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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:
0938-1449
ICR Reference No:
202306-0938-013
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM-CPC
Title:
Negotiation Data Elements under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10847)
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
08/03/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/30/2023
Terms of Clearance:
Prior to the submission of the information collection request (ICR) for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation Reduction Act for the 2027 negotiation process, CMS will provide an analysis of the 2026 negotiation data submissions from manufactures including, but not limited to, a meta-analysis of data from sections C: Research and Development Costs and Recoupment and D: Current Unit Costs of Production and Distribution. Also, in its 2027 ICR submission, CMS will address how it made improvements to the agency’s ability to audit the manufacturers’ data and improvements to the data collection more broadly from its analysis of the 2026 negotiation data.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2024
36 Months From Approved
Responses
3,310
0
0
Time Burden (Hours)
17,000
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The Centers for Medicare & Medicaid Services (CMS) is requesting review and approval of data collection related to the Inflation Reduction Act of 2022 (P.L. 117-169) (the Act). Sections 1193 and 1194 of the Act requires drug manufacturers to submit data to the Secretary of the Department of Health and Human Services, in a form and manner specified by the Secretary; information on the non-Federal average manufacturer price; and information that the Secretary requires to carry out the negotiation (or renegotiation process). The Act establishes a Drug Price Negotiation Program for certain selected drugs covered under Medicare Part B and Part D. The Secretary is required to negotiate maximum fair prices (MFPs) with drug manufacturers for 10 qualifying Part D drugs for 2026, 15 Part D drugs for 2027, 15 Part B and Part D drugs in 2028, and 20 Part B and Part D drugs for 2029 and each following year.
Authorizing Statute(s):
PL:
Pub.L. 117 - 169 1193 and 1194
Name of Law: Inflation Reduction Act
Citations for New Statutory Requirements:
PL: Pub.L. 117 - 169 1193 and 1194 Name of Law: Inflation Reduction 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:
88 FR 16983
03/21/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 42722
06/30/2023
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
General Public (individual and organization)
CMS-10847
Negotiation Data Elements Form
Primary Manufacturers
CMS-10847
Negotiation Data Elements Form
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
3,310
0
3,310
0
0
0
Annual Time Burden (Hours)
17,000
0
17,000
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 is a new information collection request.
Annual Cost to Federal Government:
$3,447,654
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]?
No
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:
Stephan McKenzie 410 786-1943 stephan.mckenzie@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:
06/30/2023
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