92692 Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices 

Industry and Food and Drug 

Administration Staff’’ 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 selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Mahlet Zinah, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4452, Silver Spring, 

MD 20993–0002, 240–402–2623. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Non-spinal, non-resorbable bone 

plates, screws, and washers are implants 

intended for bone fixation. These are 

class II medical devices for which the 

safety and effectiveness are wellestablished. This guidance provides 

recommendations for the content and 

organization of premarket notification 

(510(k)) submissions including the 

information FDA recommends industry 

include in a 510(k) submission for these 

device types (e.g., non-clinical testing, 

sterility, reprocessing, biocompatibility). 

This guidance is intended to facilitate 

consistency in information provided in 

submissions by addressing common 

deficiencies related to device 

description and performance testing and 

by identifying applicable cross-cutting 

guidances and consensus standards. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of March 29, 2023 (88 FR 

18549). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including clarification 

regarding recommended language for 

indications for use statements as well as 

additional considerations for predicate 

device comparisons when leveraging 

information from previously cleared 

devices. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Non-Spinal Bone 

Plates, Screws, and Washers—Premarket 

Notification (510(k)) Submissions.’’ 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 and https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Non-Spinal Bone 

Plates, Screws, and Washers—Premarket 

Notification (510(k)) Submissions; 

Guidance for Industry and Food and 

Drug Administration Staff’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number GUI00019023 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: 

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

No. 

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

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

‘‘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 Regulations; Unique Device Identification.0910–0485 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System 

(QS) Regulation.

0910–0073 

50, 56 .......................................................................................... Protection of Human Subjects and Institutional Review Boards 0910–0130 

Dated: November 12, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–27114 Filed 11–21–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Health Resources 

and Services Administration Uniform 

Data System 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than January 21, 2025. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14NWH04, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices 92693 

1https://www.cms.gov/medicare/quality/ 

measures. 

2https://ecqi.healthit.gov/now-available-updatedecqm-specifications-and-implementation-resources2025-performance/reporting-period. 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Health Resources and Services 

Administration (HRSA) Uniform Data 

System (UDS), OMB No. 0915–0193— 

Revision. 

Abstract: The Health Center Program, 

administered by HRSA, is authorized 

under section 330 of the Public Health 

Service (PHS) Act (42 U.S.C. 254b). 

Health centers are community-based 

and patient-directed organizations that 

deliver affordable, accessible, quality, 

and cost-effective primary health care 

services to patients regardless of their 

ability to pay. Nearly 1,400 health 

centers operate approximately 15,500 

service delivery sites that provide 

primary health care to more than 31 

million people in every U.S. state, the 

District of Columbia, Puerto Rico, the 

U.S. Virgin Islands, and the Pacific 

Basin. 

HRSA uses the UDS for annual 

reporting of program-specific data by 

Health Center Program awardees (those 

funded under section 330 of the PHS 

Act), Health Center Program look-alikes 

(entities meeting requirements of, but 

not funded under, section 330 of the 

PHS Act), and Nurse Education, 

Practice, Quality and Retention 

(NEPQR) and Advanced Nursing 

Education (ANE) Program awardees 

(specifically those funded under the 

practice priority areas of sections 831(b) 

and 811 of the PHS Act). 

Some NEPQR and ANE Program 

awardees establish and expand nursing 

practice arrangements in 

noninstitutional settings to demonstrate 

methods to improve access to primary 

health care in medically underserved 

communities. Nursing grantees 

implementing nursing practice 

arrangements have historically used the 

same data collection system as the 

Health Center Program. 

Need and Proposed Use of the 

Information: HRSA requires the 

collection of information through UDS 

to monitor and evaluate the 

performance of health centers under 

section 330 and select NEPQR and ANE 

recipients under sections 831(b) and 

811. These data aid in program 

compliance, guide quality improvement 

initiatives, and inform federal health 

policy decisions. HRSA also leverages 

UDS data to assess the impact of health 

centers and NEPQR and ANE recipients 

on patient health outcomes and to 

allocate funding and resources 

effectively across the Health Center 

Program. To keep this instrument 

relevant and responsive to the health 

center program’s needs and the evolving 

healthcare landscape, periodic updates 

are essential. HRSA plans to make the 

following updates for the performance 

year 2025 UDS data collection: 

Table 6A (Selected Diagnoses and 

Services Rendered) Additions 

• Tobacco Use Cessation 

Pharmacotherapies: A new measure is 

being added to line 26c2 to identify the 

number of visits where patients received 

tobacco cessation pharmacotherapies as 

an intervention and the number of 

patients who received this 

pharmacologic treatment. While the 

Preventive Care and Screening: Tobacco 

Use: Screening and Cessation 

Intervention electronic-specified 

clinical quality measures (CMS138v12) 

(Table 6B, Line 14a) that is currently 

reported in the UDS assesses for 

cessation, it lacks the capacity to 

disaggregate and report a distinct 

percentage for patients receiving 

counseling or recommendation to 

cessation pharmacotherapies. Adding a 

line for reporting of tobacco use 

cessation pharmacotherapies will 

promote greater understanding of the 

breadth of tobacco cessation 

interventions provided at health centers, 

specifically allowing HRSA to see 

differences in tobacco use cessation 

approaches. 

• Medications for Opioid Use 

Disorder (MOUD): A new measure for 

MOUD services will be reported on line 

26c3 for the number of visits where 

MOUD was administered and the 

number of patients who received this 

medication-based intervention. This 

new measure will enhance the existing 

MOUD related measures that health 

centers currently report on in Appendix 

E: Other Data Elements (e.g., number of 

providers who treat opioid use disorder 

with MOUD). The inclusion of this 

measure is critical for supporting public 

health efforts to address the ongoing 

opioid epidemic. Greater understanding 

of the use of MOUD in health centers is 

necessary both to understand existing 

services and identify remaining 

healthcare gaps. 

• Alzheimer’s Disease and Related 

Dementias (ADRD) Screening: A new 

measure is being added to line 26f to 

capture the number of visits where 

patients received ADRD screenings and 

the number of patients who received the 

screenings. This measure will 

encompass assessments representing 

standardized tools used for the 

evaluation of cognition and mental 

status of older adults. The addition of a 

measure to capture screening of ADRD 

will be valuable in understanding the 

level of need and resources required to 

continue to support the growing aging 

population served by the Health Center 

Program and will foster early detection 

for those at risk for ADRD. 

Table 6B (Quality of Care Measures) 

Addition 

• Initiation and Engagement of 

Substance Use Disorder Treatment: A 

new measure with two distinct rates is 

being added to Lines 23a and b to 

capture the initiation and engagement of 

substance use disorder treatment, in 

alignment with electronic-specified 

clinical quality measure CMS137v13. 

This measure will report on the 

percentage of patients 13 years and 

older with a new substance use disorder 

episode who received treatment, 

including (a) those who initiated 

treatment within 14 days and (b) those 

who engaged in ongoing treatment 

within 34 days. By incorporating this 

measure, HRSA strengthens its 

alignment with national performance 

standards and gains greater insight into 

how effectively health centers are 

initiating and engaging patients in 

substance use disorder treatment. 

Table 6B (Quality of Care Measures) 

and Table 7 (Health Outcomes and 

Disparities) 

Updates 

• Tables 6B and 7 collect UDS 

clinical quality measures,1 and where 

applicable, clinical quality measures 

will be updated in alignment with 

specifications of the issued performance 

year 2025 electronic-specified clinical 

quality measures. These specifications 

were released by the Centers for 

Medicare and Medicaid Services (CMS) 

on May 2, 2024, for use by eligible 

providers.2 Clinical performance 

measure alignment across national 

programs promotes data 

standardization, quality, and 

transparency, and decreases reporting 

burden for providers and organizations 

participating in multiple federal 

programs. 


ddrumheller on DSK120RN23PROD with NOTICES1
92694 Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices 

3https://ecqi.healthit.gov/fhir. 4https://ecqi.healthit.gov/fhir. 

UDS+ Test Submissions for Health 

Centers 

• Beginning with the 2024 UDS, 

health centers will be able to submit deidentified, patient-level data in 

fulfillment of data elements on Tables: 

Æ Table PBZC (Patients by ZIP Code) 

Æ Table 3A (Patients by Age and Sex 

Assigned at Birth) 

Æ Table 3B (Demographic 

Characteristics) 

Æ Table 4 (Selected Characteristics) 

Æ Table 6A (Selected Diagnoses and 

Services Rendered) 

Æ Table 6B (Quality of Care Measures) 

Æ Table 7 (Health Outcomes and 

Disparities 

UDS+ Patient-Level Reporting 

leverages a shift in processes by which 

health centers will submit their annual 

UDS reports while maintaining historic 

UDS measures. Health Centers are 

encouraged to submit data through 

UDS+. 

UDS+ is currently in the testing phase 

and data submission supports system 

capacity building and progress towards 

full implementation. The technical test 

will inform next steps for scaling this 

innovation. High-quality accessible data 

are critical to strategically meeting the 

unique needs of health center patients 

and identifying training and technical 

assistance opportunities for clinical 

process improvement. The growth in 

health information technology coupled 

with the near universal adoption of 

electronic health records across health 

centers has transformed patient care 

delivery and underscored the need for 

secure and rapid exchange of health 

data between disparate systems. Fast 

Healthcare Interoperability Resources®

is a Health Level Seven International®

standard for exchanging health care 

information electronically.3 The health 

care community is adopting this next 

generation exchange framework to 

advance interoperability.4 Leveraging 

Fast Healthcare Interoperability 

Resources® to collect patient-level data 

through the UDS+ system will support 

improved data granularity, allowing for 

the development of robust HRSAsupported patient care programs and 

improved equitable access to HRSAsupported high-quality, cost-effective 

primary care services. This electronic 

reporting mechanism will reduce 

reliance on manual data entry to 

populate the annual UDS report, in turn 

yielding a reduction in reporting effort 

burden, and will greatly increase the 

analytical value of UDS data for 

informing policy and program decisionmaking. 

Likely Respondents: Respondents will 

include Health Center Program award 

recipients and Health Center Program 

look-alikes carrying out programs under 

section 330 of the PHS Act and NEPQR 

and ANE award recipients funded under 

the practice priority areas of section 

831(b) and 811 of the PHS Act. 

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 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Estimated total 

burden hours 

Universal Report .............................................................................................. * 1,538 1.00 238 366,044 

Grant Report .................................................................................................... ** 420 1.22 22 11,273 

UDS+ Test Submissions .................................................................................. 1,507 1.25 10 18,838 

Total .......................................................................................................... 3,465 ........................ 270 396,155 

* Consists of 1,363 health center program awardees, 133 Health Center Look-alikes, and 42 NEPQR and ANE respondents. 

** Health Centers submitted one or more grant reports in 2023: 339 (1 report), 70 (2 reports), 11 (3 reports). 

HRSA specifically requests comments 

on: (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–27394 Filed 11–21–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Notice of Purchased/Referred Care 

Delivery Area Redesignation for the 

Pokagon Band of Potawatomi Indians 

of Michigan and Indiana 

AGENCY: Indian Health Service, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: Notice is hereby given that 

the Indian Health Service (IHS) has 

decided to expand the geographic 

boundaries of the Purchased/Referred 

Care Delivery Area (PRCDA) for the 

Pokagon Band of Potawatomi Indians of 

Michigan and Indiana (‘‘Pokagon 

Band’’) to include the counties of 

Kalamazoo, Kent, and Ottawa in the 

State of Michigan. The final PRCDA for 

the Pokagon Band now includes the 

Michigan counties of Allegan, Berrien, 

Cass, Kalamazoo, Kent, Ottawa, and Van 

Buren, and the Indiana counties of 

Elkhart, Kosciusko, La Porte, Marshall, 

St. Joseph, and Starke. The sole purpose 

of this expansion is to authorize 

additional Pokagon Band members and 

beneficiaries to receive Purchased/ 

Referred Care (PRC) services. 

DATES: This expansion is effective as of 

the date of publication of this notice. 

ADDRESSES: This notice can be found at 

https://www.federalregister.gov. Written 

requests for information should be 

delivered to: CAPT John Rael, Director, 


ddrumheller on DSK120RN23PROD with NOTICES1