National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 14390 [2015-06266]
Download as PDF
<![CDATA[
14390
Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ruth Barratt, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, Rm. 4540, Silver Spring,
MD 20993–0002, 301–796–2600.
SUPPLEMENTARY INFORMATION:
Rmajette on DSK2VPTVN1PROD with NOTICES
I. Background
Since publication of the 2011
‘‘Identifying CDER’s Science and
Research Needs’’ report, FDA has been
engaged in efforts to further assess and
prioritize the needs articulated therein.
As part of these efforts, CDER’s Safety
Research Interest Group (SRIG), a
subcommittee of the Science
Prioritization and Review Committee,
assessed CDER’s overall drug safetyrelated regulatory science needs in view
of FDA’s ongoing research efforts and
highlighted areas that would benefit
from additional resources and
collaboration.
The SRIG identified the following
seven overall needs for drug safetyrelated regulatory science:
1. Improve access to postmarket data
sources and explore the feasibility of
their use in safety signal analyses
2. Improve risk assessment and
management strategies to reinforce the
safe use of drugs
3. Evaluate the effectiveness of risk
communications of drug safety
information to health care providers and
the public
4. Improve product quality and
design, manufacturing processes, and
product performance relating to safety
5. Develop and improve predictive
models of safety in humans, including
nonclinical biomarkers
6. Improve clinical trial statistical
analyses for safety, including benefitrisk assessment
7. Investigate clinical biomarkers of
safety, including standards for
qualification.
Particular priorities within the seven
overall needs requiring further resources
and outside participation were also
identified. FDA seeks to stimulate
collaborations with external partners
and stakeholders to address these needs
by asking them to: (1) Submit
descriptions of their ongoing research
and initiatives related to the seven
overall needs, especially the identified
priorities, and (2) indicate their interest
in working with FDA to address these
needs. Outside parties are being asked
to submit comments to the docket and
VerDate Sep<11>2014
15:18 Mar 18, 2015
Jkt 235001
email address CDER_Science_Needs@
fda.hhs.gov.
II. Comments
Interested persons may submit either
electronic comments regarding the
report to https://www.regulations.gov
and email address CDER_Science_
Needs@fda.hhs.gov, or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the report at https://
www.regulations.gov.
Dated: March 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06288 Filed 3–18–15; 8:45 am]
BILLING CODE 4164–01–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 (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 Ancillary
R01 Telephone Review SEP.
Date: April 3, 2015
Time: 2:30 p.m. to 3:30 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).
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Contact Person: Xiaodu Guo, MD, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes Of Health,
Room 761, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–4719,
guox@extra.niddk.nih.gov.
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
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Collaborative
Interdisciplinary Team Science in Diabetes
and Obesity (R24).
Date: April 6, 2015.
Time: 2:30 p.m. to 4:30 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: Ann A. Jerkins, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 759, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–2242,
jerkinsa@niddk.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: March 13, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–06266 Filed 3–18–15; 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;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Diabetes and Digestive and Kidney
Diseases Special Emphasis Panel, March
31, 2015, 04:00 p.m. to April 01, 2015,
05:00 p.m., Churchill Hotel, 1914
Connecticut Avenue NW., Washington,
DC, 20009 which was published in the
Federal Register on March 09, 2015, 80
FR 12494.
The meeting is being amended to
reflect location change. The new
meeting location is the Hyatt Regency
Bethesda, One Bethesda Metro Center,
Bethesda, MD 20814. The meeting is
closed to the public.
E:\FR\FM\19MRN1.SGM
19MRN1
]]>Agencies
[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Page 14390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06266]
-----------------------------------------------------------------------
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 Ancillary R01
Telephone Review SEP.
Date: April 3, 2015
Time: 2:30 p.m. to 3:30 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: Xiaodu Guo, MD, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes Of Health,
Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301)
594-4719, guox@extra.niddk.nih.gov.
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 Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; Collaborative
Interdisciplinary Team Science in Diabetes and Obesity (R24).
Date: April 6, 2015.
Time: 2:30 p.m. to 4:30 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: Ann A. Jerkins, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 759, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, 301-
594-2242, jerkinsa@niddk.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: March 13, 2015.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-06266 Filed 3-18-15; 8:45 am]
BILLING CODE 4140-01-P
