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 IRSÂ 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
Reginfo record details
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)