National Institute of Diabetes and Digestive And Kidney Diseases; Notice of Closed Meetings, 69092-69093 [2010-28295]
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Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
able to listen to the meeting but will not be
heard. If you experience any technical
problems with the conference call, please email:
IACCTechSupport@acclaroresearch.com.
Individuals who participate in person or by
using these electronic services and who need
special assistance, such as captioning of the
conference call or other reasonable
accommodations, should submit a request to
the Contact Person listed on this notice at
least 7 days prior to the meeting.
As a part of security procedures, attendees
should be prepared to present a photo ID at
the meeting registration desk during the
check-in process. Pre-registration is
recommended. Seating will be limited to the
room capacity and seats will be on a first
come, first served basis, with expedited
check-in for those who are pre-registered.
Please note: Online pre-registration will close
by 5 p.m. the day before the meeting. After
that time, registration will have to be done
onsite the day of the meeting.
Meeting schedule subject to change.
Information about the IACC and a
registration link for this meeting are available
on the Web site: http//:www.iacc.hhs.gov.
Dated: November 2, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
emcdonald on DSK2BSOYB1PROD with NOTICES
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 meeting.
The meeting 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
General Medical Sciences Special Emphasis
Panel MBRS SCORE Meeting.
Date: December 2–3, 2010.
Time: 10 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Room
3AN12, Bethesda, MD 20892. (Virtual
Meeting)
Jkt 223001
[FR Doc. 2010–28298 Filed 11–9–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of General Medical
Sciences; Notice of Closed Meeting
BILLING CODE 4140–01–P
18:25 Nov 09, 2010
Dated: November 3, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
National Institutes of Health
[FR Doc. 2010–28299 Filed 11–9–10; 8:45 am]
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Contact Person: Lisa Dunbar, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN12, Bethesda,
MD 20892. 301–594–2849.
dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
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 meeting.
The meeting 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
General Medical Sciences Special Emphasis
Panel MBRS Behavioral Science Panel.
Date: December 2, 2010.
Time: 11 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Room
3AN18, Bethesda, MD 20892. (Telephone
Conference Call)
Contact Person: Rebecca H. Johnson, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18C, Bethesda,
MD 20892. 301–594–2771.
johnsonrh@nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
PO 00000
Frm 00047
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Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: November 3, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–28297 Filed 11–9–10; 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 (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, DDK–B Conflicts.
Date: December 2, 2010.
Time: 9 a.m. to 12 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, PhD,
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.
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, CKD And CVD
Ancillary Studies.
Date: December 17, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
E:\FR\FM\10NON1.SGM
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Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call)
Contact Person: Robert Wellner, PhD,
Scientific Review Officer, Review Branch,
Dea, Niddk, National Institutes of Health,
Room 706, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452. 301–594–4721.
Rw175w@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: November 3, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–28295 Filed 11–9–10; 8:45 am]
Time: 2 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: Lakshmanan Sankaran,
PhD Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 755, 6707 Democracy
Boulevard, Bethesda, Md 20892–5452. (301)
594–7799. Ls38z@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: November 3, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–28293 Filed 11–9–10; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
emcdonald on DSK2BSOYB1PROD with NOTICES
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, Pediatric Ancillary
Study to ASSESS–AKI.
Date: December 7, 2010.
Time: 2:15 p.m. to 3 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: Lakshmanan Sankaran,
PhD Scientific Review Officer, Review
Branch, Dea, NIDDK, National Institutes Of
Health, Room 755, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7799, Ls38z@Nih.Gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Bone
Morphogenesis Program Project Review.
Date: December 8, 2010.
VerDate Mar<15>2010
18:25 Nov 09, 2010
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0128]
Prescription Drug User Fee Act;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening until
October 31, 2011, the comment period
for the notice of public meeting that
published in the Federal Register of
March 16, 2010 (75 FR 12555). In the
notice, FDA announced a public
meeting to solicit input on the
reauthorization of the Prescription Drug
User Fee Act (PDUFA) program. The
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) requires public review
of the recommendations for the human
drug review program after negotiations
with the regulated industry conclude.
FDA expects that this additional public
process will be complete by October
2011. FDA is reopening the comment
period for the expected duration of the
public part of the reauthorization
process to ensure that all interested
stakeholders have the opportunity to
share their views on the matter.
DATES: Submit either electronic or
written comments by October 31, 2011.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
SUMMARY:
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69093
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:
Patrick Frey, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1174, Silver Spring,
MD 20993–0002, 301–796–3844, FAX:
301–847–8443, e-mail:
PDUFAReauthorization@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 16,
2010 (75 FR 12555), FDA published a
notice of a public meeting on PDUFA
reauthorization and invited comments.
In the notice, the Agency stated that the
authority for PDUFA expires in
September 2012. Without new
legislation, FDA will no longer be able
to collect user fees to fund the human
drug review process. Section 736B(d)(2)
(21 U.S.C. 379h-2(d)(2)) of the FD&C Act
requires that before FDA begins
negotiations with the regulated industry
on PDUFA reauthorization, we do the
following: (1) Publish a notice in the
Federal Register requesting public input
on the reauthorization, (2) hold a public
meeting at which the public may
present its views on the reauthorization,
(3) provide a period of 30 days after the
public meeting to obtain written
comments from the public suggesting
changes, and (4) publish the comments
on the FDA Web site.
The public meeting was held on April
12, 2010, and interested persons were
given until May 12, 2010, to submit
comments. The written comments
submitted during that period are now
published on the FDA Web site at
https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm215804.htm. To ensure that all
interested persons have sufficient
opportunity to share their views on
PDUFA throughout the reauthorization
process, FDA is reopening the comment
period until October 31, 2011. The
FD&C Act requires public review of the
recommendations for the human drug
review program after negotiations with
the regulated industry conclude. FDA
expects that the public component of
the reauthorization process will be
complete by October 2011. Therefore,
the Agency is reopening the comment
period for this anticipated duration to
ensure that all interested stakeholders
have the opportunity to share their
views on the matter.
E:\FR\FM\10NON1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Notices]
[Pages 69092-69093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28295]
-----------------------------------------------------------------------
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, DDK-B Conflicts.
Date: December 2, 2010.
Time: 9 a.m. to 12 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, PhD, 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.
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, CKD And CVD Ancillary
Studies.
Date: December 17, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy
[[Page 69093]]
Boulevard, Bethesda, MD 20892. (Telephone Conference Call)
Contact Person: Robert Wellner, PhD, Scientific Review Officer,
Review Branch, Dea, Niddk, National Institutes of Health, Room 706,
6707 Democracy Boulevard, Bethesda, MD 20892-5452. 301-594-4721.
Rw175w@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: November 3, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-28295 Filed 11-9-10; 8:45 am]
BILLING CODE 4140-01-P
