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