Standardized Pharmacy Notice: Your Prescription Cannot be Filled (f/k/a Medicare Prescription Drug Coverage and Your Rights)

Forms and Documents

Document Name	Status
Form CMS-10147 Standardized Pharmacy Notice Form	Modified
CMS-10147 - Supporting Statement A [rev 8-29-2014 by OSORA PRA].docx Supporting Statement A	2014-08-29
Responses to Comments.docx Supplementary Document	2014-08-29

IC Document Collections

IC ID	Document Title	Status
37927	Standardized Pharmacy Notice Form	Modified

ICR Details

OMB Control No: 0938-0975	ICR Reference No: 201408-0938-016
Status: Historical Active	Previous ICR Reference No: 201203-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Standardized Pharmacy Notice: Your Prescription Cannot be Filled (f/k/a Medicare Prescription Drug Coverage and Your Rights)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/30/2014
	Date Received in OIRA: 08/29/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	01/31/2015
Responses	37,620,240	0	37,087,402
Time Burden (Hours)	626,749	0	617,876
Cost Burden (Dollars)	0	0	0

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Abstract: Pursuant to 42 CFR 423.562(a)(3) and 423.128(b)(7)(iii), Part D plan sponsors must arrange with their network pharmacies to provide a printed copy of the standardized pharmacy notice to enrollees (beneficiaries) at the point of sale when an enrollee's prescription cannot be filled.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1860 Name of Statute: null
   Statute at Large: 18 Stat. 1852 Name of Statute: null
  

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:
	79 FR 33927	06/13/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 51569	08/29/2014
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Standardized Pharmacy Notice	CMS-10147, CMS-10147	Notice: Medicare Prescription Drug Coverage and Your Rights ,   Notice (Spanish): La cobertura de Medicare de las recetas médicas y sus derechos

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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	37,620,240	37,087,402	0	0	532,838	0
Annual Time Burden (Hours)	626,749	617,876	0	0	8,873	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: The annual hourly burden associated with this collection is estimated to be 626,749 hours. The annual hourly burden in the 2011 PRA submission for this collection was 617,876 hours. The increase in the burden hours from the previous PRA submission is due to an adjustment in the agency's estimate of the number of standardized pharmacy notices that are likely to be distributed based on CY 2013 prescription drug event data.

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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: 08/29/2014

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