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Policies and Guidelines Relating to the Cancer Center Support Grant
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Policies and Guidelines Relating to the Cancer Center Support Grant
Policies
and Guidelines Related to the Cancer Center Support Grant
IV Instructions
for Non-Competing Continuation Applications
February
2005
These instructions supplement
those provided in the "U.S. Department of Health and Human Services
Public Health Service Non-Competing Grant Progress Report" (PHS 2590,
rev. 9/04) instructions. Per PHS policy a continuation application
and progress report must be submitted for each continuing year of the
grant by two months prior to the beginning date of the next budget
period. It is the responsibility of the applicant to obtain the
appropriate forms and instructions (<a href=http://grants.nih.gov/grants/forms.htmhttp://grants.nih.gov/grants/forms.htm).
The completed, signed original
progress report and one copy (with required signatures) must be submitted
to the centralized mailing address below:
Division
of Extramural Activities Support, OER
National
Institutes of Health
6705
Rockledge Drive, Room 2207, MSC 7987
Bethesda,
MD 20892-7987 (for regular or US Postal Service express mail)
Bethesda,
MD 20817 (for other courier/express mail delivery only)
Phone
Number (301) 594-6584
Grantees may access a website
(<a href=http://era.nih.gov/userreports/pr_due.cfmhttp://era.nih.gov/userreports/pr_due.cfm)
to determine when a progress
report is due. The list is updated on or around the 30th
of each month. In addition to this website, email reminders are
sent to the principal investigator.
The information provided in
the Cancer Center Support Grant (CCSG) continuation application serves
as a basis for continued support, and is used to monitor scientific
and programmatic progress and to ensure that public funds are used appropriately
within all NCI//NIH/PHS guidelines and regulations. The narrative portions
are particularly useful in demonstrating the importance of the NCI-designated
cancer centers to the Department of Health and Human Services, the public,
and Congress.
Formatting Instructions
for Non-Competing Continuation Applications
Face Page:
Complete the face page as described in the PHS 2590 (rev. 9/04) instructions.
Table of Contents:
Provide headings with correct page references.
Detailed Budget for Next
Budget Period: Complete an overall budget as described in the PHS
2590 Form (rev. 9/04). You must also provide a separate detailed
budget for each component (e.g., senior leaders, program leaders, developmental
funds, shared resources, etc.) in the same sequence used in your
competing application. For the overall and separate budgets,
provide a budget justification only
for those line items and amounts that represent a significant change
from those previously recommended. This requirement includes changes
in any effort for key personnel.
Biographical Sketch:
Provide a biographical sketch for all new key personnel added since
the last submission.
Other Support:
Provide active support information for key personnel only.
Director's Scientific
Overview:
Scientific Progress
and Plans
Broadly discuss progress
over the current year, noting any important changes in key personnel,
scientific Programs, shared resources, and/or institutional commitments
that have enhanced the scientific capability and productivity of the
center. Discuss next year's plans for developing any new scientific
directions and/or taking advantage of new research opportunities.
Highlight the most significant published scientific accomplishments
that you believe should be considered by the NCI when reporting to its
advisory groups and to Congress.
Major Scientific
Accomplishments
Please prepare in lay
language a description of three to five
major scientific accomplishments occurring in your center during
the current reporting period, and their potential significance to cancer
prevention, diagnosis, and treatment.
Standard Cancer Center
Summaries: The summaries listed below should be submitted
annually with the non-competing continuation application. Specific instructions
for the summaries are found in a separate guidelines section entitled,
"Attachment: Formatting for Standard Cancer Information Summaries."
This document may be viewed or downloaded at <a href=http://cancer.gov/cancercentershttp://cancer.gov/cancercenters.
Cancer
Centers must also submit an electronic copy of their
summary information, in a format compatible with Cancer Centers Branch
database, directly to the Cancer Centers Branch at the same time the
application is submitted.
Electronic information should be sent to <a href=mailto:ccsgdata@mail.nih.govccsgdata@mail.nih.gov.
Summaries to be included in
the application and sent electronically include:
Summaries 1A, 1B, 1C, 1D
Summaries 2A, 2B
Summary 3
Summary 4
Progress Reports:
Provide a brief progress report for each component to accompany the
budget request and justification; these should be in the same sequence
used in your competing application. Where relevant, discuss how
the major concerns identified in the last summary statement are
being addressed.
Describe the scientific
progress and achievements for the current year for each Research
Program, emphasizing the most significant published scientific
accomplishments, and indicate how the center has facilitated
these accomplishments. Please highlight those accomplishments
of direct or potential importance to cancer. In addition, discuss plans
for the development of new scientific capabilities, directions, and
opportunities, if any, and their potential impact on the goals and objectives
of the Program. Include a selected list of program-related publications
of the current year, highlighting those that illustrate inter-and intra-
programmatic collaborations.
Describe how the
Program Planning and Evaluation activities of the center
helped the center achieve its scientific goals and objectives in the
current year and how they will be used to enhance the strategic development
of the center's scientific objectives in the next year. Specifically
elaborate on the important recommendations of the External Advisory
Boards (EAB) during the past year and plans for their implementation.
Note any changes in the membership of the committee and indicate each
new member's area of expertise and the institution to which he/she
belongs.
For any proposed
changes in Staff Investigators, follow the guidelines in Part
II, Section 7.3, and Part III, Review Criteria.
Fully describe how
funds in various sub-categories of the Developmental Funds budget
were used in the current year, highlighting for each subcategory those
activities that benefited and enhanced the strategic development of
the center's scientific capability. Discuss any recommendations
of the EAB for developmental fund use and provide a detailed description
of how developmental funds will be used in the coming year.
For each Shared
Resource, report any major changes made in the resource's scientific
and/or technical capabilities and usage, including those planned for
the next year, and briefly discuss the importance of these changes on
the scientific productivity of the research activities it serves.
Describe the status
of pilot/early phase I research protocols supported in the current year
by the Protocol Specific Research component and indicate which
protocols have led to the next level of studies (e.g., phase II) and/or
have received external peer reviewed support.
Indicate and highlight
revisions or modifications in the Data and Safety Monitoring Plan
since the last review of the plan.
In accordance with
the NIH policy, the application should include a Data
Sharing Plan if applicable (e.g., pilot projects in developmental
funds category, phase I studies conducted with the resources of the
Protocol Specific Research component, a shared resource that serves
as a final repository of data, etc.).
Under a separate
heading, provide a progress report for any Supplements to the
Cancer Center Support Grant as required by the Terms of Award for that
supplement. Please include data on accrual of women and minorities
according to the PHS categories.
Checklist:
Complete the checklist in accordance with PHS Form 2590 instructions
(rev. 9/04). Ensure that program income and expenditures (e.g., from
shared resource charge backs or other sources) is reported here.
General Considerations for
all Budget Requests and Justifications
Requirement of Notification
(via Letter and/or Type 5 application): The grantee is required to notify
the Grants Management Office (GMO) in writing if the PI or key personnel
specifically named in the Notice of Grant Award will withdraw from the
project entirely, be absent from the project during any continuous period
of 3 months or more, or reduce time devoted to the project by 25 percent
or more from the level that was approved at the time of award (for example,
a proposed change from 40 percent effort to 30 percent or less effort).
NIH must approve any alternate arrangement proposed by the grantee,
including any replacement of the PI or key personnel named in the NGA.
The request for approval of
a substitute in a key personnel position should include justification
for the change, the biographical sketch of the individual proposed,
other sources of support and any budget changes resulting from the proposed
change.
Expanded Authorities:
Cancer Center Support Grants are administered under the provisions of
Expanded Authorities as specified in the following excerpt from the
NIH Grants Policy Statement: <a href=http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600128http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600128.
In addition to the above- referenced
summary of authorities routinely granted to all NIH awards, NCI has
elected to provide automatic carryover authority to its Cancer Center
Support Grant (P30) awards. The following language is cited from
the NIH Grants Policy Statement for those awards subject to expanded
authorities but excluded from Streamlined Non-Competing Award Process
(SNAP):
"For those awards subject
to expanded authorities but excluded from SNAP, the FSR must specify
the amount to be carried over. The notification must be provided under
item 12, "Remarks," on the FSR. When a grantee reports a balance
of unobligated funds in excess of 25 percent of the total amount awarded,
the GMO will review the circumstances resulting in the balance to ensure
that these funds are necessary to complete the project, and may request
additional information from the grantee, including a revised budget,
as part of the review."
If the NCI determines that
some or all of the unobligated funds are not necessary to complete the
project, it may reduce the level of funding for the current or subsequent
budget periods.
Center directors have considerable
flexibility to move funds between CCSG components in response to changing
needs and opportunities. In accordance with the PHS 2590 instructions,
a detailed budget justification must be provided for items and amounts
that represent a significant change from that previously recommended.
Prior Approval Requirement
by the NCI: The following kinds of requests require NCI approval
and should be submitted separately from the non-competing continuation
application.
The creation of
a new budget category (e.g., a new shared resource) from within
the committed levels on the award statement that would constitute a
change in scope and normally be subject to peer review evaluation.
Any requests for
additional funding beyond that committed in the Notice of Grant
Award (NGA). Applicants should note that requests of this nature
are approved only under exceptional circumstances.
Replacement or other
changes in time commitment of the Principal Investigator (as described
above under "Requirement of Notification.").
Funding Policies: In years
of significant budgetary constraint, NCI funding plans will spread the
impact over their entire Centers program (non-competing as well as competing
grants) to reduce the adverse impact on those institutions that happen
to compete during a difficult year. If funds become available in future
years, funds may be restored.
This document can be viewed
or downloaded online in its entirety at the following address: <a href=http://cancer.gov/cancercentershttp://cancer.gov/cancercenters.
Policies and Guidelines Relating to the Cancer Center Support Grant
Policies
and Guidelines Related to the Cancer Center Support Grant
IV Instructions
for Non-Competing Continuation Applications
February
2005
These instructions supplement
those provided in the "U.S. Department of Health and Human Services
Public Health Service Non-Competing Grant Progress Report" (PHS 2590,
rev. 9/04) instructions. Per PHS policy a continuation application
and progress report must be submitted for each continuing year of the
grant by two months prior to the beginning date of the next budget
period. It is the responsibility of the applicant to obtain the
appropriate forms and instructions (<a href=http://grants.nih.gov/grants/forms.htmhttp://grants.nih.gov/grants/forms.htm).
The completed, signed original
progress report and one copy (with required signatures) must be submitted
to the centralized mailing address below:
Division
of Extramural Activities Support, OER
National
Institutes of Health
6705
Rockledge Drive, Room 2207, MSC 7987
Bethesda,
MD 20892-7987 (for regular or US Postal Service express mail)
Bethesda,
MD 20817 (for other courier/express mail delivery only)
Phone
Number (301) 594-6584
Grantees may access a website
(<a href=http://era.nih.gov/userreports/pr_due.cfmhttp://era.nih.gov/userreports/pr_due.cfm)
to determine when a progress
report is due. The list is updated on or around the 30th
of each month. In addition to this website, email reminders are
sent to the principal investigator.
The information provided in
the Cancer Center Support Grant (CCSG) continuation application serves
as a basis for continued support, and is used to monitor scientific
and programmatic progress and to ensure that public funds are used appropriately
within all NCI//NIH/PHS guidelines and regulations. The narrative portions
are particularly useful in demonstrating the importance of the NCI-designated
cancer centers to the Department of Health and Human Services, the public,
and Congress.
Formatting Instructions
for Non-Competing Continuation Applications
Face Page:
Complete the face page as described in the PHS 2590 (rev. 9/04) instructions.
Table of Contents:
Provide headings with correct page references.
Detailed Budget for Next
Budget Period: Complete an overall budget as described in the PHS
2590 Form (rev. 9/04). You must also provide a separate detailed
budget for each component (e.g., senior leaders, program leaders, developmental
funds, shared resources, etc.) in the same sequence used in your
competing application. For the overall and separate budgets,
provide a budget justification only
for those line items and amounts that represent a significant change
from those previously recommended. This requirement includes changes
in any effort for key personnel.
Biographical Sketch:
Provide a biographical sketch for all new key personnel added since
the last submission.
Other Support:
Provide active support information for key personnel only.
Director's Scientific
Overview:
Scientific Progress
and Plans
Broadly discuss progress
over the current year, noting any important changes in key personnel,
scientific Programs, shared resources, and/or institutional commitments
that have enhanced the scientific capability and productivity of the
center. Discuss next year's plans for developing any new scientific
directions and/or taking advantage of new research opportunities.
Highlight the most significant published scientific accomplishments
that you believe should be considered by the NCI when reporting to its
advisory groups and to Congress.
Major Scientific
Accomplishments
Please prepare in lay
language a description of three to five
major scientific accomplishments occurring in your center during
the current reporting period, and their potential significance to cancer
prevention, diagnosis, and treatment.
Standard Cancer Center
Summaries: The summaries listed below should be submitted
annually with the non-competing continuation application. Specific instructions
for the summaries are found in a separate guidelines section entitled,
"Attachment: Formatting for Standard Cancer Information Summaries."
This document may be viewed or downloaded at <a href=http://cancer.gov/cancercentershttp://cancer.gov/cancercenters.
Cancer
Centers must also submit an electronic copy of their
summary information, in a format compatible with Cancer Centers Branch
database, directly to the Cancer Centers Branch at the same time the
application is submitted.
Electronic information should be sent to <a href=mailto:ccsgdata@mail.nih.govccsgdata@mail.nih.gov.
Summaries to be included in
the application and sent electronically include:
Summaries 1A, 1B, 1C, 1D
Summaries 2A, 2B
Summary 3
Summary 4
Progress Reports:
Provide a brief progress report for each component to accompany the
budget request and justification; these should be in the same sequence
used in your competing application. Where relevant, discuss how
the major concerns identified in the last summary statement are
being addressed.
Describe the scientific
progress and achievements for the current year for each Research
Program, emphasizing the most significant published scientific
accomplishments, and indicate how the center has facilitated
these accomplishments. Please highlight those accomplishments
of direct or potential importance to cancer. In addition, discuss plans
for the development of new scientific capabilities, directions, and
opportunities, if any, and their potential impact on the goals and objectives
of the Program. Include a selected list of program-related publications
of the current year, highlighting those that illustrate inter-and intra-
programmatic collaborations.
Describe how the
Program Planning and Evaluation activities of the center
helped the center achieve its scientific goals and objectives in the
current year and how they will be used to enhance the strategic development
of the center's scientific objectives in the next year. Specifically
elaborate on the important recommendations of the External Advisory
Boards (EAB) during the past year and plans for their implementation.
Note any changes in the membership of the committee and indicate each
new member's area of expertise and the institution to which he/she
belongs.
For any proposed
changes in Staff Investigators, follow the guidelines in Part
II, Section 7.3, and Part III, Review Criteria.
Fully describe how
funds in various sub-categories of the Developmental Funds budget
were used in the current year, highlighting for each subcategory those
activities that benefited and enhanced the strategic development of
the center's scientific capability. Discuss any recommendations
of the EAB for developmental fund use and provide a detailed description
of how developmental funds will be used in the coming year.
For each Shared
Resource, report any major changes made in the resource's scientific
and/or technical capabilities and usage, including those planned for
the next year, and briefly discuss the importance of these changes on
the scientific productivity of the research activities it serves.
Describe the status
of pilot/early phase I research protocols supported in the current year
by the Protocol Specific Research component and indicate which
protocols have led to the next level of studies (e.g., phase II) and/or
have received external peer reviewed support.
Indicate and highlight
revisions or modifications in the Data and Safety Monitoring Plan
since the last review of the plan.
In accordance with
the NIH policy, the application should include a Data
Sharing Plan if applicable (e.g., pilot projects in developmental
funds category, phase I studies conducted with the resources of the
Protocol Specific Research component, a shared resource that serves
as a final repository of data, etc.).
Under a separate
heading, provide a progress report for any Supplements to the
Cancer Center Support Grant as required by the Terms of Award for that
supplement. Please include data on accrual of women and minorities
according to the PHS categories.
Checklist:
Complete the checklist in accordance with PHS Form 2590 instructions
(rev. 9/04). Ensure that program income and expenditures (e.g., from
shared resource charge backs or other sources) is reported here.
General Considerations for
all Budget Requests and Justifications
Requirement of Notification
(via Letter and/or Type 5 application): The grantee is required to notify
the Grants Management Office (GMO) in writing if the PI or key personnel
specifically named in the Notice of Grant Award will withdraw from the
project entirely, be absent from the project during any continuous period
of 3 months or more, or reduce time devoted to the project by 25 percent
or more from the level that was approved at the time of award (for example,
a proposed change from 40 percent effort to 30 percent or less effort).
NIH must approve any alternate arrangement proposed by the grantee,
including any replacement of the PI or key personnel named in the NGA.
The request for approval of
a substitute in a key personnel position should include justification
for the change, the biographical sketch of the individual proposed,
other sources of support and any budget changes resulting from the proposed
change.
Expanded Authorities:
Cancer Center Support Grants are administered under the provisions of
Expanded Authorities as specified in the following excerpt from the
NIH Grants Policy Statement: <a href=http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600128http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600128.
In addition to the above- referenced
summary of authorities routinely granted to all NIH awards, NCI has
elected to provide automatic carryover authority to its Cancer Center
Support Grant (P30) awards. The following language is cited from
the NIH Grants Policy Statement for those awards subject to expanded
authorities but excluded from Streamlined Non-Competing Award Process
(SNAP):
"For those awards subject
to expanded authorities but excluded from SNAP, the FSR must specify
the amount to be carried over. The notification must be provided under
item 12, "Remarks," on the FSR. When a grantee reports a balance
of unobligated funds in excess of 25 percent of the total amount awarded,
the GMO will review the circumstances resulting in the balance to ensure
that these funds are necessary to complete the project, and may request
additional information from the grantee, including a revised budget,
as part of the review."
If the NCI determines that
some or all of the unobligated funds are not necessary to complete the
project, it may reduce the level of funding for the current or subsequent
budget periods.
Center directors have considerable
flexibility to move funds between CCSG components in response to changing
needs and opportunities. In accordance with the PHS 2590 instructions,
a detailed budget justification must be provided for items and amounts
that represent a significant change from that previously recommended.
Prior Approval Requirement
by the NCI: The following kinds of requests require NCI approval
and should be submitted separately from the non-competing continuation
application.
The creation of
a new budget category (e.g., a new shared resource) from within
the committed levels on the award statement that would constitute a
change in scope and normally be subject to peer review evaluation.
Any requests for
additional funding beyond that committed in the Notice of Grant
Award (NGA). Applicants should note that requests of this nature
are approved only under exceptional circumstances.
Replacement or other
changes in time commitment of the Principal Investigator (as described
above under "Requirement of Notification.").
Funding Policies: In years
of significant budgetary constraint, NCI funding plans will spread the
impact over their entire Centers program (non-competing as well as competing
grants) to reduce the adverse impact on those institutions that happen
to compete during a difficult year. If funds become available in future
years, funds may be restored.
This document can be viewed
or downloaded online in its entirety at the following address: <a href=http://cancer.gov/cancercentershttp://cancer.gov/cancercenters.