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

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 Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(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, 

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] 

BILLING CODE 4163–18–P 

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, 


daltland on DSKBBV9HB2PROD with NOTICES
45444 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 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: 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. 

DATES: CDC must receive written 

comments on or before November 6, 

2018. 

ADDRESSES: 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 

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 


daltland on DSKBBV9HB2PROD with NOTICES