Federal Register Notice

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Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who have Sex with Men (MSM): Randomized Controlled Trial

Federal Register Notice

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73402

Federal Register / Vol. 81, No. 206 / Tuesday, October 25, 2016 / Notices

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

mstockstill on DSK3G9T082PROD with NOTICES

Subcommittee for Dose
Reconstruction Reviews (SDRR),
Advisory Board on Radiation and
Worker Health (ABRWH or the
Advisory Board), National Institute for
Occupational Safety and Health
(NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting for the
aforementioned subcommittee:
Time and Date: 10:30 a.m.–5:00 p.m.,
EST, November 22, 2016.
Place: Audio Conference Call via FTS
Conferencing.
Status: Open to the public, but
without a public comment period. The
public is welcome to submit written
comments in advance of the meeting, to
the contact person below. Written
comments received in advance of the
meeting will be included in the official
record of the meeting. The public is also
welcome to listen to the meeting by
joining the teleconference at the USA
toll-free, dial-in number at 1–866–659–
0537 and the pass code is 9933701.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 to advise the
President on a variety of policy and
technical functions required to
implement and effectively manage the
new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines that
have been promulgated by the
Department of Health and Human
Services (HHS) as a final rule; advice on
methods of dose reconstruction, which
have also been promulgated by HHS as
a final rule; advice on the scientific
validity and quality of dose estimation
and reconstruction efforts being
performed for purposes of the
compensation program; and advice on
petitions to add classes of workers to the
Special Exposure Cohort (SEC).
In December 2000, the President
delegated responsibility for funding,
staffing, and operating the Advisory
Board to HHS, which subsequently
delegated this authority to CDC. NIOSH
implements this responsibility for CDC.
The charter was issued on August 3,
2001, renewed at appropriate intervals,
rechartered on March 22, 2016 pursuant
to Executive Order 13708, and will
expire on September 30, 2017.

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Purpose: The Advisory Board is
charged with (a) providing advice to the
Secretary, HHS, on the development of
guidelines under Executive Order
13179; (b) providing advice to the
Secretary, HHS, on the scientific
validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at
any Department of Energy facility who
were exposed to radiation but for whom
it is not feasible to estimate their
radiation dose, and on whether there is
reasonable likelihood that such
radiation doses may have endangered
the health of members of this class. The
Subcommittee for Dose Reconstruction
Reviews was established to aid the
Advisory Board in carrying out its duty
to advise the Secretary, HHS, on dose
reconstruction.
Matters for Discussion: The agenda for
the Subcommittee meeting includes the
following dose reconstruction review
activities: dose reconstruction cases
under review from Sets 14–18 and Set
22 (‘‘blind reviews’’), including the Oak
Ridge sites (Y–12, K–25, Oak Ridge
National Laboratory), Hanford, Feed
Materials Production Center
(‘‘Fernald’’), Mound Plant, Rocky Flats
Plant, Nevada Test Site, Idaho National
Laboratory, and Savannah River Site;
and consideration of new dose
reconstruction review methods and/or
case selection criteria to evaluate the
consistency of certain dose
reconstruction methods.
The agenda is subject to change as
priorities dictate.
Contact Person for More Information:
Theodore Katz, Designated Federal
Officer, NIOSH, CDC, 1600 Clifton
Road, Mailstop E–20, Atlanta, Georgia
30329, Telephone (513)533–6800, Toll
Free 1(800)CDC–INFO, Email ocas@
cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2016–25728 Filed 10–24–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17AX; Docket No. CDC–2016–
0100]

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 efforts 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 the proposed information
collection project entitled ‘‘Mobile
Messaging Intervention to Present New
HIV Prevention Options for Men who
have Sex with Men (MSM) Study.’’ The
collect is part of a research study
designed to evaluate the efficacy of
smartphone-based platform for
delivering sexual health and prevention
messages to MSM.
DATES: Written comments will be
received on or before December 27,
2016.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2016–
0100 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. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment
should be submitted 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
ADDRESSES:

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Federal Register / Vol. 81, No. 206 / Tuesday, October 25, 2016 / Notices
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the 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 OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying

information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Mobile Messaging Intervention to
Present New HIV Prevention Options for
Men Who Have Sex with Men (MSM)
Study—New—National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention
is requesting approval for two years of
data collection entitled, ‘‘Mobile
Messaging Intervention to Present New
HIV Prevention Options for MSM.’’ The
purpose of this study is to evaluate the
efficacy of a smartphone-based HIV
prevention intervention, known as M3,
through a randomized controlled trial.
The information collected through this
study will be used to evaluate whether
the M3 mobile-messaging intervention is
an effective HIV-prevention strategy, by
assessing whether exposure to the
message-delivery platform results in
improvements in participants’ selfreported sexual health and HIV
prevention behaviors, beliefs and
attitudes. The trial will assess whether
intervention participants’ behaviors
significantly change from baseline to
post-intervention when compared to
participants in a waitlist control arm,
and whether these changes are
sustained at 6-month and 9-month
follow-ups.
This study will be carried out in three
metropolitan areas in the United States:
Atlanta, Georgia, Detroit, Michigan and
New York City, New York. These cities
were selected not only because they
have high rates of HIV, but also because
significant disparities in HIV among
men who have sex with men (MSM)
have been observed by race/ethnicity
and age.

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Type of respondent

General
General
General
General

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

Number of
respondents

Form name

The study population will include
1,206 adult MSM living in Atlanta,
Detroit, and New York City. Men
recruited to the study will be at least 18
years in age, who have had anal sex
with at least one man in the past 12
months, and who own and use an
Android and iOS smartphone.
Across the three sites, we will ensure
that at least 40% of participants are
people of color (non-white or Hispanic)
by quota sampling. Participants will be
recruited to the study through a
combination of approaches, including
online advertisement, traditional print
advertisement, referral, in-person
outreach, and through word of mouth.
A quantitative assessment will be
used to collect information for this
study, which will be delivered at the
time of study enrollment and again at 3month, 6-month and 9-month followups. The assessment will be used to
measure changes in condom use
behavior, number of sex partners, HIV
testing, sexually transmitted disease
(STD) testing, health care engagement,
pre-exposure prophylaxis uptake and
adherence, and antiretroviral therapy
uptake and adherence following
completion of the intervention.
Participants will complete the
assessment in-person at baseline and 9months, using a computer in a private
location, and remotely via their personal
computer or tablet device at the 3month and 6-month follow-ups.
It is expected that 50% of men
screened will meet study eligibility and
provide contact information, that 75%
will schedule and show up for an inperson appointment, and that 95% of
these men will remain eligible after
reverification. We expect the initial
screening to take approximately four
minutes to complete, that providing
contact information will take one
minute, and the rescreening prior to
study enrollment to take another four
minutes. The assessment will take 90
minutes (11⁄2 hour) to complete, and
will be administered to 1,206 men a
total of four times. The total number of
burden hours are 5,164.
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
hours

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

Participant Screening (Eligibility) .....
Contact Information Form ................
Participant Screening (Verification) ..
Assessment ......................................

1,356
678
508
482

1
1
1
4

4/60
1/60
4/60
1.5

90
11
34
2,892

Total ...........................................

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

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

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

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

3,027

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Federal Register / Vol. 81, No. 206 / Tuesday, October 25, 2016 / 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. 2016–25677 Filed 10–24–16; 8:45 am]

authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2016–25729 Filed 10–24–16; 8:45 am]
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Centers for Disease Control and
Prevention

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Mine Safety and Health Research
Advisory Committee, National Institute
for Occupational Safety and Health
(MSHRAC, NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting for the
aforementioned committee:
Time and Date: 8:00 a.m.–12:30 p.m.
(PST), November 14, 2016.
Place: CDC/NIOSH Spokane Mining
Research Division, 315 E. Montgomery,
Spokane, WA 99207. Teleconference
and webinar is also available. If you
wish to attend in person, or by phone
or webinar, please contact Marie
Chovanec by email at MChovanec@
cdc.gov or by phone at 412–386–5302 at
least 5 days in advance.
Status: Open to public, limited only
by the space available. In person, the
meeting room accommodates
approximately 30 people. By webinar,
the webinar system accommodates a
maximum of 100 people.
Purpose: This committee is charged
with providing advice to the Secretary,
Department of Health and Human
Services; the Director, CDC; and the
Director, NIOSH, on priorities in mine
safety and health research, including
grants and contracts for such research,
30 U.S.C. 812(b)(2), Section 102(b)(2).
Matters for Discussion: The meeting
will focus on mining safety and health
research projects, partnerships and
initiatives, including the mining
program strategic goals, and priority
research areas. The meeting will also
include updates from the Pittsburgh
Mining Research Division, and the
Spokane Mining Research Division.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Jeffrey H. Welsh, Executive Secretary,
MSHRAC, NIOSH, CDC, 626 Cochrans
Mill Road, Pittsburgh, PA, telephone
(412)386–4040, fax (412)386–6614. The
Director, Management Analysis and
Services Office, has been delegated the

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Request for Nominations of
Candidates To Serve on the World
Trade Center Health Program
Scientific/Technical Advisory
Committee (the STAC or the
Committee), Centers for Disease
Control and Prevention, Department of
Health and Human Services
The CDC is soliciting nominations for
membership on the World Trade Center
(WTC) Health Program Scientific/
Technical Advisory Committee (STAC).
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010,
Pub. L. 111–347 (Jan. 2, 2011), amended
by Pub. L. 114–113 (Dec. 18, 2015),
added Title XXXIII to the Public Health
Service Act (PHS Act), establishing the
WTC Health Program within HHS (42
U.S.C. 300mm to 300mm–61). Section
3302(a) of the PHS Act established the
WTC Health Program STAC. The STAC
is governed by the provisions of the
Federal Advisory Committee Act, as
amended (Pub. L. 92–463, 5 U.S.C.
App.), which sets forth standards for the
formation and use of advisory
committees in the Executive Branch.
PHS Act Section 3302(a)(1) establishes
that the STAC will review scientific and
medical evidence and make
recommendations to the WTC Program
Administrator on additional WTC
Health Program eligibility criteria and
on additional WTC-related health
conditions. Section 3341(c) of the PHS
Act requires the WTC Program
Administrator to also consult with the
STAC on research regarding certain
health conditions related to the
September 11, 2001 terrorist attacks.
The STAC may also be consulted on
other matters related to implementation
and improvement of the WTC Health
Program, as outlined in the PHS Act, at
the discretion of the WTC Program
Administrator.

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In accordance with Section 3302(a)(2)
of the PHS Act, the WTC Program
Administrator will appoint the members
of the committee, which must include at
least:
• 4 occupational physicians, at least
two of whom have experience treating
WTC rescue and recovery workers;
• 1 physician with expertise in
pulmonary medicine;
• 2 environmental medicine or
environmental health specialists;
• 2 representatives of WTC
responders;
• 2 representatives of certifiedeligible WTC survivors;
• 1 industrial hygienist;
• 1 toxicologist;
• 1 epidemiologist; and
• 1 mental health professional.
At this time the Administrator is
seeking nominations for members
fulfilling the following categories:
• Mental Health Professional
• Occupational physician who has
experience treating WTC rescue and
recovery workers;
• Industrial Hygienist;
• Representative of WTC responders;
• Representative of certified-eligible
WTC survivors
Additional members may be
appointed at the discretion of the WTC
Program Administrator.
A STAC member’s term appointment
may last 3 years. If a vacancy occurs, the
WTC Program Administrator may
appoint a new member who fulfills the
same membership category as the
predecessor. STAC members may be
appointed to successive terms. The
frequency of committee meetings shall
be determined by the WTC Program
Administrator based on program needs.
Meetings may occur up to four times a
year. Members are paid the Special
Government Employee rate of $250 per
day, and travel costs and per diem are
included and based on the Federal
Travel Regulations.
Any interested person or organization
may self-nominate or nominate one or
more qualified persons for membership.
Nominations must include the
following information:
• The nominee’s contact information
and current occupation or position;
• The nominee’s resume or
curriculum vitae, including prior or
current membership on other National
Institute for Occupational Safety and
Health (NIOSH), CDC, or HHS advisory
committees or other relevant
organizations, associations, and
committees;
• The category of membership
(environmental medicine or
environmental health specialist,
occupational physician, pulmonary

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