Att B_60d FRN

69417

Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices

The questionnaire will collect contact
information, demographic information,
respiratory symptoms and diagnoses,
work history, and cigarette smoking
history. The questionnaire will allow
NIOSH to report individual medical test
results to each participant and to
analyze aggregate data from the
workforce to determine risk factors for
abnormal lung health indices derived
from the medical test results. The
individual results will be used by
employees and their personal
physicians to make medical decisions,
such as whether to pursue additional
testing. The aggregate results will be
used by NIOSH, facility management,
and employees in ongoing efforts to
reduce exposures and monitor key
health indices.
For this study, we will recruit all
current employees of the ITO
production facility. Participation is
voluntary. Employees who wish to
participate in the questionnaire and
medical testing will review and sign an
informed consent document. Employees
who wish to participate in the personal
air sampling and would like to receive
personal results will complete a contact
information form. We anticipate
approximately 100 study participants.
The questionnaire will be administered
privately at the workplace during
normal working hours by trained
NIOSH staff. Employees who are not
available at the workplace during the
study will be offered the opportunity to
respond to the questionnaire at a later
date by telephone. There are no costs to
participants other than their time.
The total estimated burden for the
one-time collection of data is 66 hours.

Proposed Project
An Investigation of Lung Health at an
Indium-Tin Oxide Production Facility—
New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–14–14CL]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

Background and Brief Description
The mission of the National Institute
for Occupational Safety and Health
(NIOSH) is to promote safety and health
at work for all people through research
and prevention. The Occupational
Safety and Health Act, Public Law 91–
596 (section 20[a] [1]), authorizes
NIOSH to conduct research to advance
the health and safety of workers. NIOSH
is proposing to conduct a study
regarding the lung health of workers at
an indium-tin oxide production facility.
Indium-tin oxide (ITO) is a sintered
material used in the manufacture of
devices such as liquid crystal displays,
touch panels, solar cells, and
architectural glass. Indium lung disease
is a novel, potentially fatal industrial
disease that has occurred in workers
making, using, or recycling ITO. This
project aims to understand and prevent
this occupational lung disease by
investigating the relationship between
exposure and lung health among current
ITO manufacturing workers.
CDC requests Office of Management
and Budget (OMB) approval to collect
standardized information from current
employees of the ITO production
facility through an informed consent
document, an interviewer-administered
questionnaire, and a contact information
form. As part of the same project,
employees will be offered the
opportunity to participate in medical
testing and personal air sampling.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

Form name

Current ITO production facility employees.

Informed consent document ............

100

1

15/60

25

Questionnaire ...................................
Contact information form ..................

100
100

1
1

20/60
5/60

33
8

...........................................................

........................

........................

........................

66

Total ...........................................

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Number of
respondents

Type of respondents

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69418

Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices

LeRoy Richardson,
Chief, Office of Scientific Integrity, Office of
the Associate Director for Science, Office of
the Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–27653 Filed 11–18–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3288–NC]

Patient Protection and Affordable Care
Act; Exchanges and Qualified Health
Plans, Quality Rating System (QRS),
Framework Measures and
Methodology
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment.
AGENCY:

This notice with comment
describes the overall Quality Rating
System (QRS) framework for rating
Qualified Health Plans (QHPs) offered
through an Exchange. The purpose of
this notice is to solicit comments on the
list of proposed QRS quality measures
that QHP issuers would be required to
collect and report, the hierarchical
structure of the measure sets and the
elements of the QRS rating
methodology. In addition, this notice
solicits comments on ways to ensure the
integrity of QRS ratings, and on priority
areas for future QRS measure
enhancement and development.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on January 21, 2014.
ADDRESSES: In commenting, refer to file
code CMS–3288–NC. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to http://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address only: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3288–NC, P.O. Box 8016,
Baltimore, MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.

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SUMMARY:

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3. By express or overnight mail. You
may send written comments to the
following address only: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3288–NC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written only to the following
addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Nidhi Singh Shah, (301) 492–5110, for
general information. Elizabeth FlowDelwiche, (410) 786–1718, for matters
relating to the Quality Rating System.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: http://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.

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Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
A. Legislative Background
The Patient Protection and Affordable
Care Act of 2010 (Pub. L. 111–148) as
amended by the Health Care and
Education Reconciliation Act of 2010
(Pub. L. 111–309) (collectively referred
to as the Affordable Care Act) establish
Affordable Insurance Exchange or
Exchange (also known as a Health
Insurance Marketplace or Marketplace)
within each state. Qualified individuals
and qualified employers in each state
will be able to shop for affordable health
insurance through Exchanges.
The Department of Health and Human
Services (the Secretary) holds primary
responsibility for establishing the
standards and guidelines for the
Exchanges. The Affordable Care Act
provides States with the flexibility to
establish and operate their own
Exchange (State-based Exchange).
However, if a state elects not to establish
a State-based Exchange or if a state will
not have an Exchange that is operational
by January 1, 2014, pursuant to section
1321(c)(1) of the Affordable Care Act,
the Secretary will establish and operate
a Federally-facilitated Exchange in those
states. The Affordable Care Act and
applicable Exchange regulations
establish that health plans offered
through an Exchange must meet specific
standards to be certified as QHPs and to
offer coverage in an Exchange beginning
in January 2014.
The Affordable Care Act also requires
the Secretary to develop a number of
reporting requirements to support the
delivery of quality health care coverage
offered in the Exchanges. Specifically,
sections 1311(c)(3) and (c)(4) of the
Affordable Care Act direct the Secretary
to develop—(1) a system that rates
qualified health plans (QHPs) based on
the relative quality and price; and (2) an
enrollee satisfaction survey system that
assesses the level of enrollee experience
(that is, consumer experience) with
QHPs. Because we believe that QHP
consumer experience is an important
part of rating the overall quality of a
QHP, we intend to use some of the
information collected from the Enrollee

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