National Institute on Aging; Notice of Meeting, 17149-17150 [2010-7668]
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jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 64 / Monday, April 5, 2010 / Notices
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In the Federal Register of February
17, 2009 (74 FR 7447), FDA published
a notice announcing the availability of
a draft tripartite guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 7: Dissolution Test
General Chapter.’’ The notice gave
interested persons an opportunity to
submit comments by April 20, 2009.
After consideration of the comments
received and revisions to the guidance,
a final draft guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 7: Dissolution Test
General Chapter’’ was submitted to the
ICH Steering Committee and endorsed
by the three participating regulatory
agencies in October 2009.
The guidance provides the specific
evaluation outcome from the ICH Q4B
process for the Dissolution Test General
Chapter harmonization proposal
originating from the three-party PDG.
This guidance is in the form of an annex
to the core ICH Q4B guidance made
available in the Federal Register of
February 21, 2008 (73 FR 9575). When
implemented, the annex will provide
guidance for industry and regulators on
the use of the specific pharmacopoeial
texts evaluated by the ICH Q4B process.
Following receipt of comments on the
draft, no substantive changes were made
to the annex.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
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The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: March 31, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–7593 Filed 4–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 Board
of Scientific Counselors, NIA.
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 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
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17149
evaluation of individual intramural
programs and projects conducted by the
National Institute on Aging, 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, NIA.
Date: May 11–12, 2010.
Closed: May 11, 2010, 8 a.m. to 8:30 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: May 11, 2010, 8:30 a.m. to 12 p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: May 11, 2010, 12 p.m. to 1:15 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: May 11, 2010, 1:15 p.m. to 4:15 p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: May 11, 2010, 4:15 p.m. to 4:30
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: May 11, 2010, 4:30 p.m. to 5 p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: May 11, 2010, 5 p.m. to 6 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: May 12, 2010, 8 a.m. to 9 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: May 12, 2010, 9 a.m. to 11:30 a.m.
Agenda: Committee Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
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17150
Federal Register / Vol. 75, No. 64 / Monday, April 5, 2010 / Notices
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: May 12, 2010, 11:30 a.m. to 12:45
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: May 12, 2010, 12:45 p.m. to 3:45
p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: May 12, 2010, 3:45 p.m. to 5 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Contact Person: Michele K. Evans, MD,
Acting Scientific Director, National Institute
on Aging, 251 Bayview Boulevard, Suite 100,
Room 04C221, Baltimore, MD 21224.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: March 31, 2010.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–7668 Filed 4–2–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on DSKJ8SOYB1PROD with NOTICES
National Institute on Deafness and
Other Communication Disorders;
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 Deafness and Other
Communication Disorders Advisory
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
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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 Deafness and
Other Communication Disorders Advisory
Council.
Date: May 14, 2010.
Closed: 8:30 a.m. to 10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Bethesda, MD
20892.
Open: 10:15 a.m. to 2:30 p.m.
Agenda: Staff reports on divisional,
programmatic, and special activities.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Bethesda, MD
20892.
Contact Person: Craig A. Jordan, PhD,
Director, Division of Extramural Activities,
NIDCD, NIH, Executive Plaza South, Room
400C, 6120 Executive Blvd., Bethesda, MD
20892–7180. 301–496–8693.
jordanc@nidcd.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
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,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcd.nih.gov/about/groups/ndcdac/,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
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 materials,
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
Mental Health Special Emphasis Panel; Child
Interventions Review.
Date: April 14, 2010.
Time: 2:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Marina Broitman, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6153, MSC 9608,
Bethesda, MD 20892–9608, 301–402–8152,
mbroitman@mail.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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: March 29, 2010.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–7675 Filed 4–2–10; 8:45 am]
BILLING CODE 4140–01–P
Dated: March 30, 2010.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–7671 Filed 4–2–10; 8:45 am]
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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National Institutes of Health
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 USC,
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Agencies
[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Notices]
[Pages 17149-17150]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7668]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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
Board of Scientific Counselors, NIA.
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 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 on Aging, 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, NIA.
Date: May 11-12, 2010.
Closed: May 11, 2010, 8 a.m. to 8:30 a.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Open: May 11, 2010, 8:30 a.m. to 12 p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Closed: May 11, 2010, 12 p.m. to 1:15 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Open: May 11, 2010, 1:15 p.m. to 4:15 p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Closed: May 11, 2010, 4:15 p.m. to 4:30 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Open: May 11, 2010, 4:30 p.m. to 5 p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Closed: May 11, 2010, 5 p.m. to 6 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Closed: May 12, 2010, 8 a.m. to 9 a.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Open: May 12, 2010, 9 a.m. to 11:30 a.m.
Agenda: Committee Discussion.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview
[[Page 17150]]
Boulevard, 3rd Floor Conference Room, Baltimore, MD 21224.
Closed: May 12, 2010, 11:30 a.m. to 12:45 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Open: May 12, 2010, 12:45 p.m. to 3:45 p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Closed: May 12, 2010, 3:45 p.m. to 5 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institute on Aging, Biomedical Research Center,
251 Bayview Boulevard, 3rd Floor Conference Room, Baltimore, MD
21224.
Contact Person: Michele K. Evans, MD, Acting Scientific
Director, National Institute on Aging, 251 Bayview Boulevard, Suite
100, Room 04C221, Baltimore, MD 21224.
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: March 31, 2010.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-7668 Filed 4-2-10; 8:45 am]
BILLING CODE 4140-01-P