Section 9008 of the Patient Protection
and Affordable Care Act (ACA), Public Law 111-148 (124 Stat. 119
(2010)), as amended by section 1404 of the Health Care and
Education Reconciliation Act of 2010 (HCERA), Public Law 111-152
(124 Stat. 1029 (2010)) imposes an annual fee on manufacturers and
importers of branded prescription drugs that have gross receipts of
over $5 million from the sales of these drugs to certain government
programs (covered entity/covered entities). The temporary
regulations describe how the IRS will administer the branded
prescription drug fee. Section 51.7T(b) of the temporary
regulations provides that the IRS will send each covered entity
notification of its preliminary fee calculation by May 15 of the
fee year. If a covered entity chooses to dispute the IRS'
preliminary fee calculation, the covered entity must follow the
procedures for submitting an error report that are established in
§51.8T.
Affordable Care Act
[PPACA, P.L. 111-148 & 111-152]. The reason for this emergency
submission is to provide as soon as possible a covered entity with
a dispute resolution process for a fee that the covered entity must
pay by September 30, 2011. By May 16, 2011, the IRS will provide a
covered entity with a preliminary fee calculation. If a covered
entity disputes the IRS preliminary fee calculation, the covered
entity must submit, previously described in section 4.01 of Revenue
Procedure 2011-24 and now covered under §51.8T, an error report,
postmarked by June 1, 2011, to the IRS. A covered entity must
include in its error report an explanation of the error and the
data to substantiate the claimed error. The IRS must resolve fee
disputes by July 15, 2011, in order to provide a covered entity
with a final fee determination by August 15, 2011.
Section 9008 of the Patient
Protection and Affordable Care Act (ACA), Public Law 111-148 (124
Stat. 119 (2010)), as amended by section 1404 of the Health Care
and Education Reconciliation Act of 2010 (HCERA), Public Law
111-152 (124 Stat. 1029 (2010)) imposes an annual fee on
manufacturers and importers of branded prescription drugs that have
gross receipts of over $5 million from the sales of these drugs to
certain government programs (covered entity/covered entities). The
temporary regulations describe how the IRS will administer the
branded prescription drug fee. Section 51.7T(b) of the temporary
regulations provides that the IRS will send each covered entity
notification of its preliminary fee calculation by May 15 of the
fee year. If a covered entity chooses to dispute the IRS'
preliminary fee calculation, the covered entity must follow the
procedures for submitting an error report that are established in
§51.8T. For fee year 2011, only 36 fee payers submitted error
reports. We project 45 fee payers may submit error reports in the
future. Based on these updated projections, we are requesting a
decrease in the total burden by 2,960 hours and a decrease in the
estimated number of annual responses by 74.
$0
No
No
Yes
No
No
Uncollected
Celia Gabrysh 202
622-3130
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.
REG-112805-10 - Branded Prescription Drugs (TD XXXX -temp)