Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices 92691 

under title XIX of the Social Security 

Act (hereinafter referred to as the Act). 

Section 1859(f)(3)(D) of the Act and 

42 CFR 422.107 established the 

requirement for D–SNPs to have 

contracts with state Medicaid agencies 

in addition to other contracting 

requirements that that apply to all MA 

plans. 

MA organizations with D–SNPs and 

states use the information in the 

contract to provide benefits, or arrange 

for the provision of Medicaid benefits, 

to which an enrollee is entitled. CMS 

reviews the D–SNP contract with the 

state Medicaid agency to ensure that it 

meets the minimum contract 

requirements at § 422.107(c) and (d). 

CMS uses the attestations and matrices 

in the appendices of this package to 

identify the types of D–SNPs an MA 

organization(s) offers and the location of 

the contract requirements in the 

document. Form Number: CMS–10796 

(OMB control number: 0938–1410); 

Frequency: Yearly; Affected Public: 

State, Local, or Tribal Governments, 

Federal Government and Private Sector; 

Number of Respondents: 886; Total 

Annual Responses: 893; Total Annual 

Hours: 17,403. (For policy questions 

regarding this collection contact Marla 

Rothouse at 410–786–8063 or 

Marla.rothouse@cms.hhs.gov). 

William N. Parham III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–27358 Filed 11–21–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–0488] 

Orthopedic Non-Spinal Bone Plates, 

Screws, and Washers—Premarket 

Notification (510(k)) Submissions; 

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 a final 

guidance entitled ‘‘Orthopedic NonSpinal Bone Plates, Screws, and 

Washers—Premarket Notification 

(510(k)) Submissions.’’ This guidance 

document provides recommendations 

for information to include in 510(k) 

submissions for non-resorbable bone 

plate, screw, and washer devices. The 

scope of this guidance includes devices 

that are indicated for orthopedic bone 

fixation but does not include devices 

indicated for spinal, mandibular, 

maxillofacial, cranial, and orbital 

fracture fixation. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 22, 2024. 

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–D–0488 for ‘‘Orthopedic NonSpinal Bone Plates, Screws, and 

Washers—Premarket Notification 

(510(k)) Submissions; Guidance for 

Industry and Food and Drug 

Administration Staff.’’ 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)). 

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 ‘‘Orthopedic NonSpinal Bone Plates, Screws, and 

Washers—Premarket Notification 

(510(k)) Submissions; Guidance for 


ddrumheller on DSK120RN23PROD with NOTICES1
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