83_FR_61106 83 FR 60878 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

83 FR 60878 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 228 (November 27, 2018)

Page Range60878-60879
FR Document2018-25789

Federal Register, Volume 83 Issue 228 (Tuesday, November 27, 2018)
[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60878-60879]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25789]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; Notice of 
Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, 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 of Allergy and Infectious 
Diseases Special Emphasis Panel; Centers for AIDS Research and 
Developmental Centers for AIDS Research (P30).
    Date: December 11-12, 2018.
    Time: 9:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda North Marriott Hotel & Conference Center, 5701 
Marinelli Road, Bethesda, MD 20852.
    Contact Person: Audrey O. Lau, Ph.D., MPH, Acting Senior 
Scientific Review Officer, AIDS Review Branch, SRP, Rm. 3E70, 
National Institutes of Health, NIAID, 5601 Fishers Lane, MSC 9834, 
Rockville, MD 20852-9834, 240-669-2081, [email protected].

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; NIAID Investigator Initiated 
Program Project Applications (P01).
    Date: December 19, 2018.
    Time: 12:30 p.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 5601 Fishers Lane, 
Rockville, MD 20892 (Telephone Conference Call).
    Contact Person: Frank S. De Silva, Ph.D., Scientific Review 
Officer, Scientific Review Program, Division of Extramural 
Activities, Room #3E72A, National Institutes of Health/NIAID, 5601 
Fishers Lane, MSC 9823, Rockville, MD 20892-9823, (240) 669-5023, 
[email protected].

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; NIAID Investigator Initiated 
Program Project Applications (P01).
    Date: December 20, 2018.
    Time: 9:00 a.m. to 1:00 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 60879]]

    Place: National Institutes of Health, 5601 Fishers Lane, 
Rockville, MD 20892 (Telephone Conference Call).
    Contact Person: Frank S. De Silva, Ph.D., Scientific Review 
Officer, Scientific Review Program, Division of Extramural 
Activities, Room #3E72A, National Institutes of Health/NIAID, 5601 
Fishers Lane, MSC 9823, Rockville, MD 20892-9823, (240) 669-5023, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.855, 
Allergy, Immunology, and Transplantation Research; 93.856, 
Microbiology and Infectious Diseases Research, National Institutes 
of Health, HHS)

    Dated: November 20, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-25789 Filed 11-26-18; 8:45 am]
 BILLING CODE 4140-01-P



                                              60878                              Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices

                                              Child Care and Indian Child Care                                           regular contact with, or control over,                            the age of 18 to assure that all existing
                                              Worker Positions (OMB No. 0917–0028).                                      Indian children. 25 U.S.C. 3207(a)(1)                             and newly hired employees undergo a
                                              Type of Information Collection Request:                                    and (2). Title 25 U.S.C. 3207(a)(3)                               criminal history background check. The
                                              Extension, without revision, of currently                                  requires regulations prescribing the                              background investigation is to be
                                              approved information collection, 0917–                                     minimum standards of character for                                initiated through the personnel program
                                              0028, Addendum to Declaration for                                          individuals appointed to positions                                of the applicable Federal agency. This
                                              Federal Employment, Child Care and                                         involving regular contact with, or                                section requires employment
                                              Indian Child Care Worker Positions.                                        control over, Indian children, and                                applications for individuals who are
                                              There are no program changes or                                            section 3207(b) provides that such                                seeking work for an agency of the
                                              adjustments in burden hours. Form(s):                                      standards shall ensure that no such                               Federal Government, or for a facility or
                                              Addendum to Declaration for Federal                                        individuals have been found guilty of,                            program operated by (or through
                                              Employment, Child Care and Indian                                          or entered a plea of nolo contendere or                           contract with) the Federal Government,
                                              Child Care Worker Positions. Need and                                      guilty to any felonious offense, or any                           in positions involved with the provision
                                              Use of Information Collection: This is a                                   two or more misdemeanor offenses,                                 of child care services to children under
                                              request for approval of the collection of                                  under Federal, State, or Tribal law                               the age of 18, to contain a question
                                              information as required by section 408                                     involving crimes of violence; sexual                              asking whether the individual has ever
                                              of the Indian Child Protection and                                         assault, molestation, exploitation,                               been arrested for or charged with a
                                              Family Violence Prevention Act, Public                                     contact or prostitution; crimes against                           crime involving a child, and if so,
                                              Law (Pub. L.) 101–630, 104 Stat. 4544,                                     persons; or offenses committed against                            requiring a description of the
                                              and 25 United States Code (U.S.C.)                                         children.                                                         disposition of the arrest or charge.
                                              §§ 3201–3210.                                                                 In addition, 34 U.S.C. 20351 (formerly
                                                The IHS is required to compile a list                                    codified at 42 U.S.C. 13041, which was                              Affected Public: Individuals and
                                              of all authorized positions within the                                     transferred to 34 U.S.C. 20351) requires                          households. Type of Respondents:
                                              IHS where the duties and                                                   each agency of the Federal Government,                            Individuals.
                                              responsibilities involve regular contact                                   and every facility operated by the                                  The table below provides: Types of
                                              with, or control over, Indian children;                                    Federal Government (or operated under                             data collection instruments, Estimated
                                              and to conduct an investigation of the                                     contract with the Federal Government),                            number of respondents, Number of
                                              character of each individual who is                                        that hires (or contracts for hire)                                responses per respondent, Average
                                              employed, or is being considered for                                       individuals involved with the provision                           burden hour per response, and Total
                                              employment, in a position having                                           of child care services to children under                          annual burden hour(s).

                                                                                                                           ESTIMATED ANNUAL BURDEN HOURS
                                                                                                                                                                                                                       Average               Total annual
                                                                                                                                                                                         Number of
                                                                                                                                                                       Number of                                     burden per                  burden
                                                                                 Data collection instrument(s)                                                                         responses per
                                                                                                                                                                      respondents                                     response                responses
                                                                                                                                                                                         respondent                   (in hours)               (in hours)

                                              Addendum to Declaration for Federal Employment (OMB 0917–0028) .........                                                         3,000                        1                    12/60                600

                                                   Total ..........................................................................................................            3,000   ........................   ........................            600



                                                There are no Capital Costs, Operating                                    provisions set forth in sections                                  20852–9834, 240–669–2081, audrey.lau@
                                              Costs, and/or Maintenance Costs to                                         552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                        nih.gov.
                                              report.                                                                    as amended. The grant applications and                              Name of Committee: National Institute of
                                                Dated: November 19, 2018.                                                the discussions could disclose                                    Allergy and Infectious Diseases Special
                                                                                                                         confidential trade secrets or commercial                          Emphasis Panel; NIAID Investigator Initiated
                                              Michael D. Weahkee,                                                                                                                          Program Project Applications (P01).
                                                                                                                         property such as patentable material,
                                              Assistant Surgeon General, U.S. Public Health                                                                                                  Date: December 19, 2018.
                                              Service, Principal Deputy Director, Indian
                                                                                                                         and personal information concerning
                                                                                                                         individuals associated with the grant                               Time: 12:30 p.m. to 4:30 p.m.
                                              Health Service.                                                                                                                                Agenda: To review and evaluate grant
                                              [FR Doc. 2018–25819 Filed 11–26–18; 8:45 am]
                                                                                                                         applications, the disclosure of which
                                                                                                                                                                                           applications.
                                                                                                                         would constitute a clearly unwarranted
                                              BILLING CODE 4165–16–P                                                                                                                         Place: National Institutes of Health, 5601
                                                                                                                         invasion of personal privacy.                                     Fishers Lane, Rockville, MD 20892
                                                                                                                           Name of Committee: National Institute of                        (Telephone Conference Call).
                                              DEPARTMENT OF HEALTH AND                                                   Allergy and Infectious Diseases Special                             Contact Person: Frank S. De Silva, Ph.D.,
                                              HUMAN SERVICES                                                             Emphasis Panel; Centers for AIDS Research                         Scientific Review Officer, Scientific Review
                                                                                                                         and Developmental Centers for AIDS                                Program, Division of Extramural Activities,
                                              National Institutes of Health                                              Research (P30).                                                   Room #3E72A, National Institutes of Health/
                                                                                                                           Date: December 11–12, 2018.                                     NIAID, 5601 Fishers Lane, MSC 9823,
                                              National Institute of Allergy and                                            Time: 9:00 a.m. to 6:00 p.m.                                    Rockville, MD 20892–9823, (240) 669–5023,
                                              Infectious Diseases; Notice of Closed                                        Agenda: To review and evaluate grant
                                                                                                                                                                                           fdesilva@niaid.nih.gov.
                                                                                                                         applications.
                                              Meetings
amozie on DSK3GDR082PROD with NOTICES1




                                                                                                                           Place: Bethesda North Marriott Hotel &                            Name of Committee: National Institute of
                                                                                                                         Conference Center, 5701 Marinelli Road,                           Allergy and Infectious Diseases Special
                                                Pursuant to section 10(d) of the                                                                                                           Emphasis Panel; NIAID Investigator Initiated
                                                                                                                         Bethesda, MD 20852.
                                              Federal Advisory Committee Act, as                                           Contact Person: Audrey O. Lau, Ph.D.,                           Program Project Applications (P01).
                                              amended, notice is hereby given of the                                     MPH, Acting Senior Scientific Review                                Date: December 20, 2018.
                                              following meetings.                                                        Officer, AIDS Review Branch, SRP, Rm.                               Time: 9:00 a.m. to 1:00 p.m.
                                                The meetings will be closed to the                                       3E70, National Institutes of Health, NIAID,                         Agenda: To review and evaluate grant
                                              public in accordance with the                                              5601 Fishers Lane, MSC 9834, Rockville, MD                        applications.



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                                                                         Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices                                                60879

                                                Place: National Institutes of Health, 5601            with the Acquired Immunodeficiency                       • Increase in melting temperature (10
                                              Fishers Lane, Rockville, MD 20892                       Syndrome (AIDS) pandemic.                             degrees over BG505 SOSIP).
                                              (Telephone Conference Call).                               One approach researchers have taken                   Development Stage: In vivo testing
                                                Contact Person: Frank S. De Silva, Ph.D.,             to elicit broadly neutralizing antibodies             (rodents).
                                              Scientific Review Officer, Scientific Review
                                                                                                      against HIV–1 is to stabilize the                        Inventors: Peter Kwong (NIAID), John
                                              Program, Division of Extramural Activities,
                                              Room #3E72A, National Institutes of Health/             structurally flexible HIV–1 envelope                  Mascola (NIAID), Gwo-Yu Chuang
                                              NIAID, 5601 Fishers Lane, MSC 9823,                     (Env) trimer. Researchers stabilized the              (NIAID), Cheng Cheng (NIAID), Hui
                                              Rockville, MD 20892–9823, (240) 669–5023,               Env trimer in a conformation that                     Geng (NIAID), Yongping Yang (NIAID)
                                              fdesilva@niaid.nih.gov.                                 displays predominantly broadly                        and Jeffrey C. Boyington (NIAID).
                                              (Catalogue of Federal Domestic Assistance               neutralizing epitopes and few non-                       Intellectual Property: HHS Reference
                                              Program Nos. 93.855, Allergy, Immunology,               neutralizing epitopes. Currently, BG505               Number E–240–2017 includes U.S.
                                              and Transplantation Research; 93.856,                   DS–SOSIP is a leading vaccine                         Provisional Patent Application Number
                                              Microbiology and Infectious Diseases                    candidate with the desired                            62/579,973 filed 10/16/2017.
                                              Research, National Institutes of Health, HHS)                                                                    Related Intellectual Property: HHS
                                                                                                      conformation and antigenicity.
                                                Dated: November 20, 2018.                                Ideally, to be useful as a vaccine, such           Reference Number E–187–2014 includes
                                              Natasha M. Copeland,                                    a conformationally fixed Env                          U.S. Provisional Patent Application
                                              Program Analyst, Office of Federal Advisory             immunogen should have high                            Number 62/046,059 filed 9/4/2014, U.S.
                                              Committee Policy.                                       thermostability and should remain in                  Provisional Patent Application Number
                                              [FR Doc. 2018–25789 Filed 11–26–18; 8:45 am]            the desired antigenic state, even in the              62/136,480 filed 3/21/2015, PCT
                                              BILLING CODE 4140–01–P                                  presence of CD4, a glycoprotein found                 Application No. PCT/US2015/048729
                                                                                                      on the surface of immune cells.                       filed 9/4/2015, US Patent Application
                                                                                                         Researchers at the Vaccine Research                15/508,885 filed 3/3/2017, EP Patent
                                              DEPARTMENT OF HEALTH AND                                Center (VRC) of the National Institute of             Application Number 15766697.5 filed
                                              HUMAN SERVICES                                          Allergy and Infectious Diseases (NIAID)               3/29/2017.
                                                                                                      undertook efforts to improve the                         Licensing Contact: Barry Buchbinder,
                                              National Institutes of Health                           properties of BG505 DS–SOSIP for use                  Ph.D., 240–627–3678;
                                                                                                      as a vaccine. The VRC researchers                     barry.buchbinder@nih.gov.
                                              Government-Owned Inventions;                            introduced three additional mutations                    Dated: November 14, 2018.
                                              Availability for Licensing                              to further stabilize BG505 DS–SOSIP in                Suzanne M. Frisbie,
                                              AGENCY:    National Institutes of Health,               the vaccine-preferred prefusion-closed                Deputy Director, Technology Transfer and
                                              HHS.                                                    conformation and refer to the                         Intellectual Property Office, National Institute
                                              ACTION:   Notice.                                       engineered BG505 DS–SOSIP as BG505                    of Allergy and Infectious Diseases.
                                                                                                      DS–SOSIP.3mut. Experiments showed                     [FR Doc. 2018–25787 Filed 11–26–18; 8:45 am]
                                              SUMMARY:   The invention listed below is                that these modifications conferred                    BILLING CODE 4140–01–P
                                              owned by an agency of the U.S.                          improved thermostability that will
                                              Government and is available for                         allow easier transport and storage of
                                              licensing to achieve expeditious                        BG505 DS–SOSIP.3mut compared to                       DEPARTMENT OF HEALTH AND
                                              commercialization of results of                         BG505 DS–SOSIP. In addition, BG505                    HUMAN SERVICES
                                              federally-funded research and                           DS–SOSIP.3mut has lower antigenicity
                                              development. Foreign patent                             toward non/weak neutralizing                          National Institutes of Health
                                              applications are filed on selected                      antibodies compared to BG505 DS–
                                              inventions to extend market coverage                    SOSIP, which suggests that it could                   National Cancer Institute; Notice of
                                              for companies and may also be available                 potentially elicit higher neutralization              Closed Meetings
                                              for licensing.                                          titer by targeting only broadly                         Pursuant to section 10(d) of the
                                              FOR FURTHER INFORMATION CONTACT:                        neutralizing antibodies. With improved                Federal Advisory Committee Act, as
                                              Barry Buchbinder, Ph.D., 240–627–                       antigenicity and stability, this version              amended, notice is hereby given of the
                                              3678; barry.buchbinder@nih.gov.                         may have utility as an HIV–1                          following meetings.
                                              Licensing information and copies of the                 immunogen or in other antigen-specific                  The meetings will be closed to the
                                              U.S. patent application listed below                    contexts, such as for use with B-cell                 public in accordance with the
                                              may be obtained by communicating                        probes.                                               provisions set forth in sections
                                              with the indicated licensing contact at                    This technology is available for                   552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                              the Technology Transfer and                             licensing for commercial development                  as amended. The grant applications and
                                              Intellectual Property Office, National                  in accordance with 35 U.S.C. 209 and 37               the discussions could disclose
                                              Institute of Allergy and Infectious                     CFR part 404.                                         confidential trade secrets or commercial
                                              Diseases, 5601 Fishers Lane, Rockville,                 Potential Commercial Applications                     property such as patentable material,
                                              MD 20852; tel. 301–496–2644. A signed                                                                         and personal information concerning
                                              Confidential Disclosure Agreement will                    • Vaccine—to elicit potent                          individuals associated with grant
                                              be required to receive copies of                        neutralizing antibodies against the HIV–              applications, the disclosure of which
                                              unpublished patent applications.                        1 Env glycoprotein.                                   would constitute a clearly unwarranted
                                              SUPPLEMENTARY INFORMATION:
                                                                                                        • Probes—to identify broad and                      invasion of personal privacy.
                                              Technology description follows.                         potent HIV–1-neutralizing antibodies.
                                                                                                                                                               Name of Committee: National Cancer
amozie on DSK3GDR082PROD with NOTICES1




                                              Recombinant HIV–1 Envelope Proteins                     Competitive Advantages                                Institute Special Emphasis Panel; NCI SPORE
                                                                                                                                                            I (P50) Review.
                                              and Their Use                                              Compared to previous engineered Env                   Date: January 29–30, 2019.
                                                                                                      trimer versions:                                         Time: 8:00 a.m. to 12:00 p.m.
                                              Description of Technology                                  • 300-fold reduction in CD4-binding                   Agenda: To review and evaluate grant
                                                An effective human                                    affinity.                                             applications.
                                              immunodeficiency virus type 1 (HIV–1)                      • Reduced binding affinity to                         Place: Hilton Washington/Rockville Hotel,
                                              vaccine has long been sought to contend                 ineffective HIV–1 antibodies.                         1750 Rockville Pike, Rockville, MD 20850.



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Document Created: 2018-11-27 01:24:09
Document Modified: 2018-11-27 01:24:09
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
DatesDecember 11-12, 2018.
FR Citation83 FR 60878 

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