Proposed Data Collections Submitted for Public Comment and Recommendations, 66934-66935 [2013-26693]
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Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
compared with the open biopsy
technique in the diagnosis of a breast
abnormality?
III. What clinician and facility factors
influence the harms of core-needle
breast biopsy when compared with the
open biopsy technique in the diagnosis
of a breast abnormality?
Question 3
How do open biopsy and various
core-needle techniques differ in terms of
patient preference, availability, costs,
availability of qualified pathologist
interpretations, and other factors that
may influence choice of a particular
technique?
Study Eligibility Criteria (PICOTS:
Population, Intervention, Comparators,
Outcomes, Timing, and Setting)
Population
The population for all KQs is women
who have been referred for biopsy for
the diagnosis of primary breast cancer
(including multifocal and bilateral
disease) following self-examination,
physical examination, or screening
mammography. Studies carried out in
women at high baseline risk of breast
cancer (e.g., due to BRCA mutations)
will therefore be included; however
studies carried out in women who have
been previously diagnosed with breast
cancer and are being examined for
recurrence will be excluded a.
tkelley on DSK3SPTVN1PROD with NOTICES
Interventions
For all KQs, the intervention is a coreneedle biopsy done to evaluate whether
a breast lesion is malignant. Other uses
of biopsy techniques (e.g., use of biopsy
to examine the sentinel lymph nodes in
women with an established diagnosis of
breast cancer) are excluded.
Comparators (Reference Standard and
Comparator Index Tests)
For test performance outcomes (KQ 1)
the reference standard is either open
surgical biopsy or follow-up by clinical
examination and/or mammography for
at least 6 months. The diagnostic
performance of each core biopsy
technique (each index test) will be
quantified versus the reference
standard b. The comparative diagnostic
performance of alternative core-needle
biopsy techniques is also of interest c.
For harms and patient-relevant
outcomes (outcomes other than
diagnostic performance; KQs 2 and 3)
the comparators are:
I. Open surgical biopsy
II. Follow-up by clinical examination
and/or mammography for at least 6
months
III. Alternative core-needle biopsy
methods (e.g., stereotactic
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mammography vs. ultrasound to
locate the breast lesion; use vs.
nonuse of vacuum assistance to
extract tissue samples)
Outcomes
I. For KQ 1, test performance
outcomes, as assessed by the following
measures:
A. Sensitivity (proportion of cancerous
tumors detected by the reference
standard that are also detected by
core-needle biopsy)
B. False-negative rate (proportion of
negative findings according to coreneedle biopsy that are classified as
positive by the reference standard)
C. The underestimation rate for atypical
ductal hyperplasia (ADH;
proportion of core needle biopsy
findings of ADH that are found to
be malignant according to the
reference standard)
D. The underestimation rate for DCIS
(proportion of core-needle biopsy
findings of DCIS that are found to
be invasive according to the
reference standard)
II. For KQ 2:
A. Rate of inconclusive biopsy findings
(e.g., inadequate sampling of the
lesion)
B. Repeat biopsy rate
C. Subsequent false-positive and falsenegative rates on mammography
D. Dissemination (seeding) of cancerous
cells along the needle track
E. Patient-centered outcomes (including
bruising, bleeding or hematomas,
pain, use of pain medication,
infections, fainting or near fainting,
and time to recover)
III. For KQ 3:
A. Patient-relevant outcomes
1. Patient preferences for specific
procedures
2. Cosmetic results
3. Quality of life
4. Anxiety and other psychological
outcomes
5. Time to complete tumor removal
(for women with cancer)
6. Recurrence rate (for women with
cancer, including local, regional,
and distant recurrence)
7. Cancer-free survival and overall
survival
B. Resource use and logistics
1. Costs
2. Resource utilization other than cost
(number of additional surgical
procedures [e.g., re-excisions,
procedural time])
3. Subsequent surgical procedures
4. Wait time for test results
C. Availability of technology and
relevant expertise
1. Physician experience
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2. Availability of equipment
3. Availability of (qualified)
pathologists to evaluate biopsy
samples
Timing
Duration of clinical and/or
mammographic follow-up must be at
least 6 months in studies where open
surgical biopsy was not performed.
Setting
Studies in all geographic locations
and care settings will be evaluated,
including general hospitals, academic
medical centers, and ambulatory
surgical centers, among others.
Explanation to References in
Population and Interventions Sections
Above
a The original review excluded studies
carried out in women at high risk of breast
cancer; however, magnetic resonance
imaging (MRI)-guided biopsy, which has
been identified as a topic of interest for the
updated review, is used mainly in this subset
of patients. For this reason, following
extensive discussions with the TEP
(Technical Expert Panel), we decided to
broaden the scope of the review to cover
women at high risk for cancer. In effect, this
will be a de novo review with respect to this
population subset.
b Most assessments of diagnostic
performance quantify the sensitivity and the
specificity of each index test—here each
core-needle biopsy technique. Sensitivity and
specificity are probabilities conditional on
true disease status and are noncomparative in
nature. The reference standard is used in
their definition and is not a ‘‘comparator
test.’’
c That is, differences or ratios of
sensitivities and of specificities between
alternative core-needle biopsy techniques.
Dated: October 31, 2013.
Richard Kronick,
AHRQ Director.
[FR Doc. 2013–26617 Filed 11–6–13; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–14–0026]
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
E:\FR\FM\07NON1.SGM
07NON1
Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
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.
Proposed Project
Report of Verified Case of
Tuberculosis (RVCT), (OMB No. 0920–
0026 exp. 5/31/2014)—Extension—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In the United States, an estimated 10
to 15 million people are infected with
Mycobacterium tuberculosis and about
10% of these persons will develop
tuberculosis (TB) disease at some point
in their lives. The purpose of this
project is to continue ongoing national
tuberculosis surveillance using the
standardized Report of Verified Case of
Tuberculosis (RVCT). Data collected
using the RVCT help state and federal
infectious disease officials to assess
changes in the diagnosis and treatment
of TB, monitor trends in TB
epidemiology and outbreaks, and
develop strategies to meet the national
goal of TB elimination.
CDC currently conducts and
maintains the national TB surveillance
system (NTSS) pursuant to the
provisions of Section 301(a) of the
Public Service Act [42 U.S.C. 241] and
Section 306 of the Public Service Act
[42 U.S.C. 241(a)]. Data are collected by
60 reporting areas (the 50 states, the
District of Columbia, New York City,
Puerto Rico, and 7 jurisdictions in the
Pacific and Caribbean). The last major
revision of the RVCT data collection
66935
instrument was approved in 2009, in
consultation with CDC’s Division of
Tuberculosis Elimination (DTBE), state
and local health departments, and
partner organizations including the
National TB Controllers Association, the
Council for State and Territorial
Epidemiologists, and the Advisory
Committee for the Elimination of
Tuberculosis. No revisions to the RVCT
are proposed in this data collection
extension request.
CDC publishes an annual report using
RVCT data to summarize national TB
statistics and also periodically conducts
special analyses for publication to
further describe and interpret national
TB data. These data assist in public
health planning, evaluation, and
resource allocation. Reporting areas also
review and analyze their RVCT data to
monitor local TB trends, evaluate
program success, and focus resources to
eliminate TB.
No other Federal agency collects this
type of national TB data. In addition to
providing technical assistance on the
use of RVCT, CDC provides technical
support for reporting software. In this
request, CDC is requesting approval for
approximately 5,810 burden hours.
There is no cost to respondents except
for their time.
ESTIMATE OF ANNUALIZED BURDEN TABLE
Types of respondents
Form name
Number of
responses per
respondent
Number of
respondents
Average burden
per response
(in hours)
Total burden
(in hours)
Local, state, and territorial health departments ...........................................
RVCT Form
60
166
35/60
5,810
Total ................................................
..............................
..............................
..............................
..............................
5,810
LeRoy 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. 2013–26693 Filed 11–6–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
tkelley on DSK3SPTVN1PROD with NOTICES
[60-Day–14–14BA]
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
VerDate Mar<15>2010
16:24 Nov 06, 2013
Jkt 232001
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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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.
Proposed Project
Annual Survey of the National Breast
and Cervical Cancer Early Detection
Program (NBCCEDP) Grantees—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
To improve access to cancer
screening, Congress passed the Breast
and Cervical Cancer Mortality
Prevention Act of 1990 (Public Law
101–354) which directed CDC to create
E:\FR\FM\07NON1.SGM
07NON1
]]>Agencies
[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66934-66935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26693]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-14-0026]
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
[[Page 66935]]
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.
Proposed Project
Report of Verified Case of Tuberculosis (RVCT), (OMB No. 0920-0026
exp. 5/31/2014)--Extension--National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
In the United States, an estimated 10 to 15 million people are
infected with Mycobacterium tuberculosis and about 10% of these persons
will develop tuberculosis (TB) disease at some point in their lives.
The purpose of this project is to continue ongoing national
tuberculosis surveillance using the standardized Report of Verified
Case of Tuberculosis (RVCT). Data collected using the RVCT help state
and federal infectious disease officials to assess changes in the
diagnosis and treatment of TB, monitor trends in TB epidemiology and
outbreaks, and develop strategies to meet the national goal of TB
elimination.
CDC currently conducts and maintains the national TB surveillance
system (NTSS) pursuant to the provisions of Section 301(a) of the
Public Service Act [42 U.S.C. 241] and Section 306 of the Public
Service Act [42 U.S.C. 241(a)]. Data are collected by 60 reporting
areas (the 50 states, the District of Columbia, New York City, Puerto
Rico, and 7 jurisdictions in the Pacific and Caribbean). The last major
revision of the RVCT data collection instrument was approved in 2009,
in consultation with CDC's Division of Tuberculosis Elimination (DTBE),
state and local health departments, and partner organizations including
the National TB Controllers Association, the Council for State and
Territorial Epidemiologists, and the Advisory Committee for the
Elimination of Tuberculosis. No revisions to the RVCT are proposed in
this data collection extension request.
CDC publishes an annual report using RVCT data to summarize
national TB statistics and also periodically conducts special analyses
for publication to further describe and interpret national TB data.
These data assist in public health planning, evaluation, and resource
allocation. Reporting areas also review and analyze their RVCT data to
monitor local TB trends, evaluate program success, and focus resources
to eliminate TB.
No other Federal agency collects this type of national TB data. In
addition to providing technical assistance on the use of RVCT, CDC
provides technical support for reporting software. In this request, CDC
is requesting approval for approximately 5,810 burden hours. There is
no cost to respondents except for their time.
Estimate of Annualized Burden Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Types of respondents Form name Number of responses per per response (in Total burden (in
respondents respondent hours) hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local, state, and territorial health departments......... RVCT Form 60 166 35/60 5,810
����������������������������������������������������������
Total................................................ ................. ................. ................. ................. 5,810
--------------------------------------------------------------------------------------------------------------------------------------------------------
LeRoy 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. 2013-26693 Filed 11-6-13; 8:45 am]
BILLING CODE 4163-18-P
