82 FR 25806 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 106 (June 5, 2017)

Page Range		25806-25807
FR Document		2017-11496

Federal Register, Volume 82 Issue 106 (Monday, June 5, 2017)

[Federal Register Volume 82, Number 106 (Monday, June 5, 2017)]
[Notices]
[Pages 25806-25807]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11496]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney 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: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; NIDDK Research Project 
Grants.
    Date: June 20, 2017.
    Time: 3:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Elena Sanovich, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7351, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-
594-8886, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; Time-Sensitive Obesity.
    Date: June 21, 2017.
    Time: 10:30 a.m. to 12:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Michele L. Barnard, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301) 
594-8898, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; Preventing Type 2 
Diabetes.
    Date: June 28, 2017.
    Time: 10:00 a.m. to 11:00 a.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Michele L. Barnard, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301) 
594-8898, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; NIDDK PTH Receptor 
(P01).
    Date: July 25, 2017.
    Time: 12:00 p.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 25807]]

    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Jason D. Hoffert, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20817, 301-496-
9010, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.847, 
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive 
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology 
and Hematology Research, National Institutes of Health, HHS)

    Dated: May 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-11496 Filed 6-2-17; 8:45 am]
 BILLING CODE 4140-01-P

25806 Federal Register / Vol. 82, No. 106 / Monday, June 5, 2017 / Notices

Dated: May 30, 2017. conjunction with anti-malarials to treat provisions set forth in sections
David Clary, children with HCM. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Program Analyst, Office of Federal Advisory The inventors, listed below, have as amended. The grant applications and
Committee Policy. discovered that glutamine antagonists the discussions could disclose
[FR Doc. 2017–11497 Filed 6–2–17; 8:45 am] can be used to treat mice with confidential trade secrets or commercial
BILLING CODE 4140–01–P
experimental cerebral malaria (ECM) in property such as patentable material,
conjunction with anti-malarials. It was and personal information concerning
found that glutamine antagonist, 6- individuals associated with the grant
DEPARTMENT OF HEALTH AND diazo-5-L-norleucine (DON) applications, the disclosure of which
HUMAN SERVICES successfully restored blood-brain barrier would constitute a clearly unwarranted
integrity and decreased brain swelling invasion of personal privacy.
National Institutes of Health in ECM mice. This finding suggests that
Name of Committee: National Institute of
glutamine antagonists may be effective Diabetes and Digestive and Kidney Diseases
Government-Owned Inventions; in treating neurological damage in HCM Special Emphasis Panel; NIDDK Research
Availability for Licensing patients. Project Grants.
AGENCY: National Institutes of Health, This technology is available for Date: June 20, 2017.
HHS. licensing for commercial development Time: 3:00 p.m. to 4:00 p.m.
in accordance with 35 U.S.C. 209 and 37 Agenda: To review and evaluate grant
ACTION: Notice. CFR part 404, as well as for further applications.
development and evaluation under a Place: National Institutes of Health, Two
SUMMARY: The inventions listed below
research collaboration. Democracy Plaza, 6707 Democracy
are owned by an agency of the U.S. Boulevard, Bethesda, MD 20892 (Telephone
Government and are available for Potential Commercial Applications:
licensing to achieve expeditious • Therapeutic for cerebral malaria Conference Call).
Competitive Advantages: Contact Person: Elena Sanovich, Ph.D.,
commercialization of results of • Effective adjunctive therapeutics for Scientific Review Officer, Review Branch,
federally-funded research and cerebral malaria are not available. DEA, NIDDK, National Institutes of Health,
development. Foreign patent Development Stage: Pre-Clinical. Room 7351, 6707 Democracy Boulevard,
applications are filed on selected Bethesda, MD 20892–2542, 301–594–8886,
Inventors: Susan K. Pierce, NIAID,
inventions to extend market coverage sanoviche@mail.nih.gov.
NIH, Johnathan Powell, Johns Hopkins
for companies and may also be available Name of Committee: National Institute of
University.
for licensing. Diabetes and Digestive and Kidney Diseases
Publications: Gordon, Emile B., et al.
Special Emphasis Panel; Time-Sensitive
FOR FURTHER INFORMATION CONTACT: (2015) Targeting glutamine metabolism Obesity.
Chris Kornak, J.D., 240–627–3705, rescues mice from late-stage cerebral Date: June 21, 2017.
chris.kornak@nih.gov. Licensing malaria. PNAS 112(42): 13075–13080. Time: 10:30 a.m. to 12:00 p.m.
information and copies of the U.S. Intellectual Property: HHS Reference Agenda: To review and evaluate grant
patent applications listed below may be No. E–202–2015/0—US Provisional applications.
obtained by communicating with the Patent Application No. 62/175,000 filed Place: National Institutes of Health, Two
indicated licensing contact at the June 12, 2015; PCT Patent Application Democracy Plaza, 6707 Democracy
Technology Transfer and Intellectual No. PCT/US2016/036996 filed June 10, Boulevard, Bethesda, MD 20892 (Telephone
Property Office, National Institute of 2016. Conference Call).
Allergy and Infectious Diseases, 5601 Licensing Contact: Chris Kornak, J.D., Contact Person: Michele L. Barnard, Ph.D.,
240–627–3705, chris.kornak@nih.gov. Scientific Review Officer, Review Branch,
Fishers Lane, Rockville, MD, 20852; tel. DEA, NIDDK, National Institutes of Health,
301–496–2644. A signed Confidential Collaborative Research Opportunity:
Room 7353, 6707 Democracy Boulevard,
Disclosure Agreement will be required For collaboration opportunities, please
Bethesda, MD 20892–2542, (301) 594–8898,
to receive copies of unpublished patent contact Chris Kornak, J.D. 240–627– barnardm@extra.niddk.nih.gov.
applications. 3705, chris.kornak@nih.gov.
Name of Committee: National Institute of
SUPPLEMENTARY INFORMATION: Dated: May 24, 2017. Diabetes and Digestive and Kidney Diseases
Technology description follows. Suzanne Frisbie, Special Emphasis Panel; Preventing Type 2
Deputy Director, Technology Transfer and Diabetes.
Methods for Treating Cerebral Edema Date: June 28, 2017.
Intellectual Property Office, National Institute
and Restoring Blood-Brain Barrier of Allergy and Infectious Diseases. Time: 10:00 a.m. to 11:00 a.m.
Integrity Agenda: To review and evaluate grant
[FR Doc. 2017–11492 Filed 6–2–17; 8:45 am]
applications.
Description of Technology: There are BILLING CODE 4140–01–P Place: National Institutes of Health, Two
nearly 600 million clinical cases of Democracy Plaza, 6707 Democracy
Plasmodium falciparum malaria Boulevard, Bethesda, MD 20892 (Telephone
annually. For most individuals living in DEPARTMENT OF HEALTH AND Conference Call).
endemic areas, malaria is HUMAN SERVICES Contact Person: Michele L. Barnard, Ph.D.,
uncomplicated and resolves with time. Scientific Review Officer, Review Branch,
However, malaria can become severe National Institutes of Health DEA, NIDDK, National Institutes of Health,
and life threatening in young children, Room 7353, 6707 Democracy Boulevard,
National Institute of Diabetes and Bethesda, MD 20892–2542, (301) 594–8898,
asabaliauskas on DSKBBXCHB2PROD with NOTICES

which resulted in 429,000 deaths in
2015. One of the most deadly Digestive and Kidney Diseases; Notice barnardm@extra.niddk.nih.gov.
complications of P. falciparum infection of Closed Meetings Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
is cerebral malaria (HCM) characterized Pursuant to section 10(d) of the Special Emphasis Panel; NIDDK PTH
by the onset of severe neurological signs Federal Advisory Committee Act, as Receptor (P01).
such as altered consciousness, seizures, amended (5 U.S.C. App.), notice is Date: July 25, 2017.
and coma. Thus, there is an urgent need hereby given of the following meetings. Time: 12:00 p.m. to 2:00 p.m.
for the development of effective The meetings will be closed to the Agenda: To review and evaluate grant
adjunctive therapies that can be used in public in accordance with the applications.

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Federal Register / Vol. 82, No. 106 / Monday, June 5, 2017 / Notices 25807

Place: National Institutes of Health, Two Programs, SAMHSA/CSAP, 5600 Aegis Analytical Laboratories, Inc., 345
Democracy Plaza, 6707 Democracy Fishers Lane, Room 16N03A, Rockville, Hill Ave., Nashville, TN 37210, 615–
Boulevard, Bethesda, MD 20892 (Telephone Maryland 20857; 240–276–2600 (voice). 255–2400 (Formerly: Aegis Sciences
Conference Call). Corporation, Aegis Analytical
Contact Person: Jason D. Hoffert, Ph.D., SUPPLEMENTARY INFORMATION: The
Scientific Review Officer, Review Branch, Department of Health and Human Laboratories, Inc., Aegis Analytical
DEA, NIDDK, National Institutes of Health, Services (HHS) notifies federal agencies Laboratories)
Room 7343, 6707 Democracy Boulevard, of the laboratories and Instrumented Alere Toxicology Services, 1111 Newton
Bethesda, MD 20817, 301–496–9010, Initial Testing Facilities (IITF) currently St., Gretna, LA 70053, 504–361–8989/
hoffertj@niddk.nih.gov. certified to meet the standards of the 800–433–3823 (Formerly: Kroll
(Catalogue of Federal Domestic Assistance Mandatory Guidelines for Federal Laboratory Specialists, Inc.,
Program Nos. 93.847, Diabetes, Workplace Drug Testing Programs Laboratory Specialists, Inc.)
Endocrinology and Metabolic Research; (Mandatory Guidelines). The Mandatory Alere Toxicology Services, 450
93.848, Digestive Diseases and Nutrition Southlake Blvd., Richmond, VA
Guidelines were first published in the
Research; 93.849, Kidney Diseases, Urology 23236, 804–378–9130 (Formerly:
and Hematology Research, National Institutes Federal Register on April 11, 1988 (53
FR 11970), and subsequently revised in Kroll Laboratory Specialists, Inc.,
of Health, HHS)
the Federal Register on June 9, 1994 (59 Scientific Testing Laboratories, Inc.;
Dated: May 30, 2017. Kroll Scientific Testing Laboratories,
FR 29908); September 30, 1997 (62 FR
David Clary, 51118); April 13, 2004 (69 FR 19644); Inc.)
Program Analyst, Office of Federal Advisory November 25, 2008 (73 FR 71858); Baptist Medical Center–Toxicology
Committee Policy. December 10, 2008 (73 FR 75122); and Laboratory, 11401 I–30, Little Rock,
[FR Doc. 2017–11496 Filed 6–2–17; 8:45 am] on April 30, 2010 (75 FR 22809). AR 72209–7056, 501–202–2783
BILLING CODE 4140–01–P The Mandatory Guidelines were (Formerly: Forensic Toxicology
initially developed in accordance with Laboratory Baptist Medical Center)
Executive Order 12564 and section 503 Clinical Reference Laboratory, Inc., 8433
DEPARTMENT OF HEALTH AND of Public Law 100–71. The ‘‘Mandatory Quivira Road, Lenexa, KS 66215–
HUMAN SERVICES Guidelines for Federal Workplace Drug 2802, 800–445–6917,
Testing Programs,’’ as amended in the DrugScan, Inc., 200 Precision Road,
Substance Abuse and Mental Health Suite 200, Horsham, PA 19044, 800–
revisions listed above, requires strict
Services Administration 235–4890
standards that laboratories and IITFs
Current List of HHS-Certified must meet in order to conduct drug and Dynacare *, 245 Pall Mall Street,
Laboratories and Instrumented Initial specimen validity tests on urine London, ONT, Canada N6A 1P4, 519–
Testing Facilities Which Meet Minimum specimens for federal agencies. 679–1630 (Formerly: Gamma-
Standards To Engage in Urine Drug To become certified, an applicant Dynacare Medical Laboratories)
Testing for Federal Agencies laboratory or IITF must undergo three ElSohly Laboratories, Inc., 5 Industrial
rounds of performance testing plus an Park Drive, Oxford, MS 38655, 662–
AGENCY: Substance Abuse and Mental on-site inspection. To maintain that 236–2609
Health Services Administration, HHS. certification, a laboratory or IITF must Laboratory Corporation of America
ACTION: Notice. participate in a quarterly performance Holdings, 7207 N. Gessner Road,
testing program plus undergo periodic, Houston, TX 77040, 713–856–8288/
SUMMARY: The Department of Health and on-site inspections. 800–800–2387
Human Services (HHS) notifies federal Laboratories and IITFs in the Laboratory Corporation of America
agencies of the laboratories and applicant stage of certification are not to Holdings, 69 First Ave., Raritan, NJ
Instrumented Initial Testing Facilities be considered as meeting the minimum 08869, 908–526–2400/800–437–4986
(IITF) currently certified to meet the requirements described in the HHS (Formerly: Roche Biomedical
standards of the Mandatory Guidelines Mandatory Guidelines. A HHS-certified Laboratories, Inc.)
for Federal Workplace Drug Testing laboratory or IITF must have its letter of Laboratory Corporation of America
Programs (Mandatory Guidelines). certification from HHS/SAMHSA Holdings, 1904 Alexander Drive,
A notice listing all currently HHS- (formerly: HHS/NIDA), which attests Research Triangle Park, NC 27709,
certified laboratories and IITFs is that it has met minimum standards. 919–572–6900/800–833–3984
published in the Federal Register In accordance with the Mandatory (Formerly: LabCorp Occupational
during the first week of each month. If Guidelines dated November 25, 2008 Testing Services, Inc., CompuChem
any laboratory or IITF certification is (73 FR 71858), the following HHS- Laboratories, Inc.; CompuChem
suspended or revoked, the laboratory or certified laboratories and IITFs meet the Laboratories, Inc., A Subsidiary of
IITF will be omitted from subsequent minimum standards to conduct drug Roche Biomedical Laboratory; Roche
lists until such time as it is restored to and specimen validity tests on urine CompuChem Laboratories, Inc., A
full certification under the Mandatory specimens: Member of the Roche Group)
Guidelines. Laboratory Corporation of America
If any laboratory or IITF has HHS-Certified Instrumented Initial Holdings, 1120 Main Street,
withdrawn from the HHS National Testing Facilities Southaven, MS 38671, 866–827–8042/
Laboratory Certification Program (NLCP)
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Dynacare, 6628 50th Street NW., 800–233–6339 (Formerly: LabCorp
during the past month, it will be listed Edmonton, AB Canada T6B 2N7, 780– Occupational Testing Services, Inc.;
at the end and will be omitted from the 784–1190 (Formerly: Gamma- MedExpress/National Laboratory
monthly listing thereafter. Dynacare Medical Laboratories) Center)
This notice is also available on the LabOne, Inc. d/b/a Quest Diagnostics,
Internet at http://www.samhsa.gov/ HHS-Certified Laboratories 10101 Renner Blvd., Lenexa, KS
workplace. ACM Medical Laboratory, Inc., 160 66219, 913–888–3927/800–873–8845
FOR FURTHER INFORMATION CONTACT: Elmgrove Park, Rochester, NY 14624, (Formerly: Quest Diagnostics
Giselle Hersh, Division of Workplace 844–486–9226 Incorporated; LabOne, Inc.; Center for

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Document Created: 2018-11-14 10:01:08
Document Modified: 2018-11-14 10:01:08

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		June 20, 2017.
FR Citation		82 FR 25806

82 FR 25806 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 106 (June 5, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health