Agency Information Collection Activities: Proposed Collection; Comment Request, 5427-5428 [2018-02433]
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sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices
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: 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: Fee-for-Service
Recovery Audit Prepayment Review
Demonstration and Prior Authorization
Demonstration; Use: The Office of
Management and Budget approved the
collections required for two
demonstrations of prepayment review
and prior authorization. The first
demonstration allows Medicare
Recovery Auditors to review claims on
a pre-payment basis in certain States.
The second demonstration established a
prior authorization program for Power
Mobility Device claims in certain States.
The first demonstration has ended, so
we are only extending the collection of
information for the second
demonstration, prior authorization of
power mobility devices.
For the Prior Authorization of Power
Mobility Devices (PMDs)
Demonstration, we are piloting prior
authorization for PMDs. Prior
authorization will allow the applicable
documentation that supports a claim to
be submitted before the item is
delivered. For prior authorization,
relevant documentation for review is
submitted before the item is delivered or
the service is rendered. CMS will
conduct this demonstration in
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18:17 Feb 06, 2018
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California, Florida, Illinois, Michigan,
New York, North Carolina, Texas,
Pennsylvania, Ohio, Louisiana,
Missouri, Maryland, New Jersey,
Indiana, Kentucky, Georgia, Tennessee,
Washington, and Arizona based on
beneficiary address as reported to the
Social Security Administration and
recorded in the Common Working File
(CWF). For the demonstration, a prior
authorization request can be completed
by the (ordering) physician or treating
practitioner and submitted to the
appropriate Durable Medical Equipment
Medicare Administrative Contractor
(DME MAC) for an initial decision. The
supplier may also submit the request on
behalf of the physician or treating
practitioner. The physician, treating
practitioner or supplier who submits the
request on behalf of the physician or
treating practitioner, is referred to as the
‘‘submitter.’’ Under this demonstration,
the submitter will submit to the DME
MAC a request for prior authorization
and all relevant documentation to
support Medicare coverage of the PMD
item. Form Number: CMS–10421 (OMB
control number: 0938–1169); Frequency:
Occasionally; Affected Public: State,
Local or Tribal Governments; Number of
Respondents: 50,500; Total Annual
Responses: 50,500; Total Annual Hours:
25,125. (For policy questions regarding
this collection contact Daniel Schwartz
at 410–786–4197.)
Dated: February 2, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–02467 Filed 2–6–18; 8:45 am]
BILLING CODE 4120–01–P
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
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
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
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
5427
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 https://
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 ll, 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
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
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
E:\FR\FM\07FEN1.SGM
07FEN1
5428
Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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
§ 422.216(d)(1), all Medicare Advantage
plan types that offer an M+C fee-forservice 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 § 422.111(b), as
specified in § 422.111(a)(3), at the time
of enrollment and at least annually
thereafter, 15 days before the annual
coordinated election period. Form
VerDate Sep<11>2014
18:17 Feb 06, 2018
Jkt 244001
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 SpeechLanguage 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, speechlanguage 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 forprofit 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0575]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Expedited Programs for
Serious Conditions—Drugs and
Biologics
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00029
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 9,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0389. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Guidance for Industry: ‘‘Expedited
Programs for Serious Conditions—
Drugs and Biologics’’
OMB Control Numbers 0910–0389 and
0910–0765—Revision
This information collection supports
the previous captioned Agency
guidance. The guidance provides a
single resource for information on
FDA’s policies and procedures related
to the following expedited programs for
serious conditions: (1) Fast track
designation, (2) breakthrough therapy
designation, (3) accelerated approval,
and (4) priority review designation. The
guidance describes threshold criteria
generally applicable to expedited
programs, including what is meant by
serious condition, unmet medical need,
and available therapy. The guidance
addresses the applicability of expedited
programs to rare diseases, clarification
on available therapy, and additional
detail on possible flexibility in
manufacturing and product quality. The
guidance also clarifies the qualifying
criteria for breakthrough therapy
designation and provides examples of
surrogate endpoints and intermediate
clinical endpoints used to support
accelerated approval.
E:\FR\FM\07FEN1.SGM
07FEN1
Agencies
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5427-5428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02433]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
https://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 https://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: 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