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OMB Control No: 0938-0921	ICR Reference No: 201112-0938-002
Status: Historical Active	Previous ICR Reference No: 200904-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations
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: 03/23/2012
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/08/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	36 Months From Approved	06/30/2012
Responses	720	0	720
Time Burden (Hours)	34,560	0	28,800
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): PL: Pub.L. 108 - 17 303 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   US Code: 42 USC 1395(a)(1)(S)
   US Code: 42 USC 1395u(o)
   US Code: 42 USC 1395w-3
   Statute at Large: 18 Stat. 1847
   Statute at Large: 19 Stat. 1927

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AQ25	Final or interim final rulemaking	76 FR 73026	11/28/2011

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 42772	07/19/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 73026	11/28/2011
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	720	720	0
Annual Time Burden (Hours)	34,560	28,800	5,760
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The burden hours were increased due to agency discretion to include collection of additional data elements. The increase in reporting burden arises from the Agency's (CMS's) need to apply appropriate payments for drugs and biologicals. This need is not new; the original ASP statute requires a calculation of payment amounts for drugs and biologicals. Section 1847A specifies that the payment amount for drugs and biologicals is determined based on the ASP for the products as submitted by manufacturers. These data are proprietary. Therefore, CMS must collect these data directly from manufacturers.

Annual Cost to Federal Government: $200,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

Agency Contact: William Parham 4107864669

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