 -------------------------------------------------------------------------------
    Total.......................       \1\ 1,000  ..............           5,000  ..............           1,400
----------------------------------------------------------------------------------------------------------------
\1\ The 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
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