Federal Register Notice

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Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices

respondents other than their time. The

total estimated annualized burden hours
are 38.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

State
State
State
State

Public Health Director ...........................
Public Health Manager ..........................
Medicaid Director ..................................
Medicaid Manager .................................

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. 2018–02205 Filed 2–2–18; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[60Day–18–0307; Docket No. CDC–2018–
0019]

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 ‘‘Gonococcal Isolate Surveillance
Project (GISP)’’. The purpose of GISP is
to monitor trends in antimicrobial
resistance in N. gonorrhoeae strains in
the United States in order to establish a
scientific basis for the selection of
gonococcal therapies and to allow
proactive changes to treatment
guidelines before widespread resistance
and failures of treatment occur.
DATES: CDC must receive written
comments on or before April 6, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0019 by any of the following methods:

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

• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions for
submitting comments.
• Mail: Leroy A. Richardson, Information
Collection Review Office, Centers for Disease
Control and Prevention, 1600 Clifton Road
NE, MS–D74, Atlanta, Georgia 30329.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
[email protected].
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
FOR FURTHER INFORMATION CONTACT:

Proposed Data Collection Submitted
for Public Comment and
Recommendations

18:08 Feb 02, 2018

Guide
Guide
Guide
Guide

Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

Centers for Disease Control and
Prevention

VerDate Sep<11>2014

Interview
Interview
Interview
Interview

Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.

BILLING CODE 4163–18–P

SUMMARY:

Number of
respondents

Form name

PO 00000

Frm 00045

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Sfmt 4703

6
11
6
6

Number of
responses
per
respondent

Average
burden per
response
(in hours)
1
1
1
1

75/60
75/60
75/60
75/60

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
Gonococcal Isolate Surveillance
Project (OMB Control Number 0920–
0307, Expiration 2/28/2019)—
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 Gonococcal Isolate Surveillance
Project (GISP) was created in 1986 to
monitor trends in antimicrobial
susceptibilities of N. gonorrhoeae
strains in the United States. 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 improve the specificity of GISP, this
submission is a revision to include
collection of additional isolates and data
elements.
The Centers for Disease Control and
Prevention 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

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Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
National Strategy for Combating
Antibiotic Resistant Bacteria by
improving and strengthening
surveillance of antimicrobial resistance

through GISP. Additionally, data from
GISP will also allow CDC to monitor
and evaluate the effectiveness of public
health interventions conducted to

support the National Strategy for
Combating Antibiotic Resistant Bacteria.
There are no costs to respondents other
than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Sentinel site conducting core surveillance.
Sentinel site conducting enhanced
surveillance.
Regional laboratory ...........................

Demographic/Clinical Data ...............

20

240

11/60

880

Demographic/Clinical Data ...............

10

840

12/60

1,680

4

3,300

40/60

8,800

Regional laboratory ...........................

Antimicrobial Susceptibility Testing
Results.
Control Strain Susceptibility Testing

4

48

5/60

16

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

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

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

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

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

11,376

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. 2018–02222 Filed 2–2–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0773]

Agency Forms Undergoing Paperwork
Reduction Act Review

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Number of
responses per
respondent

Number of
respondents

Type of respondents

In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled National
Surveillance for Severe Adverse Events
Among Persons on Treatment of Latent
Tuberculosis Infection 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 August
22, 2017 to obtain comments from the
public and affected agencies. CDC
received one 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

VerDate Sep<11>2014

18:08 Feb 02, 2018

Jkt 244001

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
National Surveillance for Severe
Adverse Events Associated with
Treatment of Latent Tuberculosis
Infection—(0920–0773, expiration
01/31/2018)—Extension—Division of
Tuberculosis Elimination (DTBE),
National Center for HIV, Viral Hepatitis,
STD, and TB Prevention NCHHSTP),
Centers for Disease Control and
Prevention (CDC).

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Background and Brief Description
This project seeks a three-year
extension to continue the passive
reporting system for severe adverse
events (SAEs) associated with therapy
for Latent Tuberculosis Infection (LTBI).
The system will rely on medical chart
review and/or onsite investigations by
TB control staff. In 2004, CDC began
collecting reports of SAEs associated
with any treatment regimen for LTBI.
For surveillance purposes, an SAE was
defined as any drug-associated reaction
resulting in a patient’s hospitalization or
death after at least one treatment dose
for LTBI. Reports of SAEs related to
rifampicin plus pyrazinamide (RZ) and
isoniazid (INH) INH have prompted a
need for this project a national
surveillance system of such events.
The objective of the project is to
determine the annual number and
temporal trends of SAEs associated with
any treatment for LTBI in the United
States. Surveillance of such events will
provide data to support periodic
evaluation or potential revision of
guidelines for treatment of persons with
LTBI.
Potential respondents are any of the
60 reporting areas for the national TB
surveillance system (the 50 states, the
District of Columbia, New York City,
Puerto Rico, and 7 jurisdictions in the
Pacific and Caribbean). Data will be
collected using the data collection form
for SAEs associated with LTBI
treatment. The data collection form is
completed by healthcare providers and
health departments for each reported
hospitalization or death related to
treatment of LTBI and contains
demographic, clinical, and laboratory
information. Reporting of SAEs will be
conducted through telephone, email, or
during CDC site visits.

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