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:
0938-0676
ICR Reference No:
201107-0938-007
Status:
Historical Active
Previous ICR Reference No:
201001-0938-009
Agency/Subagency:
HHS/CMS
Agency Tracking No:
Title:
Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304/304a)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/23/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/20/2011
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2014
36 Months From Approved
03/31/2013
Responses
4,044
0
3,820
Time Burden (Hours)
183,120
0
141,080
Cost Burden (Dollars)
0
0
0
Abstract:
Section 1927 of the Social Security Act requires drug manufacturers to enter into and have in effect a rebate agreement with CMS in order for States to receive funding for drugs dispensed to Medicaid recipients. Drug manufacturers must explain to States any rebate payment adjustments for the current quarter, and any prior quarters. The information is used to reconcile drug rebate payments made by manufacturers with the State invoices of rebates due.
Authorizing Statute(s):
Statute at Large:
21 Stat. 1927
PL:
Pub.L. 111 - 148 2501(C)
Name of Law: Patient Protection and Affordable Care Act
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 148 2501(C) Name of Law: Patient Protection and Affordable Care Act
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:
76 FR 21370
04/15/2011
30-day Notice:
Federal Register Citation:
Citation Date:
76 FR 40369
07/08/2011
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304)
CMS-304
Reconciliation of State Invoice (ROSI)
Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304A)
CMS-304a
Prior Quarter Adjustment Statement (PQAS)
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
4,044
3,820
224
0
0
0
Annual Time Burden (Hours)
183,120
141,080
42,040
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:
In accordance with the new reporting requirements established by the Patient Protection and Affordable Care Act, the State invoice is being revised to include a new column that will enable States to distinguish between fee-for service and managed care utilization. Consequently, form 304 and 304a are being revised to reflect a similar new field that will enable manufacturers to separately identify fee-for-service and managed care units. As a result, the burden estimate has been changed to reflect the increased time it will take manufacturers to complete the forms.
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:
Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.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:
07/20/2011
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