81 FR 26235 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 84 (May 2, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 84 (May 2, 2016)
| Page Range | 26235-26236 | |
| FR Document | 2016-10232 |
[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)] [Notices] [Pages 26235-26236] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10232] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices 26235
become a PO must submit an SUMMARY: The Centers for Medicare & FOR FURTHER INFORMATION CONTACT:
application to CMS that describes how Medicaid Services (CMS) is announcing Reports Clearance Office at (410) 786–
the entity meets all the requirements in an opportunity for the public to 1326.
the PACE program. An entity’s comment on CMS’ intention to collect SUPPLEMENTARY INFORMATION:
application must be accompanied by an information from the public. Under the
assurance from the State Administering Paperwork Reduction Act of 1995 (the Contents
Agency (SAA) of the State in which the PRA), federal agencies are require; to This notice sets out a summary of the
PO is going to be located. publish notice in the Federal Register use and burden associated with the
Beginning in 2016, initial PACE concerning each proposed collection of following information collections. More
applications will be submitted via a new information (including each proposed detailed information can be found in
automated, electronic submission extension or reinstatement of an existing each collection’s supporting statement
process. An application also must be collection of information) and to allow and associated materials (see
submitted for a PO that seeks to expand 60 days for public comment on the ADDRESSES).
its service area and/or add a new PACE proposed action. Interested persons are CMS–367 Medicaid Drug Program—
center site. invited to send comments regarding our Monthly and Quarterly Drug
The purpose of this PRA package is to burden estimates or any other aspect of Reporting Format
enable the submission of both initial this collection of information, including CMS–10243 Testing Experience and
PACE applications, as well as service any of the following subjects: (1) The Functional Tools: Functional
area expansion applications. We have necessity and utility of the proposed Assessment Standardized Items
successfully transitioned the Medicare information collection for the proper (FASI) Based on the CARE Tool
Advantage application and Prescription performance of the agency’s functions; Under the PRA (44 U.S.C. 3501–
Drug Plan (PDP) application to a fully (2) the accuracy of the estimated 3520), federal agencies must obtain
electronic submission process, enabling burden; (3) ways to enhance the quality, approval from the Office of Management
a more organized and streamlined utility, and clarity of the information to and Budget (OMB) for each collection of
review, and would like to bring those be collected; and (4) the use of information they conduct or sponsor.
same efficiencies to all PACE automated collection techniques or The term ‘‘collection of information’’ is
application processes. OMB approval other forms of information technology to defined in 44 U.S.C. 3502(3) and 5 CFR
would help ensure applicant minimize the information collection 1320.3(c) and includes agency requests
compliance with CMS’ requirements burden. or requirements that members of the
and ability to gather data used to public submit reports, keep records, or
DATES: Comments must be received by
support approval or denial of either an provide information to a third party.
July 1, 2016
initial PACE application or a service Section 3506(c)(2)(A) of the PRA
area expansion application submitted by ADDRESSES: When commenting, please
reference the document identifier or requires federal agencies to publish a
an existing PO. Form Number: CMS–R– 60-day notice in the Federal Register
244 (OMB control number: 0938–0790); OMB control number. To be assured
consideration, comments and concerning each proposed collection of
Frequency: Once and occasionally; information, including each proposed
Affected Public: Private sector (Not-for- recommendations must be submitted in
any one of the following ways: extension or reinstatement of an existing
profit institutions); Number of collection of information, before
Respondents: 730; Total Annual 1. Electronically. You may send your
comments electronically to http:// submitting the collection to OMB for
Responses: 55,060; Total Annual Hours: approval. To comply with this
5,748. (For policy questions regarding www.regulations.gov. Follow the
instructions for ‘‘Comment or requirement, CMS is publishing this
this collection contact Debbie Vanhoven notice.
at 410–786–6625.) Submission’’ or ‘‘More Search Options’’
to find the information collection 1. Type of Information Collection
Dated: April 27, 2016. document(s) that are accepting Request: Revision of a currently
William N. Parham, III, comments. approved collection; Title of
Director, Paperwork Reduction Staff, Office 2. By regular mail. You may mail Information Collection: Medicaid Drug
of Strategic Operations and Regulatory written comments to the following Program—Monthly and Quarterly Drug
Affairs. address: CMS, Office of Strategic Reporting Format; Use: Labelers
[FR Doc. 2016–10231 Filed 4–29–16; 8:45 am] Operations and Regulatory Affairs, transmit drug product and pricing data
BILLING CODE 4120–01–P Division of Regulations Development, to CMS within 30 days after the end of
Attention: Document Identifier/OMB each calendar month and quarter. CMS
Control Number ___, Room C4–26–05, calculates the unit rebate amount (URA)
DEPARTMENT OF HEALTH AND 7500 Security Boulevard, Baltimore, and the unit rebate offset amount
HUMAN SERVICES Maryland 21244–1850. (UROA) for each new drug application
To obtain copies of a supporting (NDC) and distributes to all State
Centers for Medicare & Medicaid statement and any related forms for the Medicaid agencies. States use the URA
Services proposed collection(s) summarized in to invoice the labeler for rebates and the
[Document Identifiers: CMS–367 and CMS– this notice, you may make your request UROA to report onto the CMS–64. The
10243] using one of following: monthly data is used to calculate
1. Access CMS’ Web site address at Federal Upper Limit (FUL) prices for
Agency Information Collection applicable drugs and for states that opt
srobinson on DSK5SPTVN1PROD with NOTICES
http://www.cms.hhs.gov/
Activities: Proposed Collection; PaperworkReductionActof1995. to use this data to establish their
Comment Request 2. Email your request, including your pharmacy reimbursement methodology.
AGENCY: Centers for Medicare & address, phone number, OMB number, Form Number: CMS–367 (OMB control
Medicaid Services, Department of and CMS document identifier, to number: 0938–0578); Frequency:
Health and Human Services. Paperwork@cms.hhs.gov. Monthly and Quarterly; Affected Public:
3. Call the Reports Clearance Office at Private sector (Business or other for-
ACTION: Notice.
(410) 786–1326. profits); Number of Respondents: 610;
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![26236 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices
Total Annual Responses: 12,810; Total conduct their own analysis, to the Dogs and Cats,’’ dated September 10,
Annual Hours: 3,618,703. (For policy extent they propose to do such tasks. 2012.
questions regarding this collection The states have been funded under the DATES: Submit either electronic or
contact Samone Angel at 410–786– demonstration grant to conduct the written comments on Agency guidances
1123.) round 2 data collection and analysis. at any time.
2. Type of Information Collection These states will submit reports to CMS
Request: Reinstatement with change of a ADDRESSES: You may submit comments
describing their experience in the
previously approved collection; Title of Round 2 data collection, including the as follows:
Information Collection: Testing items they collected, how they planned Electronic Submissions
Experience and Functional Tools: to use the data, and the types of
Functional Assessment Standardized Submit electronic comments in the
challenges and successes they
Items (FASI) Based on the CARE Tool; following way:
encountered in doing so. The reports
Use: In 2012, CMS funded a project • Federal eRulemaking Portal: http://
may be used by CMS in their evaluation
entitled, Technical Assistance to States www.regulations.gov. Follow the
of the TEFT grants. Form Number:
for Testing Experience and Functional instructions for submitting comments.
CMS–10243 (OMB control number:
Tools (TEFT) Grants. One component of 0938–1037); Frequency: On occasion; Comments submitted electronically,
this demonstration is to amend and test Affected Public: Individuals and including attachments, to http://
the reliability of a setting-agnostic, households; Number of Respondents: www.regulations.gov will be posted to
interoperable set of data elements, 5,650; Total Annual Responses: 5,650; the docket unchanged. Because your
called ‘‘items,’’ that can support Total Annual Hours: 2,825. (For policy comment will be made public, you are
standardized assessment of individuals questions regarding this collection solely responsible for ensuring that your
across the continuum of care. Items that contact Allison Weaver at 410–786– comment does not include any
were created for use in post-acute care 4924.) confidential information that you or a
settings using the Continuity third party may not wish to be posted,
Dated: April 27, 2016. such as medical information, your or
Assessment Record and Evaluation
William N. Parham, III, anyone else’s Social Security number, or
(CARE) tool have been adopted,
Director, Paperwork Reduction Staff, Office confidential business information, such
modified, or supplemented for use in of Strategic Operations and Regulatory
community-based long-term services as a manufacturing process. Please note
Affairs. that if you include your name, contact
and supports (CB–LTSS) programs. This
[FR Doc. 2016–10232 Filed 4–29–16; 8:45 am] information, or other information that
project will test the reliability and
validity of the function-related BILLING CODE 4120–01–P identifies you in the body of your
assessment items, now referred to as comments, that information will be
Functional Assessment Standardized posted on http://www.regulations.gov.
DEPARTMENT OF HEALTH AND • If you want to submit a comment
Items (FASI), when applied in HUMAN SERVICES
community settings, and in various with confidential information that you
populations: Elders (65 years and older); Food and Drug Administration do not wish to be made available to the
younger adults (18–64) with physical public, submit the comment as a
disabilities; and adults of any age with [Docket No. FDA–2012–D–0755] written/paper submission and in the
intellectual or developmental manner detailed (see ‘‘Written/Paper
Compliance Policy Guide Sec. 690.150 Submissions’’ and ‘‘Instructions’’).
disabilities, with severe mental illness, Labeling and Marketing of Dog and Cat
or with traumatic brain injury. Food Diets Intended To Diagnose, Written/Paper Submissions
Individual-level data will be collected
Cure, Mitigate, Treat, or Prevent Submit written/paper submissions as
two times using the TEFT FASI Item
Diseases; Availability follows:
Set. The first data collection effort will
collect data that can be analyzed to AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
evaluate the reliability and validity of HHS. written/paper submissions): Division of
the FASI items when used with the five ACTION: Notice. Dockets Management (HFA–305), Food
waiver populations. Assessors will and Drug Administration, 5630 Fishers
conduct functional assessments in client SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
homes using the TEFT FASI Item Set. Administration (FDA) is announcing the • For written/paper comments
Changes may be recommended to availability of a compliance policy submitted to the Division of Dockets
individual TEFT FASI items, to be made guide (CPG) entitled ‘‘Compliance Management, FDA will post your
prior to releasing the TEFT FASI items Policy Guide Sec. 690.150 Labeling comment, as well as any attachments,
for use by the states. The FASI Field and Marketing of Dog and Cat Food except for information submitted,
Test Report will be released to the Diets Intended to Diagnose, Cure, marked and identified, as confidential,
public. Mitigate, Treat, or Prevent Diseases.’’ if submitted as detailed in
The second data collection will be This CPG provides guidance to FDA ‘‘Instructions.’’
conducted by the states to demonstrate staff on issues related to dog and cat Instructions: All submissions received
their use of the FASI data elements. The diets that are labeled and/or marketed as must include the Docket No. FDA–
assessment data could be used by the intending to diagnose, cure, mitigate, 2012–D–0755 for ‘‘Compliance Policy
states for multiple purposes. They may treat, or prevent diseases and to provide Guide Sec. 690.150 Labeling and
use the standardized items to determine all or most nutrients in support of Marketing of Dog and Cat Food Diets
srobinson on DSK5SPTVN1PROD with NOTICES
individual eligibility for state programs, meeting the animal’s total daily nutrient Intended to Diagnose, Cure, Mitigate,
or to help determine levels of care requirements. This CPG finalizes the Treat, or Prevent Diseases.’’ Received
within which people can receive draft CPG entitled ‘‘Compliance Policy comments will be placed in the docket
services, or other purposes. In the Guide Sec. 690.150 Labeling and and, except for those submitted as
second round of data collection, states Marketing of Nutritional Products ‘‘Confidential Submissions,’’ publicly
will demonstrate their proposed uses, Intended for Use to Diagnose, Cure, viewable at http://www.regulations.gov
manage their FASI data collection and Mitigate, Treat, or Prevent Disease in or at the Division of Dockets
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Document Created: 2016-04-30 13:35:40
Document Modified: 2016-04-30 13:35:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by July 1, 2016 | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 26235 |
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