[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Notices]
[Pages 26235-26236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10232]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-367 and CMS-10243]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human Services.

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 require; 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 any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by July 1, 2016

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 following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    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: Reports Clearance Office at (410) 786-
1326.

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-367 Medicaid Drug Program--Monthly and Quarterly Drug Reporting 
Format
CMS-10243 Testing Experience and Functional Tools: Functional 
Assessment Standardized Items (FASI) Based on the CARE Tool

    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.
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Program--Monthly and Quarterly Drug Reporting Format; Use: Labelers 
transmit drug product and pricing data to CMS within 30 days after the 
end of each calendar month and quarter. CMS calculates the unit rebate 
amount (URA) and the unit rebate offset amount (UROA) for each new drug 
application (NDC) and distributes to all State Medicaid agencies. 
States use the URA to invoice the labeler for rebates and the UROA to 
report onto the CMS-64. The monthly data is used to calculate Federal 
Upper Limit (FUL) prices for applicable drugs and for states that opt 
to use this data to establish their pharmacy reimbursement methodology. 
Form Number: CMS-367 (OMB control number: 0938-0578); Frequency: 
Monthly and Quarterly; Affected Public: Private sector (Business or 
other for-profits); Number of Respondents: 610;

[[Page 26236]]

Total Annual Responses: 12,810; Total Annual Hours: 3,618,703. (For 
policy questions regarding this collection contact Samone Angel at 410-
786-1123.)
    2. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Testing Experience and Functional Tools: Functional 
Assessment Standardized Items (FASI) Based on the CARE Tool; Use: In 
2012, CMS funded a project entitled, Technical Assistance to States for 
Testing Experience and Functional Tools (TEFT) Grants. One component of 
this demonstration is to amend and test the reliability of a setting-
agnostic, interoperable set of data elements, called ``items,'' that 
can support standardized assessment of individuals across the continuum 
of care. Items that were created for use in post-acute care settings 
using the Continuity Assessment Record and Evaluation (CARE) tool have 
been adopted, modified, or supplemented for use in community-based 
long-term services and supports (CB-LTSS) programs. This project will 
test the reliability and validity of the function-related assessment 
items, now referred to as Functional Assessment Standardized Items 
(FASI), when applied in community settings, and in various populations: 
Elders (65 years and older); younger adults (18-64) with physical 
disabilities; and adults of any age with intellectual or developmental 
disabilities, with severe mental illness, or with traumatic brain 
injury.
    Individual-level data will be collected two times using the TEFT 
FASI Item Set. The first data collection effort will collect data that 
can be analyzed to evaluate the reliability and validity of the FASI 
items when used with the five waiver populations. Assessors will 
conduct functional assessments in client homes using the TEFT FASI Item 
Set. Changes may be recommended to individual TEFT FASI items, to be 
made prior to releasing the TEFT FASI items for use by the states. The 
FASI Field Test Report will be released to the public.
    The second data collection will be conducted by the states to 
demonstrate their use of the FASI data elements. The assessment data 
could be used by the states for multiple purposes. They may use the 
standardized items to determine individual eligibility for state 
programs, or to help determine levels of care within which people can 
receive services, or other purposes. In the second round of data 
collection, states will demonstrate their proposed uses, manage their 
FASI data collection and conduct their own analysis, to the extent they 
propose to do such tasks. The states have been funded under the 
demonstration grant to conduct the round 2 data collection and 
analysis. These states will submit reports to CMS describing their 
experience in the Round 2 data collection, including the items they 
collected, how they planned to use the data, and the types of 
challenges and successes they encountered in doing so. The reports may 
be used by CMS in their evaluation of the TEFT grants. Form Number: 
CMS-10243 (OMB control number: 0938-1037); Frequency: On occasion; 
Affected Public: Individuals and households; Number of Respondents: 
5,650; Total Annual Responses: 5,650; Total Annual Hours: 2,825. (For 
policy questions regarding this collection contact Allison Weaver at 
410-786-4924.)

    Dated: April 27, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-10232 Filed 4-29-16; 8:45 am]
 BILLING CODE 4120-01-P