81 FR 26234 - Agency Information Collection Activities: Submission for OMB Review; 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 | 26234-26235 | |
| FR Document | 2016-10231 |
[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)] [Notices] [Pages 26234-26235] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10231] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-R-131 and CMS-R-244] Agency Information Collection Activities: Submission for OMB Review; Comment Request 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 (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 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 on the collection(s) of information must be received by the OMB desk officer by June 1, 2016. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR, Email: [email protected]. 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: 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: Advance Beneficiary Notice of Noncoverage (ABN); Use: The Advance Beneficiary Notice (ABN) is delivered by Part B paid physicians, providers (including institutional providers like outpatient hospitals), practitioners (such as chiropractors), and suppliers, as well as hospice providers and Religious Non-medical Health Care Institutions paid under Part A. Home health agencies providing items and services under Part A or Part B also use the ABN. Other Medicare institutional providers paid under Part A use other approved notices for this purpose. With this PRA submission, minimal formatting changes have been made to the ABN form, including the addition of language informing beneficiaries of their rights under Section 504 of the Rehabilitation Act of 1973 (Section 504) by alerting the beneficiary to CMS's nondiscrimination practices and the availability of alternate forms of this notice, if needed. Additionally, minor language and grammatical changes have been made to the form's instructions to improve provider/ supplier comprehension and decrease the probability of errors in completing the ABN. There are no substantive changes to the form or to the instructions. Form Number: CMS-R-131 (OMB control number: 0938- 0566); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 1,540,850; Total Annual Responses: 63,601,300; Total Annual Hours: 7,420,364. (For policy questions regarding this collection contact Evelyn Blaemire at 410-786-1803.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: The PACE Organization (PO) Application Process in 42 CFR part 460; Use: In general, Programs of All-Inclusive Care for the Elderly (PACE) services are provided through a PO. An entity wishing to [[Page 26235]] become a PO must submit an application to CMS that describes how the entity meets all the requirements in the PACE program. An entity's application must be accompanied by an assurance from the State Administering Agency (SAA) of the State in which the PO is going to be located. Beginning in 2016, initial PACE applications will be submitted via a new automated, electronic submission process. An application also must be submitted for a PO that seeks to expand its service area and/or add a new PACE center site. The purpose of this PRA package is to enable the submission of both initial PACE applications, as well as service area expansion applications. We have successfully transitioned the Medicare Advantage application and Prescription Drug Plan (PDP) application to a fully electronic submission process, enabling a more organized and streamlined review, and would like to bring those same efficiencies to all PACE application processes. OMB approval would help ensure applicant compliance with CMS' requirements and ability to gather data used to support approval or denial of either an initial PACE application or a service area expansion application submitted by an existing PO. Form Number: CMS-R-244 (OMB control number: 0938-0790); Frequency: Once and occasionally; Affected Public: Private sector (Not- for-profit institutions); Number of Respondents: 730; Total Annual Responses: 55,060; Total Annual Hours: 5,748. (For policy questions regarding this collection contact Debbie Vanhoven at 410-786-6625.) Dated: April 27, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-10231 Filed 4-29-16; 8:45 am] BILLING CODE 4120-01-P
![26234 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices
4—PREGNANCY REGISTRY
Number of Avg. burden
Number of Total burden
Type of respondents Form name responses per per response
respondents (in hrs.)
respondent (in hrs.)
State and Local Health Departments Maternal Health History Form ........... 100 5 30/60 250
Specimen Collection Form ................ 100 1 15/60 25
Clinicians and other providers ........... Assessment at Delivery Form ........... 100 1 30/60 50
Infant Health Follow-Up Form ........... 100 1 30/60 50
Total ............................................ ............................................................ ........................ ........................ ........................ 400
Leroy A. Richardson, ADDRESSES: When commenting on the 1. Type of Information Collection
Chief, Information Collection Review Office, proposed information collections, Request: Extension of a currently
Office of Scientific Integrity, Office of the please reference the document identifier approved collection; Title of
Associate Director for Science, Office of the or OMB control number. To be assured Information Collection: Advance
Director, Centers for Disease Control and consideration, comments and Beneficiary Notice of Noncoverage
Prevention. recommendations must be received by (ABN); Use: The Advance Beneficiary
[FR Doc. 2016–10113 Filed 4–29–16; 8:45 am] the OMB desk officer via one of the Notice (ABN) is delivered by Part B paid
BILLING CODE 4163–18–P following transmissions: OMB, Office of physicians, providers (including
Information and Regulatory Affairs, institutional providers like outpatient
Attention: CMS Desk Officer, Fax hospitals), practitioners (such as
DEPARTMENT OF HEALTH AND Number: (202) 395–5806 OR, Email: chiropractors), and suppliers, as well as
HUMAN SERVICES OIRA_submission@omb.eop.gov. hospice providers and Religious Non-
To obtain copies of a supporting medical Health Care Institutions paid
Centers for Medicare & Medicaid
statement and any related forms for the under Part A. Home health agencies
Services
proposed collection(s) summarized in providing items and services under Part
[Document Identifiers: CMS–R–131 and this notice, you may make your request A or Part B also use the ABN. Other
CMS–R–244] using one of following: Medicare institutional providers paid
1. Access CMS’ Web site address at under Part A use other approved notices
Agency Information Collection http://www.cms.hhs.gov/ for this purpose. With this PRA
Activities: Submission for OMB PaperworkReductionActof1995. submission, minimal formatting changes
Review; Comment Request 2. Email your request, including your have been made to the ABN form,
address, phone number, OMB number, including the addition of language
ACTION: Notice. and CMS document identifier, to informing beneficiaries of their rights
SUMMARY: The Centers for Medicare & Paperwork@cms.hhs.gov. under Section 504 of the Rehabilitation
Medicaid Services (CMS) is announcing 3. Call the Reports Clearance Office at Act of 1973 (Section 504) by alerting the
an opportunity for the public to (410) 786–1326. beneficiary to CMS’s nondiscrimination
comment on CMS’ intention to collect FOR FURTHER INFORMATION CONTACT: practices and the availability of
information from the public. Under the Reports Clearance Office at (410) 786– alternate forms of this notice, if needed.
Paperwork Reduction Act of 1995 1326. Additionally, minor language and
(PRA), federal agencies are required to SUPPLEMENTARY INFORMATION: Under the grammatical changes have been made to
publish notice in the Federal Register Paperwork Reduction Act of 1995 (PRA) the form’s instructions to improve
concerning each proposed collection of (44 U.S.C. 3501–3520), federal agencies provider/supplier comprehension and
information, including each proposed must obtain approval from the Office of decrease the probability of errors in
extension or reinstatement of an existing Management and Budget (OMB) for each completing the ABN. There are no
collection of information, and to allow collection of information they conduct substantive changes to the form or to the
a second opportunity for public or sponsor. The term ‘‘collection of instructions. Form Number: CMS–R–
comment on the notice. Interested information’’ is defined in 44 U.S.C. 131 (OMB control number: 0938–0566);
persons are invited to send comments 3502(3) and 5 CFR 1320.3(c) and Frequency: Occasionally; Affected
regarding the burden estimate or any includes agency requests or Public: Private sector (Business or other
other aspect of this collection of requirements that members of the public for-profits and Not-for-profit
information, including any of the submit reports, keep records, or provide institutions); Number of Respondents:
following subjects: (1) The necessity and information to a third party. Section 1,540,850; Total Annual Responses:
utility of the proposed information 3506(c)(2)(A) of the PRA (44 U.S.C. 63,601,300; Total Annual Hours:
collection for the proper performance of 3506(c)(2)(A)) requires federal agencies 7,420,364. (For policy questions
the agency’s functions; (2) the accuracy to publish a 30-day notice in the regarding this collection contact Evelyn
of the estimated burden; (3) ways to Federal Register concerning each Blaemire at 410–786–1803.)
enhance the quality, utility, and clarity proposed collection of information, 2. Type of Information Collection
of the information to be collected; and including each proposed extension or Request: Revision of a currently
srobinson on DSK5SPTVN1PROD with NOTICES
(4) the use of automated collection reinstatement of an existing collection approved collection; Title of
techniques or other forms of information of information, before submitting the Information Collection: The PACE
technology to minimize the information collection to OMB for approval. To Organization (PO) Application Process
collection burden. comply with this requirement, CMS is in 42 CFR part 460; Use: In general,
DATES: Comments on the collection(s) of publishing this notice that summarizes Programs of All-Inclusive Care for the
information must be received by the the following proposed collection(s) of Elderly (PACE) services are provided
OMB desk officer by June 1, 2016. information for public comment: through a PO. An entity wishing to
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![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;
VerDate Sep<11>2014 20:30 Apr 29, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\02MYN1.SGM 02MYN1](https://thefederalregister.org/doc/81_FR_26318/page/2.svg)
Document Created: 2016-04-30 13:34:39
Document Modified: 2016-04-30 13:34:39
| 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 on the collection(s) of information must be received by the OMB desk officer by June 1, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 26234 |
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