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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:
1545-2209
ICR Reference No:
201104-1545-010
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
TREAS/IRS
Agency Tracking No:
ah-XXXX-010
Title:
Rev. Proc. 2011-24, Branded Prescription Drug Sales Dispute Resolution Process for 2011 Preliminary Fee Calculation
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:
04/28/2011
OIRA Conclusion Action:
Approved with change
Conclusion Date:
04/26/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/22/2011
Terms of Clearance:
Burden hours readjusted to capture both recordkeeping and reporting burden hours. In future submissions, agency must itemize and explain in the supporting statement the source of any recordkeeping, reporting, and disclosure burden hours.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2011
6 Months From Approved
Responses
119
0
0
Time Burden (Hours)
4,760
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
This revenue procedure establishes a dispute resolution process for the preliminary fee calculation for the 2011 annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. The fee was enacted by 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)). All references in this revenue procedure to section 9008 are references to section 9008 of the ACA, as amended by section 1404 of HCERA.
Emergency Justfication:
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, as described in section 4.01 of the proposed revenue procedure, 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.
Authorizing Statute(s):
PL:
Pub.L. 111 - 148 9008
Name of Law: Affordable Care Act (ACA)
PL:
Pub.L. 111 - 152 1404
Name of Law: Health Care and Education Reconciliation Act of 2010 (HCERA)
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 148 9008 Name of Law: Affordable Care Act (ACA)
PL: Pub.L. 111 - 152 1404 Name of Law: Health Care and Education Reconciliation Act of 2010 (HCERA)
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
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
RP-108248-11, Branded Prescription Drug Sales Dispute Resolution Process for 2011 Preliminary Fee Calculation
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
119
0
119
0
0
0
Annual Time Burden (Hours)
4,760
0
4,760
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 revenue procedure establishes a dispute resolution process for the preliminary fee calculation for the 2011 annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. This is a new collection related to the Patient Protection and Affordable Care Act (ACA). As a result of this new collection, we estimate the number of new responses of 119 and estimated total burden increase of 4,760 hours.
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]?
No
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:
Celia Gabrysh 202 622-3130
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:
04/22/2011