Proposed Data Collections Submitted for Public Comment and Recommendations, 42956-42957 [2013-17263]
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42956
Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices
(e.g., overtreatment,
undertreatment).
Comparators
• Any direct comparisons of the
imaging tests of interest
• Any direct comparisons of
variations of any of the imaging tests of
interest (e.g., diffusion-weighted MRI vs.
T2-weighted MRI)
Comparators thought to be of
particular clinical interest are listed
below:
• For colon cancer: A contrastenhanced CT of the chest, abdomen, and
pelvis versus whole-body PET/CT
versus a contrast-enhanced MRI of the
chest, abdomen, and pelvis
• For rectal cancer: A contrastenhanced CT of the abdomen and pelvis
versus an MRI of the abdomen and
pelvis
• For rectal cancer: Endoscopic
ultrasound versus MRI
• For suspected liver metastasis: CT
scan versus MRI or PET/CT of the
abdomen
• For suspected widespread
metastasis, CT of the chest, abdomen,
and pelvis versus whole-body PET/CT
or contrast-enhanced MRI of the chest,
abdomen, and pelvis
We note that this list is based on a
preliminary literature search and
discussions with a limited number of
clinicians and the Technical Expert
Panel (TEP). Thus, we do not anticipate
that the listed items cover all of the
comparisons of interest. We expect that
additional comparisons will be
identified during the literature review.
TKELLEY on DSK3SPTVN1PROD with NOTICES
Outcomes
• Test performance outcomes.
• Test performance (e.g., sensitivity,
specificity, understaging, and
overstaging) against a reference
standard test (pathological
examination, intraoperative
findings, clinical followup).
• Intermediate outcomes.
• Stage reclassification.
• Changes in therapeutic
management.
• Clinical outcomes.
• Overall mortality.
• Colorectal cancer–specific
mortality.
• Quality of life and anxiety.
• Need for additional staging tests,
including invasive procedures.
• Need for additional treatment,
including surgery, radiotherapy, or
chemotherapy.
• Resource utilization related to
testing and treatment (when
reported in the included studies).
• Adverse effects and harms.
• Harms of testing per se (e.g.,
radiation exposure).
• Harms from test-directed treatments
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Timing
• Primary staging.
• Interim restaging.
• Duration of followup will vary by
outcome (e.g., from no followup for test
performance measurements to many
years for mortality).
Setting
• Any setting will be considered.
Dated: July 11, 2013.
Carolyn M. Clancy,
AHRQ Director.
[FR Doc. 2013–17176 Filed 7–17–13; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–13–0307]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
The Gonococcal Isolate Surveillance
Project (GISP), OMB No. 0920–0307
exp. 12/31/2013)—Revision—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The purpose of this request is to
obtain Office of Budget and
Management (OMB) approval to revise
the data collection for the Gonococcal
Isolate Surveillance Project (GISP)
(OMB No. 0920–0307, expires 12/31/
2013). CDC seeks a three-year approval
to conduct the GISP project. Revisions
to this ICR consist of removing 4
variables from Form 1: Demographic/
Clinical Data. The four variables to be
removed are: (1) Total monthly number
of gonococcal infections; (2) date of
PO 00000
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Fmt 4703
Sfmt 4703
birth of the patient; (3) zip code of the
patient; and (4) reason for visit. The
variables to be removed have not proven
useful at the federal level and removal
of the variables will not increase or
decrease the burden. The objectives of
GISP are: (1) To monitor trends in
antimicrobial susceptibility of strains of
Neisseria gonorrhoeae in the United
States and (2) to characterize resistant
isolates. Surveillance of N. gonorrhoeae
antimicrobial resistance is important
because: (1) Nearly all gonococcal
infections are treated empirically and
susceptibility testing data are not
routinely available in clinical practice;
(2) N. gonorrhoeae has consistently
demonstrated the ability to develop
resistance to the antimicrobials used for
treatment; (3) effective treatment of
gonorrhea is a critical component of
gonorrhea control and prevention, and
(4) untreated or inadequately treated
gonorrhea can cause serious
reproductive health complications. GISP
is the only source in the United States
of critical national, regional, and sitespecific gonococcal antimicrobial
resistance data. GISP provides
information to support informed and
scientifically-based treatment
recommendations.
GISP was established in 1986 as a
voluntary surveillance project and now
involves 5 regional laboratories and 30
publicly funded sexually transmitted
disease (STD) clinics around the
country. The STD clinics submit up to
25 gonococcal specimens (or isolates)
per month to the regional laboratories,
which measure susceptibility of the
isolates to multiple antimicrobial drugs.
Limited demographic and clinical
information corresponding to the
isolates (and that do not allow
identification of the patient) are
submitted directly by the clinics to CDC.
During 1986–2012, GISP has
demonstrated the ability to effectively
achieve its objectives. The emergence of
resistance in the United States to
penicillin, tetracyclines, and
fluoroquinolones among N. gonorrhoeae
isolates was identified through GISP.
Increased prevalence of
fluoroquinolone-resistant N.
gonorrhoeae (QRNG), as documented by
GISP data, prompted CDC to update
treatment recommendations for
gonorrhea in CDC’s Sexually
Transmitted Diseases Treatment
Guidelines, 2006 and to release an
MMWR article stating that CDC no
longer recommended fluoroquinolones
for treatment of gonococcal infections.
Recently, GISP isolates demonstrated
increasing minimum inhibitory
concentrations of cefixime, which can
be an early warning of impending
E:\FR\FM\18JYN1.SGM
18JYN1
42957
Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices
resistance. This worrisome trend
prompted CDC to again update
treatment recommendations and no
longer recommend the use of cefixime
as first-line treatment for gonococcal
infections.
Under the GISP protocol, each of the
30 clinics submit an average of 20
isolates per clinic per month (i.e., 240
times per year) recorded on Form 1:
Demographic/Clinical Data. The
estimated time for clinical personnel to
abstract data for Form 1: Demographic/
Clinical Data is 11 minutes per
response.
Each of the five Regional laboratories
receives and processes approximately
20 isolates from each referring clinic per
month (i.e., 121 isolates per regional
laboratory per month [based on 2011
specimen volume]) using Form 2:
Antimicrobial Susceptibility Testing.
For Form 2: Antimicrobial
Susceptibility Testing, the annual
frequency of responses per respondent
is 1,452 (121 isolates × 12 months).
Based on previous laboratory
experience, the estimated burden of
completing Form 2 for each
participating laboratory is 1 hour per
response, which includes the time
required for laboratory processing of the
patient’s isolate, gathering and
maintaining the data needed, and
completing and reviewing the collection
of information. For Form 3: Control
Strain Susceptibility Testing, a
‘‘response’’ is defined as the processing
and recording of Regional laboratory
data for a set of seven control strains. It
takes approximately 12 minutes to
process and record the Regional
laboratory data on Form 3 for one set of
seven control strains, of which there are
4 sets. The number of responses per
respondent is 48 (4 sets × 12 months).
There are no additional costs to
respondents. The total estimated annual
burden hours are 8,628.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Clinic .......................................
Laboratory ...............................
Demographic Clinical Data Form 1 ........................................
Antimicrobial Susceptibility Testing Form 2 ...........................
Control Strain Susceptibility Testing Form 3 .........................
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. 2013–17263 Filed 7–17–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Comments on the collection(s) of
information must be received by the
OMB desk officer by August 19, 2013:
DATES:
[Document Identifier CMS–10062, CMS–
10146, CMS–10191, CMS–10308, CMS–R–43
and CMS–10453]
ACTION:
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, or Email:
OIRA_submission@omb.eop.gov .
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
ADDRESSES:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
30
5
5
Number of
responses per
respondent
240
1,452
48
Average
burden per
response
(in hours)
11/60
1
12/60
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Collection of
Diagnostic Data from Medicare
Advantage Organizations for Risk
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18JYN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 138 (Thursday, July 18, 2013)]
[Notices]
[Pages 42956-42957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17263]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-0307]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC or
by fax to (202) 395-5806. Written comments should be received within 30
days of this notice.
Proposed Project
The Gonococcal Isolate Surveillance Project (GISP), OMB No. 0920-
0307 exp. 12/31/2013)--Revision--National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The purpose of this request is to obtain Office of Budget and
Management (OMB) approval to revise the data collection for the
Gonococcal Isolate Surveillance Project (GISP) (OMB No. 0920-0307,
expires 12/31/2013). CDC seeks a three-year approval to conduct the
GISP project. Revisions to this ICR consist of removing 4 variables
from Form 1: Demographic/Clinical Data. The four variables to be
removed are: (1) Total monthly number of gonococcal infections; (2)
date of birth of the patient; (3) zip code of the patient; and (4)
reason for visit. The variables to be removed have not proven useful at
the federal level and removal of the variables will not increase or
decrease the burden. The objectives of GISP are: (1) To monitor trends
in antimicrobial susceptibility of strains of Neisseria gonorrhoeae in
the United States and (2) to characterize resistant isolates.
Surveillance of N. gonorrhoeae antimicrobial resistance is important
because: (1) Nearly all gonococcal infections are treated empirically
and susceptibility testing data are not routinely available in clinical
practice; (2) N. gonorrhoeae has consistently demonstrated the ability
to develop resistance to the antimicrobials used for treatment; (3)
effective treatment of gonorrhea is a critical component of gonorrhea
control and prevention, and (4) untreated or inadequately treated
gonorrhea can cause serious reproductive health complications. GISP is
the only source in the United States of critical national, regional,
and site-specific gonococcal antimicrobial resistance data. GISP
provides information to support informed and scientifically-based
treatment recommendations.
GISP was established in 1986 as a voluntary surveillance project
and now involves 5 regional laboratories and 30 publicly funded
sexually transmitted disease (STD) clinics around the country. The STD
clinics submit up to 25 gonococcal specimens (or isolates) per month to
the regional laboratories, which measure susceptibility of the isolates
to multiple antimicrobial drugs. Limited demographic and clinical
information corresponding to the isolates (and that do not allow
identification of the patient) are submitted directly by the clinics to
CDC.
During 1986-2012, GISP has demonstrated the ability to effectively
achieve its objectives. The emergence of resistance in the United
States to penicillin, tetracyclines, and fluoroquinolones among N.
gonorrhoeae isolates was identified through GISP. Increased prevalence
of fluoroquinolone-resistant N. gonorrhoeae (QRNG), as documented by
GISP data, prompted CDC to update treatment recommendations for
gonorrhea in CDC's Sexually Transmitted Diseases Treatment Guidelines,
2006 and to release an MMWR article stating that CDC no longer
recommended fluoroquinolones for treatment of gonococcal infections.
Recently, GISP isolates demonstrated increasing minimum inhibitory
concentrations of cefixime, which can be an early warning of impending
[[Page 42957]]
resistance. This worrisome trend prompted CDC to again update treatment
recommendations and no longer recommend the use of cefixime as first-
line treatment for gonococcal infections.
Under the GISP protocol, each of the 30 clinics submit an average
of 20 isolates per clinic per month (i.e., 240 times per year) recorded
on Form 1: Demographic/Clinical Data. The estimated time for clinical
personnel to abstract data for Form 1: Demographic/Clinical Data is 11
minutes per response.
Each of the five Regional laboratories receives and processes
approximately 20 isolates from each referring clinic per month (i.e.,
121 isolates per regional laboratory per month [based on 2011 specimen
volume]) using Form 2: Antimicrobial Susceptibility Testing. For Form
2: Antimicrobial Susceptibility Testing, the annual frequency of
responses per respondent is 1,452 (121 isolates x 12 months). Based on
previous laboratory experience, the estimated burden of completing Form
2 for each participating laboratory is 1 hour per response, which
includes the time required for laboratory processing of the patient's
isolate, gathering and maintaining the data needed, and completing and
reviewing the collection of information. For Form 3: Control Strain
Susceptibility Testing, a ``response'' is defined as the processing and
recording of Regional laboratory data for a set of seven control
strains. It takes approximately 12 minutes to process and record the
Regional laboratory data on Form 3 for one set of seven control
strains, of which there are 4 sets. The number of responses per
respondent is 48 (4 sets x 12 months). There are no additional costs to
respondents. The total estimated annual burden hours are 8,628.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Clinic............................. Demographic Clinical Data 30 240 11/60
Form 1.
Laboratory......................... Antimicrobial 5 1,452 1
Susceptibility Testing
Form 2.
Control Strain 5 48 12/60
Susceptibility Testing
Form 3.
----------------------------------------------------------------------------------------------------------------
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. 2013-17263 Filed 7-17-13; 8:45 am]
BILLING CODE 4163-18-P
