82 FR 27069 - Office of the Director; Notice of Charter Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 112 (June 13, 2017)

Page Range		27069-27069
FR Document		2017-12143

Federal Register, Volume 82 Issue 112 (Tuesday, June 13, 2017)

[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Notices]
[Page 27069]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12143]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director; Notice of Charter Renewal

    In accordance with Title 41 of the U.S. Code of Federal 
Regulations, Section 102-3.65(a), notice is hereby given that the 
Charter for the Advisory Committee to the Director, National Institutes 
of Health, was renewed for an additional two-year period on May 31, 
2017.
    It is determined that the Advisory Committee to the Director, 
National Institutes of Health, is in the public interest in connection 
with the performance of duties imposed on the National Institutes of 
Health by law, and that these duties can best be performed through the 
advice and counsel of this group.
    Inquiries may be directed to Jennifer Spaeth, Director, Office of 
Federal Advisory Committee Policy, Office of the Director, National 
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, 
Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or 
[email protected].

    Dated: June 7, 2017.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-12143 Filed 6-12-17; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices 27069

exploiting cell surface proteases present Publications HHS E–293–1999—US Patent Nos.
at high levels in tumors, they have Chen KH, et al., Selection of anthrax 7,468,352, filed 22 Mar 2002;
developed a tumor-targeted anthrax toxin protective antigen variants 8,791,074, filed 20 Oct 2008, and
based toxin that inactivates the blood that discriminate between the 9,403,872 filed 24 Jun 2014.
vessels within tumors. While in some cellular receptors tem8 and cmg2 Licensing Contact: Dr. Natalie Greco,
cases cancer cells are also killed by the and achieve targeting of tumor cells. 301–761–7898; Natalie.Greco@nih.gov.
tumor-targeted toxin, the primary J Biol Chem. 2007 Mar 30; 282(13):
mechanism of action is thought to be a Collaborative Research Opportunity:
9834–9845 [PMID: 17251181
decrease in blood flow to the center of The National Institute of Allergy and
PMCID: PMC2530824]
tumors, causing cancer cell death and Liu S, et al., Solid tumor therapy by Infectious Diseases is seeking statements
tumor necrosis. Preliminary and on- selectively targeting stromal of capability or interest from parties
going studies have demonstrated that endothelial cells. Proc Natl Acad interested in collaborative research to
the targeted toxins have antitumor Sci U S A. 2016 Jul 12; 113(28): further develop, evaluate or
effects on melanomas, lung cancers and E4079–E4087 [PMID: 27357689 commercialize anthrax toxin-based
colon cancer in mouse models, and on PMCID: PMC4948345] cancer therapeutics. For collaboration
feline and canine oral tumors. Wein AN, et al., An anthrax toxin opportunities, please contact Dr. Natalie
Interestingly, this therapy does not variant with an improved activity in Greco, 301–761–7898; Natalie.Greco@
target a specific type of cancer cell, tumor targeting. Sci Rep. 2015; 5: nih.gov.
rather it targets the vasculature in and 16267 [PMID: 26584669 PMCID: Dated: June 1, 2017.
around tumors. Therefore, it has great PMC4653645] Suzanne Frisbie,
potential to treat a wide range of solid Peters DE, et al., Comparative toxicity
tumors. Additionally, because few non- and efficacy of engineered anthrax Deputy Director, Technology Transfer and
lethal toxin variants with broad Intellectual Property Office, National Institute
surgical treatments are available to treat
of Allergy and Infectious Diseases.
many human and veterinary solid anti-tumor activities. Toxicol Appl
[FR Doc. 2017–12147 Filed 6–12–17; 8:45 am]
tumors, this technology would fill an Pharmacol. 2014 Sep 1; 279(2):
unmet need in cancer therapy. 220–229 [PMID: 24971906 PMCID: BILLING CODE 4140–01–P

This technology is available for PMC4137396]
licensing for commercial development Bachran C, et al., Cytolethal distending
in accordance with 35 U.S.C. 209 and 37 toxin B as a cell-killing component DEPARTMENT OF HEALTH AND
CFR part 404, as well as for further of tumor-targeted anthrax toxin HUMAN SERVICES
development and evaluation under a fusion proteins. Cell Death Dis.
2014 Jan; 5(1): e1003 [PMID: National Institutes of Health
research collaboration.
24434511 PMCID: PMC4040664]
Potential Commercial Applications Wein AN, et al., Tumor therapy with a Office of the Director; Notice of Charter
urokinase plasminogen activator- Renewal
Therapeutic agent for a wide range of
human and veterinary solid tumors, activated anthrax lethal toxin alone
and in combination with paclitaxel. In accordance with Title 41 of the
including: U.S. Code of Federal Regulations,
Invest New Drugs. 2013 Feb; 31(1):
• Melanomas Section 102–3.65(a), notice is hereby
206–212 [PMID: 22843210 PMCID:
• Lung and colon cancers PMC3757568] given that the Charter for the Advisory
• Oral squamous carcinomas Phillips DD, et al., Engineering Anthrax Committee to the Director, National
Toxin Variants That Exclusively Institutes of Health, was renewed for an
Competitive Advantages
Form Octamers and Their additional two-year period on May 31,
• Proven effective in a variety of Application to Targeting Tumors. J 2017.
models, including models of important Biol Chem. 2013 Mar 29; 288(13): It is determined that the Advisory
veterinary cancers. 9058–9065 [PMID: 23393143 Committee to the Director, National
• Agent is only active in tumor micro- PMCID: PMC3610978] Institutes of Health, is in the public
environments, resulting in low toxicity Liu S, et al., Intermolecular interest in connection with the
to healthy tissue. complementation achieves high performance of duties imposed on the
• Cancer cells are not directly specificity tumor targeting by National Institutes of Health by law, and
targeted, so this agent can be used to anthrax toxin. Nat Biotechnol. 2005 that these duties can best be performed
treat a broad spectrum of solid tumors Jun; 23(6): 725–730 [PMID: through the advice and counsel of this
and resistance is unlikely to arise. 15895075 PMCID: PMC2405912] group.
• Fills an unmet need in cancer Intellectual Property Inquiries may be directed to Jennifer
therapy, because few non-surgical Spaeth, Director, Office of Federal
treatments exist. HHS E–256–2015—US Application Nos.
62/210,771, filed 27 Aug 2015; 62/ Advisory Committee Policy, Office of
Development Stage 323,218, filed 15 Apr 2016; PCT App. the Director, National Institutes of
No. PCT/US16/48706, filed 25 Aug Health, 6701 Democracy Boulevard,
• in vitro data available Suite 1000, Bethesda, Maryland 20892
2016.
• in vivo data available (animal) HHS E–120–2013—US App. No. 14/ (Mail code 4875), Telephone (301) 496–
• prototype 898,248, filed 14 Dec 2015; PCT App. 2123, or spaethj@od.nih.gov.
nlaroche on DSK30NT082PROD with NOTICES

Inventors: S. Leppla (NIAID); S.-H. No. PCT/US2014/043131, filed 19 Jun Dated: June 7, 2017.
Liu (NIAID); T. Bugge (NIDCR); A.Wein 2014.
(NIAID); D. Peters (NIDCR); J. Liu Jennifer Spaeth,
HHS E–246–2012—US App. No. 14/
(NHLBI); K.-H.Chen (NIAID); H. 423,408, filed 23 Feb 2015; PCT App. Director, Office of Federal Advisory
Birkedal-Hansen (NIDCR); S. Netzel- No. PCT/US13/56205 Committee Policy.
Arnett (NIDCR); D. Phillips (NIAID); C. HHS E–059–2004—US Patent No. [FR Doc. 2017–12143 Filed 6–12–17; 8:45 am]
Leysath (NIAID); C. Bachran (NIAID) 7,947,289, filed 09 Feb 2005. BILLING CODE 4140–01–P

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		82 FR 27069

82 FR 27069 - Office of the Director; Notice of Charter Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 112 (June 13, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health