National Institute of Dental & Craniofacial Research; Notice of Meeting, 13561-13562 [2010-6121]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of
Meetings
pwalker on DSK8KYBLC1PROD 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 meetings of the National
Advisory Allergy and Infectious
Diseases Council.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council.
Date: May 24, 2010.
Open: 10:30 a.m. to 11:40 a.m.
Agenda: Report from the Institute Director.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive,
Conference Rooms E1/E2, Bethesda, MD
20892.
Closed: 11:40 a.m. to 12:40 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive,
Conference Rooms E1/E2, Bethesda, MD
20892.
Contact Person: Marvin R. Kalt, PhD,
Director, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7610, Bethesda, MD
20892–7610, 301–496–7291,
kaltmr@niaid.nih.gov.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council
Acquired Immunodeficiency Syndrome
Subcommittee.
Date: May 24, 2010.
Closed: 8:30 a.m. to 10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive,
Conference Room A, Bethesda, MD 20892.
VerDate Nov<24>2008
16:41 Mar 19, 2010
Jkt 220001
Open: 1 p.m. to adjournment.
Agenda: Program advisory discussions and
reports from division staff.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive,
Conference Rooms E1/E2, Bethesda, MD
20892.
Contact Person: Marvin R. Kalt, PhD,
Director, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7610, Bethesda, MD
20892–7610, 301–496–7291,
kaltmr@niaid.nih.gov.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council
Allergy, Immunology and Transplantation
Subcommittee.
Date: May 24, 2010.
Closed: 8:30 a.m. to 10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive,
Conference Room D, Bethesda, MD 20892.
Open: 1 p.m. to adjournment.
Agenda: Reports from the Division Director
and other staff.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive,
Conference Room D, Bethesda, MD 20892.
Contact Person: Marvin R. Kalt, PhD,
Director, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7610, Bethesda, MD
20892–7610, 301–496–7291,
kaltmr@niaid.nih.gov.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council
Microbiology and Infectious Diseases
Subcommittee.
Date: May 24, 2010.
Closed: 8:30 a.m. to 10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive,
Conference Rooms F1/F2, Bethesda, MD
20892.
Open: 1 p.m. to adjournment.
Agenda: Reports from the Division Director
and other staff.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive,
Conference Rooms F1/F2, Bethesda, MD
20892.
Contact Person: Marvin R. Kalt, PhD,
Director, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7610, Bethesda, MD
20892–7610, 301–496–7291,
kaltmr@niaid.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.niaid.nih.gov/facts/facts.htm, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
13561
Dated: March 15, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–6124 Filed 3–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Dental and
Craniofacial Research Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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 Advisory
Dental and Craniofacial Research Council.
Date: May 20, 2010.
Open: 8:30 a.m. to 12 p.m.
Agenda: Report of the Director, NIDCR.
Place: National Institutes of Health,
Building 31, 6th Floor, 31 Center Drive,
Conference Room 10, Bethesda, MD 20892.
Closed: 1 p.m. to Adjournment.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 6th Floor, 31 Center Drive,
Conference Room 10, Bethesda, MD 20892.
Contact Person: Alicia J. Dombroski, PhD,
Director, Division of Extramural Activities,
Natl Inst of Dental and Craniofacial Research,
National Institutes of Health, Bethesda, MD
20892.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
E:\FR\FM\22MRN1.SGM
22MRN1
13562
Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcr.nih.gov/about, where an agenda
and any additional information for the
meeting will be posted when available.
Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: March 15, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–6121 Filed 3–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Place: National Institutes of Health,
Building 30, 30 Center Drive, Room 117,
Bethesda, MD 20892.
Time: June 9, 2010, 8 a.m. to 2 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, 30 Center Drive, Room 117,
Bethesda, MD 20892.
Contact Person: Alicia J. Dombroski, PhD,
Director, Division of Extramural Activities,
Natl Inst of Dental and Craniofacial Research,
National Institutes of Health, Bethesda, MD
20892.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcr.nih.gov/about/
CouncilCommittees.asp, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: March 15, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, National
Institute of Dental and Craniofacial
Research.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Dental &
Craniofacial Research, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
pwalker on DSK8KYBLC1PROD with NOTICES
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
[FR Doc. 2010–6119 Filed 3–19–10; 8:45 am]
Name of Committee: Board of Scientific
Counselors, National Institute of Dental and
Craniofacial Research.
Date: June 6–9, 2010.
Time: June 6, 2010, 6 p.m. to 9 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: Pook’s Hill Marriott, 5151 Pook Hill
Road, Bethesda, MD 20814.
Time: June 7, 2010, 8 a.m. to 6:40 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, 30 Center Drive, Room 117,
Bethesda, MD 20892.
Time: June 8, 2010, 8 a.m. to 5 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
VerDate Nov<24>2008
16:41 Mar 19, 2010
Jkt 220001
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0133]
Revised Draft Guidance for Industry on
Pharmacokinetics in Patients With
Impaired Renal Function—Study
Design, Data Analysis, and Impact on
Dosing and Labeling; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Pharmacokinetics
in Patients With Impaired Renal
Function—Study Design, Data Analysis,
and Impact on Dosing and Labeling.’’
The draft guidance is intended to assist
sponsors planning to conduct studies to
assess the influence of renal impairment
on the pharmacokinetics of an
investigational drug. It provides
recommendations on when studies
should be conducted to assess the
influence of renal impairment on the
pharmacokinetics of an investigational
drug, the design of such studies, and
how such studies should be carried out.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by May 21, 2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Shiew-Mei Huang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3188,
Silver Spring, MD 20993–0002, 301–
796–1541, or;
Lei Zhang, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3106, Silver Spring,
MD 20993–0002, 301–796–1635.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance entitled
‘‘Pharmacokinetics in Patients With
Impaired Renal Function—Study
Design, Data Analysis, and Impact on
Dosing and Labeling.’’ The
pharmacokinetics (PK) and
pharmacodynamics of drugs primarily
eliminated through the kidneys may be
altered by impaired renal function to the
extent that the dosage regimen needs to
be changed from that used in patients
with normal renal function. Although
the most obvious type of change arising
from renal impairment is a decrease in
renal excretion of a drug or its
metabolites, changes in renal
metabolism can also occur. Renal
impairment can also adversely affect
some pathways of hepatic and/or gut
drug metabolism and has been
associated with other changes, such as
changes in absorption, plasma protein
binding, transport, and tissue
distribution. These changes may be
particularly prominent in patients with
severely impaired renal function and
have been observed even when the renal
route is not the primary route of
elimination of a drug. Thus, for most
E:\FR\FM\22MRN1.SGM
22MRN1
]]>Agencies
[Federal Register Volume 75, Number 54 (Monday, March 22, 2010)]
[Notices]
[Pages 13561-13562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6121]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of
Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
National Advisory Dental and Craniofacial Research Council.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the 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 Advisory Dental and Craniofacial
Research Council.
Date: May 20, 2010.
Open: 8:30 a.m. to 12 p.m.
Agenda: Report of the Director, NIDCR.
Place: National Institutes of Health, Building 31, 6th Floor, 31
Center Drive, Conference Room 10, Bethesda, MD 20892.
Closed: 1 p.m. to Adjournment.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, 6th Floor, 31
Center Drive, Conference Room 10, Bethesda, MD 20892.
Contact Person: Alicia J. Dombroski, PhD, Director, Division of
Extramural Activities, Natl Inst of Dental and Craniofacial
Research, National Institutes of Health, Bethesda, MD 20892.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license,
[[Page 13562]]
or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home
page: https://www.nidcr.nih.gov/about, where an agenda and any
additional information for the meeting will be posted when
available.
Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral
Diseases and Disorders Research, National Institutes of Health, HHS)
Dated: March 15, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-6121 Filed 3-19-10; 8:45 am]
BILLING CODE 4140-01-P
