46996 Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Notices 

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. 2017–21752 Filed 10–6–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day-17–17AZI; Docket No. CDC–2017– 

0075] 

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 to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed study titled 

‘‘Understanding Decisions and Barriers 

about PrEP Use and Uptake among Men 

Who Have Sex with Men.’’ This study 

will provide insight on individual and 

community level PrEP-related decisionmaking, and identify barriers and 

facilitators to successful PrEP initiation 

and PrEP acceptability. 

DATES: CDC must receive written 

comments on or before December 11, 

2017. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2017– 

0075 by any of the following methods: 

• 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. 

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 Federal 

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 

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 

(NCHHSTP), 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 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 3 

months). 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Notices 46997 

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 Unite States. Findings will also 

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 costs to the 

respondents other than their time, travel 

costs, and the total estimated annual 

burden hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

General Public—Adults ..................... Screener #1 ...................................... 600 1 5/60 50 

General Public—Adults ..................... Consent Forms ................................. 300 1 1/60 5 

General Public—Adults ..................... In-depth Interview Guide .................. 60 1 45/60 45 

General Public—Adults ..................... Focus Group Moderator Guide ........ 60 1 1 60 

General Public—Adults ..................... Eligibility verification (verification of 

continuing eligibility).

300 1 5/60 25 

General Public—Adults ..................... Behavioral Assessment .................... 300 1 30/60 150 

Total ........................................... ........................................................... ........................ ........................ ........................ 335 

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. 2017–21750 Filed 10–6–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Re-designation of the Delivery Area for 

the Passamaquoddy Tribe at Indian 

Township 

AGENCY: Indian Health Service, 

Department of Health and Human 

Services. 

ACTION: Final Notice. 

SUMMARY: This final notice advises the 

public that the Indian Health Service 

(IHS) has decided to expand the 

geographic boundaries of the 

Purchased/Referred Care Delivery Area 

(PRCDA) for the Passamaquoddy Tribe’s 

reservation at Indian Township 

(Passamaquoddy at Indian Township or 

Tribe) in the State of Maine. 

DATES: October 10, 2017. 

Inspection of Public Comments: The 

IHS published a Federal Register Notice 

entitled, ‘‘Notice To Propose the ReDesignation of the Service Delivery Area 

for the Passamaquoddy Tribe at Indian 

Township,’’ on March 8, 2017 (82 FR 

12968), and did not receive any 

comments regarding the notice. 

FOR FURTHER INFORMATION CONTACT: 

Terri Schmidt, Acting Director, Office of 

Resource Access and Partnerships, 

Indian Health Service, 5600 Fishers 

Lane, Mailstop: 10E85C, Rockville, 

Maryland 20857. Telephone (301) 443– 

2694 (This is not a toll free number). 

SUPPLEMENTARY INFORMATION: The 

Passamaquoddy PRCDA previously 

covered Aroostook and Washington 

Counties in the State of Maine. The 

expanded PRCDA for the Tribe’s 

reservation at Indian Township includes 

Hancock County in the State of Maine. 

This notice only relates to the expansion 

of the Tribe’s PRCDA for the Indian 

Township reservation. 

The Maine Indian Claims Settlement 

Act of 1980 (Pub. L. 96–420; H. Rept. 

96–1353) includes the intent of 

Congress to fund and provide 

Purchased/Referred Care (PRC) to the 

Passamaquoddy Tribe. The 

Passamaquoddy Tribe has two 

reservations: Indian Township and 

Pleasant Point. The PRCDA for the 

Indian Township reservation is 

Aroostook County, Maine, and 

Washington County, Maine. The PRCDA 

for the Pleasant Point reservation is 

Washington County, Maine, south of 

State Route 9, and Aroostook County, 

Maine. 

Background: The IHS currently 

provides services under regulations 

codified at 42 CFR part 136, subparts A 

through C. Subpart C defines a PRCDA, 

formerly referred to as a Contract Health 

Service Delivery Area or Purchased/ 

Referred Care Service Delivery Area, as 

the geographic area within which PRC 

will be made available by the IHS to 

members of an identified Indian 

community who reside in the area. 

Residence in a PRCDA by a person who 

is within the scope of the Indian health 

program, as set forth in 42 CFR 136.12, 

creates no legal entitlement to PRC, only 

potential eligibility for services. 

Services needed but not available at an 

IHS or Tribal facility are provided under 

the PRC program depending on the 

availability of funds, the person’s 

relative medical priority, and the actual 

availability and accessibility of alternate 

resources in accordance with the 

regulations. 

As applicable to the Tribes, these 

regulations provide that, unless 

otherwise designated, a PRCDA shall 

consist of a county that includes all or 

part of a reservation and any county or 

counties that have a common boundary 

with the reservation, 42 CFR 

136.22(a)(6). The regulations also 

provide that after consultation with the 

Tribal governing body or bodies on 

those reservations included within the 

PRCDA, the Secretary may from time to 

time, re-designate areas within the 

United States for inclusion in or 

exclusion from a PRCDA. The 

regulations require that certain criteria 

must be considered before any redesignation is made. The criteria are as 

follows: 

(1) The number of Indians residing in 

the area proposed to be so included or 

excluded; 

(2) Whether the Tribal governing body 

has determined that Indians residing in 

the area near the reservation are socially 

and economically affiliated with the 

Tribe; 

(3) The geographic proximity to the 

reservation of the area whose inclusion 

or exclusion is being considered; and 


sradovich on DSK3GMQ082PROD with NOTICES