81 FR 72814 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 204 (October 21, 2016)

Page Range		72814-72815
FR Document		2016-25473

Federal Register, Volume 81 Issue 204 (Friday, October 21, 2016)

[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72814-72815]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25473]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Arthritis and Musculoskeletal and Skin 
Diseases; Notice of Closed Meetings

    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

[[Page 72815]]

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 Arthritis and 
Musculoskeletal and Skin Diseases Special Emphasis Panel; Ancillary 
Studies Review Meeting.
    Date: November 9, 2016.
    Time: 9:30 a.m. to 12:30 p.m.
    Agenda: To review and evaluate grant applications
    Place: National Institutes of Health, One Democracy Plaza, 6701 
Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Xincheng Zheng, MD, Ph.D., Scientific Review 
Officer, Scientific Review Branch, National Institute of Arthritis, 
Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Boulevard, 
Suite 820, Bethesda, MD 20892, 301-451-4838, [email protected].

    Name of Committee: National Institute of Arthritis and 
Musculoskeletal and Skin Diseases Special Emphasis Panel; AMS Member 
Conflict Meeting.
    Date: November 9, 2016.
    Time: 2:00 p.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Bethesda, MD 20892 
(Telephone Conference Call).
    Contact Person: Kan Ma, Ph.D., Scientific Review Officer, 
Scientific Review Branch, National Institute of Arthritis, 
Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Boulevard, 
Suite 814, Bethesda, MD 20892, 301-451-4838,[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.846, 
Arthritis, Musculoskeletal and Skin Diseases Research, National 
Institutes of Health, HHS)

    Dated: October 17, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-25473 Filed 10-20-16; 8:45 am]
BILLING CODE 4140-01-P

72814 Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices

and Skin Diseases Clinical Trials Review FOR FURTHER INFORMATION CONTACT: no significant metabolic CYP liabilities.
Committee. Information on licensing and co- These compounds possess very
Date: October 25–26, 2016. development research collaborations, favorable in vivo rodent
Time: 8:00 a.m. to 5:00 p.m.
and copies of the U.S. patent pharmacokinetics and bioavailability
Agenda: To review and evaluate grant
applications. applications listed below may be and are well tolerated in rodents, even
Place: Bethesda Marriott Suites, 6711 obtained by contacting: Attn: Sury Vepa, when dosed at high levels.
Democracy Boulevard, Bethesda, MD 20817. Ph.D., J.D., Senior Licensing and
Potential Commercial Applications
Contact Person: Kathy Salaita, SCD, Patenting Manager, National Center for
Scientific Review Officer, Scientific Review Advancing Translational Sciences, NIH, • Potential treatment of cancer (AML
Branch, National Institute of Arthritis, 9800 Medical Center Drive, Rockville, or other solid tumors listed above).
Musculoskeletal and Skin Diseases, NIH, MD 20850, Phone: 301–217–9197, Fax: • Potential treatment of rare diseases
6701 Democracy Blvd., Building One, Room including Maffucci Syndrome and
301–217–5736, or email
818, Bethesda, MD 20892, 301–594–5033, Ollier Disease.
kathy.salaita@nih.gov. NCATSPartnerships@mail.nih.gov. A
This notice is being published less than 15
signed Confidential Disclosure Value Proposition
days prior to the meeting due to the timing Agreement may be required to receive
copies of the patent applications. • Novel mutant IDH1 inhibitors are
limitations imposed by the review and
funding cycle. effective at lowering the oncometabolite,
SUPPLEMENTARY INFORMATION: This
2–HG in in vivo mouse proof-of-concept
Name of Committee: National Institute of notice is made in accordance with 35
Arthritis and Musculoskeletal and Skin studies and are well suited for IND
U.S.C. 209 and 37 CFR part 404 to
Diseases Special Emphasis Panel; NIAMS enabling studies.
achieve expeditious commercialization
Institutional Training Grants (T32) Review Development Stage: Pre-clinical (in
of results of federally-funded research
Meeting. vivo validation).
and development.
Date: October 28, 2016. Inventor(s): Matt Boxer, Kyle
Time: 8:00 a.m. to 5:00 p.m. Intellectual Property Brimacombe, Mindy Davis, Rajan
Agenda: To review and evaluate grant Pragani, Jason Rohde, Li Liu, Surendra
applications. Description of Technology: Isocitrate
Karavadhi, Daniel Urban, Min Shen,
Place: 6701 Democracy Boulevard, dehydrogenase 1 (IDH1) is an enzyme
Anton Simeonov, Ajit Jadhav (NCATS)
Building One, Conference Room 807, whose normal function is to convert
Bethesda, MD 20892. Xiaodong Wang and Andrew McIver
isocitrate to a-ketoglutarate. Mutated
Contact Person: Yin Liu, Ph.D., MD, (Univ. of North Carolina at Chapel Hill)
forms of this enzyme (mIDH1) are
Scientific Review Officer, Scientific Review Intellectual Property:
common in a variety of cancers
Branch, National Institute of Arthritis, 1. International Application No. PCT/
Musculoskeletal and Skin Diseases, NIH, including acute myeloid leukemia
US15/067406 filed on 12/22/2015
6701 Democracy Blvd., Building One, Room (AML), glioma, cholangiocarcinoma,
which is entitled ‘‘Mutant IDH1
824, Bethesda, MD 20892, 301–594–8919, chondrosarcoma and melanoma. The
Inhibitors Useful for Treating Cancer’’
liuy@mail.nih.gov. IDH1 mutation at position 132 and
(HHS Ref. No: E–243–2014/0–PCT–02),
This notice is being published less than 15 similar IDH1 mutations result in the
and
days prior to the meeting due to the timing enzyme gaining the ability to catalyze
2. U.S. Provisional Application No.
limitations imposed by the review and the NADPH-dependent reduction of the
funding cycle. 62/353298 filed on 06/22/2016 which is
wild type enzyme’s product, a-
entitled ‘‘Mutant IDH1 Inhibitors Useful
(Catalogue of Federal Domestic Assistance ketoglutarate to R–2-hydroxyglutarate
Program Nos. 93.846, Arthritis, for Treating Cancer’’ (HHS Ref. No. E–
(2–HG). 2–HG is an oncometabolite, and
Musculoskeletal and Skin Diseases Research, 189–2016/0–US–01).
its elevated levels have been shown to
National Institutes of Health, HHS) lead to de-differentiation of cells. Dated: October 5, 2016.
Dated: October 17, 2016. Mutant IDH1 is an attractive target for Pamela McInnes,
Sylvia L. Neal, anti-cancer therapeutics as inhibition Deputy Director, Office of the Director,
Program Analyst, Office of Federal Advisory reduces levels of 2–HG. It is expected National Center for Advancing Translational
Committee Policy. that lower 2–HG levels will result in Sciences.
[FR Doc. 2016–25472 Filed 10–20–16; 8:45 am] fewer undifferentiated cancer cells. [FR Doc. 2016–25468 Filed 10–20–16; 8:45 am]
BILLING CODE 4140–01–P
Furthermore, inhibition of mutant IDH1 BILLING CODE 4140–01–P
is expected to have little effect on non-
cancerous cells, as these cells do not
DEPARTMENT OF HEALTH AND express the IDH1 mutation resulting in DEPARTMENT OF HEALTH AND
HUMAN SERVICES lower toxicity than typical cytotoxic HUMAN SERVICES
anticancer agents.
National Institutes of Health In collaboration with the University of National Institutes of Health
North Carolina, the National Center for National Institute of Arthritis and
Notice of Availability of License; Advancing Translational Sciences
Mutant IHD1 Inhibitors Useful for Musculoskeletal and Skin Diseases;
(NCATS) investigators have discovered Notice of Closed Meetings
Treating Cancer a series of novel compounds that
AGENCY: National Institutes of Health, potently and selectively inhibit mIDH1. Pursuant to section 10(d) of the
These compounds reduce 2–HG levels Federal Advisory Committee Act, as
asabaliauskas on DSK3SPTVN1PROD with NOTICES

HHS.
ACTION: Notice. in cell lines in vitro as well as in human amended (5 U.S.C. App.), notice is
cancer cells grown in mouse xenografts hereby given of the following meetings.
SUMMARY: The invention Mutant IHD1 in vivo. These compounds show greater The meetings will be closed to the
Inhibitors Useful for Treating Cancer is than 250-fold selectivity for the mutant public in accordance with the
owned by an agency of the U.S. enzyme over the wild-type, show provisions set forth in sections
Government and is available for favorable in vitro stability (in mouse, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
licensing and/or co-development in the rat, dog and human hepatocyte exposure as amended. The grant applications and
U.S. studies), are AMES negative, and exhibit the discussions could disclose

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Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices 72815

confidential trade secrets or commercial provisions set forth in sections amended (5 U.S.C. App.), notice is
property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., hereby given of the following meeting.
and personal information concerning as amended. The grant applications and The meeting will be closed to the
individuals associated with the grant the discussions could disclose public in accordance with the
applications, the disclosure of which confidential trade secrets or commercial provisions set forth in sections
would constitute a clearly unwarranted property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
invasion of personal privacy. and personal information concerning as amended. The grant applications and
Name of Committee: National Institute of individuals associated with the grant the discussions could disclose
Arthritis and Musculoskeletal and Skin applications, the disclosure of which confidential trade secrets or commercial
Diseases Special Emphasis Panel; Ancillary would constitute a clearly unwarranted property such as patentable material,
Studies Review Meeting. invasion of personal privacy. and personal information concerning
Date: November 9, 2016. Name of Committee: National Institute of individuals associated with the grant
Time: 9:30 a.m. to 12:30 p.m. applications, the disclosure of which
Child Health and Human Development
Agenda: To review and evaluate grant would constitute a clearly unwarranted
Special Emphasis Panel; Physical Activity
applications invasion of personal privacy.
and Leukocyte Activation: Harnessing the
Place: National Institutes of Health, One Molecular Pathways of Exercise Adaptation. Name of Committee: Center for Scientific
Democracy Plaza, 6701 Democracy Date: November 28, 2016. Review Special Emphasis Panel; Member
Boulevard, Bethesda, MD 20892 (Virtual Time: 2:00 p.m. to 6:00 p.m. Conflict: Autism, Epilepsy, other
Meeting). Agenda: To review and evaluate grant Neurological Disorders.
Contact Person: Xincheng Zheng, MD, applications. Date: November 8, 2016.
Ph.D., Scientific Review Officer, Scientific Place: National Institutes of Health, 6710B Time: 11:00 a.m. to 1:30 p.m.
Review Branch, National Institute of Rockledge Drive, Bethesda, MD 20817 Agenda: To review and evaluate grant
Arthritis, Musculoskeletal and Skin Diseases, (Telephone Conference Call). applications.
NIH, 6701 Democracy Boulevard, Suite 820, Contact Person: Rita Anand, Ph.D., Place: National Institutes of Health, 6701
Bethesda, MD 20892, 301–451–4838, Scientific Review Officer, Division of Rockledge Drive, Bethesda, MD 20892,
xincheng.zheng@nih.gov. Scientific Review, National Institute of Child (Telephone Conference Call).
Name of Committee: National Institute of Health And Human Development, NIH, Contact Person: Samuel C. Edwards, Ph.D.,
Arthritis and Musculoskeletal and Skin 6710B Rockledge Drive, Room 2131C, IRG CHIEF, Center for Scientific Review,
Diseases Special Emphasis Panel; AMS Bethesda, MD 20892, 301–496–1487, National Institutes of Health, 6701 Rockledge
Member Conflict Meeting. anandr@mail.nih.gov. Drive, Room 5210, MSC 7846, Bethesda, MD
Date: November 9, 2016. 20892, (301) 435–1246, edwardss@
Name of Committee: National Institute of
Time: 2:00 p.m. to 3:00 p.m. csr.nih.gov.
Child Health and Human Development
Agenda: To review and evaluate grant Special Emphasis Panel. (Catalogue of Federal Domestic Assistance
applications. Date: December 7, 2016. Program Nos. 93.306, Comparative Medicine;
Place: National Institutes of Health, Time: 11:00 a.m. to 2:30 p.m. 93.333, Clinical Research, 93.306, 93.333,
Bethesda, MD 20892 (Telephone Conference Agenda: To review and evaluate grant 93.337, 93.393–93.396, 93.837–93.844,
Call). applications. 93.846–93.878, 93.892, 93.893, National
Contact Person: Kan Ma, Ph.D., Scientific Place: National Institutes of Health, Institutes of Health, HHS)
Review Officer, Scientific Review Branch, Rockledge 6700, 6700B Rockledge Drive,
National Institute of Arthritis, Dated: October 17, 2016.
Bethesda, MD 20817 (Telephone Conference
Musculoskeletal and Skin Diseases, NIH, Sylvia L. Neal,
Call).
6701 Democracy Boulevard, Suite 814, Contact Person: Carla T. Walls, Ph.D., Program Analyst, Office of Federal Advisory
Bethesda, MD 20892, 301–451–4838,mak2@ Scientific Review Administrator, Scientific Committee Policy.
mail.nih.gov. Review Branch, National Institute of Child [FR Doc. 2016–25470 Filed 10–20–16; 8:45 am]
(Catalogue of Federal Domestic Assistance Health and Human Development, NIH, 6710B
Program Nos. 93.846, Arthritis, BILLING CODE 4140–01–P
Rockledge Drive, Room 2131C, Bethesda, MD
Musculoskeletal and Skin Diseases Research, 20892, (301) 435–6898, wallsc@mail.nih.gov.
National Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance
Dated: October 17, 2016. Program Nos. 93.864, Population Research; DEPARTMENT OF HOMELAND
Sylvia L. Neal, 93.865, Research for Mothers and Children; SECURITY
93.929, Center for Medical Rehabilitation
Program Analyst, Office of Federal Advisory Coast Guard
Research; 93.209, Contraception and
Committee Policy.
Infertility Loan Repayment Program, National [Docket No. USCG–2016–0937]
[FR Doc. 2016–25473 Filed 10–20–16; 8:45 am] Institutes of Health, HHS)
BILLING CODE 4140–01–P
Dated: October 17, 2016. Lower Mississippi River Waterway
Michelle Trout, Safety Advisory Committee
DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory AGENCY: Coast Guard, Department of
HUMAN SERVICES Committee Policy.
Homeland Security.
[FR Doc. 2016–25474 Filed 10–20–16; 8:45 am]
ACTION: Notice of Federal advisory
National Institutes of Health BILLING CODE 4140–01–P
committee meeting.
Eunice Kennedy Shriver National SUMMARY: The Lower Mississippi River
Institute of Child Health & Human DEPARTMENT OF HEALTH AND Waterway Safety Advisory Committee
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Development; Notice of Closed HUMAN SERVICES will meet on November 8, 2016 in New
Meetings Orleans, LA to discuss committee
National Institutes of Health matters relating to the safe transit of
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as vessels and cargoes to and from the
Center for Scientific Review; Notice of
amended (5 U.S.C. App.), notice is ports of the Lower Mississippi River.
Closed Meeting
hereby given of the following meetings. The meeting will be open to the public.
The meetings will be closed to the Pursuant to section 10(d) of the DATES: The Lower Mississippi River
public in accordance with the Federal Advisory Committee Act, as Waterway Safety Advisory Committee

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Document Created: 2018-02-13 16:35:57
Document Modified: 2018-02-13 16:35:57

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
Dates		November 9, 2016.
FR Citation		81 FR 72814

81 FR 72814 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 204 (October 21, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health