National Heart, Lung, and Blood Institute; Amended Notice of Meeting, 7951-7952 [05-2956]
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Federal Register / Vol. 70, No. 31 / Wednesday, February 16, 2005 / Notices
March 16, 2005, the comment period for
the notice that appeared in the Federal
Register of August 16, 2004 (69 FR
50386). In the notice, FDA announced a
public workshop on scientific and
technical considerations related to the
development of follow-on protein
pharmaceutical products and plans to
develop draft guidance and requested
comments related to developing and
approving follow-on protein
pharmaceutical products. The agency is
taking this action in response to
requests for an extension to allow
interested persons additional time to
submit comments.
DATES: Submit written and electronic
comments by March 16, 2005.
ADDRESSES: Submit written comments
on scientific topics related to follow-on
protein products 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Keith Webber, Center for Drug
Evaluation and Research (HFD–121),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20852,
301–443–5089, e-mail:
keith.webber@fda.gov, or Chris Joneckis,
Center for Biologics Evaluation and
Research (HFM–1), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20892, 301–827–2000, email: christopher.joneckis@fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 16,
2004 (69 FR 50386), FDA published a
notice with a 90-day comment period to
request comments on the scientific and
technological perspectives of
manufacturers, academia, and other
interested persons to determine the state
of the science as it relates to protein
characterization, production, and
assessment of similarity.
The agency has received requests for
an extension of the comment period for
the notice. In response to these requests,
FDA has decided to reopen the
comment period for the notice for an
additional 30 days, until March 16,
2005.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on this document. Two
copies of mailed comments are to be
submitted, except that individuals may
submit one copy. Comments are to be
identified with the docket number
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found in brackets in the heading of this
document. Received comments are
available for public examination in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 11, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–3027 Filed 2–11–05; 4:50 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Health Professions Preparatory, Health
Professions Pregraduate and Indian
Health Professions Scholarship
Programs: Correction
ACTION:
Notice; correction.
SUMMARY: The Indian Health Service
published a document in the Federal
Register on January 19, 2005. The
document contained two errors.
FOR FURTHER INFORMATION CONTACT: Mr.
Jess Brien, Chief, Scholarship Branch,
Indian Health Service, 801 Thompson
Avenue, Suite 120, Rockville, Maryland
20852; Telephone (301) 443–6197. (This
is not a toll-free number.)
Correction
In the Federal Register of January 19,
2005, in FR Doc. 05–1030, on page 3046,
in the second column, correct the
Anticipated Award Start Date to read
August 1, 2005; page 3048, in the
second column, Application Receipt
Date, correct February 28, 2005 to
March 28, 2005.
Dated: January 27, 2005.
Charles W. Grim,
Assistant Surgeon General, Director, Indian
Health Service.
[FR Doc. 05–2971 Filed 2–15–05; 8:45 am]
BILLING CODE 4160–16–M
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
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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 Cancer
Institute Special Emphasis Panel Innovations
in Cancer Sample Preparation.
Date: April 28, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, EPN–
J, 6130 Executive Boulevard, Rockville, MD
20852.
Contact Person: Timothy C. Meeker, MD,
Scientific Review Administrator, Special
Referral and Resources Branch, Division of
Extramural Activities, National Cancer
Institute, 6116 Executive Boulevard, Room
8088, Rockville, MD 20852, (301) 594–1279.
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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: February 8, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–2957 Filed 2–15–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
7951
Sfmt 4703
National Heart, Lung, and Blood
Institute; Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Heart, Lung,
and Blood Institute Special Emphasis
Panel, March 2, 2005, 8 a.m. to March
2, 2005, 5 p.m., Sheraton Inner Harbor
Hotel, 300 South Charles Street,
Baltimore, MD 21201 which was
published in the Federal Register on
January 18, 2005, FR70:2867–2868.
The meeting will be held on March 1
at 8 a.m. instead of March 2, 2005 as
previously advertised. The meeting is
closed to the public.
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7952
Federal Register / Vol. 70, No. 31 / Wednesday, February 16, 2005 / Notices
Dated: February 8, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–2956 Filed 2–15–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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/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 Institute of
Neurological Disorders and Stroke Special
Emphasis Panel, Hunter SNRP Type 2.
Date: February 24–25, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: Excelsior Hotel, 45 West 81st Street,
New York, NY 10024.
Contact Person: Phillip F. Wiethorn,
Scientific Review Administrator, DHHS/NIH/
NINDS/DER/SRB, 6001 Executive Boulevard;
MSC 9529, Neuroscience Center; Room 3203,
Bethesda, MD 20892–9529, (301) 496–5388,
wiethorp@ninds.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: February 9, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–2953 Filed 2–15–05; 8:45 am]
BILLING CODE 4140–01–M
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Arthritis and
Musculoskeletal and Skin Diseases
Special Grants Review Committee,
February 28, 2005, 8 a.m. to February
28, 2005, 5 p.m., Bethesda Marriott,
5151 Pooks Hill Road, Bethesda, MD,
20814 which was published in the
Federal Register on January 26, 2005,
FR 70, 3721–3722.
The meeting date has changed to
February 27–28, 2005. The meeting will
begin the evening of February 27, 2005
from 7 p.m.–11 p.m. The morning of
February 28, 2005 the meeting will
begin at 7 a.m.–5 p.m. The meeting is
closed to the public.
Dated: February 9, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–2954 Filed 2–15–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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
Mental Health Special Emphasis Panel,
Statistical and Psychometric Applications for
Clinical Studies.
Date: February 24, 2005.
Time: 9 a.m. to 10:45 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
PO 00000
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Fmt 4703
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Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Mark Czarnolewski, PhD,
Scientific Review Administrator, Division of
Extramural Activities, Neuroscience Center,
6001 Executive Blvd., Room 8122, MSC 9667,
Bethesda, MD 20892–9667, 301–345–4582,
mczarnol@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.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel,
Imaging and Mood Disorders II.
Date: March 3, 2005.
Time: 1:30 p.m. to 2:30 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: Peter J. Sheridan, PhD,
Scientific Review Administrator, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6142, MSC 9606,
Bethesda, MD 20892–9606, 301–443–1513,
psherida@mail.nih.gov.
(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: February 8, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–2955 Filed 2–15–05; 8:45 am]
BILLING CODE 4140–01–M
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
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Board of Scientific Counselors, National
Institute of Mental Health.
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 Mental Health,
including consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
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Agencies
[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Notices]
[Pages 7951-7952]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2956]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of
Meeting
Notice is hereby given of a change in the meeting of the National
Heart, Lung, and Blood Institute Special Emphasis Panel, March 2, 2005,
8 a.m. to March 2, 2005, 5 p.m., Sheraton Inner Harbor Hotel, 300 South
Charles Street, Baltimore, MD 21201 which was published in the Federal
Register on January 18, 2005, FR70:2867-2868.
The meeting will be held on March 1 at 8 a.m. instead of March 2,
2005 as previously advertised. The meeting is closed to the public.
[[Page 7952]]
Dated: February 8, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-2956 Filed 2-15-05; 8:45 am]
BILLING CODE 4140-01-M