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.
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.
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).
$0
No
No
Yes
Uncollected
No
Uncollected
P Shaughness 2029271885
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:
(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;
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.
Form 8947-Report Covered Pharmaceutical Manufacturers and Importers