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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:
0938-1443
ICR Reference No:
202509-0938-014
Status:
Active
Previous ICR Reference No:
202410-0938-001
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM
Title:
Negotiation Program Drug Selection for Initial Price Applicability Year 2028 (CMS-10844) - IRA
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:
11/10/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/30/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2028
36 Months From Approved
11/30/2025
Responses
65
0
25
Time Burden (Hours)
3,677
0
415
Cost Burden (Dollars)
0
0
0
Abstract:
In accordance with section 1192(d)(2) of the Act, the term “negotiation-eligible drug” excludes, with respect to the initial price applicability years 2026, 2027, and 2028, a qualifying single source drug that meets the requirements for the exception for small biotech drugs (the “Small Biotech Exception,” or “SBE”). This information is required in order for CMS to accurately identify whether a given drug meets the criteria for the Small Biotech Exception in accordance with section 1192(d)(2) of the Act. To ensure that drugs covered under Part B and/or Part D that meet the requirements for the SBE are excluded from the term “negotiation-eligible drug,” a manufacturer that seeks the SBE for its drug covered under Part B and/or Part D (“Submitting Manufacturer”) must submit information to CMS about the company and its products in order for the drug to be considered for the exception. If the Submitting Manufacturer seeks the SBE for a drug covered under Part B and/or Part D it acquired after December 31, 2021, the Submitting Manufacturer must also submit information related to the separate entity that had the Medicare Coverage Gap Discount Program agreement for the drug on December 31, 2021 for drugs covered under Part D and information related to the holder of the New Drug Application(s) (NDA)(s) or Biologics License Applications(s) (BLA)(s) as of December 31, 2021 for drugs covered under Part B. If the Submitting Manufacturer was acquired by another entity after December 31, 2021, the Submitting Manufacturer must provide information regarding that acquiring entity for CMS to assess whether the acquisition triggers the limitation at section 1192(d)(2)(B)(ii) of the Act. Under section 1192(f)(1)(B) of the Act, the manufacturer of a biosimilar biological product (“Biosimilar Manufacturer” of a “Biosimilar”) may submit a request, prior to the selected drug publication date, for CMS’ consideration to delay the inclusion of a negotiation-eligible drug that includes the reference product for the Biosimilar (such a negotiation-eligible drug is herein referred to as a “Reference Drug”) on the selected drug list for a given initial price applicability year. CMS needs to collect information to identify the Biosimilar Drug, the Reference Drug, the Biosimilar Manufacturer and the Section 1194(f) of the Act establishes the requirements governing the identification of renegotiation-eligible drugs and selection of drugs for renegotiation. CMS must collect information from Primary Manufacturers to determine which selected drugs qualify as a renegotiation-eligible drug and may be selected for renegotiation in accordance with section 1194(f)(3) of the Act. Specifically, section 1194(f)(2)(D) of the Act instructs CMS to identify whether a selected drug is eligible for renegotiation based on a material change to any of the factors listed in section 1194(e) of the Act, which include the data in section 1194(e)(1) that must be submitted by the Primary Manufacturer of a selected drug. Additionally, once a drug has been selected for renegotiation, CMS must also consider section 1194(e)(1) data during the renegotiation period in the development of offers and consideration of counteroffers.
Authorizing Statute(s):
PL:
Pub.L. 117 - 169 11001 and 11002
Name of Law: The Inflation Reduction Act of 2022
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 20305
05/13/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 46895
09/30/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Biosimilar Delay
CMS-10844
Negotiation Program Drug Selection Information Collection Forms
Identification and Selection of Renegotiation-Eligible Drugs
CMS-10844
Negotiation Program Drug Selection Information Collection Forms
Small Biotech Exception
CMS-10844
Negotiation Program Drug Selection Information Collection Forms
Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021)
CMS-10844
Small Biotech Exception and Biosimilar Delay Information Collection Request
Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not After December 31, 2021)
CMS-10844
Small Biotech Exception and Biosimilar Delay Information Collection Request
Small Biotech Exception with CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021)
CMS-10844
Small Biotech Exception and Biosimilar Delay Information Collection Request
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
65
25
0
40
0
0
Annual Time Burden (Hours)
3,677
415
0
3,262
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
Burden has increased due the revisions made to the Small Biotech Exception request and the new burden estimate for a Primary Manufacturer’s voluntary completion of the identification and selection of renegotiation-eligible drugs. As a result, respondents has increased and the overall burden has increased from the previously approved 415 to 3,677.
Annual Cost to Federal Government:
$486,002
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:
09/30/2025
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