Agency Forms Undergoing Paperwork Reduction Act Review, 45443-45444 [2018-19383]
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45443
Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
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
Understanding Decisions and Barriers
about PrEP Use and Uptake Among Men
Who Have Sex With Men—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention,
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
This project involves original,
formative research toward improving
the uptake and adherence necessary to
achieve efficacious levels of protection
offered by pre-exposure prophylaxis
(PrEP) among the most highly affected
population. HIV incidence and
prevalence are higher among gay,
bisexual, and other men who have sex
with men (MSM) than any other risk
group in the U.S. Approximately half of
all diagnosed HIV infections are among
gay, bisexual, and other MSM. The
FDA-approved PrEP regimen, daily
Tenofovir/emtricitabine (aka Truvada®),
has shown greater than 90% efficacy in
reducing HIV infections among MSM
when taken in accordance with its
prescribed daily schedule. In 2014, CDC
published clinical practice guidelines
for the use of PrEP in high-risk
populations, and began national
promotion of PrEP as an effective HIV
prevention strategy for MSM. While
hailed as an HIV-prevention ‘‘gamechanger,’’ in reality PrEP uptake has
been slow. Some studies report a wide
range in the percentages of MSM (28–
81%) interested in PrEP. In addition,
other studies indicate that specific cities
have alarmingly low rates of PrEP
uptake (for example, the estimate for
Atlanta is 2%). Moreover, recent survey
findings have shown that less than 1 in
10 MSM on PrEP are adherent to their
PrEP regimen; adherence is necessary to
optimize efficacy.
In order to develop effective programs
that increase PrEP uptake among MSM
at greatest risk for HIV, studies are
needed to better understand the
decisions men make about their HIV
prevention needs. Qualitative methods
will be used to explore in-depth the
‘‘Whys’’ and ‘‘How’s’’ of MSM’s
decisions to refuse or use PrEP, and
barriers and challenges to successfully
undertake a PrEP medication regimen.
Quantitative methods will be used to
understand the HIV risk behavior
context, attitudes towards PrEP, health
seeking behavior, and acceptability of
new modes of PrEP delivery (that differ
from current recommendation of daily
PrEP and that are in development or
discussion) and emerging biomedical
HIV prevention options.
The purpose of this research is to
explore decisions, barriers, and
facilitators about PrEP use among MSM:
(1) Who were offered PrEP but refused
it; (2) who were interested in or started
a PrEP regimen but did not follow
through; and (3) who are eligible for
PrEP per CDC guidelines (report
condomless anal sex within last three
months) but not currently on PrEP.
This study will provide insight on
individual and community level PrEPrelated decision-making, and identify
barriers and facilitators to successful
PrEP initiation and PrEP acceptability.
Findings will improve programming, in
line with the CDC Division of HIV/AIDS
Prevention goal of high-impact
prevention to reduce HIV infections in
the U.S. Findings will assist the CDC
and frontline public health programs in
identifying and designing programs and
intervention approaches that encourage,
support, and maintain appropriate PrEP
uptake among eligible MSM and
anticipate future HIV prevention needs,
including anticipated changes in PrEP
delivery.
The total annual burden hours are
335. There are no other costs to the
respondents other than their time to
participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
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General
General
General
General
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Public—Adults
Public—Adults
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Public—Adults
Public—Adults
Number of
respondents
Form name
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Screener .......................................................................................
Contact Information Form ............................................................
In-Depth Interview Guide .............................................................
Focus Group Moderator Guide ....................................................
Eligibility verification (verification of continuing eligibility) ............
Structured response self-administered behavioral assessment ..
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. 2018–19378 Filed 9–6–18; 8:45 am]
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ACTION:
Centers for Disease Control and
Prevention
SUMMARY:
[60Day–18–1102]
Agency Forms Undergoing Paperwork
Reduction Act Review
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
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Average
burden per
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(in hours)
5/60
1/60
45/60
1
5/60
30/60
Notice with comment period;
withdrawal.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
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600
300
60
60
300
300
Number of
responses per
respondent
The Centers for Disease
Control and Prevention (CDC) in the
Department of Health and Human
Services (HHS) announces the
withdrawal of the notice published
under the same title on August 22, 2018
for public comment.
DATES: Applicable September 7, 2018.
FOR FURTHER INFORMATION CONTACT:
Information Collection Review Office,
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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
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: On August
22, 2018 CDC published a notice in the
Federal Register titled ‘‘Information
Collection for Tuberculosis Data from
Panel Physicians’’ (Vol. 83, No. 163
Docket No. CDC–2018–0049, Pages
42502–542503). This notice was
published inadvertently. The notice is
being withdrawn immediately for public
comment.
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. 2018–19383 Filed 9–6–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0666; Docket No. CDC–2018–
0042]
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 National Healthcare Safety
Network (NHSN). NHSN is a public
health surveillance system that collects,
analyzes, reports, and makes available
data for monitoring, measuring, and
responding to healthcare associated
infections (HAIs), antimicrobial use and
resistance, blood transfusion safety
events, and the extent to which
healthcare facilities adhere to infection
prevention practices and antimicrobial
stewardship.
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
CDC must receive written
comments on or before November 6,
2018.
DATES:
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17:55 Sep 06, 2018
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You may submit comments,
identified by Docket No. CDC–2018–
0042 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
(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 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:
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
ADDRESSES:
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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
National Healthcare Safety Network
(NHSN)—Revision—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
NHSN is a public health surveillance
system that collects, analyzes, reports,
and makes available data for
monitoring, measuring, and responding
to healthcare associated infections
(HAIs), antimicrobial use and resistance,
blood transfusion safety events, and the
extent to which healthcare facilities
adhere to infection prevention practices
and antimicrobial stewardship. The data
collected will be used to inform and
detect changes in the epidemiology of
adverse events resulting from new and
current medical therapies and changing
risks. NHSN is comprised of six
components: Patient Safety, Healthcare
Personnel Safety, Biovigilance, LongTerm Care Facility, Outpatient
Procedure, and Dialysis.
Changes were made to 33 data
collection facility surveys with this new
ICR. CDC revised three annual facility
surveys for the Patient Safety
component for Hospitals, Long-Term
Acute Care Facilities, and Inpatient
Rehabilitation Facilities. CDC’s
revisions clarify the reporting
requirements for the data collected on
fungal testing, facility locations, and
laboratory testing locations.
Additionally, corresponding response
options for these questions have been
revised to include updated testing
methods used by facilities to capture
current HAI specific data specification
requirements for NHSN. New required
questions have been added to all Patient
Safety component surveys. The new
questions are designed to provide data
on surveillance processes, policies, and
standards that are used by reporting
facilities to ensure that when an event
is detected, the facility has the
appropriate mechanism to conduct
complete reporting. The Hospital
Annual Survey added new required
questions to provide data about neonatal
antimicrobial stewardship practices
because the focus of stewardship efforts
in neonatology differ from the focus in
adult and pediatric practice. Questions
were removed and replaced on all three
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[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45443-45444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19383]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-1102]
Agency Forms Undergoing Paperwork Reduction Act Review
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) announces the withdrawal
of the notice published under the same title on August 22, 2018 for
public comment.
DATES: Applicable September 7, 2018.
FOR FURTHER INFORMATION CONTACT: Information Collection Review Office,
[[Page 45444]]
Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; email: [email protected].
SUPPLEMENTARY INFORMATION: On August 22, 2018 CDC published a notice in
the Federal Register titled ``Information Collection for Tuberculosis
Data from Panel Physicians'' (Vol. 83, No. 163 Docket No. CDC-2018-
0049, Pages 42502-542503). This notice was published inadvertently. The
notice is being withdrawn immediately for public comment.
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. 2018-19383 Filed 9-6-18; 8:45 am]
BILLING CODE 4163-18-P
