Medicare Part B Drug and Biological Competitive Acquisition Program and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 414.910, 414.914, 414.916, and 414.917

Forms and Documents

Document Name	Status
CMS-10145 Supporting Statement [rev 06-13-11].doc Supporting Statement A	2011-06-14

IC Document Collections

IC ID	Document Title	Status
8810	Medicare Part B Drug and Biological Competitive Acquisition Program and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 414.910, 414.914, 414.916, and 414.917 (CMS-10145)	Modified

ICR Details

OMB Control No: 0938-0954	ICR Reference No: 201106-0938-011
Status: Historical Inactive	Previous ICR Reference No: 200805-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Part B Drug and Biological Competitive Acquisition Program and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 414.910, 414.914, 414.916, and 414.917
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 08/04/2011
	Date Received in OIRA: 06/15/2011
Terms of Clearance: Withdrawn at agency's request

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved	09/11/2011
Responses	156,000	0	156,000
Time Burden (Hours)	31,188	0	31,188
Cost Burden (Dollars)	0	0	0

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Abstract: Section 303(d) of the MMA provides an alternative payment methodology for Part B covered drugs that are not paid on a cost or prospective payment basis. In particular, Section 303(d) of the MMA amends Title XVIII of the Social Security Act (the Act) by adding a new section 1847B, which establishes a competitive acquisition program for the acquisition of and payment for Part B covered drugs and biologicals furnished on or after January 1, 2006.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 303(d)(1) Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   PL: Pub.L. 109 - 432 108 Name of Law: MIEA-TRHCA 2006
   US Code: 42 USC 1395w-3b Name of Law: Competitive acquisition of outpatient drugs and biologicals
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 16790	03/25/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 34075	06/10/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Medicare Part B Drug and Biological Competitive Acquisition Program and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 414.910, 414.914, 414.916, and 414.917 (CMS-10145)

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

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

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Common Form ICR:  No

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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: 06/15/2011

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