National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 15391 [2018-07268]
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Federal Register / Vol. 83, No. 69 / Tuesday, April 10, 2018 / Notices
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under
section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA,
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that the
following approved drugs meet the
redemption criteria:
• PRALUENT (alirocumab) approved
July 24, 2015,
• SOLIQUA (insulin glargine and
lixisenatide) approved November 21,
2016, and
• JULUCA (dolutegravir and
rilpivirine) approved November 21,
2017.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about PRALUENT
(alirocumab), SOLIQUA (insulin
glargine and lixisenatide), and JULUCA
(dolutegravir and rilpivirine), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: April 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07256 Filed 4–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
daltland on DSKBBV9HB2PROD with NOTICES
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, 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
VerDate Sep<11>2014
16:56 Apr 09, 2018
Jkt 244001
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; CRIC Ancillary
Study (R01)
Date: May 17, 2018.
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: Jason D. Hoffert, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7343, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 496–9010,
hoffertj@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Pragmatic Research
and Natural Experiments.
Date: May 18, 2018.
Time: 10:00 a.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: 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,
barnardm@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR–18–012:
NIDDK Program Projects (P01).
Date: May 24, 2018.
Time: 12:00 p.m. to 3:00 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: Dianne Camp, Ph.D.,
Scientific Review Officer, Review branch,
DEA, NIDDK, National Institutes of Health,
Room 7013, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–7682,
campd@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; P01 Application
Bladder Physiology.
Date: May 31, 2018.
Time: 2:00 p.m. to 5:00 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: Ryan G. Morris, Ph.D.,
Scientific Review Officer, review branch,
DEA, NIDDK, National Institutes of Health,
Room 7015, 6707 Democracy Boulevard,
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
15391
Bethesda, MD 20892–2542, (301) 594–4721,
ryan.morris@nih.gov.
(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: April 4, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–07268 Filed 4–9–18; 8:45 am]
BILLING CODE 4140–01–P
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, 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;
Time-Sensitive Obesity Research.
Date: May 1, 2018.
Time: 1:00 p.m. to 2:30 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
barnardm@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR–17–270:
NIDDK Central Repositories Non-renewable
Samples Access (X01).
Date: May 2, 2018.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
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[Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)]
[Notices]
[Page 15391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07268]
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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, 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; CRIC Ancillary Study
(R01)
Date: May 17, 2018.
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: Jason D. Hoffert, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301)
496-9010, [email protected].
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; Pragmatic Research and
Natural Experiments.
Date: May 18, 2018.
Time: 10:00 a.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: 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; PAR-18-012: NIDDK
Program Projects (P01).
Date: May 24, 2018.
Time: 12:00 p.m. to 3:00 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: Dianne Camp, Ph.D., Scientific Review Officer,
Review branch, DEA, NIDDK, National Institutes of Health, Room 7013,
6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301) 594-7682,
[email protected].
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; P01 Application Bladder
Physiology.
Date: May 31, 2018.
Time: 2:00 p.m. to 5:00 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: Ryan G. Morris, Ph.D., Scientific Review
Officer, review branch, DEA, NIDDK, National Institutes of Health,
Room 7015, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301)
594-4721, [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: April 4, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-07268 Filed 4-9-18; 8:45 am]
BILLING CODE 4140-01-P
