National Cancer Institute; Notice of Closed Meeting, 70973-70974 [06-9577]
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70973
Federal Register / Vol. 71, No. 235 / Thursday, December 7, 2006 / Notices
that is provided to the government of
Chile and posted on FDA’s Internet site,
which identifies U.S. dairy product
manufacturers/processors that have
expressed interest to FDA in exporting
dairy products to Chile, are subject to
FDA jurisdiction, and are not the subject
of a pending judicial enforcement action
(i.e., an injunction or seizure) or a
pending warning letter. The term ‘‘dairy
products,’’ for purposes of this list, is
not intended to cover the raw
agricultural commodity raw milk.
Application for inclusion on the list is
voluntary. However, Chile has advised
that dairy products from firms not on
this list could be delayed or prevented
by Chilean authorities from entering
commerce in Chile. The revised
guidance explains what information
firms should submit to FDA in order to
be considered for inclusion on the list
and what criteria FDA intends to use to
determine eligibility for placement on
the list. The document also explains
how FDA intends to update the list and
how FDA intends to communicate any
new information to Chile. Finally, the
revised guidance notes that FDA
considers the information on this list,
which is provided voluntarily with the
understanding that it will be posted on
FDA’s Internet site and communicated
to, and possibly further disseminated
by, Chile, to be information that is not
protected from disclosure under 5
U.S.C. 552(b)(4). Under this guidance,
FDA recommends that U.S. firms that
want to be placed on the list send the
following information to FDA: Name
and address of the firm and the
manufacturing plant; name, telephone
number, and e-mail address (if
available) of the contact person; a list of
products presently shipped and
expected to be shipped in the next 3
years; identities of agencies that inspect
the plant and the date of last inspection;
plant number and copy of last
inspection notice; and, if other than an
FDA inspection, copy of last inspection
report. FDA requests that this
information be updated every 2 years.
In the Federal Register of July 31,
2006 (71 FR 43202), FDA published a
60–day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
No. of Respondents
New Written Requests To Be
Placed On The List
Biannual Update
Occasional Updates
Total
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1There
Annual Frequency
per Response
15
55
25
Total Annual Responses
1
1
1
Hours per Response
15
55
25
Total Hours
1.5
1.0
0.5
22.5
55.0
12.5
90
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms
that will submit new written requests to
be placed on the list, biannual updates
and occasional updates is based on the
FDA’s experience maintaining the list
over the past 3 years. The estimate of
the number of hours that it will take a
firm to gather the information needed to
be placed on the list or update its
information is based on FDA’s
experience with firms submitting
similar requests. FDA believes that the
information to be submitted will be
readily available to the firms.
To date, over 110 producers have
sought to be included on the list. FDA
estimates that, each year, approximately
15 new firms will apply to be added to
the list. FDA estimates that a firm will
require 1.5 hours to read the guidance,
gather the information needed, and to
prepare a communication to FDA that
contains the information and requests
that the firm be placed on the list.
Under the revised guidance, every 2
years each producer on the list must
provide updated information in order to
remain on the list. FDA estimates that
each year approximately half of the
firms on the list, 55 firms, will resubmit
the information to remain on the list.
FDA estimates that a firm already on the
list will require 1.0 hours to biannually
update and resubmit the information to
FDA, including time reviewing the
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information and corresponding with
FDA. In addition, FDA expects that,
each year, approximately 25 firms will
need to submit an occasional update
and each firm will require 0.5 hours to
prepare a communication to FDA
reporting the change.
Dated: November 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–20704 Filed 12–6–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0426]
Withdrawal of Federal Register Notice
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice; withdrawal.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal of a 60-day notice that
published in the Federal Register of
October 31, 2006 (71 FR 63765). The
document published in error.
DATES: December 7, 2006.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
PO 00000
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Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: FDA is
withdrawing a 60-day notice entitled
‘‘Medical Device User Fee and
Modernization Act Small Business
Qualification Certification (Form FDA
3602),’’ which published in the Federal
Register of October 31, 2006 (71 FR
63765), because it is a duplicate of an
earlier 60-day notice. The earlier 60-day
notice published in the Federal Register
of August 29, 2006 (71 FR 51196). The
October 31 notice was published in
error.
Dated: November 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–20705 Filed 12–6–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
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Federal Register / Vol. 71, No. 235 / Thursday, December 7, 2006 / Notices
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 purpose of this
meeting is to evaluate proposals for
support through the RAID program by
making available to the research
community, on a competitive basis, NCI
new agent development contract
resources for the preclinical
development of drugs and biologics.
The outcome of the evaluation will be
a decision whether NCI should support
the request and make available contract
resources for support through the RAID
program to the research community,
NCI new agent development for the
preclinical development of drugs and
biologics. The research proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the
proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
sroberts on PROD1PC70 with NOTICES
Name of Committee: National Cancer
Institute Special Emphasis Panel Rapid
Access to Intervention Development.
Date: December 20, 2006.
Time: 8:30 a.m.–5 p.m.
Agenda: To evaluate Rapid Access to
Intervention Development Portfolio.
Place: National Institutes of Health, 6130
Executive Boulevard, Rm. 319, Rockville, MD
20852.
Contact Person: Phyllis G. Bryant,
Executive Secretary, Program Analyst,
Developmental Therapeutics Program,
National Cancer Institute, NIH, 6130
Executive Boulevard, Rm. 8022, Bethesda,
MD 20892, 301 435–9137.
(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: November 30, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–9577 Filed 12–6–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
National Institutes of Health
Dated: December 1, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–9573 Filed 12–6–06; 8:45 am]
National Heart, Lung, and Blood
Institute; 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 Heart, Lung,
and Blood Institute Special Emphasis Panel,
Demonstration and Education Research
Grants.
Date: December 15, 2006.
Time: 9 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Patricia A. Haggerty, PhD,
Scientific Review Administrator, National
Heart, Lung, and Blood Institute/NIH,
Clinical Studies & Training Studies Rev.
Grp., Division of Extramural Affairs/Section
Chief, 6701 Rockledge Drive, Room 7194,
Bethesda, MD 20892, 301/435–0288,
haggertp@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 Heart, Lung,
and Blood Institute Special Emphasis Panel,
Coronary Intervention Trial.
Date: December 19, 2006.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: William J. Johnson, PhD,
Scientific Review Administrator, Review
Branch, Division of Extramural Research
Activities, NIH/NHLBI, 6701 Rockledge
Drive, Bethesda, MD 20892–7924, 301–435–
0317, johnsonw@nhlbi.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. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; 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: Center for Inherited
Disease Research Access Committee Group
A.
Date: January 5, 2007.
Time: 8:30 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Jerry Roberts, PhD,
Scientific Review Administrator, Scientific
Review Branch, National Institutes of Health,
Building 38A, Bethesda, MD 20892, 301 402–
0838.
Name of Committee: Center for Inherited
Disease Research Access Committee Group B.
Date: January 5, 2007.
Time: 3:15 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Rudy Pozzatti, PhD,
Scientific Review Administrator, Scientific
Review Branch, National Human Genome
Research Institute, 5635 Fishers Lane, Suite
4076, MSC 9306, Bethesda, MD 20852, (301)
402–0838, pozzattr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
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Agencies
[Federal Register Volume 71, Number 235 (Thursday, December 7, 2006)]
[Notices]
[Pages 70973-70974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-9577]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
[[Page 70974]]
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 purpose of this meeting is to evaluate
proposals for support through the RAID program by making available to
the research community, on a competitive basis, NCI new agent
development contract resources for the preclinical development of drugs
and biologics. The outcome of the evaluation will be a decision whether
NCI should support the request and make available contract resources
for support through the RAID program to the research community, NCI new
agent development for the preclinical development of drugs and
biologics. The research proposals and the discussions could disclose
confidential trade secrets or commercial property such as patentable
material, and personal information concerning individuals associated
with the proposed research projects, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Cancer Institute Special Emphasis
Panel Rapid Access to Intervention Development.
Date: December 20, 2006.
Time: 8:30 a.m.-5 p.m.
Agenda: To evaluate Rapid Access to Intervention Development
Portfolio.
Place: National Institutes of Health, 6130 Executive Boulevard,
Rm. 319, Rockville, MD 20852.
Contact Person: Phyllis G. Bryant, Executive Secretary, Program
Analyst, Developmental Therapeutics Program, National Cancer
Institute, NIH, 6130 Executive Boulevard, Rm. 8022, Bethesda, MD
20892, 301 435-9137.
(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: November 30, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 06-9577 Filed 12-6-06; 8:45 am]
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