83 FR 5427 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 26 (February 7, 2018)

Page Range		5427-5428
FR Document		2018-02433

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.

Federal Register, Volume 83 Issue 26 (Wednesday, February 7, 2018)

[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5427-5428]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10453 and CMS-1856]


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 April 9, 2018.

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' website address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William 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

[[Page 5428]]

and associated materials (see ADDRESSES).

CMS-10453 The Medicare Advantage and Prescription Drug Program: Part C 
Explanation of Benefits and Supporting Regulations
CMS-1856 Request for Certification in the Medicare/Medicaid Program for 
Providers of Outpatient Physical Therapy and/or Speech-Language 
Pathology

    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: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: The Medicare Advantage and Prescription Drug Program: Part 
C Explanation of Benefits and Supporting Regulations; Use: The Medicare 
Advantage disclosure requirements in 42 CFR 422.111(b) sets out the 
authority for CMS to require that Medicare Advantage Organizations 
(MAOs) furnish a written explanation of benefits (EOB) directly to 
enrollees, in a manner specified by CMS and in a form easily 
understandable to enrollees, when benefits are provided under part 422. 
In Sec.  422.216(d)(1), all Medicare Advantage plan types that offer an 
M+C fee-for-service plan must provide to plan enrollees, for each claim 
filed by the enrollee or the provider that furnished the service, an 
appropriate explanation of benefits. The explanation must include a 
clear statement of the enrollee's liability for deductibles, 
coinsurance, copayment, and balance billing. Plans must disclose the 
information specified in Sec.  422.111(b), as specified in Sec.  
422.111(a)(3), at the time of enrollment and at least annually 
thereafter, 15 days before the annual coordinated election period. Form 
Number: CMS-10453 (OMB control number: 0938-1228); Frequency: On 
occasion; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 468; Number of Responses: 5,616; Total 
Annual Hours: 74,880. (For policy questions regarding this collection 
contact Natalie Albright at 410-786-1671.)
    2. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Request for Certification in the Medicare/Medicaid Program for 
Providers of Outpatient Physical Therapy and/or Speech-Language 
Pathology; Use: The form is used as an application to be completed by 
providers of outpatient physical therapy and/or speech-language 
pathology services requesting participation in the Medicare and 
Medicaid programs. This form initiates the process for obtaining a 
decision as to whether the conditions of participation are met as a 
provider of outpatient physical therapy, speech-language pathology 
services, or both. It is used by the State agencies to enter new 
providers into the Automated Survey Process Environment (ASPEN). Form 
Number: CMS-1856 (OMB control number: 0938-0065); Frequency: Annually, 
occasionally; Affected Public: Private sector--Business or other for-
profit and Not-for-profit institutions; Number of Respondents: 350; 
Total Annual Responses: 350; Total Annual Hours: 88. (For policy 
questions regarding this collection contact Peter Ajuonuma at 410-786-
3580.)

    Dated: February 2, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-02433 Filed 2-6-18; 8:45 am]
 BILLING CODE 4120-01-P

5428 Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices

and associated materials (see Number: CMS–10453 (OMB control SUMMARY: The Food and Drug
ADDRESSES). number: 0938–1228); Frequency: On Administration (FDA) is announcing
CMS–10453 The Medicare Advantage occasion; Affected Public: Private sector that a proposed collection of
and Prescription Drug Program: Part C (Business or other for-profits); Number information has been submitted to the
Explanation of Benefits and of Respondents: 468; Number of Office of Management and Budget
Supporting Regulations Responses: 5,616; Total Annual Hours: (OMB) for review and clearance under
CMS–1856 Request for Certification in 74,880. (For policy questions regarding the Paperwork Reduction Act of 1995.
the Medicare/Medicaid Program for this collection contact Natalie Albright DATES: Fax written comments on the
Providers of Outpatient Physical at 410–786–1671.) collection of information by March 9,
Therapy and/or Speech-Language 2. Type of Information Collection 2018.
Pathology Request: Reinstatement of a previously ADDRESSES: To ensure that comments on
Under the PRA (44 U.S.C. 3501– approved collection; Title of the information collection are received,
3520), federal agencies must obtain Information Collection: Request for OMB recommends that written
approval from the Office of Management Certification in the Medicare/Medicaid comments be faxed to the Office of
and Budget (OMB) for each collection of Program for Providers of Outpatient Information and Regulatory Affairs,
information they conduct or sponsor. Physical Therapy and/or Speech- OMB, Attn: FDA Desk Officer, Fax: 202–
The term ‘‘collection of information’’ is Language Pathology; Use: The form is 395–7285, or emailed to oira_
defined in 44 U.S.C. 3502(3) and 5 CFR used as an application to be completed submission@omb.eop.gov. All
1320.3(c) and includes agency requests by providers of outpatient physical comments should be identified with the
or requirements that members of the therapy and/or speech-language OMB control number 0910–0389. Also
public submit reports, keep records, or pathology services requesting include the FDA docket number found
provide information to a third party. participation in the Medicare and in brackets in the heading of this
Section 3506(c)(2)(A) of the PRA Medicaid programs. This form initiates document.
requires federal agencies to publish a the process for obtaining a decision as
to whether the conditions of FOR FURTHER INFORMATION CONTACT:
60-day notice in the Federal Register Domini Bean, Office of Operations,
concerning each proposed collection of participation are met as a provider of
outpatient physical therapy, speech- Food and Drug Administration, Three
information, including each proposed White Flint North, 10A–12M, 11601
extension or reinstatement of an existing language pathology services, or both. It
is used by the State agencies to enter Landsdown St., North Bethesda, MD
collection of information, before 20852, 301–796–5733, PRAStaff@
submitting the collection to OMB for new providers into the Automated
Survey Process Environment (ASPEN). fda.hhs.gov.
approval. To comply with this
requirement, CMS is publishing this Form Number: CMS–1856 (OMB control SUPPLEMENTARY INFORMATION: In
notice. number: 0938–0065); Frequency: compliance with 44 U.S.C. 3507, FDA
Annually, occasionally; Affected Public: has submitted the following proposed
Information Collection Private sector—Business or other for- collection of information to OMB for
1. Type of Information Collection profit and Not-for-profit institutions; review and clearance.
Request: Reinstatement without change Number of Respondents: 350; Total
Guidance for Industry: ‘‘Expedited
of a previously approved collection; Annual Responses: 350; Total Annual
Programs for Serious Conditions—
Title of Information Collection: The Hours: 88. (For policy questions
Drugs and Biologics’’
Medicare Advantage and Prescription regarding this collection contact Peter
Drug Program: Part C Explanation of Ajuonuma at 410–786–3580.) OMB Control Numbers 0910–0389 and
Benefits and Supporting Regulations; Dated: February 2, 2018.
0910–0765—Revision
Use: The Medicare Advantage William N. Parham, III, This information collection supports
disclosure requirements in 42 CFR Director, Paperwork Reduction Staff, Office the previous captioned Agency
422.111(b) sets out the authority for of Strategic Operations and Regulatory guidance. The guidance provides a
CMS to require that Medicare Affairs. single resource for information on
Advantage Organizations (MAOs) [FR Doc. 2018–02433 Filed 2–6–18; 8:45 am] FDA’s policies and procedures related
furnish a written explanation of benefits BILLING CODE 4120–01–P
to the following expedited programs for
(EOB) directly to enrollees, in a manner serious conditions: (1) Fast track
specified by CMS and in a form easily designation, (2) breakthrough therapy
understandable to enrollees, when DEPARTMENT OF HEALTH AND designation, (3) accelerated approval,
benefits are provided under part 422. In HUMAN SERVICES and (4) priority review designation. The
§ 422.216(d)(1), all Medicare Advantage guidance describes threshold criteria
plan types that offer an M+C fee-for- Food and Drug Administration generally applicable to expedited
service plan must provide to plan programs, including what is meant by
enrollees, for each claim filed by the [Docket No. FDA–2013–D–0575] serious condition, unmet medical need,
enrollee or the provider that furnished and available therapy. The guidance
the service, an appropriate explanation Agency Information Collection addresses the applicability of expedited
of benefits. The explanation must Activities; Submission for Office of programs to rare diseases, clarification
include a clear statement of the Management and Budget Review; on available therapy, and additional
enrollee’s liability for deductibles, Comment Request; Guidance for detail on possible flexibility in
sradovich on DSK3GMQ082PROD with NOTICES

coinsurance, copayment, and balance Industry on Expedited Programs for manufacturing and product quality. The
billing. Plans must disclose the Serious Conditions—Drugs and guidance also clarifies the qualifying
information specified in § 422.111(b), as Biologics criteria for breakthrough therapy
specified in § 422.111(a)(3), at the time AGENCY: Food and Drug Administration, designation and provides examples of
of enrollment and at least annually HHS. surrogate endpoints and intermediate
thereafter, 15 days before the annual clinical endpoints used to support
ACTION: Notice.
coordinated election period. Form accelerated approval.

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Document Created: 2018-10-26 13:55:41
Document Modified: 2018-10-26 13:55:41

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 April 9, 2018.
Contact		William Parham at (410) 786-4669.
FR Citation		83 FR 5427

83 FR 5427 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 83, Issue 26 (February 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services