24 Component

PHS 398 Cover Letter
OMB Number: 0925-0001
Expiration Date: 9/30/2007

*Mandatory Cover Letter Filename:

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PHS 398 Cover Page Supplement
OMB Number: 0925-0001
Expiration Date: 9/30/2007

1. Project Director / Principal Investigator (PD/PI)
Prefix:

* First Name:

Middle Name:
* Last Name:
Suffix:

* New Investigator?

No

Yes

Degrees:

2. Human Subjects
Clinical Trial?

No

Yes

* Agency-Defined Phase III Clinical Trial?

No

Yes

3. Applicant Organization Contact
Person to be contacted on matters involving this application
* First Name:

Prefix:
Middle Name:
* Last Name:
Suffix:

* Phone Number:
Email:

* Title:

* Street1:
Street2:
* City:
County:
* State:
Province:
* Country:

UNITED ST * Zip / Postal Code:

Fax Number:

PHS 398 Cover Page Supplement
OMB Number: 0925-0001
Expiration Date: 9/30/2007

4. Human Embryonic Stem Cells

* Does the proposed project involve human embryonic stem cells?

No

Yes

If the proposed project involves human embryonic stem cells, list below the registration number of the
specific cell line(s) from the following list: http://stemcells.nih.gov/registry/index.asp . Or, if a specific
stem cell line cannot be referenced at this time, please check the box indicating that one from the
registry will be used:

Cell Line(s):

Specific stem cell line cannot be referenced at this time. One from the registry will be used.

PHS 398 Modular Budget, Periods 1 and 2
OMB Number: 0925-0001
Expiration Date: 9/30/2007

Budget Period: 1
Reset Entries

Start Date:

End Date:

A. Direct Costs

* Funds Requested ($)
* Direct Cost less Consortium F&A
Consortium F&A
* Total Direct Costs

B. Indirect Costs
Indirect Cost
Rate (%)

Indirect Cost Type

Indirect Cost
Base ($)

* Funds Requested ($)

1.
2.
3.
4.
Cognizant Agency (Agency Name, POC Name and Phone Number)

Indirect Cost Rate Agreement Date

Total Indirect Costs
Funds Requested ($)

C. Total Direct and Indirect Costs (A + B)
Budget Period: 2
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Start Date:

End Date:
* Funds Requested ($)

A. Direct Costs
* Direct Cost less Consortium F&A
Consortium F&A
* Total Direct Costs

B. Indirect Costs
Indirect Cost Type

Indirect Cost
Rate (%)

Indirect Cost
Base ($)

1.
2.
3.
4.
Cognizant Agency (Agency Name, POC Name and Phone Number)

Indirect Cost Rate Agreement Date

C. Total Direct and Indirect Costs (A + B)

Total Indirect Costs
Funds Requested ($)

* Funds Requested ($)

PHS 398 Modular Budget, Periods 3 and 4
OMB Number: 0925-0001
Expiration Date: 9/30/2007

Budget Period: 3
Reset Entries

Start Date:

End Date:

A. Direct Costs

* Funds Requested ($)
* Direct Cost less Consortium F&A
Consortium F&A
* Total Direct Costs

B. Indirect Costs
Indirect Cost
Rate (%)

Indirect Cost Type

Indirect Cost
Base ($)

* Funds Requested ($)

1.
2.
3.
4.
Cognizant Agency (Agency Name, POC Name and Phone Number)

Indirect Cost Rate Agreement Date

Total Indirect Costs

C. Total Direct and Indirect Costs (A + B)

Funds Requested ($)

Budget Period: 4
Reset Entries

Start Date:

End Date:
* Funds Requested ($)

A. Direct Costs
* Direct Cost less Consortium F&A
Consortium F&A
* Total Direct Costs

B. Indirect Costs
Indirect Cost Type

Indirect Cost
Rate (%)

Indirect Cost
Base ($)

1.
2.
3.
4.
Cognizant Agency (Agency Name, POC Name and Phone Number)

Indirect Cost Rate Agreement Date

C. Total Direct and Indirect Costs (A + B)

Total Indirect Costs
Funds Requested ($)

* Funds Requested ($)

PHS 398 Modular Budget, Period 5 and Cumulative
OMB Number: 0925-0001
Expiration Date: 9/30/2007

Budget Period: 5
Reset Entries

Start Date:

End Date:

A. Direct Costs

* Funds Requested ($)
* Direct Cost less Consortium F&A
Consortium F&A
* Total Direct Costs

B. Indirect Costs
Indirect Cost
Rate (%)

Indirect Cost Type

Indirect Cost
Base ($)

* Funds Requested ($)

1.
2.

3.
4.
Cognizant Agency (Agency Name, POC Name and Phone Number)

Indirect Cost Rate Agreement Date

Total Indirect Costs

C. Total Direct and Indirect Costs (A + B)

Funds Requested ($)

Cumulative Budget Information

1. Total Costs, Entire Project Period
* Section A, Total Direct Cost less Consortium F&A for Entire Project Period

$

Section A, Total Consortium F&A for Entire Project Period

$

* Section A, Total Direct Costs for Entire Project Period

$

* Section B, Total Indirect Costs for Entire Project Period

$

* Section C, Total Direct and Indirect Costs (A+B) for Entire Project Period

$

2. Budget Justifications
Personnel Justification

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Consortium Justification

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Additional Narrative Justification

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OMB Number: 0925-0001
Expiration Date: 9/30/2007

PHS 398 Research Plan
1. Application Type:
From SF 424 (R&R) Cover Page and PHS398 Checklist. The responses provided on these pages, regarding the type of application being submitted,
are repeated for your reference, as you attach the appropriate sections of the research plan.
*Type of Application:
New

Resubmission

Renewal

Continuation

Revision

2. Research Plan Attachments:
Please attach applicable sections of the research plan, below.
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2. Specific Aims

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3. Background and Significance

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4. Preliminary Studies / Progress Report

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5. Research Design and Methods

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6. Inclusion Enrollment Report

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7. Progress Report Publication List

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1. Introduction to Application
(for RESUBMISSION or REVISION only)

Human Subjects Sections
Attachments 8-11 apply only when you have answered "yes" to the question "are human subjects involved" on the R&R Other Project Information
Form. In this case, attachments 8-11 may be required, and you are encouraged to consult the Application guide instructions and/or the
specific Funding Opportunity Announcement to determine which sections must be submitted with this application.
8. Protection of Human Subjects

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9. Inclusion of Women and Minorities

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10. Targeted/Planned Enrollment

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11. Inclusion of Children

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12. Vertebrate Animals

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13. Select Agent Research

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14. Multiple PI Leadership Plan

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15. Consortium/Contractual Arrangements

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16. Letters of Support

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17. Resource Sharing Plan(s)

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Other Research Plan Sections

18. Appendix

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PHS 398 Checklist
OMB Number: 0925-0001
Expiration Date: 9/30/2007

1. Application Type:
From SF 424 (R&R) Cover Page. The responses provided on the R&R cover page are repeated here for your reference, as you answer
the questions that are specific to the PHS398.
* Type of Application:
New

Resubmission

Renewal

Continuation

Revision

Federal Identifier:

2. Change of Investigator / Change of Institution Questions
Change of principal investigator / program director

Name of former principal investigator / program director:
Prefix:
* First Name:
Middle Name:
* Last Name:
Suffix:

Change of Grantee Institution

* Name of former institution:

3. Inventions and Patents
* Inventions and Patents:

Yes

(For renewal applications only)
No

If the answer is "Yes" then please answer the following:
* Previously Reported:

Yes

No

OMB Number. 0925-0001
Expiration Date: 9/30/2007

4. * Program Income
Is program income anticipated during the periods for which the grant support is requested?
Yes

No

If you checked "yes" above (indicating that program income is anticipated), then use the format below to reflect the amount and
source(s). Otherwise, leave this section blank.
*Budget Period *Anticipated Amount ($)

*Source(s)

5. Assurances/Certifications (see instructions)
In agreeing to the assurances/certification section 18 on the SF424 (R&R) form, the authorized organizational representative agrees to
comply with the policies, assurances and/or certifications listed in the agency's application guide, when applicable. Descriptions of
individual assurances/certifications are provided at: http://grants.nih.gov/grants/funding/424

If unable to certify compliance , where applicable, provide an explanation and attach below.

Explanation:

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