Agency Forms Undergoing Paperwork Reduction Act Review, 34583-34585 [2018-15525]
Download as PDF
<![CDATA[
daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
proposing to relocate and consolidate its
Cincinnati-based functions and
personnel (approximately 550
employees) currently housed at the
three existing campuses to a new,
consolidated campus in Cincinnati.
Potential locations for the proposed
new campus were identified through a
comprehensive site selection process
conducted by GSA on behalf of CDC. In
June 2016, GSA issued a Request for
Expressions of Interest (REOI) seeking
potential sites capable of
accommodating the proposed new
campus. In response to the REOI, GSA
received seven expressions of interest.
Following an assessment of each site,
GSA found that only one site qualified
for further consideration (The Site). The
Site encompasses all land between
Martin Luther King Drive East to the
south, Harvey Avenue to the west,
Ridgeway Avenue to the north, and
Reading Road to the east in Cincinnati,
Ohio.
Under NEPA, as implemented by CEQ
Regulations (40 CFR parts 1500–1508),
Federal agencies are required to
evaluate the environmental effects of
their proposed actions and a range of
reasonable alternatives to the proposed
action before making a decision. On
February 9, 2018, in accordance with
NEPA, CDC published a Notice of
Availability announcing that a Draft EIS
for the proposed acquisition and
campus consolidation had been
prepared (83 FR 5774). The Draft EIS
evaluated the potential impacts of two
alternatives: The Proposed Action
Alternative (acquisition of the Site and
construction of a new, consolidated
CDC/NIOSH campus) and the No Action
Alternative (continued use of the
existing campuses for the foreseeable
future). Impacts on the following
resources were considered: Land use,
zoning, and plans; community facilities;
socioeconomics and environmental
justice; utilities and infrastructure;
visual quality; cultural resources;
transportation; geology, topography, and
soils; air quality; noise; and hazardous
substances.
Publication of the Draft EIS notice
initiated a 45-day review period, which
ended on March 26, 2018. During this
period, CDC received comments from
government agencies, a Native
American tribe, and the public. These
comments pertained to the proposed
action in general; the accessibility of the
proposed campus site for bicyclists;
historic buildings; traffic and air quality
impacts; sustainability; and the
potential displacement of neighborhood
residents.
All comments were considered when
preparing the Final EIS and responses to
VerDate Sep<11>2014
18:06 Jul 19, 2018
Jkt 244001
the comments are provided in the Final
EIS. No comment required substantive
revisions to the analyses presented in
the Draft EIS or to the alternatives
considered. The Final EIS identifies the
Proposed Action Alternative as CDC’s
Preferred Alternative.
CDC will make a decision on whether
to proceed with the proposed action
after August 20, 2018. At that time, CDC
will issue a Record of Decision
documenting and explaining its
decision based on the Final EIS.
Questions on the Final EIS and the
proposed action may be directed to:
Harry Marsh, Architect, Office of Safety,
Security and Asset Management
(OSSAM), Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
MS–K80, Atlanta, Georgia 30329–4027,
phone: (770) 488–8170, or email: cdccincinnati-eis@cdc.gov.
Dated: July 16, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2018–15410 Filed 7–19–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–18–0307]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request Gonococcal Isolate
Surveillance Project to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on February
5, 2018 to obtain comments from the
public and affected agencies. The CDC
received 2 non-substantive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
34583
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Gonococcal Isolate Surveillance
Project (0920–0307) (Exp. Date 02/28/
2019)—Revision—National Center for
HIV, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Gonococcal Isolate Surveillance
Project (GISP) was created in 1986 to
monitor trends in antimicrobial
susceptibilities of Neisseria gonorrhoeae
strains in the United States. GISP
continues to be a collaboration between
different branches of the CDC Division
of STD Prevention within the National
Center for HIV, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP),
selected regional laboratories and
selected state/local public health
departments and their associated STD
specialty care clinics in the U.S.
National organizations, local
jurisdictions and individuals use data
collected in GISP to understand and
prevent antibiotic resistance in N.
gonorrhoeae. Data from GISP are used to
establish a scientific basis for the
selection of gonococcal therapies and to
allow pro-active changes to treatment
guidelines before widespread resistance
and failures of treatment occur. To
increase capacity to detect and monitor
resistant gonorrhea and to improve the
specificity of GISP, this revision is being
E:\FR\FM\20JYN1.SGM
20JYN1
34584
Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
submitted to include collection of
additional isolates and data elements.
In the current approval period, GISP
isolates are only collected from males
and include <4% of reported male
gonorrhea cases in the United States.
This relatively limited scope likely
limits the speed with which new
resistance patterns are found and with
which public health officials can
respond. Published data suggest that
resistance in N. gonorrhoeae might
develop initially in non-genital
anatomic sites, such as the pharynx. It
has also been hypothesized that
susceptibility patterns may be different
among women. Upon receiving OMB
approval of the revision request, CDC
plans to begin including isolates from
the pharynx and other anatomic sites, as
well as from women. These changes are
expected to support public health efforts
to detect and respond to resistance more
quickly.
GISP surveillance can also be
strengthened by ensuring that GISP
surveillance is only being conducted on
N. gonorrhoeae and not on other similar
bacteria. Neisseria meningitidis can
cause clinical syndromes that are
indistinguishable from gonorrhea. Using
nucleic acid amplification tests (a more
specific diagnostic test) in conjunction
with bacterial culture from all anatomic
sites can ensure that non-gonococcal
bacteria are excluded from GISP data.
This is expected to strengthen the
accuracy and usefulness of GISP data.
Historically, healthcare providers at
approximately 30 participating sentinel
sites (i.e., STD clinic or multiple STD
clinics affiliated with a single public
health department) obtain urethral N.
gonorrhoeae isolates from the first 25
men with urethral gonorrhea each
month with occasional month-to-month
variability. With this revision, we are
now asking for a subset of sentinel sites
(10 out of 30 sites) to conduct enhanced
surveillance activities, collecting
additional isolates (including from the
pharynx, rectum, and cervix of exposed
persons) with a limited number of
additional data elements. We anticipate
that approximately 50 additional
isolates per month will be collected by
each of these 10 sites (total of
approximately 70 isolates per month per
enhanced surveillance site). All isolates
will be shipped each month to a
regional laboratory for antimicrobial
susceptibility testing. When isolates that
appear to be bacteria other than N.
gonorrhoeae are identified at one of the
ten sentinel sites conducting enhanced
surveillance, the isolate will be shipped
to the regional laboratory and then to
CDC. Based on informal discussions
with current GISP sentinel sites, we
anticipate that approximately 10 such
isolates will be identified at each site
per year. Sentinel sites that are not part
of this small subset will continue to
function as they already are.
Under this revision, the data
collection and reporting processes have
been streamlined to minimize burden.
All demographic/clinical data from the
sentinel sites, and antimicrobial
susceptibility testing results from the
regional laboratories, will be submitted
electronically (1) directly from the
sentinel site to the GISP data manager
at CDC through a secure data portal, (2)
through a secure GISP-web based
application, or (3) through the CDC
Secure Access Management Services
partner portal. To minimize burden,
comma-separated values (csv) files that
provide standardized structure of the
electronic data are provided to sentinel
sites and laboratories. Additionally, to
further minimize burden, the regional
laboratories will be able to extract
electronic data from electronic
laboratory information systems instead
of hand entering data and will no longer
be required to report control strain
testing results.
This project will not collect name,
social security number, or date of birth.
A Patient ID, a unique patient identifier
assigned by the site that allows for
linking of multiple isolates from a single
person at a single clinic visit and across
multiple clinic visits, is requested and
will be provided to CDC for purposes of
enhanced surveillance. Sensitive
information such as sex of sex partners,
HIV status, sex work exposure, and
injection drug use are collected. Patient
data are obtained through review of
medical records by the clinic staff and
included in collection reporting of
demographic/clinical information. All
personally identifiable information (PII)
is retained by the STD clinics that
treated the patient and is not recorded
with data sent to CDC or regional
laboratories. At sites where enhanced
surveillance will not occur isolates are
collected from patients as part of their
routine care when a gonorrhea infection
is suspected. The electronic GISP
database is stored on the CDC
mainframe computer and only approved
Division of STD Prevention (DSTDP)
staff have access rights to the data. As
part of the revision, we will continue to
systematically identify the risks and
potential effects of collecting,
maintaining, and disseminating PII and
to examine and evaluate alternative
processes for handling that information
to mitigate potential privacy risks and
risks to confidentiality.
The CDC has designated N.
gonorrhoeae as one of three ‘‘urgent’’
antibiotic resistance threats in the
United States. The CDC is requesting a
three-year OMB approval for this
revision, which directly responds to the
National Strategy for Combating
Antibiotic Resistant Bacteria by
improving and strengthening
surveillance of antimicrobial resistance
through GISP. This GISP data can help
monitor and evaluate the effectiveness
of public health interventions
conducted to support the National
Strategy for Combating AntibioticResistant Bacteria. Sentinel sites and
regional laboratories voluntarily apply
to participate in the GISP cooperative
agreement program. Once funded,
participation in the GISP information
collection and isolate processing plan is
required. The total estimated annualized
burden hours are 11,376. There are no
costs to respondents other than their
time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
daltland on DSKBBV9HB2PROD with NOTICES
Form name
Sentinel site conducting core surveillance .....
Sentinel site conducting enhanced surveillance.
Regional laboratory .........................................
Regional laboratory .........................................
Demographic/Clinical Data .............................
Demographic/Clinical Data .............................
20
10
240
840
11/60
12/60
Antimicrobial Susceptibility Testing Results ..
Control Strain Susceptibility Testing ..............
4
4
3,300
48
40/60
5/60
VerDate Sep<11>2014
18:06 Jul 19, 2018
Jkt 244001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Number of
respondents
Average
burden per
response
(in hours)
Type of
respondents
E:\FR\FM\20JYN1.SGM
20JYN1
Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
Jeffrey M. Zirger,
Acting 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. 2018–15525 Filed 7–19–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–18AMQ; Docket No. CDC–2018–
0061]
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 Assessing impact of the NIOSH
research. The goal of the generic
information collection request is to
improve the ability of NIOSH to assess
and demonstrate the extent to which its
various research efforts are likely to or
have led to improvements in workplace
safety and health.
DATES: CDC must receive written
comments on or before September 18,
2018.
SUMMARY:
You may submit comments,
identified by Docket No. CDC–2018–
0061 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
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
daltland on DSKBBV9HB2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
18:06 Jul 19, 2018
Jkt 244001
(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 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.
5. Assess information collection costs.
Proposed Project
Assessing impact of the NIOSH
research—New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Institute for
Occupational Safety and Health
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
34585
(NIOSH) is responsible for conducting
research and making recommendations
to prevent worker injury and illness, as
authorized in Section 20(a)(1) of the
Occupational Safety and Health Act (29
U.S.C. 669). NIOSH is strongly
committed to program evaluation as a
way to maximize its contributions to
improved occupational safety and
health. NIOSH is requesting a new
generic information collection request
for a three-year period that will support
the timely information collection
needed for upcoming program
evaluation activities, such as external
reviews of NIOSH research programs
(which fulfill a Government
Performance and Results Act (GPRA)
requirement, studies to understand the
economic value of NIOSH research,
process evaluations of NIOSH programs,
and evaluations of large research
projects. NIOSH needs to collect
information about research
dissemination and achieved outcomes
from key audiences (grantees, potential
NIOSH research users and relevant
safety and health experts) for
accountability and program
improvement purposes. NIOSH is
specifically interested in assessing
intermediate outcomes—the use of
NIOSH research products and findings
by external stakeholders and partners to
improve safety and health—as evidence
of research impact. Being able to collect
information on intermediate outcomes
from grantees, as well as past, present
and potential future users of NIOSH
research would allow us to provide
more robust evidence of use or adoption
of NIOSH research products or findings.
The evaluation findings and
recommendations from the various
program evaluation activities described
above will be used as an input for future
direction of the programs and
incorporated into analyses and reports
to either investigate the value of
NIOSH’s research, or improve program
operations to maximize impact. Data
will be collected through semistructured key informant interviews
with grantees, potential or known users
of NIOSH research and subject matter
experts in safety and health. NIOSH
estimates that 30 respondents will be
involved in phone interviews, which
would last between 30–60 minutes.
However, participants might be
burdened an additional hour reading the
invitation email and providing relevant
documents such as evidence of research
impact. Therefore, the estimated burden
for each participant is two hours. The
total estimated burden is 60 hours.
There is no cost to respondents other
than their time.
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34583-34585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15525]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-18-0307]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request Gonococcal Isolate Surveillance Project to the
Office of Management and Budget (OMB) for review and approval. CDC
previously published a ``Proposed Data Collection Submitted for Public
Comment and Recommendations'' notice on February 5, 2018 to obtain
comments from the public and affected agencies. The CDC received 2 non-
substantive comments related to the previous notice. This notice serves
to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Gonococcal Isolate Surveillance Project (0920-0307) (Exp. Date 02/
28/2019)--Revision--National Center for HIV, Viral Hepatitis, STD, and
TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The Gonococcal Isolate Surveillance Project (GISP) was created in
1986 to monitor trends in antimicrobial susceptibilities of Neisseria
gonorrhoeae strains in the United States. GISP continues to be a
collaboration between different branches of the CDC Division of STD
Prevention within the National Center for HIV, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP), selected regional laboratories and
selected state/local public health departments and their associated STD
specialty care clinics in the U.S. National organizations, local
jurisdictions and individuals use data collected in GISP to understand
and prevent antibiotic resistance in N. gonorrhoeae. Data from GISP are
used to establish a scientific basis for the selection of gonococcal
therapies and to allow pro-active changes to treatment guidelines
before widespread resistance and failures of treatment occur. To
increase capacity to detect and monitor resistant gonorrhea and to
improve the specificity of GISP, this revision is being
[[Page 34584]]
submitted to include collection of additional isolates and data
elements.
In the current approval period, GISP isolates are only collected
from males and include <4% of reported male gonorrhea cases in the
United States. This relatively limited scope likely limits the speed
with which new resistance patterns are found and with which public
health officials can respond. Published data suggest that resistance in
N. gonorrhoeae might develop initially in non-genital anatomic sites,
such as the pharynx. It has also been hypothesized that susceptibility
patterns may be different among women. Upon receiving OMB approval of
the revision request, CDC plans to begin including isolates from the
pharynx and other anatomic sites, as well as from women. These changes
are expected to support public health efforts to detect and respond to
resistance more quickly.
GISP surveillance can also be strengthened by ensuring that GISP
surveillance is only being conducted on N. gonorrhoeae and not on other
similar bacteria. Neisseria meningitidis can cause clinical syndromes
that are indistinguishable from gonorrhea. Using nucleic acid
amplification tests (a more specific diagnostic test) in conjunction
with bacterial culture from all anatomic sites can ensure that non-
gonococcal bacteria are excluded from GISP data. This is expected to
strengthen the accuracy and usefulness of GISP data.
Historically, healthcare providers at approximately 30
participating sentinel sites (i.e., STD clinic or multiple STD clinics
affiliated with a single public health department) obtain urethral N.
gonorrhoeae isolates from the first 25 men with urethral gonorrhea each
month with occasional month-to-month variability. With this revision,
we are now asking for a subset of sentinel sites (10 out of 30 sites)
to conduct enhanced surveillance activities, collecting additional
isolates (including from the pharynx, rectum, and cervix of exposed
persons) with a limited number of additional data elements. We
anticipate that approximately 50 additional isolates per month will be
collected by each of these 10 sites (total of approximately 70 isolates
per month per enhanced surveillance site). All isolates will be shipped
each month to a regional laboratory for antimicrobial susceptibility
testing. When isolates that appear to be bacteria other than N.
gonorrhoeae are identified at one of the ten sentinel sites conducting
enhanced surveillance, the isolate will be shipped to the regional
laboratory and then to CDC. Based on informal discussions with current
GISP sentinel sites, we anticipate that approximately 10 such isolates
will be identified at each site per year. Sentinel sites that are not
part of this small subset will continue to function as they already
are.
Under this revision, the data collection and reporting processes
have been streamlined to minimize burden. All demographic/clinical data
from the sentinel sites, and antimicrobial susceptibility testing
results from the regional laboratories, will be submitted
electronically (1) directly from the sentinel site to the GISP data
manager at CDC through a secure data portal, (2) through a secure GISP-
web based application, or (3) through the CDC Secure Access Management
Services partner portal. To minimize burden, comma-separated values
(csv) files that provide standardized structure of the electronic data
are provided to sentinel sites and laboratories. Additionally, to
further minimize burden, the regional laboratories will be able to
extract electronic data from electronic laboratory information systems
instead of hand entering data and will no longer be required to report
control strain testing results.
This project will not collect name, social security number, or date
of birth. A Patient ID, a unique patient identifier assigned by the
site that allows for linking of multiple isolates from a single person
at a single clinic visit and across multiple clinic visits, is
requested and will be provided to CDC for purposes of enhanced
surveillance. Sensitive information such as sex of sex partners, HIV
status, sex work exposure, and injection drug use are collected.
Patient data are obtained through review of medical records by the
clinic staff and included in collection reporting of demographic/
clinical information. All personally identifiable information (PII) is
retained by the STD clinics that treated the patient and is not
recorded with data sent to CDC or regional laboratories. At sites where
enhanced surveillance will not occur isolates are collected from
patients as part of their routine care when a gonorrhea infection is
suspected. The electronic GISP database is stored on the CDC mainframe
computer and only approved Division of STD Prevention (DSTDP) staff
have access rights to the data. As part of the revision, we will
continue to systematically identify the risks and potential effects of
collecting, maintaining, and disseminating PII and to examine and
evaluate alternative processes for handling that information to
mitigate potential privacy risks and risks to confidentiality.
The CDC has designated N. gonorrhoeae as one of three ``urgent''
antibiotic resistance threats in the United States. The CDC is
requesting a three-year OMB approval for this revision, which directly
responds to the National Strategy for Combating Antibiotic Resistant
Bacteria by improving and strengthening surveillance of antimicrobial
resistance through GISP. This GISP data can help monitor and evaluate
the effectiveness of public health interventions conducted to support
the National Strategy for Combating Antibiotic-Resistant Bacteria.
Sentinel sites and regional laboratories voluntarily apply to
participate in the GISP cooperative agreement program. Once funded,
participation in the GISP information collection and isolate processing
plan is required. The total estimated annualized burden hours are
11,376. There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Sentinel site conducting core Demographic/Clinical 20 240 11/60
surveillance. Data.
Sentinel site conducting enhanced Demographic/Clinical 10 840 12/60
surveillance. Data.
Regional laboratory................... Antimicrobial 4 3,300 40/60
Susceptibility Testing
Results.
Regional laboratory................... Control Strain 4 48 5/60
Susceptibility Testing.
----------------------------------------------------------------------------------------------------------------
[[Page 34585]]
Jeffrey M. Zirger,
Acting 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. 2018-15525 Filed 7-19-18; 8:45 am]
BILLING CODE 4163-18-P
