Agency Information Collection Activities: Proposed Collection; Comment Request, 92690-92691 [2024-27358]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 19:28 Nov 21, 2024 Jkt 265001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10796] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 https:// 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. SUMMARY: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22NON1.SGM 22NON1 Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices 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). Electronic Submissions Food and Drug Administration 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’’). [Docket No. FDA–2023–D–0488] Written/Paper Submissions 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 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. 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 SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES1 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: VerDate Sep<11>2014 19:28 Nov 21, 2024 Jkt 265001 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 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 92691 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-201509-18/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 E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 89, Number 226 (Friday, November 22, 2024)]
[Notices]
[Pages 92690-92691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27358]


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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 
https://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/PRA-Listing.

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

[[Page 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 Sec.  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 [email protected]).

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

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