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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:
1545-2192
ICR Reference No:
201008-1545-058
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
TREAS/IRS
Agency Tracking No:
EC-1545-XXXX-058
Title:
Form 8947-Report of Covered Pharmaceutical Manufacturers and Importers
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
09/10/2010
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/13/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/09/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2011
6 Months From Approved
Responses
400
0
0
Time Burden (Hours)
3,680
0
0
Cost Burden (Dollars)
0
0
0
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.
Emergency Justfication:
Notice NOT-132740-10 sets a due date of November 1, 2010 for covered entities to submit branded prescription drug sales information, as a practical matter this means Form 8947 is to be available as soon as possible for collecting the information. Emergency approval of a collection of information is requested under 44 U.S.C § 3507(j)(1) for Form-8947. Form-8947 will be used by specified government entities for reporting branded prescription drug information as required by Section 9008(g) of the Patient Protection and Affordable Care Act (ACA), Public Law 111-148 (124 Stat. 119 (2010)). As explained below, all of the requirements of section 3507(j)(1) for emergency approval are satisfied. First, as required by section 3507(j)(1)(A)(i), the collection of information is needed prior to the expiration of the normal clearance period (approximately February 2011): The branded prescription drug sales information is needed by the IRS to properly administer the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs under Section 9008 of the Patient Protection and Affordable Care Act (ACA), Public Law 111-148 (124 Stat. 119 (2010)). Per guidance covered by NOT-132740-10, in 2010 the covered entities are requested to report information with respect to the entitys aggregate branded prescription drug sales as it was composed on December 31, 2009. The covered entities are requested to report the information on Form 8947 and submit Form 8947 to the IRS by November 1, 2010. Therefore, Form-8947 must be made available to the affected public sufficiently in advance of the November 1, 2010 deadline. Second, as required by section 3507(j)(1)(A)(ii), the collection of information is essential to the IRSs mission of administering the internal revenue laws and furthering tax compliance: The information collected using form 8947 is needed to determine the relationships amongst manufacturers and importers of prescription drugs that result in the information of a covered entity, and to determine which drugs are orphan drugs, the sales of which are to be excluded when calculating a covered entitys fee. Therefore, the information is essential for accurate fee computation. In order to be able to notify covered entities of their annual fee amounts in sufficient time to allow them to meet the statutory payment date, the IRS will need data on branded prescription drug sales from the covered entities. Pursuant to section 3507(j)(1)(B), the IRS cannot reasonably comply with the nonemergency procedures of section 3507. In order to timely implement Section 9008 of the Patient Protection and Affordable Care Act (ACA), Public Law 111-148 (124 Stat. 119 (2010)), approval of the collection of Information via form 8947, is needed as quickly as possible and before it would ordinarily be granted under the standard procedures. Delaying the availability of Form-8947 until February 2011 is reasonably likely to cause missed legislative deadline.
Authorizing Statute(s):
PL:
Pub.L. 111 - 148 9008
Name of Law: Affordable Care Act
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 148 9008 Name of Law: Patient Protection and Affordable Care Act
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
75 FR 54232
09/03/2010
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
Form 8947-Report Covered Pharmaceutical Manufacturers and Importers
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
0
400
0
0
0
Annual Time Burden (Hours)
3,680
0
3,680
0
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:
No
Burden Reduction Due to:
Short Statement:
This a new form created to collect information on branded prescription drugs. The information is necessary for the IRS to calculate the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs by Section 9008 of the Patient Protection and Affordable Care Act (ACA).
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]?
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:
P Shaughness 2029271885
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:
09/09/2010
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