[Federal Register Volume 89, Number 94 (Tuesday, May 14, 2024)]
[Notices]
[Page 41968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10110]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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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 June 13, 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 currently 
approved collection; Title of Information Collection: Manufacturer 
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs 
and Biologicals; Use: Section 1847A of the Act requires that the 
Medicare Part B payment amounts for covered drugs and biologicals not 
paid on a cost or prospective payment basis be based upon 
manufacturers' average sales price data submitted quarterly to the 
Centers for Medicare & Medicaid Services (CMS). The reporting 
requirements are specified in 42 CFR part 414 Subpart J.
    CMS, specifically, the Division of Data Analysis and Market-based 
Pricing (DDAMBP) will utilize the ASP data (ASP and number of units 
sold as specific in section 1847A of the Act) to determine the Medicare 
Part B drug payment amounts for CY 2005 and beyond. The manufacturers 
submit their ASP data for all of their National Drug Codes (NDC) for 
Part B drugs. DDAMBP compiles the data, analyzes the data and runs the 
data through software to calculate the volume-weighted ASP for all of 
the NDCs that are grouped within a given HCPCS code. The formula to 
calculate the volume-weighted ASP is the Sum (ASP * units) for all 
NDCs/Sum (units * bill units per pkg) for all NDCs. DDAMBP provides ASP 
payment amounts for several components within CMS that utilize 1847(A) 
payment methodologies to implement various payment policies including, 
but not limited to, ESRD, OPPS, OTP and payment models. CMS will also 
use reported ASP and units to calculate inflation adjusted coinsurance 
and rebates. The Department of Health and Human Services' Office of the 
Inspector General also uses the ASP data in conducting studies. Form 
Number: CMS-10110 (OMB Control Number: 0938-0921); Frequency: 
Quarterly; Affected Public: Private and Business or other for-profits; 
Number of Respondents: 500; Number of Responses: 2,00; Total Annual 
Hours: 26,000. (For policy questions regarding this collection contact 
Felicia Brown at (410) 786-9287 or [email protected]).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-10541 Filed 5-13-24; 8:45 am]
BILLING CODE 4120-01-P