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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-10849]

# 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by December 26, 2024.

# ADDRESSES:

                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to                         *www.reginfo.gov/​public/​do/​PRAMain.*                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.                    

                        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 Parham at (410) 786-4669.

# SUPPLEMENTARY INFORMATION:

                    Under the Paperwork Reduction Act of 1995 (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 (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:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Negotiation Data                           ( print page 92941)                        Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request (ICR) (CMS-10849, OMB 0938-1452);                     *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. For the second year of the Negotiation Program, the Secretary of Health and Human Services (the “Secretary”) will select up to 15 high expenditure, single source drugs covered under Part D for negotiation.                

*Negotiation Data Elements:*                     The statute requires that CMS consider certain data from Primary Manufacturers as part of the negotiation process. To the extent that more than one entity meets the statutory definition of manufacturer (specified in section 1193(a)(1) of the Act) for a selected drug for purposes of initial price applicability year 2027, CMS will designate the entity that holds the New Drug Application(s) (NDA(s))/Biologics License Application(s) (BLA(s)) for the selected drug to be “the manufacturer” of the selected drug (hereinafter the “Primary Manufacturer”). The Primary Manufacturer's data submissions include non-FAMP and related data for selected drugs for the purpose of establishing a ceiling price, as outlined in section 1193(a)(4)(A) of the Act, and the negotiation factors outlined in section 1194(e)(1) of the Act for the purpose of formulating offers and counteroffers process pursuant to section 1193(a)(4)(B) of the Act. Some of these data are held by the Primary Manufacturer and are not currently available to CMS. Data described in sections 1194(e)(1) and 1193(a)(4) of the Act must be submitted by the Primary Manufacturer.                

Section 1194(e)(2) of the Act requires CMS to consider certain data on selected drugs and their alternative treatments. Because the statute does not specify where these data come from, CMS will allow for optional submission from Primary Manufacturers and the public. CMS will additionally review existing literature, conduct internal analyses, and consult subject matter and clinical experts on the factors listed in section 1194(e)(2) of the Act. Primary Manufacturers may optionally submit this information as part of their Negotiation Data Elements Information Collection Request Form. The public may also optionally submit evidence about the selected drugs and their alternative treatments.

*Drug Price Negotiation Process:*                     Any MFPs that are negotiated for the drugs selected for the second year of the Negotiation Program will apply beginning in initial price applicability year 2027. For initial price applicability year 2027, the negotiation period begins on the earlier of the date that the Primary Manufacturer enters into a Medicare Drug Price Negotiation Program Agreement or February 28, 2025.                

                    Section 1194(b)(2)(C) of the Act provides that if the Primary Manufacturer does not accept CMS' written initial offer, the Primary Manufacturer may submit an optional written counteroffer no later than 30 days after the date of receipt of CMS' written initial offer. If the Primary Manufacturer chooses to develop and submit a written counteroffer to CMS' written initial offer during the drug price negotiation process for initial price applicability year 2027 in accordance with section 1194(b)(2)(C) of the Act, the Primary Manufacturer must submit the Statutory Written Counteroffer Form.                     *Form Number:*                     CMS-10849 (OMB control number: 0938-1452);                     *Frequency:*                     Once;                     *Affected Public:*                     Private sector, Business or other for-profit;                     *Number of Respondents:*                     340;                     *Total Annual Responses:*                     340;                     *Total Annual Hours:*                     23,764 (For policy questions regarding this collection contact Elisabeth Daniel at 667-290-8793.)                

William N. Parham, III,

Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2024-27490 Filed 11-22-24; 8:45 am]

BILLING CODE 4120-01-P