[Federal Register Volume 84, Number 237 (Tuesday, December 10, 2019)]
[Notices]
[Pages 67466-67467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26594]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-304/-304a and CMS-368/-R-144]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid 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 (the 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 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates 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 must be received by February 10, 2020.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
http://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of the following:
1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-304/-304a Reconciliation of State Invoice and Prior Quarter
Adjustment Statement
CMS-368/-R-144 Medicaid Drug Rebate Program Forms
Under the 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 requires federal agencies
to publish a 60-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.
Information Collection
1. Type of Information Collection Request: Revision 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: Business or other for-profits; Number of Respondents: 1,255;
Total Annual Responses: 5,020; Total Annual Hours: 227,416. (For policy
questions regarding this collection contact Andrea Wellington at 410-
786-3490.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug
Rebate State Reporting Program Forms; Use: We develop the rebate amount
per drug unit from information supplied by the drug manufacturers and
distributes these data to the states. States then must report quarterly
to the drug manufacturers and report to us the total number of units of
each dosage form/strength of their covered outpatient drugs reimbursed
during a quarter and the rebate amount to be refunded. This report is
due within 60 days of the end of each calendar quarter. The information
in the report is based on claims paid by the state Medicaid agency
during a calendar quarter. Form CMS-R-144 (Quarterly Report Data) is
required from states quarterly to report utilization for any drugs paid
for during
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that quarter. Form CMS-368 (Administrative Data) is required only in
those instances where a change to the original data submittal is
necessary. Form Number: CMS-368 and -R-144 (OMB control number: 0938-
0582); Frequency: Quarterly and on occasion; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 56; Total Annual
Responses: 234; Total Annual Hours: 12,101. (For policy questions
regarding this collection contact Shannon Evans at 410-786-3083.)
Dated: December 5, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-26594 Filed 12-9-19; 8:45 am]
BILLING CODE 4120-01-P