82_FR_16467 82 FR 16404 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

82 FR 16404 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

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

Federal Register Volume 82, Issue 63 (April 4, 2017)

Page Range16404-16405
FR Document2017-06536

Federal Register, Volume 82 Issue 63 (Tuesday, April 4, 2017)
[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Pages 16404-16405]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06536]


-----------------------------------------------------------------------

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



                                                    16404                             Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Notices

                                                    strategy of pre-exposure prophylaxis                        The study population will include                               changes in condom use behavior,
                                                    (PrEP) for HIV-negative MSM who are at                    1,206 adult MSM living in Atlanta, GA,                            number of sex partners, HIV testing,
                                                    high risk of contracting HIV. For                         Detroit, MI and New York City, NY.                                sexually transmitted disease (STD)
                                                    maximum efficacy, health                                  These study sites were selected not only                          testing, health care engagement, pre-
                                                    communications about HIV prevention                       because they have high rates of HIV, but                          exposure prophylaxis uptake and
                                                    and control should be delivered to MSM                    also because significant disparities in                           adherence, and antiretroviral therapy
                                                    according to their HIV serostatus and                     HIV among men who have sex with men                               uptake and adherence following
                                                    risk category.                                            (MSM) have been observed by race/                                 completion of the intervention.
                                                       The National Center for HIV/AIDS,                      ethnicity and age. Study participants                             Participants will complete the
                                                    Viral Hepatitis, STD and TB Prevention                    will be sexually active MSM at least 18                           assessment in-person at baseline and 9-
                                                    is requesting approval to evaluate the                    years in age who own and use and                                  months, using a computer in a private
                                                    efficacy of a smartphone-based HIV                        Android and iOS smartphone. Study                                 location, and remotely via their personal
                                                    prevention intervention for MSM,                          participants will be stratified by risk                           computer or tablet device at the 3-
                                                    known as M3(M-Cubed) that has been                        category: HIV positive (one third) and                            month and 6-month follow-ups. The
                                                    designed to deliver targeted messages in                  HIV negative (one third each:                                     same information will be collected from
                                                    six intervention domains: HIV testing,                    condomless anal sex in past three                                 all participants. The burden per
                                                    sexually transmitted infection (STI)                      months; no condomless anal sex past                               response for each assessment is 1.5
                                                    testing, PrEP, antiretroviral (ARV)                       three months). Across the three sites, we                         hours.
                                                    treatment, Condoms, and Engagement in                     will ensure that at least 40% of                                     It is expected that 50% of men
                                                    Care. The smartphone and tablet                           participants are people of color (non-                            screened will meet study eligibility and
                                                    application includes 36 core messages                     white or Hispanic) by quota sampling.                             provide contact information, that 75
                                                    and 12 videos that were developed                         Participants will be recruited to the                             percent will schedule and show up for
                                                    based on CDC-sponsored iterative                          study through a combination of                                    an in-person appointment, and that 95
                                                    formative research (OMB No. 0920–                         approaches, including online                                      percent of these men will remain
                                                    0840) and a review of HIV health                          advertisement, traditional print                                  eligible after reverification. We expect
                                                    communications literature. Messages                       advertisement, referral, in-person                                the initial screening to take
                                                    will be delivered to each participant’s                   outreach, and through word of mouth.                              approximately four minutes to
                                                    device. The proposed study will assess                    Participants will be randomly assigned                            complete, that providing contact
                                                    whether exposure to the message-                          to an intervention group or a waitlist                            information will take 1 minute, and the
                                                    delivery platform results in                              control group. The control group will                             rescreening prior to study enrollment to
                                                    improvements in participants’ self-                       receive the intervention after the study                          take another four minutes.
                                                    reported sexual health and HIV                            has been completed.                                                  OMB approval is requested for two
                                                    prevention behaviors, beliefs and                           A quantitative assessment                                       years. Participation is voluntary and
                                                    attitudes. Information will be collected                  questionnaire will be administered                                there are no costs to the respondents
                                                    at baseline and 3-month, 6-month, and                     online at four points in time. The                                other than their time. The total
                                                    9-month follow-ups.                                       assessment will be used to measure                                estimated annual burden is 3,787 hours.

                                                                                                             ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                               Number of          Average
                                                                                                                                                                                Number of       responses       burden per
                                                                     Type of respondent                                             Form name                                  respondents         per           response
                                                                                                                                                                                               respondent        (in hours)

                                                    Men ≥ 18 Years of Age Who Have Sex With                  Participant Screening (Eligibility) ...................                  1,693                 1           4/60
                                                     Men.
                                                                                                             Contact Information Form ..............................                   847                  1           1/60
                                                                                                             Participant Screening (Verification) ................                     635                  1           4/60
                                                                                                             Assessment ....................................................           603                  4            1.5



                                                    Leroy A. Richardson,                                      DEPARTMENT OF HEALTH AND                                          Geographic Disparities in Diabetes and
                                                    Chief, Information Collection Review Office,              HUMAN SERVICES                                                    Cardiometabolic Health.
                                                    Office of Scientific Integrity, Office of the                                                                                 Times and Dates:
                                                    Associate Director for Science, Office of the             Centers for Disease Control and                                   10:00 a.m.–6:00 p.m., EDT, April 25,
                                                    Director, Centers for Disease Control and                 Prevention                                                          2017 (Closed)
                                                    Prevention.
                                                                                                                                                                                10:00 a.m.–6:00 p.m., EDT, April 26,
                                                    [FR Doc. 2017–06577 Filed 4–3–17; 8:45 am]                Disease, Disability, and Injury
                                                                                                                                                                                  2017 (Closed)
                                                    BILLING CODE 4163–18–P
                                                                                                              Prevention and Control Special
                                                                                                              Emphasis Panel (SEP): Initial Review                                Place: Teleconference.
                                                                                                                                                                                  Status: The meeting will be closed to
                                                                                                                In accordance with Section 10(a)(2) of                          the public in accordance with
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                              the Federal Advisory Committee Act                                provisions set forth in Section 552b(c)
                                                                                                              (Pub. L. 92–463), the Centers for Disease                         (4) and (6), Title 5 U.S.C., and the
                                                                                                              Control and Prevention (CDC)                                      Determination of the Director,
                                                                                                              announces a meeting for the initial                               Management Analysis and Services
                                                                                                              review of applications in response to                             Office, CDC, pursuant to Public Law 92–
                                                                                                              Funding Opportunity Announcement                                  463.
                                                                                                              (FOA) DP17–001, Community                                           Matters for Discussion: The meeting
                                                                                                              Characteristics Associated with                                   will include the initial review,


                                               VerDate Sep<11>2014     16:21 Apr 03, 2017   Jkt 241001   PO 00000   Frm 00071      Fmt 4703     Sfmt 4703      E:\FR\FM\04APN1.SGM    04APN1


                                                                                    Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Notices                                  16405

                                                    discussion, and evaluation of                             Name of Committee: National Institute on          Only written comments and/or
                                                                                                                                                                  DATES:
                                                    applications received in response to                    Aging Initial Review Group, Neuroscience of applications for a license which are
                                                    ‘‘Community Characteristics Associated                  Aging Review Committee,                     received by the NHLBI Office of
                                                                                                              Date: June 1–2, 2017.
                                                    with Geographic Disparities in Diabetes                   Time: 2:00 p.m. to 2:00 p.m.
                                                                                                                                                        Technology Transfer and Development
                                                    and Cardiometabolic Health’’, DP17–                       Agenda: To review and evaluate grant      on or before April 19, 2017 will be
                                                    001.                                                    applications.                               considered.
                                                       Contact Person for More Information:                   Place: Torrance Marriott Redondo Beach,   ADDRESSES: Requests for copies of the
                                                    Jaya Raman Ph.D., Scientific Review                     3635 Fashion Way, Torrance, CA 90503.       patent application, inquiries, and
                                                                                                              Contact Person: Jeannette L. Johnson,
                                                    Officer, CDC, 4770 Buford Highway,                                                                  comments relating to the contemplated
                                                                                                            Ph.D., Deputy Review Branch Chief, National
                                                    Mailstop F80, Atlanta, Georgia 30341,                   Institutes of Health, National Institute on exclusive license should be directed to:
                                                    Telephone: (770) 488–6511, kva5@                        Aging, Gateway Building, Bethesda, MD       Cristina Thalhammer-Reyero, Ph.D.,
                                                    cdc.gov.                                                20892, 301–402–7705, johnsonj9@             MBA, Senior Licensing and Patenting
                                                       The Director, Management Analysis                    nia.nih.gov.                                Manager, NHLBI Office of Technology
                                                    and Services Office, has been delegated                   Name of Committee: National Institute on  Transfer and Development, 31 Center
                                                    the authority to sign Federal Register                  Aging Initial Review Group, Clinical Aging  Drive Room 4A29, MSC2479, Bethesda,
                                                                                                            Review Committee.                           MD 20892–2479; Telephone: +1–301–
                                                    notices pertaining to announcements of                    Date: June 1–2, 2017.
                                                    meetings and other committee                                                                        435–4507; Fax: +1–301–594–3080;
                                                                                                              Time: 2:00 p.m. to 2:00 p.m.              Email: thalhamc@mail.nih.gov.
                                                    management activities, for both the                       Agenda: To review and evaluate grant
                                                    Centers for Disease Control and                         applications.                               SUPPLEMENTARY INFORMATION: The
                                                    Prevention and the Agency for Toxic                       Place: Torrance Marriott Redondo Beach,   following represents the intellectual
                                                    Substances and Disease Registry.                        3635 Fashion Way, Torrance, CA 90503.       property to be licensed under the
                                                                                                              Contact Person: Alicja L. Markowska,      prospective agreement:
                                                    Elaine L. Baker,                                        Ph.D., Dsc., National Institute on Aging,      U.S. Provisional Patent Application
                                                    Director, Management Analysis and Services              National Institutes of Health, Gateway      Serial No. 61/045,213, filed 04/15/2008;
                                                    Office, Centers for Disease Control and                 Building 2C212, 7201 Wisconsin Avenue,      PCT Application No. PCT/US2009/
                                                    Prevention.                                             Bethesda, MD 20892, 301–496–9666,
                                                                                                                                                        040560, filed 04/14/2009; U.S. Patent
                                                    [FR Doc. 2017–06536 Filed 4–3–17; 8:45 am]              markowsa@nia.nih.gov.
                                                                                                                                                        Application Serial No.12/937,974,
                                                                                                            (Catalogue of Federal Domestic Assistance
                                                    BILLING CODE 4163–18–P
                                                                                                            Program Nos. 93.866, Aging Research,
                                                                                                                                                        issued as 8,936,787 on 01/20/2015;
                                                                                                            National Institutes of Health, HHS)         Titled ‘‘Peptides Promoting Lipid
                                                                                                                                                        Efflux’’ (NIH Reference No. E–138–
                                                    DEPARTMENT OF HEALTH AND                                   Dated: March 29, 2017.                   2008/0).
                                                    HUMAN SERVICES                                          Melanie J. Pantoja,                            With respect to persons who have an
                                                                                                            Program Analyst, Office of Federal Advisory obligation to assign their right, title and
                                                    National Institutes of Health                           Committee Policy.                           interest to the Government of the United
                                                    National Institute on Aging; Notice of                  [FR Doc. 2017–06553 Filed 4–3–17; 8:45 am]  States of America, the patent rights in
                                                    Closed Meetings                                         BILLING CODE 4140–01–P                      these inventions have been assigned to
                                                                                                                                                        the Government of the United States of
                                                      Pursuant to section 10(d) of the                                                                  America.
                                                    Federal Advisory Committee Act, as                      DEPARTMENT OF HEALTH AND                       The prospective exclusive license
                                                    amended (5 U.S.C. App.), notice is                      HUMAN SERVICES                              territory may be worldwide and the
                                                    hereby given of the following meetings.                                                             field of use may be limited to:
                                                                                                            National Institutes of Health               ‘‘Treatment of Hypertriglyceridemia,
                                                      The meetings will be closed to the                                                                with or without concomitant metabolic
                                                    public in accordance with the                           Prospective Grant of Exclusive Patent       syndrome’’.
                                                    provisions set forth in sections                        License: Development and                       The invention pertains to
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Commercialization of Peptides               compositions and methods of use of
                                                    as amended. The grant applications and                  Promoting Lipid Efflux for the              ApoC–II mimetic peptides with
                                                    the discussions could disclose                          Treatment of Hypertriglyceridemia,          multiple amphipathic alpha helical
                                                    confidential trade secrets or commercial                With or Without Concomitant                 domains that have the dual ability to
                                                    property such as patentable material,                   Metabolic Syndrome                          promote lipid efflux from cells and
                                                    and personal information concerning                     AGENCY: National Institutes of Health,      stimulate lipoprotein lipase activity,
                                                    individuals associated with the grant                   HHS.                                        without inducing toxicity. This notice is
                                                    applications, the disclosure of which                                                               made in accordance with 35 U.S.C. 209
                                                                                                            ACTION: Notice.
                                                    would constitute a clearly unwarranted                                                              and 37 CFR part 404. The prospective
                                                    invasion of personal privacy.                           SUMMARY: The National Heart, Lung, and Exclusive Patent License will be royalty
                                                      Name of Committee: National Institute on              Blood Institute (NHLBI), an institute of    bearing and may be granted unless
                                                    Aging Initial Review Group, Biological Aging            the National Institutes of Health; an       within fifteen (15) days from the date of
                                                    Review Committee.                                       agency within the Department of Health this published notice, the NHLBI Office
                                                      Date: May 30–31, 2017.                                and Human Services, is contemplating        of Technology Transfer and
                                                      Time: 2:00 p.m. to 2:00 p.m.                          the grant of an exclusive patent license    Development receives written evidence
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                      Agenda: To review and evaluate grant                  to commercialize the invention(s)           and argument that establishes that the
                                                    applications.                                           embodied in the intellectual property       grant of the license would not be
                                                      Place: Torrance Marriott Redondo Beach,
                                                    3635 Fashion Way, Torrance, CA 90503.
                                                                                                            estate stated in the Summary                consistent with the requirements of 35
                                                      Contact Person: Bita Nakhai, Ph.D.,                   Information section of this notice to       U.S.C. 209 and 37 CFR part 404.
                                                    Scientific Review Branch, National Institute            Corvidia Therapeutics Inc. (Corvidia)          Complete applications for a license in
                                                    on Aging, Gateway Bldg., 2C212, 7201                    located in Waltham, MA and                  the prospective field of use that are
                                                    Wisconsin Avenue, Bethesda, MD 20814,                   incorporated under the laws of              timely filed in response to this notice
                                                    301–402–7701, nakhaib@nia.nih.gov.                      Delaware.                                   will be treated as objections to the grant


                                               VerDate Sep<11>2014   16:21 Apr 03, 2017   Jkt 241001   PO 00000   Frm 00072   Fmt 4703   Sfmt 4703   E:\FR\FM\04APN1.SGM   04APN1



Document Created: 2017-04-03 23:54:07
Document Modified: 2017-04-03 23:54:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation82 FR 16404 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR