View Information Collection Request (ICR) Package
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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:
202501-1545-016
Status:
Active
Previous ICR Reference No:
202112-1545-001
Agency/Subagency:
TREAS/IRS
Agency Tracking No:
Title:
Branded Prescription Drugs
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/26/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/30/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2028
36 Months From Approved
06/30/2025
Responses
45
0
45
Time Burden (Hours)
1,800
0
1,800
Cost Burden (Dollars)
0
0
0
Abstract:
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 (covered entities) that have gross receipts of over $5 million from the sales of these drugs to certain government programs. The TD 9544 temporary regulations were superseded by TD 9684 temporary and final regulations (79 FR 43639) dated July 28, 2014 and by TD 9823 final regulations (82 FR 34611) dated July 24, 2017. The final regulation supersedes the temporary regulations and describes how the IRS will administer the branded prescription drug fee. Section 51.6(b) of the Branded Prescription Drug Fee regulations provides that the IRS will send each covered entity notification of its preliminary fee calculation. 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 §51.7 and Notice 2014-42.
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:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 8103
01/23/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 17507
04/25/2025
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
TD 9544 (REG-112805-10) - Branded Prescription Drugs
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
45
45
0
0
0
0
Annual Time Burden (Hours)
1,800
1,800
0
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:
Annual Cost to Federal Government:
$0
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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?
No
Agency Contact:
Rachel Smith 202 317-6855 rachel.s.smith@irscounsel.treas.gov
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:
04/30/2025
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