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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.

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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

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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 [email protected].
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

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
[60-Day–14–14BA]
tkelley on DSK3SPTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

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 [email protected].
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

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