Form 8947-Report of Branded Prescription Drug Information

OMB Control No: 1545-2192	ICR Reference No: 201107-1545-015
Status: Historical Active	Previous ICR Reference No: 201012-1545-045
Agency/Subagency: TREAS/IRS	Agency Tracking No: EM-1545-2192
Title: Form 8947-Report of Branded Prescription Drug Information
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/19/2012
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/09/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2014	05/31/2014	05/31/2014
Responses	400	0	400
Time Burden (Hours)	3,584	0	3,680
Cost Burden (Dollars)	0	0	0

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Abstract: Per Section 9008 of the Patient Protection and Affordable Care Act (ACA), Public Law 111-148 (124 Stat. 119 (2010))form 8947 is used to report controlled group status and information on orphan drug credits allowed for covered pharmaceutical manufacturers and importers.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 9008 Name of Law: Affordable Care Act

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:
	75 FR 54232	09/03/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 14458	03/16/2011
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 Form 8947-Report of Branded Prescription Drug Information 8947 Report of Branded Prescription Drug Information

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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	400	400	0	0	0	0
Annual Time Burden (Hours)	3,584	3,680	0	-96	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Requested by LB&I the special team assembled to implement section 908 of ACA: To allow that subsequent year filers would not have to repeat sending in the entire drug data listed on their initial year filing of Form 8947 (for some filers, hundreds of pages), the form is expanded from 6 pages to 9 pages. Part I is renamed Schedule A. Schedules B, C, and D are added. The Continuation Sheet for Part II is deleted. The instructions are revised to conform to Temporary Regulations sections 51.1T through 51.12T, and section 51.6302-1T. These regulations obsolete Notices 2011-9 and 2011-46, and Rev. Proc. 2011-24. These program changes result in a decrease in estimated burden time of 96 hours due to agency discretion.

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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]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Yes

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: Michael Cyrus 202 927-9545

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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: 02/09/2012

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