National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings, 57301-57302 [05-19540]
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Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices
that ‘‘A recall communication can be
accomplished by telegrams, mailgrams,
or first class letters* * *.’’ Given the
use of the term ‘‘can,’’ we read the three
examples as being illustrative rather
than the sole means of accomplishing
recall communications. Electronic
notification is a viable alternative to
more traditional methods.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on using electronic means to distribute
certain product information. 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comments on the draft guidance. 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. The draft guidance and
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 either
https://www.fda.gov/oc/guidance/
electronic.html or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: September 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–19731 Filed 9–28–05; 1:53 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
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
meeting.
The meeting will be closed to the
public in accordance with the
provisions set 552b(c)(4) and 552b(c)(6),
VerDate Aug<31>2005
16:14 Sep 29, 2005
Jkt 205001
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 be constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Sickle Cell Disease Clinical Research
Network.
Date: October 31–November 1, 2005.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Double Tree Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: William J. Johnson, PhD,
Review Branch, Division of Extramural
Affairs, NIH/NHLBI, 6701 Rockledge Drive,
Bethesda, MD 20892–7924, 301–435–0317,
johnsonw@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 23, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–19537 Filed 9–29–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
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
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 discuss
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 Heart, Lung,
and Blood Institute Special Emphasis Panel,
NHLBI Patient-Oriented K Applications.
Date: October 27–28, 2005.
Time: 9 a.m. to 4 p.m.
PO 00000
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57301
Agenda: To review and evaluate grant
applications.
Place: Sheraton Columbia Hotel, 10207
Wincopin Circle, Columbia, MD 21044.
Contact Person: Roy L White, PhD,
Scientific Review Administrator, Division of
Extramural Affairs, Review Branch, National
Heart, Lung, and Blood Institute, NIH, 6701
Rockledge Drive, Rm. 7202, Bethesda, MD
20892–7924, 301/435–0310,
whiterl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 23, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–19538 Filed 9–29–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of 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 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 accordance with the provisions
set forth in sections 552(b)(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
Initial Review Group, Kidney, Urologic and
Hematologic Diseases D Subcommittee.
Date: October 18–19, 2005.
Open: October 18, 2005, 2 p.m. to 2:30 p.m.
Agenda: To review procedures and discuss
policy.
E:\FR\FM\30SEN1.SGM
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57302
Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Closed: October 19, 2005, 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: Neal A. Musto, PhD,
Scientific Review Administrator, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 751, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7798, muston@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group, Digestive Disease and
Nutrition C Subcommittee.
Date: October 27–28, 2005.
Open: October 27, 2005, 8 a.m. to 8:30 a.m.
Agenda: To review procedures and discuss
policy.
Place: Renaissance Hotel, 999 Ninth Street
Northwest, Washington, DC 20001.
Closed: October 27, 2005, 8:30 a.m. to 5
p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Hotel, 999 Ninth Street
Northwest, Washington, DC 20001.
Closed: October 28, 2005, 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Hotel, 999 Ninth Street
Northwest, Washington, DC 20001.
Contact Person: Paul A. Rushing, PhD,
Scientific Review Administrator, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 747, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–8895, rushingp@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group, Diabetes,
Endocrinology and Metabolic Diseases B
Subcommittee.
Date: November 3–4, 2005.
Open: November 3, 2005, 6 p.m. to 6:30
p.m.
Agenda: To review procedures and discuss
policy.
Place: Holiday Inn Select Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Closed: November 3, 2005, 6:30 p.m. to 11
p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn Select Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Closed: November 4, 2005, 8 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn Select Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: John F. Connaughton, PhD,
Scientific Review Administrator, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 757, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7797,
connaughtonj@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93l.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
VerDate Aug<31>2005
16:14 Sep 29, 2005
Jkt 205001
and Hematology Research, National Institutes
of Health, HHS)
Dated: September 21, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–19540 Filed 9–29–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute on
Deafness and Other Communications
Disorders Special Emphasis Panel,
November 2, 2005, 8 a.m. to November
2, 2005, 5 p.m., Residence Inn Bethesda,
7335 Wisconsin Avenue, Bethesda, MD,
20814 which was published in the
Federal Register on September 16, 2005,
70 FR 54759–54760.
The meeting will be held at the
Bethesda Marriott Suites, 6711
Democracy Blvd., Bethesda, MD 20817,
rather than at the Residence Inn
Bethesda, as previously reported. The
meeting is closed to the public.
Dated: September 22, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–19541 Filed 9–29–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 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 contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
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Fmt 4703
Sfmt 4703
Name of Committee: National Institute on
Aging Special Emphasis Panel, Rodent
Tissue Bank.
Date: October 13, 2005.
Time: 2 p.m. to 3:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute on Aging, 7201
Wisconsin Avenue, Bethesda, MD 20814,
(Telephone Conference Call).
Contact Person: Ramesh Vemuri, PhD,
Scientific Review Office, National Institute
on Aging, National Institutes of Health, Room
2C212, 7201 Wisconsin Avenue, Bethesda,
MD 20892, 301–402–7700, rv23r@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. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: September 22, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–19542 Filed 9–29–05; 8:45 am]
BILLING CODE 4140–01–M
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. 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
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Translational
Research for the Prevention and Control of
Diabetes.
Date: October 17, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Michelle L. Barnard, PhD,
Scientific Review Administrator, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 753, 6707 Democracy
E:\FR\FM\30SEN1.SGM
30SEN1
Agencies
[Federal Register Volume 70, Number 189 (Friday, September 30, 2005)]
[Notices]
[Pages 57301-57302]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19540]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of 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 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 accordance with the
provisions set forth in sections 552(b)(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 Initial Review Group, Kidney, Urologic and
Hematologic Diseases D Subcommittee.
Date: October 18-19, 2005.
Open: October 18, 2005, 2 p.m. to 2:30 p.m.
Agenda: To review procedures and discuss policy.
[[Page 57302]]
Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD
20814.
Closed: October 19, 2005, 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD
20814.
Contact Person: Neal A. Musto, PhD, Scientific Review
Administrator, Review Branch, DEA, NIDDK, National Institutes of
Health, Room 751, 6707 Democracy Boulevard, Bethesda, MD 20892-5452,
(301) 594-7798, muston@extra.niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Initial Review Group, Digestive Disease and
Nutrition C Subcommittee.
Date: October 27-28, 2005.
Open: October 27, 2005, 8 a.m. to 8:30 a.m.
Agenda: To review procedures and discuss policy.
Place: Renaissance Hotel, 999 Ninth Street Northwest,
Washington, DC 20001.
Closed: October 27, 2005, 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance Hotel, 999 Ninth Street Northwest,
Washington, DC 20001.
Closed: October 28, 2005, 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance Hotel, 999 Ninth Street Northwest,
Washington, DC 20001.
Contact Person: Paul A. Rushing, PhD, Scientific Review
Administrator, Review Branch, DEA, NIDDK, National Institutes of
Health, Room 747, 6707 Democracy Boulevard, Bethesda, MD 20892-5452,
(301) 594-8895, rushingp@extra.niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Initial Review Group, Diabetes, Endocrinology
and Metabolic Diseases B Subcommittee.
Date: November 3-4, 2005.
Open: November 3, 2005, 6 p.m. to 6:30 p.m.
Agenda: To review procedures and discuss policy.
Place: Holiday Inn Select Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
Closed: November 3, 2005, 6:30 p.m. to 11 p.m.
Agenda: To review and evaluate grant applications.
Place: Holiday Inn Select Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
Closed: November 4, 2005, 8 a.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: Holiday Inn Select Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
Contact Person: John F. Connaughton, PhD, Scientific Review
Administrator, Review Branch, DEA, NIDDK, National Institutes of
Health, Room 757, 6707 Democracy Boulevard, Bethesda, MD 20892-5452,
(301) 594-7797, connaughtonj@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93l.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: September 21, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-19540 Filed 9-29-05; 8:45 am]
BILLING CODE 4140-01-M