81 FR 72813 - 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		72813-72814
FR Document		2016-25472

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

[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72813-72814]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25472]


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

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 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: Arthritis and Musculoskeletal and Skin 
Diseases Initial Review Group; Arthritis and Musculoskeletal

[[Page 72814]]

and Skin Diseases Clinical Trials Review Committee.
    Date: October 25-26, 2016.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, 
Bethesda, MD 20817.
    Contact Person: Kathy Salaita, SCD, Scientific Review Officer, 
Scientific Review Branch, National Institute of Arthritis, 
Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Blvd., 
Building One, Room 818, Bethesda, MD 20892, 301-594-5033, 
[email protected].

    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: National Institute of Arthritis and 
Musculoskeletal and Skin Diseases Special Emphasis Panel; NIAMS 
Institutional Training Grants (T32) Review Meeting.
    Date: October 28, 2016.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: 6701 Democracy Boulevard, Building One, Conference Room 
807, Bethesda, MD 20892.
    Contact Person: Yin Liu, Ph.D., MD, Scientific Review Officer, 
Scientific Review Branch, National Institute of Arthritis, 
Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Blvd., 
Building One, Room 824, Bethesda, MD 20892, 301-594-8919, 
[email protected].

    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

(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. 2016-25472 Filed 10-20-16; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices 72813

DEPARTMENT OF HEALTH AND 93.891, Alcohol Research Center Grants; Date: November 17, 2016.
HUMAN SERVICES 93.701, ARRA Related Biomedical Research Time: 8:00 a.m. to 5:00 p.m.
and Research Support Awards, National Agenda: To review and evaluate grant
National Institutes of Health Institutes of Health, HHS) applications.
Dated: October 17, 2016. Place: Bethesda Marriott, 5151 Pooks Hill
National Institute on Alcohol Abuse Road, Bethesda, MD 20814.
Melanie J. Gray,
and Alcoholism; Notice of Closed Contact Person: Jingsheng Tuo, Ph.D.,
Program Analyst, Office of Federal Advisory Scientific Review Officer, Center for
Meetings Committee Policy. Scientific Review, National Institutes of
Pursuant to section 10(d) of the [FR Doc. 2016–25471 Filed 10–20–16; 8:45 am] Health, 6701 Rockledge Drive, Room 3196,
Federal Advisory Committee Act, as BILLING CODE 4140–01–P Bethesda, MD 20892, 301–451–5953, tuoj@
amended (5 U.S.C. App.), notice is csr.nih.gov.
hereby given of the following meetings. Name of Committee: Center for Scientific
The meetings will be closed to the DEPARTMENT OF HEALTH AND Review Special Emphasis Panel; Small
HUMAN SERVICES Business: Respiratory Sciences.
public in accordance with the
Date: November 17–18, 2016.
provisions set forth in sections Time: 9:00 a.m. to 5:00 p.m.
National Institutes of Health
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant
as amended. The grant applications and Center for Scientific Review; Notice of applications.
the discussions could disclose Closed Meetings Place: National Institutes of Health, 6701
confidential trade secrets or commercial Rockledge Drive, Bethesda, MD 20892
property such as patentable material, Pursuant to section 10(d) of the (Virtual Meeting).
and personal information concerning Federal Advisory Committee Act, as Contact Person: Ghenima Dirami, Ph.D.,
individuals associated with the grant amended (5 U.S.C. App.), notice is Scientific Review Officer, Center for
hereby given of the following meetings. Scientific Review, National Institutes of
applications, the disclosure of which
The meetings will be closed to the Health, 6701 Rockledge Drive, Room 4122,
would constitute a clearly unwarranted MSC 7814, Bethesda, MD 20892, 240–498–
invasion of personal privacy. public in accordance with the
provisions set forth in sections 7546, diramig@csr.nih.gov.
Name of Committee: National Institute on 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., (Catalogue of Federal Domestic Assistance
Alcohol Abuse and Alcoholism Special Program Nos. 93.306, Comparative Medicine;
Emphasis Panel; NIAAA AA–2 & AA–3
as amended. The grant applications and
93.333, Clinical Research, 93.306, 93.333,
Member Conflict Applications. the discussions could disclose 93.337, 93.393–93.396, 93.837–93.844,
Date: November 16, 2016. confidential trade secrets or commercial 93.846–93.878, 93.892, 93.893, National
Time: 11:00 a.m. to 4:00 p.m. property such as patentable material, Institutes of Health, HHS)
Agenda: To review and evaluate grant and personal information concerning
Dated: October 17, 2016.
applications. individuals associated with the grant
Place: National Institutes of Health, applications, the disclosure of which Sylvia L. Neal,
National Institute on Alcohol Abuse and would constitute a clearly unwarranted Program Analyst, Office of Federal Advisory
Alcoholism, 5635 Fishers Lane, Conference invasion of personal privacy. Committee Policy.
Room 2098, Rockville, MD 20892 (Telephone [FR Doc. 2016–25469 Filed 10–20–16; 8:45 am]
Conference Call). Name of Committee: AIDS and Related
Research Integrated Review Group; AIDS BILLING CODE 4140–01–P
Contact Person: Ranga V. Srinivas, Ph.D.,
Chief Extramural Project Review Branch, Molecular and Cellular Biology Study
National Institute on Alcohol Abuse and Section.
Alcoholism, National Institutes of Health, Date: November 14, 2016. DEPARTMENT OF HEALTH AND
5635 Fishers Lane, Room 2085 Rockville, MD Time: 8:00 a.m. to 5:30 p.m. HUMAN SERVICES
20852, (301) 451–2067, srinivar@ Agenda: To review and evaluate grant
mail.nih.gov. applications. National Institutes of Health
Place: Residence Inn Bethesda, 7335
Name of Committee: National Institute on Wisconsin Avenue, Bethesda, MD 20814. National Institute of Arthritis and
Alcohol Abuse and Alcoholism Special Contact Person: Kenneth A. Roebuck,
Emphasis Panel; NIAAA Member Conflict Musculoskeletal and Skin Diseases;
Ph.D., Scientific Review Officer, Center for Notice of Closed Meetings
Applications—Behavioral and Clinical Scientific Review, National Institutes of
Studies. Health, 6701 Rockledge Drive, Room 5214,
Date: November 22, 2016. Pursuant to section 10(d) of the
MSC 7852, Bethesda, MD 20892, (301) 435–
Time: 1:00 p.m. to 4:00 p.m. 1166, roebuckk@csr.nih.gov. Federal Advisory Committee Act, as
Agenda: To review and evaluate grant Name of Committee: Center for Scientific
amended (5 U.S.C. App.), notice is
applications. Review Special Emphasis Panel; hereby given of the following meetings.
Place: National Institutes of Health, Implementation Science. The meetings will be closed to the
National Institute on Alcohol Abuse and Date: November 15, 2016.
Alcoholism, 5635 Fishers Lane, Conference
public in accordance with the
Time: 8:00 a.m. to 5:00 p.m. provisions set forth in sections
Room 2098, Rockville, MD 20892 (Telephone Agenda: To review and evaluate grant
Conference Call). 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
applications.
Contact Person: Ranga V. Srinivas, Ph.D., Place: Sheraton Suites Old Town as amended. The grant applications and
Chief Extramural Project Review Branch, Alexandria, 801 N. St. Asaph Street, the discussions could disclose
National Institute on Alcohol Abuse and Alexandria, VA 22314. confidential trade secrets or commercial
Alcoholism, National Institutes of Health, Contact Person: Jose H. Guerrier, Ph.D., property such as patentable material,
asabaliauskas on DSK3SPTVN1PROD with NOTICES

5635 Fishers Lane, Room 2085, Rockville, Scientific Review Officer, Center for and personal information concerning
MD 20852, (301) 451–2067, srinivar@ Scientific Review, National Institutes of individuals associated with the grant
mail.nih.gov Health, 6701 Rockledge Drive, Room 5218, applications, the disclosure of which
(Catalogue of Federal Domestic Assistance MSC 7852, Bethesda, MD 20892, 301–435–
1137, guerriej@csr.nih.gov. would constitute a clearly unwarranted
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
invasion of personal privacy.
Name of Committee: Center for Scientific
and Clinicians; 93.272, Alcohol National Review Special Emphasis Panel; Name of Committee: Arthritis and
Research Service Awards for Research Fellowships: AIDS and AIDS-related Musculoskeletal and Skin Diseases Initial
Training; 93.273, Alcohol Research Programs; Applications. Review Group; Arthritis and Musculoskeletal

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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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Document Created: 2018-02-13 16:36:11
Document Modified: 2018-02-13 16:36:11

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		October 25-26, 2016.
FR Citation		81 FR 72813

81 FR 72813 - 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