83 FR 45443 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 174 (September 7, 2018)

Page Range		45443-45444
FR Document		2018-19383

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.

Federal Register, Volume 83 Issue 174 (Friday, September 7, 2018)

[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45443-45444]
From the Federal Register Online  [www.thefederalregister.org]
[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notice is being withdrawn immediately for public comment.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

Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45443

are to respond, including, through the bisexual, and other men who have sex understand the HIV risk behavior
use of appropriate automated, with men (MSM) than any other risk context, attitudes towards PrEP, health
electronic, mechanical, or other group in the U.S. Approximately half of seeking behavior, and acceptability of
technological collection techniques or all diagnosed HIV infections are among new modes of PrEP delivery (that differ
other forms of information technology, gay, bisexual, and other MSM. The from current recommendation of daily
e.g., permitting electronic submission of FDA-approved PrEP regimen, daily PrEP and that are in development or
responses; and Tenofovir/emtricitabine (aka Truvada®), discussion) and emerging biomedical
(e) Assess information collection has shown greater than 90% efficacy in HIV prevention options.
costs. reducing HIV infections among MSM The purpose of this research is to
To request additional information on when taken in accordance with its explore decisions, barriers, and
the proposed project or to obtain a copy prescribed daily schedule. In 2014, CDC facilitators about PrEP use among MSM:
of the information collection plan and published clinical practice guidelines (1) Who were offered PrEP but refused
instruments, call (404) 639–7570 or for the use of PrEP in high-risk it; (2) who were interested in or started
send an email to omb@cdc.gov. Direct populations, and began national a PrEP regimen but did not follow
written comments and/or suggestions promotion of PrEP as an effective HIV through; and (3) who are eligible for
regarding the items contained in this prevention strategy for MSM. While PrEP per CDC guidelines (report
notice to the Attention: CDC Desk hailed as an HIV-prevention ‘‘game- condomless anal sex within last three
Officer, Office of Management and changer,’’ in reality PrEP uptake has months) but not currently on PrEP.
Budget, 725 17th Street NW, been slow. Some studies report a wide
range in the percentages of MSM (28– This study will provide insight on
Washington, DC 20503 or by fax to (202)
81%) interested in PrEP. In addition, individual and community level PrEP-
395–5806. Provide written comments
other studies indicate that specific cities related decision-making, and identify
within 30 days of notice publication.
have alarmingly low rates of PrEP barriers and facilitators to successful
Proposed Project uptake (for example, the estimate for PrEP initiation and PrEP acceptability.
Understanding Decisions and Barriers Atlanta is 2%). Moreover, recent survey Findings will improve programming, in
about PrEP Use and Uptake Among Men findings have shown that less than 1 in line with the CDC Division of HIV/AIDS
Who Have Sex With Men—New— 10 MSM on PrEP are adherent to their Prevention goal of high-impact
National Center for HIV/AIDS, Viral PrEP regimen; adherence is necessary to prevention to reduce HIV infections in
Hepatitis, STD, and TB Prevention, optimize efficacy. the U.S. Findings will assist the CDC
Centers for Disease Control and In order to develop effective programs and frontline public health programs in
Prevention (CDC). that increase PrEP uptake among MSM identifying and designing programs and
at greatest risk for HIV, studies are intervention approaches that encourage,
Background and Brief Description needed to better understand the support, and maintain appropriate PrEP
This project involves original, decisions men make about their HIV uptake among eligible MSM and
formative research toward improving prevention needs. Qualitative methods anticipate future HIV prevention needs,
the uptake and adherence necessary to will be used to explore in-depth the including anticipated changes in PrEP
achieve efficacious levels of protection ‘‘Whys’’ and ‘‘How’s’’ of MSM’s delivery.
offered by pre-exposure prophylaxis decisions to refuse or use PrEP, and The total annual burden hours are
(PrEP) among the most highly affected barriers and challenges to successfully 335. There are no other costs to the
population. HIV incidence and undertake a PrEP medication regimen. respondents other than their time to
prevalence are higher among gay, Quantitative methods will be used to participate.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Type of Number of burden per
Form name responses per
respondents respondents response
respondent (in hours)

General Public—Adults ..... Screener ....................................................................................... 600 1 5/60
General Public—Adults ..... Contact Information Form ............................................................ 300 1 1/60
General Public—Adults ..... In-Depth Interview Guide ............................................................. 60 1 45/60
General Public—Adults ..... Focus Group Moderator Guide .................................................... 60 1 1
General Public—Adults ..... Eligibility verification (verification of continuing eligibility) ............ 300 1 5/60
General Public—Adults ..... Structured response self-administered behavioral assessment .. 300 1 30/60

Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND ACTION:Notice with comment period;
Acting Chief, Information Collection Review HUMAN SERVICES withdrawal.
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office Centers for Disease Control and SUMMARY: The Centers for Disease
of the Director, Centers for Disease Control Prevention Control and Prevention (CDC) in the
and Prevention. Department of Health and Human
daltland on DSKBBV9HB2PROD with NOTICES

[FR Doc. 2018–19378 Filed 9–6–18; 8:45 am]
[60Day–18–1102] Services (HHS) announces the
withdrawal of the notice published
BILLING CODE 4163–18–P Agency Forms Undergoing Paperwork under the same title on August 22, 2018
Reduction Act Review for public comment.
AGENCY: Centers for Disease Control and DATES: Applicable September 7, 2018.
Prevention (CDC), Department of Health FOR FURTHER INFORMATION CONTACT:
and Human Services (HHS). Information Collection Review Office,

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45444 Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices

Centers for Disease Control and ADDRESSES: You may submit comments, are to respond, including through the
Prevention, 1600 Clifton Road NE, MS– identified by Docket No. CDC–2018– use of appropriate automated,
D74, Atlanta, Georgia 30329; phone: 0042 by any of the following methods: electronic, mechanical, or other
404–639–7570; email: omb@cdc.gov. • Federal eRulemaking Portal: technological collection techniques or
SUPPLEMENTARY INFORMATION: On August Regulations.gov. Follow the instructions other forms of information technology,
22, 2018 CDC published a notice in the for submitting comments. e.g., permitting electronic submissions
Federal Register titled ‘‘Information • Mail: Jeffrey M. Zirger, Information of responses.
Collection for Tuberculosis Data from Collection Review Office, Centers for 5. Assess information collection costs.
Panel Physicians’’ (Vol. 83, No. 163 Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta, Proposed Project
Docket No. CDC–2018–0049, Pages
Georgia 30329. National Healthcare Safety Network
42502–542503). This notice was
Instructions: All submissions received (NHSN)—Revision—National Center for
published inadvertently. The notice is
must include the agency name and Emerging and Zoonotic Infectious
being withdrawn immediately for public Diseases (NCEZID), Centers for Disease
Docket Number. CDC will post, without
comment. Control and Prevention (CDC).
change, all relevant comments to
Jeffrey M. Zirger, Regulations.gov.
Background and Brief Description
Acting Chief, Information Collection Review Please note: Submit all comments
Office, Office of Scientific Integrity, Office through the Federal eRulemaking portal NHSN is a public health surveillance
of the Associate Director for Science, Office (regulations.gov) or by U.S. mail to the system that collects, analyzes, reports,
of the Director, Centers for Disease Control address listed above. and makes available data for
and Prevention. FOR FURTHER INFORMATION CONTACT: To monitoring, measuring, and responding
[FR Doc. 2018–19383 Filed 9–6–18; 8:45 am] request more information on the to healthcare associated infections
BILLING CODE 4163–18–P proposed project or to obtain a copy of (HAIs), antimicrobial use and resistance,
the information collection plan and blood transfusion safety events, and the
instruments, contact Leroy A. extent to which healthcare facilities
DEPARTMENT OF HEALTH AND Richardson, Information Collection adhere to infection prevention practices
HUMAN SERVICES Review Office, Centers for Disease and antimicrobial stewardship. The data
Control and Prevention, 1600 Clifton collected will be used to inform and
Centers for Disease Control and Road NE, MS–D74, Atlanta, Georgia detect changes in the epidemiology of
Prevention 30329; phone: 404–639–7570; Email: adverse events resulting from new and
[60Day–18–0666; Docket No. CDC–2018– omb@cdc.gov. current medical therapies and changing
0042] SUPPLEMENTARY INFORMATION: Under the
risks. NHSN is comprised of six
Paperwork Reduction Act of 1995 (PRA) components: Patient Safety, Healthcare
Proposed Data Collection Submitted (44 U.S.C. 3501–3520), Federal agencies Personnel Safety, Biovigilance, Long-
for Public Comment and must obtain approval from the Office of Term Care Facility, Outpatient
Recommendations Management and Budget (OMB) for each Procedure, and Dialysis.
collection of information they conduct Changes were made to 33 data
AGENCY: Centers for Disease Control and collection facility surveys with this new
Prevention (CDC), Department of Health or sponsor. In addition, the PRA also
requires Federal agencies to provide a ICR. CDC revised three annual facility
and Human Services (HHS). surveys for the Patient Safety
60-day notice in the Federal Register
ACTION: Notice with comment period. component for Hospitals, Long-Term
concerning each proposed collection of
information, including each new Acute Care Facilities, and Inpatient
SUMMARY: The Centers for Disease Rehabilitation Facilities. CDC’s
Control and Prevention (CDC), as part of proposed collection, each proposed
extension of existing collection of revisions clarify the reporting
its continuing effort to reduce public requirements for the data collected on
burden and maximize the utility of information, and each reinstatement of
previously approved information fungal testing, facility locations, and
government information, invites the laboratory testing locations.
general public and other Federal collection before submitting the
collection to the OMB for approval. To Additionally, corresponding response
agencies the opportunity to comment on options for these questions have been
a proposed and/or continuing comply with this requirement, we are
publishing this notice of a proposed revised to include updated testing
information collection, as required by methods used by facilities to capture
the Paperwork Reduction Act of 1995. data collection as described below.
The OMB is particularly interested in current HAI specific data specification
This notice invites comment on a requirements for NHSN. New required
proposed information collection project comments that will help:
1. Evaluate whether the proposed questions have been added to all Patient
titled National Healthcare Safety Safety component surveys. The new
Network (NHSN). NHSN is a public collection of information is necessary
for the proper performance of the questions are designed to provide data
health surveillance system that collects, on surveillance processes, policies, and
analyzes, reports, and makes available functions of the agency, including
whether the information will have standards that are used by reporting
data for monitoring, measuring, and facilities to ensure that when an event
responding to healthcare associated practical utility;
2. Evaluate the accuracy of the is detected, the facility has the
infections (HAIs), antimicrobial use and appropriate mechanism to conduct
agency’s estimate of the burden of the
resistance, blood transfusion safety complete reporting. The Hospital
proposed collection of information,
daltland on DSKBBV9HB2PROD with NOTICES

events, and the extent to which Annual Survey added new required
including the validity of the
healthcare facilities adhere to infection questions to provide data about neonatal
methodology and assumptions used;
prevention practices and antimicrobial antimicrobial stewardship practices
3. Enhance the quality, utility, and
stewardship. because the focus of stewardship efforts
clarity of the information to be
DATES:CDC must receive written collected; and in neonatology differ from the focus in
comments on or before November 6, 4. Minimize the burden of the adult and pediatric practice. Questions
2018. collection of information on those who were removed and replaced on all three

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Document Created: 2018-09-07 00:15:23
Document Modified: 2018-09-07 00:15:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period; withdrawal.
Dates		Applicable September 7, 2018.
Contact		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]
FR Citation		83 FR 45443

83 FR 45443 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 83, Issue 174 (September 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention