85538 Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Notices 

of chemical exposure to the skin. The 

final publication, which will address 

public comments, will be available on 

the NIOSH website and in the NIOSH 

docket (153–F) and in Regulations.gov 

(CDC–2024–0085). 

Background: In 2009, NIOSH 

published Current Intelligence Bulletin 

(CIB) 61: A Strategy for Assigning New 

NIOSH Skin Notations [NIOSH 2009]. 

The CIB presents a strategic framework 

that is a form of hazard identification 

designed to do the following: 

• Ensure that the assigned skin 

notations reflect the contemporary 

state of scientific knowledge 

• Provide transparency behind the 

assignment process 

• Communicate the hazards of chemical 

exposures of the skin 

• Meet the needs of health 

professionals, employers, and other 

interested parties in protecting 

workers from chemical contact with 

the skin. 

This strategy involves the assignment 

of multiple skin notations for 

distinguishing systemic (SYS), direct 

(DIR), and sensitizing (SEN) effects 

caused by exposure of skin (SK) to 

chemicals. Chemicals that are highly or 

extremely toxic and may be potentially 

lethal or life-threatening following 

exposures of the skin are designated 

with the systemic subnotation (FATAL). 

Potential irritants and corrosive 

chemicals are indicated by the direct 

effects subnotations (IRR) and (COR), 

respectively. The five draft Skin 

Notation Profiles available for review 

were developed following the 

framework in NIOSH CIB 61. 

Reference 

NIOSH [2009]. Current Intelligence 

Bulletin 61: A strategy for assigning 

new NIOSH skin notations. 

Cincinnati, OH: U.S. Department of 

Health and Human Services, 

Centers for Disease Control and 

Prevention, National Institute for 

Occupational Safety and Health, 

DHHS (NIOSH) Publication 2009– 

147, https://www.cdc.gov/niosh/ 

docs/2009-147/. 

Dated: October 23, 2024. 

John J. Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention, Department of Health and 

Human Services. 

[FR Doc. 2024–24983 Filed 10–25–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10856] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request; 

Withdrawal 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice; withdrawal. 

SUMMARY: On Thursday, September 26, 

2024, the Centers for Medicare & 

Medicaid Services (CMS) published a 

30-day Paperwork Reduction Act of 

1995 notice entitled, ‘‘Agency 

Information Collection Activities: 

Submission for OMB Review; Comment 

Request.’’ The notice invited public 

comment on Document Identifier: CMS– 

10856; Title of Information Collection: 

Medicaid Managed Care and Supporting 

Regulations; and Form Number: CMS– 

10856 (OMB control number 0938– 

1453). Through the publication of this 

document we are withdrawing the 

September 26, 2024, notice in its 

entirety. 

DATES: This withdrawal is applicable on 

October 28, 2024. 

SUPPLEMENTARY INFORMATION: Through 

the publication of this notice we are 

withdrawing FR document 2024–21982 

which published in the Federal Register 

on September 26, 2024 (89 FR 78875). 

Upon further review the associated 

collection of information request was 

not ready for public review and 

comment. The 30-day notice will 

republish at a date to be determined. 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–25019 Filed 10–25–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10912] 

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 

December 27, 2024. 

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: 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Notices 85539 

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–10912 Medicare Transaction 

Facilitator for 2026 and 2027 under 

Sections 11001 and 11002 of the 

Inflation Reduction Act (IRA) 

Information Collection Request 

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: New Collection; Title of 

Information Collection: Medicare 

Transaction Facilitator for 2026 and 

2027 under Sections 11001 and 11002 of 

the Inflation Reduction Act (IRA) 

Information Collection Request; Use: 

Under the authority in sections 11001 

and 11002 of the Inflation Reduction 

Act of 2022 (Pub. L. 117–169), the 

Centers for Medicare & Medicaid 

Services (CMS) is implementing the 

Medicare Drug Price Negotiation 

Program, codified in sections 1191 

through 1198 of the Social Security Act 

(‘‘the Act’’). The Act establishes the 

Negotiation Program to negotiate 

maximum fair prices (‘‘MFPs’’), defined 

at 1191(c)(3) of the Act, for certain high 

expenditure, single source selected 

drugs covered under Medicare Part B 

and Part D (‘‘selected drugs’’). In 

accordance with section 1193(a) of the 

Act, any Primary Manufacturer of a 

selected drug that continues to 

participate in the Negotiation Program 

and reaches agreement upon an MFP 

must provide access to the MFP to MFPeligible individuals, defined in section 

1191(c)(2)(A) of the Act, and to 

pharmacies, mail order services, other 

dispensing entities, providers and 

suppliers with respect to such MFPeligible individuals who are dispensed 

that selected drug during a price 

applicability period. The purpose of this 

information collection request (ICR) is 

for CMS to collect information from 

manufacturers of drugs covered under 

Part D selected for negotiation under the 

Inflation Reduction Act for the initial 

price applicability years 2026 and 2027 

and the dispensing entities that 

dispense the selected drugs to MFPeligible individuals. To facilitate the 

effectuation of the MFP, CMS will 

engage a Medicare Transaction 

Facilitator (‘‘MTF’’). The MTF system 

will be composed of two modules: the 

MTF Data Module (MTF DM), and the 

MTF Payment Module (MTF PM). 

Medicare Transaction Facilitator Data 

Elements: The MTF system will be 

composed of two modules: the MTF 

Data Module (MTF DM), and the MTF 

Payment Module (MTF PM). Primary 

Manufacturers participating in the 

Negotiation Program are required to 

participate in the MTF DM. Further, 

CMS intends to propose in future 

rulemaking to require Part D plan 

sponsors to include in their pharmacy 

agreements provisions requiring 

dispensing entities to participate in the 

MTF DM for purposes of data exchange. 

As such, for the purposes of this ICR, 

CMS assumes full participation in the 

MTF DM by affected Primary 

Manufacturers and dispensing entities. 

Meanwhile, participation in the MTF 

PM, for use in passing through payment 

from the Primary Manufacturer to 

dispensing entities, will be optional for 

Primary Manufacturers; as a result, 

dispensing entities may receive fund 

transfers from the MTF PM, or via an 

alternative process established by a 

Primary Manufacturer. As discussed in 

section 40.4 of the Medicare Drug Price 

Negotiation Program: Final Guidance, 

Implementation of Sections 1191–1198 

of the Social Security Act for Initial 

Price Applicability Year 2027 and 

Manufacturer Effectuation of the 

Maximum Fair Price (MFP) in 2026 and 

2027 (‘‘final guidance’’), CMS will 

engage the MTF DM to facilitate the 

exchange of certain claim-level data 

elements and payment elements for 

selected drugs. The data exchange 

component of the MTF will involve 

both the transmission of certain claimlevel data elements to the Primary 

Manufacturer and receipt of claim-level 

payment elements from the Primary 

Manufacturer. Both Primary 

Manufacturers and dispensing entities 

will need to provide certain information 

at the onset of their enrollment in the 

MTF DM system to facilitate 

effectuation of the MFP via refunds from 

Primary Manufacturers. Both Primary 

Manufacturers and dispensing entities 

will be able to submit complaints and 

disputes through their participation in 

the MTF DM. Primary Manufacturers 

will also submit information to fulfill 

their requirement to provide an MFP 

Effectuation Plan and transmit recurring 

data submissions reflecting their 

payment elements, as described in the 

final guidance. Given these information 

collection requirements, this ICR 

includes the following forms: (A) Drug 

Price Negotiation Program MTF DM 

Dispensing Entity and Third-Party 

Support Enrollment Form; (B) Drug 

Price Negotiation Program MTF DM 

Primary Manufacturer Maximum Fair 

Price (MFP) Effectuation Plan Form; (C) 

Drug Price Negotiation Program MTF 

DM Primary Manufacturer Payment 

Elements Form; and (D) Drug Price 

Negotiation Program Complaint and 

Dispute Intake Form. Form Number: 

CMS–10912 (OMB control number: 

0938-New); Frequency: Once and Daily; 

Affected Public: Private sector, Business 

or other for-profit, and individuals; 

Number of Respondents: 85,853; Total 

Annual Responses: 93,120; Total 

Annual Hours: 821,560. (For policy 

questions regarding this collection 

contact Brennan Folsom at 667–414– 

0014.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–25009 Filed 10–25–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10261] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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 


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