Document NaanyN5DqeOX6byD4yZL0BkR
To: From: Cc: <whiter@api.org> Bcc: Received Date: Subject:
Phil,
Snyder, Phil J SCC-DCS/2 <phil.snyder@shell.com>
Howard Feldman <Feldman@api.org> Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; Russell White
2007-03-0517:29:10 GMT Shanghai extension 3-5-07
I see that you are on point for this today. Attached is the working draft API letter. Per our agreement on Friday, we are forwarding this directly to you on behalf of the Oversight Committee. Obviously, if there are any comments, we would like them as expeditiously as possible.
Howard Feldman
Howard J. Feldman
Director
Regulatory & Scientific Affairs
1220 L Street, NW
Washington, DC 20005-4070
USA
Telephone 202-682-8340
Fax 202-682-8270
E-mail
feldman@api.org
Attachments:
API proposal guide. doc image001.jpg Shanghai extension 3-5-07.doc
SHELL-MCCLURG-061941
March 5,2007
Via Electronic and U.S. Mail
Richard Irons, PhD, DABT Principal Investigator, Shanghai Health Study University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Ralph J Altiere, PhD Dean, School of Pharmacy University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Re: The Shanghai Health Study
Dear Drs. Irons and Altiere:
We are writing on behalf of the the scientific and clinical research being We appreciate Dr. Shanghai and
(API) in support of '-HH"HE:,uU~ Health Study. unique project in worthy effort.
to continue the study ~HHHH.LHVLH" from the five members of lltlOnal conditions of the study being independent Quality metrics and milestones for progress and Shanghai Health Study Proposed Budget INU.Ul'-'U November 10, 2006, submitted by Dr. Irons of ",'.HHVHLU funding up to $6,559,864 has been agreed to. This (as described in the referenced request):
Plan A Study ~V.LHIJH.,
(Tables I and 2)
$5,759,864
Plan B Laboratory
ition Personnel Proposed Budget (From Table 3) $400,000
Post Study Costs for continued publication of study findings
$400,000
TOTAL $6.559.864
Formal authorization and disbursement of these additional monies is contingent upon successful execution of an agreement between API and the research entity that will be continuing the study.
SHELL-MCCLURG-061942
Given the urgency to execute a grant/contract to continue the study, API looks forward to receiving a proposal in the near future to extend the existing grant or to establish a new contract with the University of Colorado, CynPathogen, Inc. or another entity. API Exhibits A-I to A-III, Proposal Guide For Prospective Contractors are attached; the information requested therein is necessary for the establishment of the new commitment. Sincerely, Red Cavaney Cc: C. Klaus
D. Ross D. Wilkerson
SHELL-MCCLURG-061943
March 5,2007
Via Electronic and U.S. Mail
Richard Irons, PhD, DABT Principal Investigator, Shanghai Health Study University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Ralph J Altiere, PhD Dean, School of Pharmacy University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Re: The Shanghai Health Study
Dear Drs. Irons and Altiere:
We are writing on behalf of the the scientific and clinical research being We appreciate Dr. Shanghai and
(API) in support of '-HH"HE:,uU~ Health Study. unique project in worthy effort.
January 29th SHS Oversight expressed for moving forward
Dr. Irons.
a proposal consistent with its attached
this matter, and if we can assist in facilitating
authorized to spend additional money to
API receiving formal financial commitments from the
five members
Research Consortium. Additional conditions of the
study being
implementation of an acceptable independent Quality
Assurance/Quality
plan and acceptable metrics and milestones for progress and
payment. API has
the Draft request, Shanghai Health Study Proposed Budget
for Extension and JCML Transition dated November 10, 2006, submitted by Dr. Irons of
the University of Colorado. Additional funding up to $6,559,864 has been agreed to. This
represents funding for the following (as described in the referenced request):
Plan A Study Completion Total (Tables I and 2)
$5,759,864
Plan B Laboratory Transition Personnel Proposed Budget (From Table 3) $400,000
Post Study Costs for continued publication of study findings
$400,000
TOTAL $625522864
SHELL-MCCLURG-061944
Formal authorization and disbursement of these additional monies is contingent upon successful execution of an agreement between API and the research entity that will be continuing the study.
Given the urgency to execute a grant/contract to continue the study, API looks
forward to receiving a proposal in the near future to extend the existing grant or to
establish a new contract with the University of Colorado, CynPathogen, Inc. or another
entity. API Exhibits A-I to A-III, Proposal Guide For
Contractors are
attached; the information requested therein is necessary for
of the new
commitment.
Sincerely,
Red Cavaney Cc: C. Klaus
D. Ross
SHELL-MCCLURG-061945
March 5,2007
Via Electronic and U.S. Mail
Richard Irons, PhD, DABT Principal Investigator, Shanghai Health Study University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Ralph J Altiere, PhD Dean, School of Pharmacy University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Re: The Shanghai Health Study
Dear Drs. Irons and Altiere:
We are writing on behalf of the the scientific and clinical research being We appreciate Dr. Shanghai and
(API) in support of '-HH"HE:,uU~ Health Study. unique project in worthy effort.
to continue the study ~HHHH.LHVLH" from the five members of lltlOnal conditions of the study being independent Quality metrics and milestones for progress and Shanghai Health Study Proposed Budget INU.Ul'-'U November 10, 2006, submitted by Dr. Irons of ",'.HHVHLU funding up to $6,559,864 has been agreed to. This (as described in the referenced request):
Plan A Study ~V.LHIJH.,
(Tables I and 2)
$5,759,864
Plan B Laboratory
ition Personnel Proposed Budget (From Table 3) $400,000
Post Study Costs for continued publication of study findings
$400,000
TOTAL $6.559.864
Formal authorization and disbursement of these additional monies is contingent upon successful execution of an agreement between API and the research entity that will be continuing the study.
SHELL-MCCLURG-061946
Given the urgency to execute a grant/contract to continue the study, API looks forward to receiving a proposal in the near future to extend the existing grant or to establish a new contract with the University of Colorado, CynPathogen, Inc. or another entity. API Exhibits A-I to A-III, Proposal Guide For Prospective Contractors are attached; the information requested therein is necessary for the establishment of the new commitment. Sincerely, Red Cavaney Cc: C. Klaus
D. Ross D. Wilkerson
SHELL-MCCLURG-061947
March 5,2007
Via Electronic and U.S. Mail
Richard Irons, PhD, DABT Principal Investigator, Shanghai Health Study University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Ralph J Altiere, PhD Dean, School of Pharmacy University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Re: The Shanghai Health Study
Dear Drs. Irons and Altiere:
We are writing on behalf of the the scientific and clinical research being We appreciate Dr. Shanghai and
(API) in support of '-HH"HE:,uU~ Health Study. unique project in worthy effort.
January 29th SHS Oversight expressed for moving forward
Dr. Irons.
a proposal consistent with its attached
this matter, and if we can assist in facilitating
authorized to spend additional money to
API receiving formal financial commitments from the
five members
Research Consortium. Additional conditions of the
study being
implementation of an acceptable independent Quality
Assurance/Quality
plan and acceptable metrics and milestones for progress and
payment. API has
the Draft request, Shanghai Health Study Proposed Budget
for Extension and JCML Transition dated November 10, 2006, submitted by Dr. Irons of
the University of Colorado. Additional funding up to $6,559,864 has been agreed to. This
represents funding for the following (as described in the referenced request):
Plan A Study Completion Total (Tables I and 2)
$5,759,864
Plan B Laboratory Transition Personnel Proposed Budget (From Table 3) $400,000
Post Study Costs for continued publication of study findings
$400,000
TOTAL $625522864
SHELL-MCCLURG-061948
Formal authorization and disbursement of these additional monies is contingent upon successful execution of an agreement between API and the research entity that will be continuing the study.
Given the urgency to execute a grant/contract to continue the study, API looks
forward to receiving a proposal in the near future to extend the existing grant or to
establish a new contract with the University of Colorado, CynPathogen, Inc. or another
entity. API Exhibits A-I to A-III, Proposal Guide For
Contractors are
attached; the information requested therein is necessary for
of the new
commitment.
Sincerely,
Red Cavaney Cc: C. Klaus
D. Ross
SHELL-MCCLURG-061949
March 5,2007
Via Electronic and U.S. Mail
Richard Irons, PhD, DABT Principal Investigator, Shanghai Health Study University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Ralph J Altiere, PhD Dean, School of Pharmacy University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Re: The Shanghai Health Study
Dear Drs. Irons and Altiere:
We are writing on behalf of the the scientific and clinical research being We appreciate Dr. Shanghai and
(API) in support of '-HH"HE:,uU~ Health Study. unique project in worthy effort.
to continue the study ~HHHH.LHVLH" from the five members of lltlOnal conditions of the study being independent Quality metrics and milestones for progress and Shanghai Health Study Proposed Budget INU.Ul'-'U November 10, 2006, submitted by Dr. Irons of ",'.HHVHLU funding up to $6,559,864 has been agreed to. This (as described in the referenced request):
Plan A Study ~V.LHIJH.,
(Tables I and 2)
$5,759,864
Plan B Laboratory
ition Personnel Proposed Budget (From Table 3) $400,000
Post Study Costs for continued publication of study findings
$400,000
TOTAL $6.559.864
Formal authorization and disbursement of these additional monies is contingent upon successful execution of an agreement between API and the research entity that will be continuing the study.
SHELL-MCCLURG-061950
Given the urgency to execute a grant/contract to continue the study, API looks forward to receiving a proposal in the near future to extend the existing grant or to establish a new contract with the University of Colorado, CynPathogen, Inc. or another entity. API Exhibits A-I to A-III, Proposal Guide For Prospective Contractors are attached; the information requested therein is necessary for the establishment of the new commitment. Sincerely, Red Cavaney Cc: C. Klaus
D. Ross D. Wilkerson
SHELL-MCCLURG-061951
March 5,2007
Via Electronic and U.S. Mail
Richard Irons, PhD, DABT Principal Investigator, Shanghai Health Study University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Ralph J Altiere, PhD Dean, School of Pharmacy University of Colorado Health Sciences Center 4200 East 9th Avenue, C238 Denver, CO 80262
Re: The Shanghai Health Study
Dear Drs. Irons and Altiere:
We are writing on behalf of the the scientific and clinical research being We appreciate Dr. Shanghai and
(API) in support of '-HH"HE:,uU~ Health Study. unique project in worthy effort.
January 29th SHS Oversight expressed for moving forward
Dr. Irons.
a proposal consistent with its attached
this matter, and if we can assist in facilitating
authorized to spend additional money to
API receiving formal financial commitments from the
five members
Research Consortium. Additional conditions of the
study being
implementation of an acceptable independent Quality
Assurance/Quality
plan and acceptable metrics and milestones for progress and
payment. API has
the Draft request, Shanghai Health Study Proposed Budget
for Extension and JCML Transition dated November 10, 2006, submitted by Dr. Irons of
the University of Colorado. Additional funding up to $6,559,864 has been agreed to. This
represents funding for the following (as described in the referenced request):
Plan A Study Completion Total (Tables I and 2)
$5,759,864
Plan B Laboratory Transition Personnel Proposed Budget (From Table 3) $400,000
Post Study Costs for continued publication of study findings
$400,000
TOTAL $625522864
SHELL-MCCLURG-061952
Formal authorization and disbursement of these additional monies is contingent upon successful execution of an agreement between API and the research entity that will be continuing the study.
Given the urgency to execute a grant/contract to continue the study, API looks
forward to receiving a proposal in the near future to extend the existing grant or to
establish a new contract with the University of Colorado, CynPathogen, Inc. or another
entity. API Exhibits A-I to A-III, Proposal Guide For
Contractors are
attached; the information requested therein is necessary for
of the new
commitment.
Sincerely,
Red Cavaney Cc: C. Klaus
D. Ross
SHELL-MCCLURG-061953