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:
0938-1443
ICR Reference No:
202410-0938-001
Status:
Active
Previous ICR Reference No:
202304-0938-016
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM
Title:
Small Biotech Exception and Biosimilar Delay Information Collection Request for Initial Price Applicability Year 2027 (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:
11/01/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/02/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2025
36 Months From Approved
05/31/2025
Responses
25
0
10
Time Burden (Hours)
415
0
68
Cost Burden (Dollars)
0
0
0
Abstract:
the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA), a qualifying single source drug that meets the requirements for the exception for small biotech drugs (“Small Biotech Exception”) in section 1192(d)(2) of the Social Security Act (the Act) will be excluded from the definition of “negotiation-eligible drug” with respect to initial price applicability years 2026, 2027, and 2028. Among other requirements for this exception, the statute requires that CMS consider, for Part D drugs, total 2021 Medicare expenditures for the drug under Part D; total expenditures for all covered Part D drugs for such year; and total expenditures under Part D for all covered Part D drugs for which the manufacturer has an agreement under section 1860D-14A during 2021. For the purpose of this information collection request, “controlled group” means all corporations or partnerships, proprietorships and other entities treated as a single employer under 26 U.S. Code section 52(a) or (b). In order to accurately identify, at the request of a manufacturer, whether a given covered Part D drug qualifies for the Small Biotech Exception in accordance with section 1192(d)(2) of the Act, CMS needs to collect information to identify the entity that had a Medicare Coverage Gap Discount Program Agreement under section 1860D-14A for the drug as of December 31, 2021,including all other entities that, as of December 31, 2021, were treated as a single employer with that entity under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986.
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:
89 FR 36821
07/02/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 80249
10/02/2024
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Biosimilar Delay for initial price applicability year 2027
CMS-10844
Small Biotech Exception and Biosimilar Delay Information Collection Request
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
Small Biotech Exception with CGDP Agreement (Submitting Manufacture Not 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
25
10
0
15
0
0
Annual Time Burden (Hours)
415
68
0
347
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:
No
Burden Reduction Due to:
Short Statement:
CMS slightly revised the burden estimate upwards for manufacturers to respond to the SBE ICR Form when technical assistance in completion of the necessary information may be needed by the manufacturer. CMS revised the burden estimate for small biotech drugs owned by a manufacturer when the manufacturer was acquired after 2021 to account for the additional time needed to gather the information needed for CMS determine if the acquisition renders the Submitting Manufacturer’s drug ineligible for the SBE.
Annual Cost to Federal Government:
$515,226
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:
10/02/2024
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