Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 16404-16405 [2017-06536]
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Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Notices
strategy of pre-exposure prophylaxis
(PrEP) for HIV-negative MSM who are at
high risk of contracting HIV. For
maximum efficacy, health
communications about HIV prevention
and control should be delivered to MSM
according to their HIV serostatus and
risk category.
The National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention
is requesting approval to evaluate the
efficacy of a smartphone-based HIV
prevention intervention for MSM,
known as M3(M-Cubed) that has been
designed to deliver targeted messages in
six intervention domains: HIV testing,
sexually transmitted infection (STI)
testing, PrEP, antiretroviral (ARV)
treatment, Condoms, and Engagement in
Care. The smartphone and tablet
application includes 36 core messages
and 12 videos that were developed
based on CDC-sponsored iterative
formative research (OMB No. 0920–
0840) and a review of HIV health
communications literature. Messages
will be delivered to each participant’s
device. The proposed study will assess
whether exposure to the messagedelivery platform results in
improvements in participants’ selfreported sexual health and HIV
prevention behaviors, beliefs and
attitudes. Information will be collected
at baseline and 3-month, 6-month, and
9-month follow-ups.
The study population will include
1,206 adult MSM living in Atlanta, GA,
Detroit, MI and New York City, NY.
These study sites 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. Study participants
will be sexually active MSM at least 18
years in age who own and use and
Android and iOS smartphone. Study
participants will be stratified by risk
category: HIV positive (one third) and
HIV negative (one third each:
condomless anal sex in past three
months; no condomless anal sex past
three months). Across the three sites, we
will ensure that at least 40% of
participants are people of color (nonwhite 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.
Participants will be randomly assigned
to an intervention group or a waitlist
control group. The control group will
receive the intervention after the study
has been completed.
A quantitative assessment
questionnaire will be administered
online at four points in time. 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, preexposure 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. The
same information will be collected from
all participants. The burden per
response for each assessment is 1.5
hours.
It is expected that 50% of men
screened will meet study eligibility and
provide contact information, that 75
percent will schedule and show up for
an in-person appointment, and that 95
percent 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 1 minute, and the
rescreening prior to study enrollment to
take another four minutes.
OMB approval is requested for two
years. Participation is voluntary and
there are no costs to the respondents
other than their time. The total
estimated annual burden is 3,787 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Type of respondent
Form name
Men ≥ 18 Years of Age Who Have Sex With
Men.
Participant Screening (Eligibility) ...................
1,693
1
4/60
Contact Information Form ..............................
Participant Screening (Verification) ................
Assessment ....................................................
847
635
603
1
1
4
1/60
4/60
1.5
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. 2017–06577 Filed 4–3–17; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
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 a meeting for the initial
review of applications in response to
Funding Opportunity Announcement
(FOA) DP17–001, Community
Characteristics Associated with
VerDate Sep<11>2014
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Geographic Disparities in Diabetes and
Cardiometabolic Health.
Times and Dates:
10:00 a.m.–6:00 p.m., EDT, April 25,
2017 (Closed)
10:00 a.m.–6:00 p.m., EDT, April 26,
2017 (Closed)
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section 552b(c)
(4) and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the initial review,
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Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Notices
discussion, and evaluation of
applications received in response to
‘‘Community Characteristics Associated
with Geographic Disparities in Diabetes
and Cardiometabolic Health’’, DP17–
001.
Contact Person for More Information:
Jaya Raman Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway,
Mailstop F80, Atlanta, Georgia 30341,
Telephone: (770) 488–6511, kva5@
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. 2017–06536 Filed 4–3–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Initial Review Group, Biological Aging
Review Committee.
Date: May 30–31, 2017.
Time: 2:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Torrance Marriott Redondo Beach,
3635 Fashion Way, Torrance, CA 90503.
Contact Person: Bita Nakhai, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Bldg., 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20814,
301–402–7701, nakhaib@nia.nih.gov.
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Name of Committee: National Institute on
Aging Initial Review Group, Neuroscience of
Aging Review Committee,
Date: June 1–2, 2017.
Time: 2:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Torrance Marriott Redondo Beach,
3635 Fashion Way, Torrance, CA 90503.
Contact Person: Jeannette L. Johnson,
Ph.D., Deputy Review Branch Chief, National
Institutes of Health, National Institute on
Aging, Gateway Building, Bethesda, MD
20892, 301–402–7705, johnsonj9@
nia.nih.gov.
Name of Committee: National Institute on
Aging Initial Review Group, Clinical Aging
Review Committee.
Date: June 1–2, 2017.
Time: 2:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Torrance Marriott Redondo Beach,
3635 Fashion Way, Torrance, CA 90503.
Contact Person: Alicja L. Markowska,
Ph.D., Dsc., National Institute on Aging,
National Institutes of Health, Gateway
Building 2C212, 7201 Wisconsin Avenue,
Bethesda, MD 20892, 301–496–9666,
markowsa@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
16405
Only written comments and/or
applications for a license which are
received by the NHLBI Office of
Technology Transfer and Development
on or before April 19, 2017 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Cristina Thalhammer-Reyero, Ph.D.,
MBA, Senior Licensing and Patenting
Manager, NHLBI Office of Technology
Transfer and Development, 31 Center
Drive Room 4A29, MSC2479, Bethesda,
MD 20892–2479; Telephone: +1–301–
435–4507; Fax: +1–301–594–3080;
Email: thalhamc@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement:
U.S. Provisional Patent Application
Serial No. 61/045,213, filed 04/15/2008;
PCT Application No. PCT/US2009/
040560, filed 04/14/2009; U.S. Patent
Application Serial No.12/937,974,
issued as 8,936,787 on 01/20/2015;
Titled ‘‘Peptides Promoting Lipid
Efflux’’ (NIH Reference No. E–138–
Dated: March 29, 2017.
2008/0).
Melanie J. Pantoja,
With respect to persons who have an
obligation to assign their right, title and
Program Analyst, Office of Federal Advisory
Committee Policy.
interest to the Government of the United
States of America, the patent rights in
[FR Doc. 2017–06553 Filed 4–3–17; 8:45 am]
these inventions have been assigned to
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the Government of the United States of
America.
The prospective exclusive license
DEPARTMENT OF HEALTH AND
territory may be worldwide and the
HUMAN SERVICES
field of use may be limited to:
National Institutes of Health
‘‘Treatment of Hypertriglyceridemia,
with or without concomitant metabolic
Prospective Grant of Exclusive Patent
syndrome’’.
License: Development and
The invention pertains to
Commercialization of Peptides
compositions and methods of use of
Promoting Lipid Efflux for the
ApoC–II mimetic peptides with
Treatment of Hypertriglyceridemia,
multiple amphipathic alpha helical
With or Without Concomitant
domains that have the dual ability to
Metabolic Syndrome
promote lipid efflux from cells and
stimulate lipoprotein lipase activity,
AGENCY: National Institutes of Health,
without inducing toxicity. This notice is
HHS.
made in accordance with 35 U.S.C. 209
ACTION: Notice.
and 37 CFR part 404. The prospective
SUMMARY: The National Heart, Lung, and Exclusive Patent License will be royalty
Blood Institute (NHLBI), an institute of
bearing and may be granted unless
the National Institutes of Health; an
within fifteen (15) days from the date of
agency within the Department of Health this published notice, the NHLBI Office
and Human Services, is contemplating
of Technology Transfer and
the grant of an exclusive patent license
Development receives written evidence
to commercialize the invention(s)
and argument that establishes that the
embodied in the intellectual property
grant of the license would not be
estate stated in the Summary
consistent with the requirements of 35
Information section of this notice to
U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in
Corvidia Therapeutics Inc. (Corvidia)
the prospective field of use that are
located in Waltham, MA and
timely filed in response to this notice
incorporated under the laws of
will be treated as objections to the grant
Delaware.
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DATES:
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Agencies
[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Pages 16404-16405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06536]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Initial Review
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 a meeting for the initial review of
applications in response to Funding Opportunity Announcement (FOA)
DP17-001, Community Characteristics Associated with Geographic
Disparities in Diabetes and Cardiometabolic Health.
Times and Dates:
10:00 a.m.-6:00 p.m., EDT, April 25, 2017 (Closed)
10:00 a.m.-6:00 p.m., EDT, April 26, 2017 (Closed)
Place: Teleconference.
Status: The meeting will be closed to the public in accordance with
provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C.,
and the Determination of the Director, Management Analysis and Services
Office, CDC, pursuant to Public Law 92-463.
Matters for Discussion: The meeting will include the initial
review,
[[Page 16405]]
discussion, and evaluation of applications received in response to
``Community Characteristics Associated with Geographic Disparities in
Diabetes and Cardiometabolic Health'', DP17-001.
Contact Person for More Information: Jaya Raman Ph.D., Scientific
Review Officer, CDC, 4770 Buford Highway, Mailstop F80, Atlanta,
Georgia 30341, Telephone: (770) 488-6511, kva5@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. 2017-06536 Filed 4-3-17; 8:45 am]
BILLING CODE 4163-18-P