92690 Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Environmental 

Health Hazards Checklist Medicare 

Coverage for Individuals Exposed to 

Environmental Health Hazards; Use: 

Section 1881A of the Act provides an 

enrollment basis for individuals who 

have been exposed to environmental 

health hazards. Currently, the only 

individuals eligible for Medicare under 

this provision are those who were 

present in Lincoln County, Montana, 

and have an asbestos-related disease 

(ARD) diagnosis. Eligible individuals 

must be diagnosed with one or more 

asbestos-related conditions and have 

been present in Lincoln County, 

Montana, for a total of at least 6 months 

(need not be consecutive) in the period 

ending 10 years or more before 

diagnosis of an asbestos-related 

condition. This form provides 

verification from a provider so that SSA 

can determine eligibility for Medicare 

enrollment. 

SSA uses this information to 

determine whether an individual meets 

the requirements for Medicare 

enrollment on the basis of an 

Environmental Health Hazard. The form 

is faxed to the applicant’s provider by 

SSA. The provider must complete and 

sign the form and submit it back to SSA 

via fax or mail. The information on the 

completed form is reviewed manually 

by SSA. Thus, the collection of this 

information does not involve the use of 

information technology. Form Number: 

CMS–10902 (OMB control number: 

0938-New); Frequency: Once; Affected 

Public: Individuals and Households; 

Number of Respondents: 61; Total 

Annual Responses: 61; Total Annual 

Hours: 10. (For policy questions 

regarding this collection contact Tyrissa 

Woods at 410–786–0286 or 

Tyrissa.Woods@cms.hhs.gov). 

William N. Parham III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–27359 Filed 11–21–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10796] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

January 21, 2025. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number:__, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10796 Dual Eligible Special 

Needs Plan Contract With the State 

Medicaid Agency 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collections 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Dual Eligible 

Special Needs Plan Contract with the 

State Medicaid Agency; Use: Special 

needs plans (SNPs) are Medicare 

Advantage (MA) plans created by the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (Pub. L. 108–173) that are 

specifically designed to provide targeted 

care and limit enrollment to special 

needs individuals. Under section 

1859(b)(6) of the Act, D–SNPs restrict 

enrollment to individuals entitled to 

medical assistance under a state plan 


ddrumheller on DSK120RN23PROD with NOTICES1
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