Att F_60dy FRN (published)

Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
KQ5: What is the effectiveness of
CRT–D versus CRT–P in reducing heart
failure symptoms, improving
myocardial function, reducing
hospitalization and/or improving
survival in patients with LVEF ≤35%
and a QRS duration ≥120ms?
KQ6: What are the adverse effects or
complications associated with CRT–D
versus CRT–P implantation?
KQ7a: What is the effectiveness of
alternative CRT techniques (adaptive
CRT, multipoint pacing, His bundle
pacing, quadripolar) versus
conventional CRT techniques in
reducing heart failure symptoms,
improving myocardial function,
reducing hospitalization and/or
improving survival in patients with an
LVEF ≤35% and a QRS duration
≥120ms?
KQ7b: Does the effectiveness of
alternative CRT techniques (adaptive
CRT, multipoint pacing, His bundle
pacing, quadripolar) vary by the
following subgroups:
Age
Gender
Cardiomyopathy subtype
QRS morphology
Left ventricular ejection fraction
NYHA class
Atrial fibrillation
KQ8: What are the adverse effects or
complications associated with
alternative CRT techniques (adaptive
CRT, multipoint pacing, His bundle
pacing, quadripolar)?
KQ9: What is the effectiveness of His
bundle pacing or CRT versus RV pacing
in reducing heart failure symptoms,
improving myocardial function,
reducing hospitalization and/or
improving survival in patients with an
LVEF between ≥36% to ≤50% and
atrioventricular block?
KQ10: What are the adverse effects or
complications associated with His
bundle pacing or CRT versus RV pacing
in reducing heart failure symptoms,
improving myocardial function,
reducing hospitalization and/or
improving survival in patients with an
LVEF between ≥36% to ≤50% and
atrioventricular block?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)

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Population(s)
KQ1–KQ8: Subjects of age ≥18, with
a left ventricular ejection fraction ≤35%
and a QRS duration ≥120 ms.
KQ9–10: Subjects of age ≥18, with an
LVEF between ≥36% to ≤50% and
atrioventricular block [We will use a
recently published systematic review to
address KQs 9–10].

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Interventions

KQ2, 4, 6, and 8 (Harms)

• Cardiac resynchronization therapy
with a defibrillator (CRT–D)
• Cardiac resynchronization without a
defibrillator (CRT–P)
• Alternative cardiac resynchronization
therapy alternative CRT techniques
(adaptive CRT, multipoint pacing, His
bundle pacing, quadripolar)

• Outcomes from CRT–D, CRT–P, and
alternative CRT techniques at any
time point
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2019–02985 Filed 2–20–19; 8:45 am]
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Comparators
• CRT–D vs. implantable cardioverter
defibrillator (ICD)
• CRT–P vs. optimal medical therapy
• CRT–D vs. CRT–P
• Alternative CRT techniques versus
conventional CRT techniques
Outcomes
KQ1a, 3a, 5, and 7a (Effectiveness)
Clinical outcomes
• 6 minute hall walk distance
• Left ventricular end diastolic volume/
volume index
• Left ventricular end systolic volume/
volume index
• Left ventricular ejection fraction
• Packer Score 17
Quality of life
• Minnesota Living with Heart Failure
Inventory Score
• Kansas City Cardiomyopathy Score
• SF–36
Health outcomes
• Hospitalizations for heart failure
• All-cause mortality
KQ2, KQ4, KQ6, and KQ8 (Harms)
•
•
•
•
•
•
•
•
•
•

Procedure related complications
Length of hospital stay
Pneumothorax
Pocket hematoma
Device Infection
Cardiac perforation/tamponade
Lead dislodgement
Ventricular arrhythmias
Death (within a week)
Inappropriate ICD shocks (CRT–D and
alternative CRT–D techniques only)
Age
Gender
Cardiomyopathy subtype
QRS morphology
Left ventricular ejection fraction
NYHA class
Atrial fibrillation

Timing
KQ1a, 3a, 5, and 7a, (Effectiveness)
• Outcomes from CRT–D, CRT–P, and
alternative CRT techniques at 3–6
months, 1 year, and ≥2 year endpoints

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Centers for Disease Control and
Prevention
[60-Day–19–19SJ; Docket No. CDC–2019–
0004]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 Preventive Health and Health
Services Block Grant Center for State,
Tribal, Local and Territorial Support
(CSTLTS), Centers for Disease Control
and Prevention (CDC). This study will
allow CDC to monitor awardees
progress, identify activities and
personnel supported with Block Grant
funding, conduct compliance reviews of
Block Grant awardees, and promote the
use of evidence-based guidelines and
interventions.

SUMMARY:

CDC must receive written
comments on or before April 22, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0004 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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
DATES:

KQ1b, KQ3b, 7b (Subgroups)
•
•
•
•
•
•
•

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
5. Assess information collection costs.

change, all relevant comments to
Regulations.gov.
Note: Submit all comments through the
Federal eRulemaking portal (regulations.gov)
or by U.S. mail to the address listed above.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
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
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.
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FOR FURTHER INFORMATION CONTACT:

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Proposed Project
Preventive Health and Health Services
Block Grant (OMB No. 0920–0106, exp.
7/31/2019)—Extension—Center for
State, Tribal, Local and Territorial
Support (CSTLTS), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Preventive Health and Health
Services Block Grant (PHHSBG), Public
Law 102–531, Public Health Service
Act, provides funds to 61 awardees (50
states, the District of Columbia, two
American Indian Tribes, and eight U.S.
territories) and provides funding to
address locally-defined public health
needs in innovative ways. Block Grants
allow awardees to prioritize the use of
funds to address leading causes of death
and disability. Block Grant funding also
provides awardees with the ability to
respond rapidly to emerging health
issues, including outbreaks of diseases
or pathogens. The PHHS Block Grant
program is authorized by sections 1901–
1907 of the Public Health Service Act.
CDC currently collects information
from Block Grant awardees to monitor
their objectives and activities
(Preventive Health and Health Services
Block Grant, OMB No. 0920–0106, exp.
7/31/2019). Each awardee is required to
submit an annual application for
funding (Work Plan) that describes its
objectives and the populations to be
addressed, and an Annual Report that
describes activities, progress toward
objectives, and Success Stories which
highlight the improvements Block Grant
programs have made and the value of
program activities. Information is
submitted electronically through the
web-based Block Grant Information
Management System (BGMIS).
CDC PHHS Block Grant program has
benefited from this system by efficiently
collecting mandated information in a
format that allows data to be easily
retrieved in standardized reports. The
electronic format verifies completeness
of data at data entry prior to submission
to CDC, reducing the number of resubmissions that are required to provide
concise and complete information.
The Work Plan and Annual Report are
designed to help Block Grant awardees
attain their goals and meet reporting
requirements specified in the program’s

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authorizing legislation. Each Work Plan
objective is defined in SMART format
(Specific, Measurable, Achievable,
Realistic and Time-based), and includes
a specified start date and end date.
Block Grant activities adhere to the
Healthy People (HP) framework
established by the Department of Health
and Human Services (HHS). The current
version of the BGMIS associates each
awardee-defined activity with a specific
HP National Objective, and identifies
the location where funds are applied.
There are no changes to the number
of Block Grant awardees (respondents),
or the estimated burden per response for
the Work Plan or the Annual Report.
The BGMIS does not collect data related
to assessing aggregate outcomes. A
separate information collection request,
designed to assess cross-cutting outputs
and outcomes resulting from Block
Grant activities has been developed and
is undergoing public comment.
Legislation requires awardees to be
accountable for funds they receive by
evaluating and reporting on program
activities and health status on an annual
basis. The BGMIS system allows CDC
and awardees to measure performance,
identifying the extent to which
objectives were met and identifying the
most highly successful program
interventions. CDC requests OMB
approval to continue the Block Grant
information collection for three years.
CDC will continue to use the BGMIS to
monitor awardee progress, identify
activities and personnel supported with
Block Grant funding, conduct
compliance reviews of Block Grant
awardees, and promote the use of
evidence-based guidelines and
interventions. There are no changes to
the number of respondents or the
estimated annual burden per
respondent. The Work Plan and the
Annual Report will be submitted
annually. The estimated burden per
response for the Work Plan is 20 hours
and the estimated burden per response
for the Annual Report is 15 hours.
Participation in this information
collection is required for Block Grant
awardees. There are no costs to
respondents other than their time.
Awardees continue to submit Success
Stories with their Annual Progress
reports through BGMIS, without
changes.

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Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents

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

1
1

20
15

1,220
915

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

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

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

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

2,135

BILLING CODE 4163–18–P

SUPPLEMENTARY INFORMATION:

Centers for Disease Control and
Prevention

Background

[Docket No. CDC–2019–0003]

National Health and Nutrition
Examination Survey (NHANES) DNA
Specimens: Guidelines for Proposals
To Use Samples and Cost Schedule
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces
reopening of the National Center for
Health Statistics’ (NCHS) National
Health and Nutrition Examination
Survey (NHANES) DNA Specimen
Repository for research proposals. Blood
samples for DNA purification were
collected from study participants, with
their permission, during NHANES III
(1991–1994), NHANES 1999–2000,
NHANES 2001–02, NHANES 2007–08,
NHANES 2009–10, and NHANES 2011–
12 (Office of Management and Budget
Control Numbers # 0920–0237/0920–
0950). DNA samples are being made
available to the research community for
genetic testing. The information gained
from research using these samples can
be combined with the extensive amount
of information available in NHANES
which describes the prevalence/trends
of disease, nutrition, risk behaviors, and
environmental exposures in the US
population.
A more complete description of this
program follows.
FOR FURTHER INFORMATION CONTACT:
NHANES Genetic Project Officer, Jody
McLean M.P.H., Division of Health and
SUMMARY:

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Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road,
Hyattsville, MD 20782, Phone: 301–
458–4683, Fax: 301–458–4029, Email:
NHANESgenetics@cdc.gov.
Authority: Sections 301, 306 and 308 of the
Public Health Service Act (42 U.S.C. 241,
2421 and 242m).

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Total burden
(in hours)

61
61

[FR Doc. 2019–02917 Filed 2–20–19; 8:45 am]

17:08 Feb 20, 2019

Average
burden per
response
(in hours)

Work Plan .........................................
Annual Report ..................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

VerDate Sep<11>2014

Number of
responses per
respondent

Number of
respondents

Form name

NHANES is a program of periodic
surveys conducted by NCHS.
Examination surveys conducted since
1960 by NCHS have provided national
estimates of the health and nutritional
status of the U.S. civilian noninstitutionalized population. The goals
of NHANES are (1) to estimate the
number and percentage of people in the
U.S. population and designated
subgroups with selected diseases and
risk factors for those diseases; (2) to
monitor trends in the prevalence,
awareness, treatment and control of
selected diseases; (3) to monitor trends
in risk behaviors and environmental
exposures; (4) to analyze risk factors for
selected diseases; (5) to study the
relation among diet, nutrition and
health; (6) to explore emerging public
health issues and new technologies; and
(7) to establish and maintain a national
probability sample of baseline
information on health and nutritional
status.
The availability of the NHANES III
DNA samples has been previously
announced in 2002 (67 FR 51585), 2006
(71 FR 22248), 2007 (72 FR 59094), 2009
(74 FR 45644), 2010 (75 FR 32191) and
2016 (81 FR 69822). NHANES III Phase
II DNA samples (1991–1994) are from
participants ages 12 or older (see
NHANES III DNA Samples section for a
description). For details about available
NHANES III non-genetic data see
https://wwwn.cdc.gov/nchs/nhanes/
nhanes3/default.aspx.
Beginning in 1999, NHANES became
a continuous, annual survey rather than
a periodic survey. For a variety of
reasons, including disclosure and
reliability issues, the survey data are

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released as public use data files every
two years. In addition to the analysis of
data from any two year cycle, it is
possible to combine two cycles to
increase sample size and analytic
options. Blood samples for DNA
purification were collected from
participants ages 20 years and older in
survey years 1999–2002 and 2007–12.
DNA samples are available as
collections from NHANES 1999–2002
(NHANES 1999–2000 and 2001–02
samples available as one collection),
and NHANES two-year cycles 2007–08,
2009–10, and 2011–12(see NHANES
1999–2002, 2007–08, 2009–10, and
2011–12 DNA samples section for a
description). The availability of the
NHANES 1999–2002 DNA samples has
been previously announced (2007 [72
FR 59094], 2009 [74 FR 45644], 2010 [75
FR 32191], and 2016 [81 FR 69822]).
The availability of the NHANES 2007–
08 DNA samples has been previously
announced (2009 [74 FR 45644], 2010
[75 FR 32191], and 2016 [81 FR 69822]).
The availability of the NHANES 2009–
10 DNA samples has been previously
announced (2016 [81 FR 69822]). The
data release cycle for the NHANES
corresponding to the period in which
samples were collected for DNA is
described in the following web links:
https://wwwn.cdc.gov/nchs/nhanes/
ContinuousNhanes/Default.
aspx?BeginYear=1999
https://wwwn.cdc.gov/nchs/nhanes/
ContinuousNhanes/Default.aspx?Be
ginYear=2001
https://wwwn.cdc.gov/nchs/nhanes/
continuousnhanes/default.aspx?
BeginYear=2007
https://wwwn.cdc.gov/nchs/nhanes/
ContinuousNhanes/Default.aspx?
BeginYear=2009
https://wwwn.cdc.gov/nchs/nhanes/
ContinuousNhanes/Default.aspx?
BeginYear=2011
Identifiable health information
collected in the NHANES is kept
confidential. During the informed
consent process, survey participants are
assured that data collected will be used
only for stated purposes and will not be
disclosed or released to others without
the consent of the individual in

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