National Institute of Dental & Craniofacial Research; Notice of Closed Meeting, 13562 [2010-6119]
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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.
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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]
[Page 13562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6119]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of
Closed 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
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.
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.
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.
[FR Doc. 2010-6119 Filed 3-19-10; 8:45 am]
BILLING CODE 4140-01-P
