Federal Register Notice

13752

Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices

Background and Brief Description
In 2012, CDC’s Office on Smoking and
Health obtained OMB approval of a
generic clearance to support the
development and testing of tobaccorelated health messages, including
messages disseminated through
multiple phases of a media campaign
(Message Testing for Tobacco
Communication Activities (MTTCA),
OMB Control Number 0920–0910,
expiration date 1/31/2015). In 2014,
OSH obtained approval for a
modification to the MTTCA clearance
that granted a three-year extension and
an increase in respondents and burden
hours (MTTCA, OMB Control Number
0920–0910, expiration date 3/31/2018).
CDC’s authority to collect information
for public health purposes is provided
by the Public Health Service Act (41
U.S.C. 241) Section 301.
CDC has employed the MTTCA
clearance to collect information about
adult smokers’ and nonsmokers’
attitudes and perceptions, and to pretest
draft messages and materials for clarity,
salience, appeal, and persuasiveness.
The MTTCA clearance has been used to
obtain OMB approval for a variety of
message testing activities, with
particular emphasis on communications
supporting CDC’s National Tobacco
Education Campaign (NTEC) called the
Tips from Former Smokers® campaign.
This national campaign is designed to
increase public awareness of the health

collaborative efforts with other federal
partners including, but not limited to,
the Food and Drug Administration’s
Center for Tobacco Products. At this
time, the respondents and burden
outlined in the existing MTTCA
clearance are expected to be sufficient to
test tobacco related messages developed
by CDC for the general US population
and subpopulations of interest. The
MTTCA clearance should not replace
the need for additional generic
clearance mechanisms of HHS and other
federal partners that may need to test
tobacco messages related to their
campaigns and initiatives.
The existing MTTCA clearance was
granted approval for a total of 132,648
respondents and 32,994 burden hours
over a three-year period (annualized
number of respondents of 44,216 and
annualized burden hours to 10,998). To
date, there have been 63,475
respondents and 11,737 burden hours
used in this clearance, leaving a balance
of 69,173 respondents and 21,257
burden hours (annualized number of
respondents of 23,057 and annualized
burden hours to 7,085 for each of the
three years in the requested extension).
CDC will continue to use the MTTCA
information collection plan to develop
and test messages and materials.
Participation is voluntary and there are
no costs to respondents, other than their
time.

consequences of tobacco use and
exposure to secondhand smoke. The
MTTCA clearance has also supported
formative research relating to the
development of health messages that are
not specifically associated with the
national campaign.
Information collection modes under
the MTTCA clearance that are
supported include in-depth interviews;
in-person focus groups; online focus
groups; computer-assisted, in-person, or
telephone interviews; and online
surveys. Each project approved under
the MTTCA framework is outlined in a
project-specific Information Collection
Request that describes its purpose and
methodology. Messages developed from
MTTCA data collection have been
disseminated via multiple media
channels including television, radio,
print, out-of-home, and digital formats.
CDC requests OMB approval to extend
the MTTCA clearance, without changes,
for three years. No modification is
requested for information collection
activities, methodology, respondents, or
burden from the existing generic
clearance. The extension is needed to
support CDC’s planned information
collections and to accommodate
additional needs that CDC may identify
during the next three years. For
example, the MTTCA generic clearance
may be used to facilitate the
development of tobacco-related health
communications of interest for CDC’s

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

Number of
responses per
respondent

Total burden
(in hours)

Form name

General Public and Special Populations.

Screening .........................................

23,057

1

2/60

769

Short Surveys/employment application (Online, Bulletin Board, etc.).
Medium Surveys (Online) ................

13,224

1

10/60

2,204

9,833

1

25/60

4,097

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

23,057

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

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

7,070

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

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2018–06392 Filed 3–29–18; 8:45 am]

[60Day–18–18TH; Docket No. CDC–2018–
0027]

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Number of
respondents

Type of respondents

Centers for Disease Control and
Prevention

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Notice with comment period.

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled ‘‘Assessment of a Preventive
Service Program in the Context of a Zika

SUMMARY:

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Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices
Virus Outbreak in Puerto Rico’’. Data
collected will be used to assess
implementation of a patient-centered
prevention program and associated
outcomes.
DATES: CDC must receive written
comments on or before May 29, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0027 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
[email protected].
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. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of

miscarriage, stillbirth, defects of the eye,
hearing deficits, limb abnormalities, and
impaired growth. One strategy to
prevent these devastating outcomes is to
prevent unintended pregnancy among
women at risk of Zika virus infection.
To this end, an initiative was launched
in April 2016 to train physicians at
clinics across Puerto Rico to provide
patient-centered services to women who
chose to delay or avoid pregnancy
during the Zika virus outbreak.
As part of the public health response
to the Zika virus outbreak, CDC seeks to
assess approaches to mitigating the
effects of Zika virus infection and
determine which approaches have
utility. Previous assessment of the
prevention program indicated high
satisfaction of Z–CAN patients with
program services. The specific
objectives of this data collection are to
assess: (1) Prevention strategy adherence
among Z–CAN patients at
approximately 18 months after receipt
of program services; and (2) prevention
strategy adherence, patient satisfaction,
and unmet need for services among Z–
CAN patients at approximately 30
months after receipt of program
services. The practical utility of the
collected information is to assess
services delivered to women in Puerto
Rico, monitor outcomes of interest, and
determine potential for replication/
adaptation in other jurisdictions
similarly affected by the Zika virus or
during other emergency responses.
For the information collection project,
CDC plans to conduct online surveys
with 1,600 patients approximately 18
and 30 months after receiving program
services.
Participation in all data collection
activities will be completely voluntary.
CDC intends to request a two-year OMB
approval to collect information. Total
Annualized Burden Hours are estimated
to be 259, and there are no costs to
respondents other than their time.

information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Assessment of a Preventive Service
Program in the Context of a Zika Virus
Outbreak in Puerto Rico—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Puerto Rico has reported the highest
number of Zika virus infections in the
United States, including infections in
pregnant women. Zika virus infection
during pregnancy has been identified as
a cause of microcephaly and other
severe brain abnormalities, and has been
linked to other problems such as

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Number of
responses per
respondent

Total
burden
(in hours)

Type of respondents

Form name

Patients aged 18 years or older ........
Patients aged 18 years or older who
completed 18-month survey.
Patients aged 18 years or older who
did not complete 18-month survey.

Online surveys (18-month follow-up)
Online surveys (30-month follow-up)

960
660

1
1

7/60
10/60

112
110

Online surveys (30-month follow-up)

220

1

10/60

37

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

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

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

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

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

259

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Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2018–06487 Filed 3–29–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1697–N]

Medicare Program; Public Meeting on
June 25, 2018 Regarding New and
Reconsidered Clinical Diagnostic
Laboratory Test Codes for the Clinical
Laboratory Fee Schedule for Calendar
Year 2019
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:

This notice announces a
public meeting to receive comments and
recommendations (including
accompanying data on which
recommendations are based) from the
public on the appropriate basis for
establishing payment amounts for new
or substantially revised Healthcare
Common Procedure Coding System
(HCPCS) codes being considered for
Medicare payment under the clinical
laboratory fee schedule (CLFS) for
calendar year (CY) 2019. This meeting
also provides a forum for those who
submitted certain reconsideration
requests regarding final determinations
made last year on new test codes and for
the public to provide comment on the
requests.
The Medicare Advisory Panel on
Clinical Diagnostic Laboratory Tests
(Advisory Panel on CDLTs) will
participate in this Annual Laboratory
Public Meeting by gathering information
and asking questions to presenters, and
will hold its next public meeting on July
16 and 17, 2018. The public meeting for
the Advisory Panel on CDLTs will focus
on discussion of and recommendations
for test codes presented during the June
25, 2018 Annual Laboratory Public
Meeting. The Panel meeting also will
address other CY 2019 CLFS issues that
are designated in the Panel’s charter and
specified on the meeting agenda may
also be discussed.
DATES:
Annual Laboratory Public Meeting
Date: The meeting is scheduled for
Monday, June 25, 2018 from 8:00 a.m.
to 5:00 p.m., E.D.T.

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Deadline for Registration of Presenters
and Submission of Presentations: All
presenters for the Annual Laboratory
Public Meeting must register and submit
their presentations electronically to our
CLFS dedicated email box, CLFS_
[email protected],
by June 11, 2018 at 5:00 p.m. E.D.T.
Deadline for Submitting Requests for
Special Accommodations: Requests for
special accommodations must be
received no later than 5:00 p.m. E.D.T.
on June 11, 2018.
Deadline for Submission of Written
Comments Related to the Annual
Laboratory Public Meeting: Written
comments regarding the presentations
must be received by July 9, 2018 at 5:00
p.m. E.D.T. (2 weeks after the meeting).
Publication of Proposed
Determinations: We intend to publish
our proposed determinations for new
test codes and our preliminary
determinations for reconsidered codes
(as described later in this notice in
section II. ‘‘Format’’) for CY 2019 by
early September 2018.
Deadline for Submission of Written
Comments Related to Proposed
Determinations: Comments in response
to the preliminary determinations will
be due by early October 2018.
Where to Submit Written Comments:
Interested parties should submit all
written comments on presentations and
preliminary determinations to the
address specified in the ADDRESSES
section of this notice or electronically to
our CLFS dedicated email box, CLFS_
[email protected]
(the specific date for the publication of
these determinations on the CMS
website, as well as the deadline for
submitting comments regarding these
determinations, will be published on
the CMS website).
ADDRESSES: The Annual Laboratory
Public Meeting will be held in the main
auditorium of the Centers for Medicare
& Medicaid Services (CMS), Central
Building, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
FOR FURTHER INFORMATION CONTACT:
Glenn McGuirk, (410) 786–5723.
SUPPLEMENTARY INFORMATION:
I. Background
Section 531(b) of the Medicare,
Medicaid, and SCHIP Benefits
Improvement and Protection Act of
2000 (BIPA) (Pub. L. 106–554) required
the Secretary of the Department of
Health and Human Services (the
Secretary) to establish procedures for
coding and payment determinations for
new clinical diagnostic laboratory tests
under Part B of title XVIII of the Social
Security Act (the Act) that permit public

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consultation in a manner consistent
with the procedures established for
implementing coding modifications for
International Classification of Diseases
(ICD–9–CM) (now, ICD–10–CM). The
procedures and clinical laboratory fee
schedule (CLFS) public meeting
announced in this notice for new tests
are in accordance with the procedures
published on November 23, 2001 in the
Federal Register (66 FR 58743) to
implement section 531(b) of BIPA.
Section 942(b) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173) added section 1833(h)(8) of
the Act. Section 1833(h)(8)(A) of the Act
requires the Secretary to establish by
regulation procedures for determining
the basis for, and amount of, payment
for any clinical diagnostic laboratory
test for which a new or substantially
revised Healthcare Common Procedure
Coding System (HCPCS) code is
assigned on or after January 1, 2005
(hereinafter referred to as ‘‘new tests’’).
A code is considered to be substantially
revised if there is a substantive change
to the definition of the test or procedure
to which the code applies (such as, a
new analyte or a new methodology for
measuring an existing analyte-specific
test). (See section 1833(h)(8)(E)(ii) of the
Act and 42 CFR 414.502).
Section 1833(h)(8)(B) of the Act sets
forth the process for determining the
basis for, and the amount of, payment
for new tests. Pertinent to this notice,
sections 1833(h)(8)(B)(i) and (ii) of the
Act require the Secretary to make
available to the public a list that
includes any such test for which
establishment of a payment amount is
being considered for a year and, on the
same day that the list is made available,
causes to have published a notice in the
Federal Register of a meeting to receive
comments and recommendations
(including accompanying data on which
recommendations are based) from the
public on the appropriate basis for
establishing payment amounts for the
tests on such list. This list of codes for
which the establishment of a payment
amount under the CLFS is being
considered for CY 2019 will be posted
on the CMS website concurrent with the
publication of this notice and may be
updated prior to the Annual Laboratory
Public Meeting. The Annual Laboratory
Public Meeting list of codes can be
found on the CMS website at http://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
ClinicalLabFeeSched/
index.html?redirect=/
ClinicalLabFeeSched/. Section
1833(h)(8)(B)(iii) of the Act requires that
we convene the public meeting not less

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