80 FR 57616 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 185 (September 24, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 185 (September 24, 2015)
| Page Range | 57616-57617 | |
| FR Document | 2015-24262 |
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)] [Notices] [Pages 57616-57617] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24262] ======================================================================= ----------------------------------------------------------------------- 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 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: 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
![57616 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
including benefits across a broad range must maintain all underlying or conducted, authored, or participated in
of activities ranging from athletics to supporting data that experts in the any test, study, or research of the
more routine lifestyle activities, such as relevant field generally would accept as product, program, or service; and all
reading, watching TV, and driving; relevant to an assessment of such material connections between a person
improves vision on average by 31% and testing. providing an endorsement and
two lines on the Snellen eye chart, and Part II prohibits any representation respondents or any other person
improves contrast sensitivity by 100%; about the health benefits, performance, manufacturing, labeling, advertising,
and reverses, delays, or corrects aging efficacy, safety, or side effects of any promoting, offering for sale, selling, or
eye or presbyopia, including, but not Covered Product or Service, unless it is distributing such product, program, or
limited to, by improving night vision, non-misleading and supported by service.
improving users’ ability to read in dim competent and reliable scientific Part VI provides the respondents will
light, and diminishing the need for evidence that is sufficient in quality and pay an equitable monetary payment of
glasses or other visual aids. The quantity based on standards generally $150,000 and contains other provisions
complaint also alleges that the accepted in the relevant scientific fields, related to the payment.
respondents violated Sections 5(a) and when considered in light of the entire Part VII requires the respondents to
12 by making the false or misleading body of relevant and reliable scientific provide sufficient customer information
representation that scientific testing evidence, to substantiate that the to administer redress.
proves that Ultimeyes improves vision representation is true. For purposes of Part VIII contains recordkeeping
in the above ways. this Part, competent and reliable requirements for advertisements and
The order includes injunctive relief scientific evidence means tests, substantiation relevant to
that prohibits these alleged violations analyses, research, or studies that have representations covered by Parts I
and fences in similar and related been conducted and evaluated in an through III, as well as order
violations. The order applies to objective manner by qualified persons; acknowledgments covered by Part IX.
marketing claims for any Covered and that are generally accepted in the Parts IX through XI require the
Product or Service, defined as any profession to yield accurate and reliable respondents to deliver a copy of the
Device within the meaning of Sections results. When that evidence consists of order to officers, employees, and
12 and 15 of the FTC Act, 15 U.S.C. 52, human clinical tests or studies, the representatives having managerial
55, or any program or service that is: (1) respondents must maintain all responsibilities with respect to the
Intended for use in the diagnosis of underlying or supporting data and order’s subject matter, notify the
disease or other condition, or in the documents that experts in the relevant Commission of changes in corporate
cure, mitigation, treatment, or field generally would accept as relevant structure that might affect compliance
prevention of disease, in man or other to an assessment of such testing. obligations, and file compliance reports
animals; or (2) intended to affect the Part III, triggered when the human with the Commission.
structure or any function of the body of clinical testing requirement in Parts I or Part XII provides that, with
man or other animals; and which does II applies, requires the respondents to exceptions, the order will terminate in
not achieve any of its principal intended secure and preserve all underlying or twenty years.
purposes through chemical action supporting data and documents The purpose of this analysis is to
within or on the body of man or other generally accepted by experts in the facilitate public comment on the order,
animals and which is not dependent relevant field as relevant to an
and it is not intended to constitute an
upon being metabolized for the assessment of the test, such as protocols,
official interpretation of the complaint
achievement of any of its principal instructions, participant-specific data,
or order, or to modify the order’s terms
intended purposes. As additional statistical analyses, and contracts with
in any way.
fencing-in relief, the order requires the the test’s researchers. There is an
respondents to follow appropriate exception for a ‘‘Reliably Reported’’ test, By direction of the Commission.
recordkeeping and compliance reporting defined as a test that is published in a Donald S. Clark,
requirements, as well as document peer-reviewed journal and that was not Secretary.
preservation requirements for human conducted, controlled, or sponsored by [FR Doc. 2015–24220 Filed 9–23–15; 8:45 am]
clinical studies that it conducts or any respondent or by any supplier of the BILLING CODE 6750–01–P
sponsors on any Covered Product or respondents. Also, the published report
Service. must provide sufficient information
Part I prohibits any representation about the test for experts in the relevant DEPARTMENT OF HEALTH AND
that a Covered Product or Service field to assess the reliability of the HUMAN SERVICES
improves users’ vision, unless it is non- results.
misleading and supported by competent Part IV prohibits the respondents from Centers for Medicare & Medicaid
and reliable scientific evidence. Such misrepresenting, including through the Services
evidence must consist of human clinical use of a name, endorsement, depiction,
testing of the Covered Product or or illustration, the existence, contents, [Document Identifiers: CMS–10137 and
CMS–10237]
Service that is sufficient in quality and validity, results, conclusions, or
quantity, based on standards generally interpretations of any test, study, or Agency Information Collection
accepted by experts in the relevant field, research, or that any benefits of a Activities: Submission for OMB
when considered in light of the entire product, program, or service are Review; Comment Request
body of relevant and reliable scientific scientifically proven.
tkelley on DSK3SPTVN1PROD with NOTICES
evidence, to substantiate that the Part V requires the respondents to ACTION: Notice.
representation is true. Such testing shall disclose, when triggered by certain
(1) be randomized, double-blind, and representations as to scientific support SUMMARY: The Centers for Medicare &
adequately controlled; and (2) be or endorsements in connection with the Medicaid Services (CMS) is announcing
conducted by researchers qualified by advertisement or sale of any product, an opportunity for the public to
training and experience to conduct such program, or service, any material comment on CMS’ intention to collect
testing. In addition, the respondents connections to any person that has information from the public. Under the
VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1](https://thefederalregister.org/doc/80_FR_57801/page/1.svg)
![Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 57617
Paperwork Reduction Act of 1995 information to a third party. Section plans) that voluntarily participate in the
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C. Part C program must submit a Part D
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies application and successful bid. Form
concerning each proposed collection of to publish a 30-day notice in the Number: CMS–10237 (OMB Control
information, including each proposed Federal Register concerning each Number: 0938–0935); Frequency:
extension or reinstatement of an existing proposed collection of information, Yearly; Affected Public: Private sector
collection of information, and to allow including each proposed extension or (Business or other For-profits and Not-
a second opportunity for public reinstatement of an existing collection for-profit institutions); Number of
comment on the notice. Interested of information, before submitting the Respondents: 566; Total Annual
persons are invited to send comments collection to OMB for approval. To Responses: 566; Total Annual Hours:
regarding the burden estimate or any comply with this requirement, CMS is 21,926. (For policy questions regarding
other aspect of this collection of publishing this notice that summarizes this collection contact Wanda Pigatt-
information, including any of the the following proposed collection(s) of Canty at 410–786–6177).
following subjects: (1) The necessity and information for public comment: Dated: September 21, 2015.
utility of the proposed information 1. Type of Information Collection
William N. Parham, III,
collection for the proper performance of Request: Revision of a currently
Director, Paperwork Reduction Staff, Office
the agency’s functions; (2) the accuracy approved collection; Title of of Strategic Operations and Regulatory
of the estimated burden; (3) ways to Information Collection: Solicitation for Affairs.
enhance the quality, utility, and clarity Applications for Medicare Prescription
[FR Doc. 2015–24262 Filed 9–23–15; 8:45 am]
of the information to be collected; and Drug Plan 2017 Contracts; Use: The
BILLING CODE 4120–01–P
(4) the use of automated collection information will be collected under the
techniques or other forms of information solicitation of proposals from
technology to minimize the information prescription drug plans, Medicare DEPARTMENT OF HEALTH AND
collection burden. Advantage (MA) plans that offer HUMAN SERVICES
DATES: Comments on the collection(s) of integrated prescription drug and health
information must be received by the care coverage (MA–PD) plans, Cost Plan, Centers for Medicare & Medicaid
OMB desk officer by October 26, 2015. PACE, and Employer Group Waiver Services
ADDRESSES: When commenting on the
Plan applicants. The information will be
used by CMS to: Ensure that applicants [CMS–7038–N]
proposed information collections,
please reference the document identifier meet CMS requirements and to support Health Insurance Marketplace,
the determination of contract awards.
or OMB control number. To be assured Medicare, Medicaid, and Children’s
Participation in the Part D program is Health Insurance Programs; Meeting of
consideration, comments and
voluntary. Only organizations that are the Advisory Panel on Outreach and
recommendations must be received by
interested in participating in the Education (APOE), October 7, 2015
the OMB desk officer via one of the
program will respond to the solicitation.
following transmissions: OMB, Office of
The MA–PDs that voluntarily AGENCY: Centers for Medicare &
Information and Regulatory Affairs,
participate in the Part C program must Medicaid Services (CMS), HHS.
Attention: CMS Desk Officer, Fax
submit a Part D application and ACTION: Notice of meeting.
Number: (202) 395–5806 or Email:
successful bid. Form Number: CMS–
OIRA_submission@omb.eop.gov. SUMMARY: This notice announces a
10137 (OMB Control Number: 0938–
To obtain copies of a supporting meeting of the Advisory Panel on
0936); Frequency: Yearly; Affected
statement and any related forms for the Outreach and Education (APOE) (the
Public: Private sector (Business or other
proposed collection(s) summarized in Panel) in accordance with the Federal
For-profits and Not-for-profit
this notice, you may make your request Advisory Committee Act. The Panel
institutions); Number of Respondents:
using one of following: advises and makes recommendations to
1. Access CMS’ Web site address at 254; Total Annual Responses: 230; Total
Annual Hours: 2,109. (For policy the Secretary of the U.S. Department of
http://www.cms.hhs.gov/ Health and Human Services (HHS) and
PaperworkReductionActof1995. questions regarding this collection
contact Arianne Spaccarelli at 410–786– the Administrator of the Centers for
2. Email your request, including your Medicare & Medicaid Services (CMS) on
address, phone number, OMB number, 5715).
2. Type of Information Collection opportunities to enhance the
and CMS document identifier, to effectiveness of consumer education
Request: Revision of a currently
Paperwork@cms.hhs.gov. strategies concerning the Health
3. Call the Reports Clearance Office at approved collection; Title of
Information Collection: Part C— Insurance Marketplace, Medicare,
(410) 786–1326. Medicaid, and the Children’s Health
Medicare Advantage and 1876 Cost Plan
FOR FURTHER INFORMATION CONTACT: Insurance Program (CHIP). This meeting
Expansion Application; Use: The
Reports Clearance Office at (410) 786– information will be collected under the is open to the public.
1326. solicitation of Part C applications from DATES: Meeting Date: Wednesday,
SUPPLEMENTARY INFORMATION: Under the Medicare Advantage, Employer Group October 7, 2015, 8:30 a.m. to 4:00 p.m.
Paperwork Reduction Act of 1995 (PRA) Waiver Plan, and Cost Plan applicants eastern daylight time (e.d.t).
(44 U.S.C. 3501–3520), federal agencies and will be used by CMS to ensure that Deadline for Meeting Registration,
must obtain approval from the Office of applicants meet CMS requirements, and Presentations and Comments:
Management and Budget (OMB) for each to support the determination of contract Wednesday, September 30, 2015, 5:00
tkelley on DSK3SPTVN1PROD with NOTICES
collection of information they conduct awards. Participation is voluntary p.m., e.d.t.
or sponsor. The term ‘‘collection of whereby only organizations that are Deadline for Requesting Special
information’’ is defined in 44 U.S.C. interested in participating in the Accommodations: Wednesday,
3502(3) and 5 CFR 1320.3(c) and program will respond to the solicitation. September 30, 2015, 5:00 p.m., e.d.t.
includes agency requests or Medicare Advantage (MA) organizations ADDRESSES:
requirements that members of the public that offer integrated prescription drug Meeting Location: U.S. Department of
submit reports, keep records, or provide and health care products (MA–PD Health & Human Services, Hubert H.
VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1](https://thefederalregister.org/doc/80_FR_57801/page/2.svg)
Document Created: 2018-02-26 10:17:57
Document Modified: 2018-02-26 10:17:57
| 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 October 26, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 57616 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR