[Federal Register Volume 89, Number 44 (Tuesday, March 5, 2024)]
[Notices]
[Pages 15874-15875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04591]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-304 and 304a, CMS-10383]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by April 4, 2024.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Reconciliation of 
State Invoice (ROSI) and Prior Quarter Adjustment Statement (PQAS); 
Use: Form CMS-304 (ROSI) is used by manufacturers to respond to the 
state's rebate invoice for current quarter utilization. Form CMS-304a 
(PQAS) is required only in those instances where a change to the 
original rebate data submittal is necessary. Form Number: CMS-304 and -
304a (OMB control number: 0938-0676); Frequency: Quarterly; Affected 
Public: Private sector (Business or other for-profits); Number of 
Respondents: 749; Total Annual Responses: 5,841; Total Annual Hours: 
248,584. (For policy questions regarding this collection contact Robert 
Giles at 667-290-8626.)
    2. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Review and Approval Process for Waivers for State 
Innovation; Use: The information required under this collection is 
necessary to ensure that states comply with statutory and regulatory 
requirements related to the development and implementation of section 
1332 waivers. States seeking waiver authority under section 1332 of the 
ACA are required to meet certain requirements for applications, public 
notice, and reporting. The authority for these requirements is found in 
section 1332 of the ACA. This information collection reflects the 
requirements provided in the final rules published in February 2012 (77 
FR 11700) and September 2021 (86 FR 3412).
    On October 24, 2018, the Departments published guidance (86 FR 
53575) that provided supplementary information about the requirements 
that must be met for the approval of a section 1332 waiver, the 
Secretaries' application review procedures, the calculation of pass-
through funding, certain analytical requirements, and operational 
considerations. However, the September 2021 final rule superseded and 
rescinded policies and interpretations outlined in the 2018 guidance 
and repealed the previous codification of the interpretations of the 
statutory guardrails in part 1 of the 2022 Payment Notice final rule 
(86 FR 6138). The September 2021 final rule (86 FR 53412) finalized 
modifications to section 1332 waiver implementing regulations, 
including changes to many of the policies and interpretations of the 
statutory guardrails codified in regulation. In addition, the September 
2021 final rule modified regulations to provide flexibilities in the 
public notice requirements and post-award public participation 
requirements for section 1332 waivers under certain future emergent 
situations. The final rule also provided new information regarding the 
processes and procedures for amendments and extensions for approved 
waiver plans. Form Number: CMS-10383 (OMB Control Number 0938-1389; 
Frequency: Occasionally;

[[Page 15875]]

Affected Public: State Governments; Number of Respondents: 19; Total 
Annual Responses: 399; Total Annual Hours: 5,549. (For policy questions 
regarding this collection contact Lina Rashid at 301-492-4193.)

William N. Parham, III
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-04591 Filed 3-4-24; 8:45 am]
BILLING CODE 4120-01-P