Memorandum of Understanding Between the National Cancer Institute and the Food and Drug Administration, 19534-19539 [07-1921]
Download as PDF
19534
Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices
pwalker on PROD1PC71 with NOTICES
address, company phone number, and email address. You will receive a
confirmation within 2 business days.
We also will accept walk-in
registration at the meeting site, but
space is limited, and we will close
registration when maximum seating
capacity (approximately 100) is reached.
We will try to accommodate all
persons who wish to make a
presentation. The time allotted for
presentations may depend on the
number of persons who wish to speak.
Additionally, regardless of whether
you wish to make a presentation or
simply attend the meeting, please notify
us if you need any special
accommodations (such as wheelchair
access or a sign language interpreter).
If you would like to submit comments
regarding these proposed
recommendations, please send your
comments to the Division of Dockets
Management (see ADDRESSES). Submit a
single copy of electronic comments or
two paper copies of any written
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. Submit your
comments no later than May 18, 2007.
VerDate Aug<31>2005
17:04 Apr 17, 2007
Jkt 211001
C. Will Meeting Transcripts Be
Available?
We will prepare a meeting transcript
and make it available on our Web site
(https://www.fda.gov) after the meeting.
We anticipate that transcripts will be
available approximately 30 working
days after the meeting. The transcript
will also be available for public
examination at the Division of Dockets
Management (HFA–305), 5630 Fishers
Lane, rm. 1061, Rockville, MD 20857,
between 9 a.m. and 4 p.m. Monday
through Friday.
Dated: April 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–1919 Filed 4–16–07; 1:52 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA 225–07–4301]
Memorandum of Understanding
Between the National Cancer Institute
and the Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00074
Fmt 4703
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the National Cancer Institute (NCI), part
of the National Institutes of Health
(NIH) of the Department of Health and
Human Services (DHHS). The purpose
of this MOU is to establish a formal
collaboration between FDA and NCI
regarding the creation of a common
standards-based data repository to
facilitate the electronic exchange and
analysis of data from research studies on
investigational drugs in a fully secure
manner.
The agreement became effective
March 2, 2007.
FOR FURTHER INFORMATION CONTACT:
Randy Levin, Center for Drug Evaluation
Research (HF–18), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7784 email: randy.levin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
DATES:
Dated: April 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
Sfmt 4703
E:\FR\FM\18APN1.SGM
18APN1
VerDate Aug<31>2005
17:04 Apr 17, 2007
Jkt 211001
PO 00000
Frm 00075
Fmt 4703
Sfmt 4725
E:\FR\FM\18APN1.SGM
18APN1
19535
EN18AP07.000
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices
VerDate Aug<31>2005
Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices
17:04 Apr 17, 2007
Jkt 211001
PO 00000
Frm 00076
Fmt 4703
Sfmt 4725
E:\FR\FM\18APN1.SGM
18APN1
EN18AP07.001
pwalker on PROD1PC71 with NOTICES
19536
VerDate Aug<31>2005
17:04 Apr 17, 2007
Jkt 211001
PO 00000
Frm 00077
Fmt 4703
Sfmt 4725
E:\FR\FM\18APN1.SGM
18APN1
19537
EN18AP07.002
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices
VerDate Aug<31>2005
Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices
18:01 Apr 17, 2007
Jkt 211001
PO 00000
Frm 00078
Fmt 4703
Sfmt 4725
E:\FR\FM\18APN1.SGM
18APN1
EN18AP07.003
pwalker on PROD1PC71 with NOTICES
19538
19539
[FR Doc. 07–1921 Filed 4–17–07; 8:45 am]
BILLING CODE 4160–01–C
VerDate Aug<31>2005
18:20 Apr 17, 2007
Jkt 211001
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
E:\FR\FM\18APN1.SGM
18APN1
EN18AP07.004
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices
Agencies
[Federal Register Volume 72, Number 74 (Wednesday, April 18, 2007)]
[Notices]
[Pages 19534-19539]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1921]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA 225-07-4301]
Memorandum of Understanding Between the National Cancer Institute
and the Food and Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA and the National Cancer
Institute (NCI), part of the National Institutes of Health (NIH) of the
Department of Health and Human Services (DHHS). The purpose of this MOU
is to establish a formal collaboration between FDA and NCI regarding
the creation of a common standards-based data repository to facilitate
the electronic exchange and analysis of data from research studies on
investigational drugs in a fully secure manner.
DATES: The agreement became effective March 2, 2007.
FOR FURTHER INFORMATION CONTACT: Randy Levin, Center for Drug
Evaluation Research (HF-18), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-7784 e-mail:
randy.levin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and MOUs between FDA and others
shall be published in the Federal Register, the agency is publishing
notice of this MOU.
Dated: April 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160-01-S
[[Page 19535]]
[GRAPHIC] [TIFF OMITTED] TN18AP07.000
[[Page 19536]]
[GRAPHIC] [TIFF OMITTED] TN18AP07.001
[[Page 19537]]
[GRAPHIC] [TIFF OMITTED] TN18AP07.002
[[Page 19538]]
[GRAPHIC] [TIFF OMITTED] TN18AP07.003
[[Page 19539]]
[GRAPHIC] [TIFF OMITTED] TN18AP07.004
[FR Doc. 07-1921 Filed 4-17-07; 8:45 am]
BILLING CODE 4160-01-C