Agency Information Collection Activities: Submission for OMB Review; Comment Request, 57616-57617 [2015-24262]
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tkelley on DSK3SPTVN1PROD with NOTICES
57616
Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
including benefits across a broad range
of activities ranging from athletics to
more routine lifestyle activities, such as
reading, watching TV, and driving;
improves vision on average by 31% and
two lines on the Snellen eye chart, and
improves contrast sensitivity by 100%;
and reverses, delays, or corrects aging
eye or presbyopia, including, but not
limited to, by improving night vision,
improving users’ ability to read in dim
light, and diminishing the need for
glasses or other visual aids. The
complaint also alleges that the
respondents violated Sections 5(a) and
12 by making the false or misleading
representation that scientific testing
proves that Ultimeyes improves vision
in the above ways.
The order includes injunctive relief
that prohibits these alleged violations
and fences in similar and related
violations. The order applies to
marketing claims for any Covered
Product or Service, defined as any
Device within the meaning of Sections
12 and 15 of the FTC Act, 15 U.S.C. 52,
55, or any program or service that is: (1)
Intended for use in the diagnosis of
disease or other condition, or in the
cure, mitigation, treatment, or
prevention of disease, in man or other
animals; or (2) intended to affect the
structure or any function of the body of
man or other animals; and which does
not achieve any of its principal intended
purposes through chemical action
within or on the body of man or other
animals and which is not dependent
upon being metabolized for the
achievement of any of its principal
intended purposes. As additional
fencing-in relief, the order requires the
respondents to follow appropriate
recordkeeping and compliance reporting
requirements, as well as document
preservation requirements for human
clinical studies that it conducts or
sponsors on any Covered Product or
Service.
Part I prohibits any representation
that a Covered Product or Service
improves users’ vision, unless it is nonmisleading and supported by competent
and reliable scientific evidence. Such
evidence must consist of human clinical
testing of the Covered Product or
Service that is sufficient in quality and
quantity, based on standards generally
accepted by experts in the relevant field,
when considered in light of the entire
body of relevant and reliable scientific
evidence, to substantiate that the
representation is true. Such testing shall
(1) be randomized, double-blind, and
adequately controlled; and (2) be
conducted by researchers qualified by
training and experience to conduct such
testing. In addition, the respondents
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must maintain all underlying or
supporting data that experts in the
relevant field generally would accept as
relevant to an assessment of such
testing.
Part II prohibits any representation
about the health benefits, performance,
efficacy, safety, or side effects of any
Covered Product or Service, unless it is
non-misleading and supported by
competent and reliable scientific
evidence that is sufficient in quality and
quantity based on standards generally
accepted in the relevant scientific fields,
when considered in light of the entire
body of relevant and reliable scientific
evidence, to substantiate that the
representation is true. For purposes of
this Part, competent and reliable
scientific evidence means tests,
analyses, research, or studies that have
been conducted and evaluated in an
objective manner by qualified persons;
and that are generally accepted in the
profession to yield accurate and reliable
results. When that evidence consists of
human clinical tests or studies, the
respondents must maintain all
underlying or supporting data and
documents that experts in the relevant
field generally would accept as relevant
to an assessment of such testing.
Part III, triggered when the human
clinical testing requirement in Parts I or
II applies, requires the respondents to
secure and preserve all underlying or
supporting data and documents
generally accepted by experts in the
relevant field as relevant to an
assessment of the test, such as protocols,
instructions, participant-specific data,
statistical analyses, and contracts with
the test’s researchers. There is an
exception for a ‘‘Reliably Reported’’ test,
defined as a test that is published in a
peer-reviewed journal and that was not
conducted, controlled, or sponsored by
any respondent or by any supplier of the
respondents. Also, the published report
must provide sufficient information
about the test for experts in the relevant
field to assess the reliability of the
results.
Part IV prohibits the respondents from
misrepresenting, including through the
use of a name, endorsement, depiction,
or illustration, the existence, contents,
validity, results, conclusions, or
interpretations of any test, study, or
research, or that any benefits of a
product, program, or service are
scientifically proven.
Part V requires the respondents to
disclose, when triggered by certain
representations as to scientific support
or endorsements in connection with the
advertisement or sale of any product,
program, or service, any material
connections to any person that has
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conducted, authored, or participated in
any test, study, or research of the
product, program, or service; and all
material connections between a person
providing an endorsement and
respondents or any other person
manufacturing, labeling, advertising,
promoting, offering for sale, selling, or
distributing such product, program, or
service.
Part VI provides the respondents will
pay an equitable monetary payment of
$150,000 and contains other provisions
related to the payment.
Part VII requires the respondents to
provide sufficient customer information
to administer redress.
Part VIII contains recordkeeping
requirements for advertisements and
substantiation relevant to
representations covered by Parts I
through III, as well as order
acknowledgments covered by Part IX.
Parts IX through XI require the
respondents to deliver a copy of the
order to officers, employees, and
representatives having managerial
responsibilities with respect to the
order’s subject matter, notify the
Commission of changes in corporate
structure that might affect compliance
obligations, and file compliance reports
with the Commission.
Part XII provides that, with
exceptions, the order will terminate in
twenty years.
The purpose of this analysis is to
facilitate public comment on the order,
and it is not intended to constitute an
official interpretation of the complaint
or order, or to modify the order’s terms
in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2015–24220 Filed 9–23–15; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10137 and
CMS–10237]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
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
SUMMARY:
E:\FR\FM\24SEN1.SGM
24SEN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
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 October 26, 2015.
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:
OIRA_submission@omb.eop.gov.
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
https://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:
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
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16:45 Sep 23, 2015
Jkt 235001
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: Revision of a currently
approved collection; Title of
Information Collection: Solicitation for
Applications for Medicare Prescription
Drug Plan 2017 Contracts; Use: The
information will be collected under the
solicitation of proposals from
prescription drug plans, Medicare
Advantage (MA) plans that offer
integrated prescription drug and health
care coverage (MA–PD) plans, Cost Plan,
PACE, and Employer Group Waiver
Plan applicants. The information will be
used by CMS to: Ensure that applicants
meet CMS requirements and to support
the determination of contract awards.
Participation in the Part D program is
voluntary. Only organizations that are
interested in participating in the
program will respond to the solicitation.
The MA–PDs that voluntarily
participate in the Part C program must
submit a Part D application and
successful bid. Form Number: CMS–
10137 (OMB Control Number: 0938–
0936); Frequency: Yearly; Affected
Public: Private sector (Business or other
For-profits and Not-for-profit
institutions); Number of Respondents:
254; Total Annual Responses: 230; Total
Annual Hours: 2,109. (For policy
questions regarding this collection
contact Arianne Spaccarelli at 410–786–
5715).
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Part C—
Medicare Advantage and 1876 Cost Plan
Expansion Application; Use: The
information will be collected under the
solicitation of Part C applications from
Medicare Advantage, Employer Group
Waiver Plan, and Cost Plan applicants
and will be used by CMS to ensure that
applicants meet CMS requirements, and
to support the determination of contract
awards. Participation is voluntary
whereby only organizations that are
interested in participating in the
program will respond to the solicitation.
Medicare Advantage (MA) organizations
that offer integrated prescription drug
and health care products (MA–PD
PO 00000
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Fmt 4703
Sfmt 4703
57617
plans) that voluntarily participate in the
Part C program must submit a Part D
application and successful bid. Form
Number: CMS–10237 (OMB Control
Number: 0938–0935); Frequency:
Yearly; Affected Public: Private sector
(Business or other For-profits and Notfor-profit institutions); Number of
Respondents: 566; Total Annual
Responses: 566; Total Annual Hours:
21,926. (For policy questions regarding
this collection contact Wanda PigattCanty at 410–786–6177).
Dated: September 21, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–24262 Filed 9–23–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7038–N]
Health Insurance Marketplace,
Medicare, Medicaid, and Children’s
Health Insurance Programs; Meeting of
the Advisory Panel on Outreach and
Education (APOE), October 7, 2015
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces a
meeting of the Advisory Panel on
Outreach and Education (APOE) (the
Panel) in accordance with the Federal
Advisory Committee Act. The Panel
advises and makes recommendations to
the Secretary of the U.S. Department of
Health and Human Services (HHS) and
the Administrator of the Centers for
Medicare & Medicaid Services (CMS) on
opportunities to enhance the
effectiveness of consumer education
strategies concerning the Health
Insurance Marketplace, Medicare,
Medicaid, and the Children’s Health
Insurance Program (CHIP). This meeting
is open to the public.
DATES: Meeting Date: Wednesday,
October 7, 2015, 8:30 a.m. to 4:00 p.m.
eastern daylight time (e.d.t).
Deadline for Meeting Registration,
Presentations and Comments:
Wednesday, September 30, 2015, 5:00
p.m., e.d.t.
Deadline for Requesting Special
Accommodations: Wednesday,
September 30, 2015, 5:00 p.m., e.d.t.
ADDRESSES:
Meeting Location: U.S. Department of
Health & Human Services, Hubert H.
SUMMARY:
E:\FR\FM\24SEN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57616-57617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24262]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10137 and CMS-10237]
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
[[Page 57617]]
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 October 26, 2015.
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:
OIRA_submission@omb.eop.gov.
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 https://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: 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: Revision of a currently
approved collection; Title of Information Collection: Solicitation for
Applications for Medicare Prescription Drug Plan 2017 Contracts; Use:
The information will be collected under the solicitation of proposals
from prescription drug plans, Medicare Advantage (MA) plans that offer
integrated prescription drug and health care coverage (MA-PD) plans,
Cost Plan, PACE, and Employer Group Waiver Plan applicants. The
information will be used by CMS to: Ensure that applicants meet CMS
requirements and to support the determination of contract awards.
Participation in the Part D program is voluntary. Only organizations
that are interested in participating in the program will respond to the
solicitation. The MA-PDs that voluntarily participate in the Part C
program must submit a Part D application and successful bid. Form
Number: CMS-10137 (OMB Control Number: 0938-0936); Frequency: Yearly;
Affected Public: Private sector (Business or other For-profits and Not-
for-profit institutions); Number of Respondents: 254; Total Annual
Responses: 230; Total Annual Hours: 2,109. (For policy questions
regarding this collection contact Arianne Spaccarelli at 410-786-5715).
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Part C--Medicare
Advantage and 1876 Cost Plan Expansion Application; Use: The
information will be collected under the solicitation of Part C
applications from Medicare Advantage, Employer Group Waiver Plan, and
Cost Plan applicants and will be used by CMS to ensure that applicants
meet CMS requirements, and to support the determination of contract
awards. Participation is voluntary whereby only organizations that are
interested in participating in the program will respond to the
solicitation. Medicare Advantage (MA) organizations that offer
integrated prescription drug and health care products (MA-PD plans)
that voluntarily participate in the Part C program must submit a Part D
application and successful bid. Form Number: CMS-10237 (OMB Control
Number: 0938-0935); Frequency: Yearly; Affected Public: Private sector
(Business or other For-profits and Not-for-profit institutions); Number
of Respondents: 566; Total Annual Responses: 566; Total Annual Hours:
21,926. (For policy questions regarding this collection contact Wanda
Pigatt-Canty at 410-786-6177).
Dated: September 21, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2015-24262 Filed 9-23-15; 8:45 am]
BILLING CODE 4120-01-P
