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OMB Control No: 0938-0921	ICR Reference No: 202304-0938-010
Status: Active	Previous ICR Reference No: 202007-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
Title: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/16/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/18/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved	08/31/2024
Responses	2,000	0	1,200
Time Burden (Hours)	26,000	0	15,600
Cost Burden (Dollars)	0	0	0

Abstract: In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price of manufacturers' average sales price data submitted to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR Part 414 Subpart J. In the CY2005 IFC, we published information about the ASP reporting requirements for Medicare Part B drugs and biologicals (66 FR 17935) and specified that manufacturers must report the ASP data using our Addendum A template. We also initiated additional changes to the template in 2008 (73 FR 76032). In order to facilitate more accurate and consistent ASP data reporting from manufacturers, we are now proposing revisions to the Addendum A template. Specifically, we propose to revise existing reporting fields and add new fields to the Addendum A template, as follows: o To split the current NDC column into three separate reporting fields, corresponding to the three segments of an NDC: the labeler, product, and trade package size; o To add a new field to collect an Alternate ID for products without an NDC; and o To expand the current FDA approval number column to account for multiple entries and supplemental numbers. We have also added a macro to the Addendum A template that will allow manufacturers to validate the format of their data prior to submission. This will help verify that data are complete and submitted to CMS in the correct format, thereby minimizing time and resources spent on identifying mistakes or errors. A User Guide containing general instructions on the use of the template and instructions for the reporting of dermal grafting products has also been created.

Authorizing Statute(s): US Code: 42 USC 1395u(o)
   US Code: 42 USC 1395(a)(1)(S)
   US Code: 42 USC 1395w-3
   PL: Pub.L. 108 - 17 303 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   Statute at Large: 18 Stat. 1847
   Statute at Large: 19 Stat. 1927
   US Code: 42 USC 1395w–3a

Citations for New Statutory Requirements: US Code: 42 USC 1395w–3a

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 7446	02/03/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 23429	04/17/2023
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	2,000	1,200	800
Annual Time Burden (Hours)	26,000	15,600	10,400
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Burden estimate has increased to allow for an increase in the number of respondents due to the new provision (1847A(f)(2) of the Act) that extended ASP reporting requirements to manufacturers without Medicaid Drug Rebate Agreements. Previously, ASP reporting was only required for manufacturers of drugs or biologicals payable under Part B with a Medicaid rebate agreement. we estimate that this requirement will affect approximately 500 manufacturers who will submit each quarter. Therefore, there are 500 respondents, which report 4 times per year, equal to 2000 responses. We estimate the total annual reporting burden for the number of respondents to be approximately 26,000 hours (2000 x13 annual hours per response).

Annual Cost to Federal Government: $2,239,300

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

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