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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:
202304-0938-016
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM
Title:
Small Biotech Exception (CMS-10844) - IRA
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:
05/26/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/24/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2025
36 Months From Approved
Responses
10
0
0
Time Burden (Hours)
68
0
0
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:
PL: Pub.L. 117 - 169 11001 and 11002 Name of Law: The Inflation Reduction Act of 2022
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 4184
01/24/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 24805
04/24/2023
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
Small Biotech Exception (Drugs Acquired After December 31, 2021)
CMS-10844
Small Biotech Exception Information Collection Request Form
Small Biotech Exception (Drugs Not Acquired After December 31, 2021)
CMS-10844
Small Biotech Exception Information Collection Request 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
10
0
10
0
0
0
Annual Time Burden (Hours)
68
0
68
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:
$301,208
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:
04/24/2023
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