60d FRN - published

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
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 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.
SUMMARY:

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

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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:
[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
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).

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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).

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46997

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

General
General
General
General
General

Public—Adults
Public—Adults
Public—Adults
Public—Adults
Public—Adults

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

Average
burden per
response
(in hours)

Total
burden
hours

600
300
60
60
300

1
1
1
1
1

5/60
1/60
45/60
1
5/60

50
5
45
60
25

General Public—Adults .....................

Screener #1 ......................................
Consent Forms .................................
In-depth Interview Guide ..................
Focus Group Moderator Guide ........
Eligibility verification (verification of
continuing eligibility).
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
Indian Health Service,
Department of Health and Human
Services.
ACTION: Final Notice.
AGENCY:

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
SUMMARY:

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Number of
responses per
respondent

Number of
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Form name

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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

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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

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