National Center for Research Resources; Notice of Closed Meetings, 54047 [07-4669]
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Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices
IV. Issues for Discussion
We are specifically interested in
hearing comments regarding the
following questions and any other
pertinent information related to the
feasibility of the electronic submission
of premarket applications and other
regulatory information related to the
review of human drug applications
including postmarket data sources:
1. What would help improve the
quality of electronic submissions to the
agency?
2. What would help increase the
quantity of electronic submissions to the
agency?
3. How would you prioritize these
quality and quantity improvements?
4. What data standards are needed to
implement these improvements?
5. How should FDA engage
stakeholders while developing, testing,
and implementing these solutions?
6. What topics are most useful to
include in IT plans?
7. What lead time is needed for
stakeholders to respond to and be in
alignment with FDA initiatives?
8. How should FDA coordinate with
stakeholders on the adoption and
implementation of data standards?
9. What data standards areas provide
the greatest challenge?
10. What approaches will facilitate
the most effective and efficient adoption
and implementation of data standards?
11. What key areas require new or
expanded electronic submissions
guidance?
12. What lessons learned and best
practices should FDA consider as we
transition from program-specific to
enterprise IT solutions using a reusable
and modular model?
13. What specific concerns (i.e.,
security, confidentiality, etc.) exist for a
third party entity or entities providing
services related to electronic
submissions and review and how can
they be addressed?
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V. Notice of Public Meeting
The Commissioner of Food and Drugs
is announcing that the public meeting
will be conducted by FDA senior
management. Persons who wish to
participate in the meeting must file a
written or electronic notice of
participation with the Division of
Dockets Management (see ADDRESSES
and DATES). No participant may
interrupt the presentation of another
participant. Only the presiding officer
and panel members may question any
person during or at the conclusion of
each presentation. Under 21 CFR
10.205, representatives of the electronic
media may be permitted, subject to
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certain limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants.
VI. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic notices
of participation and comments for
consideration. To permit time for all
interested persons to submit data,
information, or views on this subject,
the administrative record of the meeting
will remain open until 2 weeks prior to
the public meeting. Persons who wish to
provide additional materials for
consideration should file these materials
with the Division of Dockets
Management (see ADDRESSES). You
should annotate and organize your
comments to identify the specific
questions to which they refer (see
section IV of this document). Two paper
copies of any mailed comments are to be
submitted, 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 Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
VII. Transcripts
The meeting will be transcribed.
Transcripts of the meeting will be
available for review at the Division of
Dockets Management (see ADDRESSES)
and on the Internet at https://
www.fda.gov/ohrms/dockets
approximately 21 days after the
meeting. You may place orders for
copies of the transcript through the
Freedom of Information Office (HFI–35),
Food and Drug Administration, 5600
Fishers Lane, Rm. 6–30, Rockville, MD
20857, at a cost of 10 cents per page.
Dated: September 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–4692 Filed 9–18–07; 12:12 pm]
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54047
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 Center for
Research Resources Special Emphasis Panel,
Florida International University Site Visit.
Date: October 18–19, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Park Plaza Hotel, 415 North Monroe
Street, Tallahassee, FL 32301.
Contact Person: Guo Zhang, PhD, MD,
Scientific Review Administrator, National
Center for Research Resources, or National
Institutes of Health, 6701 Democracy
Boulevard, 1 Democracy Plaza, Room 1064,
MSC 4874, Bethesda, MD 20892–4874, 301–
435–0812, zhanggu@mail.nih.gov.
Name of Committee: National Center for
Research Resources Special Emphasis Panel,
Tulane NPRC.
Date: October 29–31, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham New Orleans, 100 Rue
Iberville, New Orleans, LA 70130.
Contact Person: Carol Lambert, PhD,
Scientific Review Administrator, Office of
Review, National Center for Research
Resources, National Institutes of Health, 6701
Democracy Blvd., 1 Dem. Plaza, Room 1076,
Bethesda, MD 20892, 301–435–0814,
lambert@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure,
93.306, 93.333, National Institutes of Health,
HHS)
Dated: September 14, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–4669 Filed 9–20–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Center for Research
Resources; 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.
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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
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[Federal Register Volume 72, Number 183 (Friday, September 21, 2007)]
[Notices]
[Page 54047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-4669]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Research Resources; 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 Center for Research Resources
Special Emphasis Panel, Florida International University Site Visit.
Date: October 18-19, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Park Plaza Hotel, 415 North Monroe Street, Tallahassee,
FL 32301.
Contact Person: Guo Zhang, PhD, MD, Scientific Review
Administrator, National Center for Research Resources, or National
Institutes of Health, 6701 Democracy Boulevard, 1 Democracy Plaza,
Room 1064, MSC 4874, Bethesda, MD 20892-4874, 301-435-0812,
zhanggu@mail.nih.gov.
Name of Committee: National Center for Research Resources
Special Emphasis Panel, Tulane NPRC.
Date: October 29-31, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Wyndham New Orleans, 100 Rue Iberville, New Orleans, LA
70130.
Contact Person: Carol Lambert, PhD, Scientific Review
Administrator, Office of Review, National Center for Research
Resources, National Institutes of Health, 6701 Democracy Blvd., 1
Dem. Plaza, Room 1076, Bethesda, MD 20892, 301-435-0814,
lambert@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure, 93.306, 93.333,
National Institutes of Health, HHS)
Dated: September 14, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 07-4669 Filed 9-20-07; 8:45 am]
BILLING CODE 4140-01-M
