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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-0921
ICR Reference No:
200904-0938-009
Status:
Historical Active
Previous ICR Reference No:
200603-0938-007
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:
06/22/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/14/2009
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2012
36 Months From Approved
06/30/2009
Responses
720
0
480
Time Burden (Hours)
28,800
0
17,760
Cost Burden (Dollars)
0
0
0
Abstract:
The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 created section 1847A of the Social Security Act (SSA), enacting the Average Sales Price (ASP) payment methodology for the vast majority of separately payable Medicare Part B drugs. The MMA also amended section 1927(b)(3)(A) to include a provision for drug manufacturers to report Average Sales Price (ASP) data for certain drugs. This information collection implements these provisions. The Centers for Medicare and Medicaid Services (CMS) began collecting ASP data from manufacturers in 2004. This information specifies the data elements and forms that manufacturers will use to submit the required data and to certify the accuracy of the submitted data. In addition to sales data, this form collects descriptive data elements that are used to convert the ASP data to the Medicare billing codes and payment amounts, and to determine the applicable payment methodology. The collected data will be used as permitted by section 1847A and section 1927 of the SSA as amended.
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-AN05
Final or interim final rulemaking
71 FR 69666
12/01/2006
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
73 FR 76034
12/15/2008
30-day Notice:
Federal Register Citation:
Citation Date:
74 FR 9819
03/06/2009
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
CMS-10110
Proposed Revised Addendum A
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
720
480
0
240
0
0
Annual Time Burden (Hours)
28,800
17,760
0
11,040
0
0
Annual Cost Burden (Dollars)
0
0
0
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 increase in reporting burden arises from the CMS's need to apply appropriate payments for single source drugs and biologicals. This need is not new; the original ASP statute requires a calculation of separate payment amounts for single source drugs and biologicals. Section 1847A specifies that the payment amount for single source drugs and biologicals is determined based on the ASP for the single source drug or biological product. Single source drugs and biologicals, as defined in the ASP statute, are identified by their FDA approval status, which is shown by a number assigned by the DHHS Food and Drug Administration (FDA). Therefore, to appropriately identify single source drugs and biologicals for purposes of calculating payment, CMS must identify and associate the FDA approval number of a product with the applicable ASP data. These data are not available to CMS from an existing source. 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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
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:
Bonnie Harkless 4107865666
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
04/14/2009
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