Guidelines

Centers

of

Research Translation

**National Institute of Arthritis and**

**Musculoskeletal and**

**Skin Diseases**

**National Institutes of Health**

**Department of Health and Human Services**

**September 2006**

**TABLE OF CONTENTS**

[GUIDELINES FOR THE CENTERS OF RESEARCH TRANSLATION (CORT)
1](#__RefHeading___Toc82583646)

[I. The NIAMS Centers of Research Translation Program
1](#__RefHeading___Toc82583647)

[I.A. Introduction 1](#__RefHeading___Toc82583648)

[I.B. Overview of the Centers of Research Translation (CORT) Program
1](#__RefHeading___Toc82583649)

[I.C. Structure of a CORT 2](#__RefHeading___Toc82583650)

[II. Application and Review Process 3](#__RefHeading___Toc82583651)

[II.A. Preapplication Process and Letter of Intent
3](#__RefHeading___Toc82583652)

[II.B. Application Procedure 4](#__RefHeading___Toc82583653)

[II.C. Review Process 5](#__RefHeading___Toc82583654)

[II.D. Center Evaluation Procedure 5](#__RefHeading___Toc82583655)

[III. Presentation of the Proposed Center
6](#__RefHeading___Toc82583656)

[III.A. Overview 6](#__RefHeading___Toc82583657)

[III.B. Qualifications of the Center Leadership
7](#__RefHeading___Toc82583658)

[III.C. Research Base for the CORT 8](#__RefHeading___Toc82583659)

[III.D. Institutional Environment and Resources
8](#__RefHeading___Toc82583660)

[III.F. Program for Pilot and Feasibility Projects
9](#__RefHeading___Toc82583661)

[III.G. Administrative Core 9](#__RefHeading___Toc82583662)

[III.H. Projects 11](#OLE_LINK2)

[III.I. Research Core(s) 13](#__RefHeading___Toc82583664)

[III.J. Review Criteria for the Overall Application
14](#__RefHeading___Toc82583665)

[IV. Suggested content order for application
15](#__RefHeading___Toc82583666)

[IV.A. General Information 15](#__RefHeading___Toc82583667)

[IV.B. Content Order for the CORT Application
15](#__RefHeading___Toc82583668)

[IV.B.1. Face Page of Form PHS 398. 15](#__RefHeading___Toc82583669)

[IV.B.2 Page 2, Description 15](#__RefHeading___Toc82583670)

[IV.B.3. Table of Contents 15](#__RefHeading___Toc82583671)

[IV.B.4. Budgets 15](#__RefHeading___Toc82583672)

[IV.B.5. Biographical Sketches 16](#__RefHeading___Toc82583673)

[IV.B.6. Assurance Documentation 16](#__RefHeading___Toc82583674)

[IV.B.7. Narrative Sections 16](#__RefHeading___Toc82583675)

[IV.B.8. Budgeted Components 17](#__RefHeading___Toc82583676)

[IV.C. Appendices 17](#__RefHeading___Toc82583677)

[V. Noncompeting Applications: Annual Reporting Requirements
19](#__RefHeading___Toc82583678)

[VI. Guidelines for Pilot and Feasibility Projects
21](#__RefHeading___Toc82583679)

[VII. Guidelines for Supplemental Applications
22](#__RefHeading___Toc82583680)

[Exhibit I Sample Table of Contents 23](#__RefHeading___Toc82583682)

[Exhibit II Grants Supporting the Research Base
26](#__RefHeading___Toc82583770)

[Exhibit III Consolidated Budget for 1^st^ Year of Requested Support
27](#__RefHeading___Toc82583771)

[Exhibit IV Initial Budget Period 28](#__RefHeading___Toc82583772)

[Exhibit V Budget for Entire Proposed Project Period
29](#__RefHeading___Toc82583775)

[Exhibit VI Approval Dates 30](#__RefHeading___Toc82583777)

[]{#__RefHeading___Toc82583646 .anchor}GUIDELINES FOR THE CENTERS OF
RESEARCH TRANSLATION (CORT)

[]{#__RefHeading___Toc82583647 .anchor}I. The NIAMS Centers of Research
Translation Program

[]{#__RefHeading___Toc82583648 .anchor}I.A. Introduction

The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) leads the federal effort for the conduct and support of
research into the causes, treatment and prevention of arthritis and
musculoskeletal and skin diseases, the training of basic and clinical
scientists to carry out this research, and the dissemination of
information on research progress in these diseases.

In fulfilling its mission to support research and research training,
NIAMS employs a number of support mechanisms. These include various
types of research projects, program projects, and career development
programs; institutional training grants and individual training
fellowships; and a number of center grant mechanisms. The center grants
are interrelated to and interdependent upon all of the other support
mechanisms.

The following guidelines provide information about the Centers of
Research Translation program, suggestions for preparation of an
applications and criteria for review.

[]{#__RefHeading___Toc82583649 .anchor}I.B. Overview of the Centers of
Research Translation (CORT) Program

Two major features of the CORT program include: 1) the overarching aim
of disease-specific research translation, and 2) the inclusion of
resources and an administrative structure to facilitate research
translation. The expectation for a CORT is that the projects will be
translational in nature, directed at elucidating the relevance of basic
research to a human disease.

Translational research is applied and clinical scientific research that
is directed towards testing the validity and limits of applicability of
knowledge derived from basic science and engineering to the
understanding of human diseases and health. It could be research
involving living human subjects (i.e., clinical) but it might also be
non-clinical involving the study of human genes, tissues, specimens, or
cells. Thus, although it is directed towards generation of knowledge
about humans, it could be non-clinical or clinical research. It could be
knowledge useful to persons (individuals, families, populations)
affected by or at risk for specific diseases.

Overall, the CORT should encompass a multidisciplinary approach to a
disease-targeted theme with individual projects providing synergy for
the theme. For purposes of the projects within a CORT, translation is
NOT to be interpreted as requiring one project to depend on another.
That is, the outcomes of a clinical research project would not be
dependent on the outcome of a basic research project. Rather, the
projects should demonstrate a synergy in which the outcomes of each
project inform the others.

-   A CORT will be focused on one of the diseases in the NIAMS mission.
    The focus cannot be generic, e.g., autoimmune diseases,
    musculoskeletal disorders, or skin diseases. The diseases within the
    NIAMS mission may be found at:
    <http://www.niams.nih.gov/rtac/funding/faq.htm>.

-   There must be an existing research base supporting the projects.

-   The projects must represent a multidisciplinary approach to the
    theme. Principal investigators should be drawn from different
    research disciplines, and may be based in different departments,
    divisions and/or institutions.

-   There must be a minimum of three highly meritorious projects with at
    least one basic and one clinical project. Overall the CORT concept
    is dual, embracing both the translation of new scientific
    information to clinical application and of clinical findings to new
    research.

    -   [Clinical research]{.underline}. NIH defines human clinical
        research as: (1) Patient-oriented research. Research conducted
        with human subjects (or on material of human origin such as
        tissues, specimens and cognitive phenomena) for which an
        investigator (or colleague) directly interacts with human
        subjects. Excluded from this definition are in vitro studies
        that utilize human tissues that cannot be linked to a living
        individual. Patient-oriented research includes: (a) mechanisms
        of human disease, (b) therapeutic interventions, (c) clinical
        trials, or (d) development of new technologies. (2)
        Epidemiologic and behavioral studies. (3) Outcomes research and
        health services research. Note: Studies falling under Exemption
        4 for human subjects research are not considered clinical
        research by this definition.

-   Each CORT will have an advisory group that includes scientific
    members who can facilitate the translational process and lay members
    who can bring the patient perspective about the disease to the
    group. The advisory group will have a dual role. One role will be to
    provide scientific and lay oversight of the ongoing progress of the
    CORT projects. A second role will be to review and recommend pilot
    and feasibility project applications for submission to NIAMS.

[]{#__RefHeading___Toc82583650 .anchor}I.C. Structure of a CORT

The minimal structure for a CORT will be:

-   At least three highly meritorious translational research projects
    with at least one basic and one clinical project;

-   An Administrative Core with an advisory group that includes
    scientific and lay members.

-   The CORT Director should also be the principal investigator of one
    of the research projects.

One or more research cores may also be proposed if they are critical to
at least two of the projects and will enhance the quality of the
research.

Once a CORT is established, pilot and feasibility projects to develop
new directions in the translational theme may be submitted to NIAMS as
administrative supplements. Pilot and feasibility projects will be
solicited once per year during the second and third year of CORT
funding. Up to three projects may be submitted annually. The scientific
review of these individual pilot and feasibility project applications
will directed by the CORT advisory group. The role of NIAMS will be to
determine funding based on funds available and the institute's
portfolio. Pilot and feasibility projects are optional.

[]{#__RefHeading___Toc82583651 .anchor}II. Application and Review
Process

[]{#__RefHeading___Toc82583652 .anchor}II.A. Preapplication Process and
Letter of Intent

Applications are solicited by Requests for Applications published in the
NIH Guide to Grants and Contracts. See the NIAMS website for current
RFAs:
[http://www.niams.nih.gov/rtac/funding/grants/rfalist.htm]{.underline}

**Individuals with a potential interest in applying for a CORT grant are
strongly encouraged to talk with a NIAMS program director to review
their concept for a CORT application.** The NIAMS program directors and
the scientific areas of their portfolios may be found at
<http://www.niams.nih.gov/rtac/index.htm>

Consultation between NIAMS staff and potential applicants prior to
submission of the formal application may be useful. Applicants should
not construe advice given by the NIAMS staff as assurance of favorable
review. The staff will not evaluate or discuss the merit of the
scientific aspects of the proposal.

The letter of intent and any inquiries about the overall program, should
be directed to:

Madeline Turkeltaub, CRNP, Ph.D., FAAN

Deputy Director, Extramural Program

NIAMS/NIH

6701 Democracy Blvd., Suite 800 -- MSC 4872

Bethesda, MD 20892-4872

\[Bethesda, MD 20817 (for express/courier service)\]

Phone: (301) 594-2463

FAX: (301) 402-7478

For fiscal and administrative matters, contact:

Melinda Nelson

Grants Management Officer

NIAMS/NIH

6701 Democracy Blvd., Suite 800 -- MSC 4872

Bethesda, MD 20892-4872

\[Bethesda, MD 20817 (for express/courier service)\]

Telephone: (301) 594-3535

FAX: (301) 480-5450

[]{#__RefHeading___Toc82583653 .anchor}II.B. Application Procedure

The research Grant Application Form PHS 398 is to be used in applying
for these centers. These forms are available at most institutional
offices of sponsored research and from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910 Bethesda, MD 20892‑7910, telephone (301)
435‑0714, E‑mail: grantsinfo@nih.gov or from the Internet Web site at:
[http://grants.nih.gov/grants/forms.htm]{.underline}

Each project and each core included in the CORT application should be
written as an individual project using form PHS 398. Page limitations
will apply to the individual projects. It is desirable for CORT
applications to be arranged in a specified format. A detailed Table of
Contents is strongly suggested (see Exhibit I). This not only makes it
easier for reviewers to use, but it can also serve as a checklist for
the applicant institution in preparing the application. The arrangement
of materials should follow both the instructions in the form PHS 398
application kit and the more specific instructions detailed in Section
IV of these guidelines.

Receipt dates for CORT applications are announced in the Request for
Applications. *For applications submitted in response to RFAs, the
application must ARRIVE AT NIH on or before the receipt date.*

**The RFA label available in the application package must be affixed to
the bottom of the face page. Failure to use this label could result in
delayed processing of the application such that it may not reach the
review committee in time for review.**

The original and three (3) signed, exact photocopies of the application
should be sent to:

Center for Scientific Review

National Institutes of Health

6701 Rockledge Drive, Room 1040 - MSC 7710

Bethesda MD 20892-7710

\[Bethesda, MD 20817 (for express/courier service)\]

In addition to mailing the application to the Center for Scientific
Review send two (2) copies of the application and [ALL 5 copies of any
appendix material]{.underline} to:

Madeline Turkeltaub, CRNP, Ph.D., FAAN

Deputy Director, Extramural Program

NIAMS/NIH

6701 Democracy Blvd., Suite 800 -- MSC 4872

Bethesda, MD 20892-4872

\[Bethesda, MD 20817 (for express/courier service)\]

Phone: (301) 594-2463

FAX: (301) 480-4543

All appendix material must be clearly marked with the name of Center
Director and the appropriate project or core. Separate copies of
appendix material should be supplied for each core or project to which
it is applicable (See Section IV.C.).

[]{#__RefHeading___Toc82583654 .anchor}II.C. Review Process

Applications submitted for CORT grants will first be screened for
completeness by the Center for Scientific Review and for responsiveness
by NIAMS staff. Applications which are complete and responsive will be
evaluated for scientific merit by a group of expert consultants convened
by the Review Branch of the NIAMS. Each application should be complete
upon submission. Site visits are not anticipated. A second level of
review will be performed by the National Arthritis and Musculoskeletal
and Skin Diseases Advisory Council.

[]{#__RefHeading___Toc82583655 .anchor}II.D. Center Evaluation Procedure

Since the NIAMS is interested in funding only the most highly
meritorious research, individual components of lesser quality may not be
funded, even if recommended, under the \"umbrella\" of the Center grant
mechanism. Each project and core (including the administrative unit)
will be individually reviewed for scientific merit and assigned a rating
by committee consensus. Merit ratings will also be voted for the center
elements: qualifications of the center leadership, the research base,
the institutional environment and resources. To be funded, there must be
at least three highly meritorious translational projects, including one
basic and one clinical research project.

After the review of the individual components of the application, an
application may be judged Anon-competitive@ and not scored, or may be
discussed and assigned an overall priority score. This score will
reflect not only the individual quality of the projects, cores, and
administration, but also how the proposed CORT will bring together all
these elements in a workable unit. The overall score may be higher or
lower than the Aaverage@ of the descriptors based on the assessment of
whether the Awhole is greater than the sum of its parts.@ (See Section
III.J.)

[]{#__RefHeading___Toc82583656 .anchor}III. Presentation of the Proposed
Center

This section of the guidelines describes the required and optional
components of the proposed CORT and the review criteria to be applied.
The suggested content order for the overall application will be covered
in Section IV. Note that these applications will be reviewed by a
committee that will have three or more applications to review;
therefore, it is very helpful for investigators to use cross-references
in these center applications. A detailed Table of Contents is especially
invaluable in providing a key for cross-references, e.g., *see Section
I.A.2. for more details.* Exhibit I is an example of a detailed Table of
Contents.

Note that NIH has policies for the inclusion of women, minorities and
children which **must** be addressed in **each** project proposal and in
**each** core, even if only to indicate why a full discussion is not
applicable. The reviewers will be instructed to address the adequacy of
inclusion plans for the work proposed as part of the scientific and
technical merit evaluation. These policies may be accessed at the
following sites:

Women & Minorities:
[http://grants.nih.gov/grants/funding/women_min/women_min.htm]{.underline}

Children:
[http://www.nih.gov/grants/funding/children/children.htm]{.underline}

The NIH expects investigators supported by NIH funding to make their
research data available to the scientific community for subsequent
analysis based on a data sharing plan approved as part of the award; see
the NIH Data Sharing Policy website at
<http://grants.nih.gov/grants/policy/data_sharing/>. This requirement on
data sharing is an extension to NIH policy regarding sharing research
resources, which expects that recipients of NIH support will provide
prompt and effective access to research tools. The data sharing plan for
the center should be described in the Administrative Core.

[]{#__RefHeading___Toc82583657 .anchor}III.A. Overview

Each application should have an OVERVIEW - a narrative section that
serves as a synopsis of the key elements of the proposed Center of
Research Translation, the qualifications of the Center Director,
Associate Director and CORT advisory group, the research theme, research
base, and the resources and environment for the Center. *This section is
intended to be read by all reviewers, even if they are not assigned to
projects within this application, so that each reviewer can get a
comprehensive view of the proposed Center.*

An additional purpose of the Overview is to provide reviewers with a
sense of how the Center will leverage its resources. A Center operates
on two levels. The first level is to assemble outstanding proposals and
carry out the proposed research. The second level is to provide
leadership at an institutional or broader level to promote quality
research through the intellectual and material resources of the Center.

The Overview serves to introduce the proposed program, to identify the
theme for the disease to be addressed in the proposed Center and to
state the Center objectives. Describe the disciplines brought together
for the proposed Center and explain the strategy for achieving the
objectives of the overall program. It is important to emphasize the
events that have led to the current application, and **especially to
describe the anticipated unique opportunities for translational research
within the proposed CORT**. Briefly describe each of the proposed
projects, identifying whether it is basic or clinical, and how that
project qualifies as translational research and addresses the
translational theme of the Center. Briefly describe any research cores
that are included in the application and how each core will assist each
of the proposed projects.

[]{#__RefHeading___Toc82583658 .anchor}III.B. Qualifications of the CORT
Leadership

The emphasis in this section should be on the qualifications of the
Center leaders. The administrative plans are presented in the
Administrative Core (see Section III.G.)

The Director of the CORT, aided by an Associate Director and an advisory
group, is expected to provide leadership to focus all research projects
on translational aims relevant to the disease theme. Either the Center
Director or Associate Director must be a clinical investigator who is
responsible for the translation of basic research to clinical research
to assure a mutually supportive interaction between scientists
conducting basic research and those performing clinical investigation.
The qualifications of the clinical investigator and the plan to promote
patient based research should be described.

The advisory group should consist of 3 to 6 members and meet formally at
least annually to review the scientific progress and to identify and
review new opportunities for research translation. The members of the
advisory group should include scientists, both from the parent and from
other research institutions, and one or more lay members who can bring
the patient perspective about the disease to the group. The advisory
group will play a role in determining which applications for pilot and
feasibility projects are submitted to NIAMS.

Describe the qualifications of the Center Director and Associate
Director to lead the CORT. Describe the qualifications of each member of
the advisory group and the rationale for including these individuals.
Applicants are advised to include sufficient information to address the
following review criteria:

*Review Criteria for CORT leadership:*

-   Do the Director and Associate Director have the leadership and
    research qualifications to lead a Center? Does the leadership team
    (Director, Associate Director, and advisory group) have the
    collective expertise to assure focused development and
    implementation of high quality and meaningful translational research
    projects?

-   Is the management program proposed appropriate for soliciting,
    reviewing and prioritizing pilot and feasibility project
    applications for submission to NIAMS?

[]{#__RefHeading___Toc82583659 .anchor}III.C. Research Base for the CORT

Describe the research base upon which the CORT builds, including
descriptions of independently funded research projects so that reviewers
can determine the extent and quality of research activities related to
the proposed CORT. The descriptions should include: the principal
investigator and other key research personnel, the project=s objectives
and progress toward them; the project=s relevance to the NIAMS disease
area, and up to 5 important publications that have resulted from this
research in the past five years. In addition, it is helpful to include a
table of the relevant research grants (see Exhibit II). Describe how
members of this research base will interact with the proposed CORT.
Applicants are advised to include sufficient information to address the
following review criteria:

*Review Criteria for Research Base:*

 Is there a substantial productive and funded research base? Is the
research base sufficiently broad to foster new multidisciplinary
translational research?

[]{#__RefHeading___Toc82583660 .anchor}III.D. Institutional Environment
and Resources

Briefly describe the features of the institutional environment that are
relevant to the effective implementation of the proposed program. As
appropriate, describe available resources, such as clinical and
laboratory facilities, participating and affiliated units, patient
populations, geographic distribution of space and personnel, and
consultative resources. Indicate if any of the proposed cores will
utilize or expand cores already existing at the institution. What
institutional commitments for space or other resources are there for the
proposed CORT? Include any letters of support for the proposed Center by
appropriate institutional officials.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research. Details of the interactions of the CORT staff with the GCRC
staff and research personnel may be provided in a statement describing
the collaborative linkages being developed. A letter of agreement from
the GCRC Program Director must be included with the application.
Applicants are advised to include sufficient information to address the
following review criteria:

*Review Criteria for Institutional Environment and Resources:*

 Is there evidence of a supportive institutional environment for the
proposed CORT? Will the CORT add an important multidisciplinary element
to the institutional environment? Does the proposed CORT utilize
available resources well?

[]{#__RefHeading___Toc82583661 .anchor}III.F. Program for Pilot and
Feasibility Projects

It is envisioned that the synergy present in the research projects of
the CORT will lead to new ideas and the need to test new hypotheses
relevant to the translational theme of the CORT. The CORT advisory group
will review such proposals and recommend which should be submitted to
NIAMS for consideration. NIAMS will determine the priority for funding
all submitted pilot and feasibility projects applications and make
appropriate administrative supplemental awards to the CORTs.

The primary eligibility criteria for a CORT pilot and feasibility
project are:

-   The hypothesis to be tested arises from the CORT research and
    addresses the CORT theme;

-   The hypothesis to be tested has the potential for developing
    ground-breaking technology or methodology that may lead to
    significant expansions of biomedical research horizons, precipitate
    a paradigm shift in research, or lead to substantial improvements in
    human health;

-   The work proposed does not overlap with the aims of currently
    supported projects but should be integrated with the translational
    theme;

-   The investigator should be clearly independent and have a faculty
    appointment; the investigator may be a new investigator or be well
    established;

-   CORT pilot and feasibility projects may request up to \$50,000 per
    year in direct costs for one or two years.

Pilot and feasibility projects will not be a part of the initial CORT
application. Once each CORT is established, pilot and feasibility
projects will be solicited once a year during the second and third year
for funding in years three and four. Up to three projects may be
submitted each time. Describe how the CORT, in consultation with the
CORT advisory group, will solicit, review, and prioritize pilot and
feasibility projects applications for submission to NIAMS.

The structure of a pilot and feasibility project application is
described in Section VI.

*Review Criterion for the Pilot and Feasibility Project Program:*

 Is the management program proposed appropriate for soliciting,
reviewing and prioritizing pilot and feasibility project applications
for submission to NIAMS?

[]{#__RefHeading___Toc82583662 .anchor}III.G. Administrative Core

The purpose of a CORT is to exploit translational opportunities for a
disease targeted theme through a minimum of three research projects. The
Administrative Core is responsible for the planning, development,
coordination, and overall administration of the CORT. A key role of this
unit is to foster productive interactions at the host institution
through Center personnel and the CORT advisory group.

**Leadership.** The Center Director is responsible for the organization
and operation of the Center. An Associate Director should be named who
will be involved in the administrative and scientific aspects of the
Center, and will serve as Acting Center Director in the absence of the
Director. Either the Center Director or Associate Director must be a
clinical investigator who is responsible for the translation of basic
research to clinical research to assure a mutually supportive
interaction between scientists conducting basic research and those
performing clinical investigation. The qualifications of the clinical
investigator and the plan to promote patient based research should be
described.

**Lines of authority**. Describe in detail, and by diagram if
appropriate, the chain of responsibility for decision‑making and
administration. Include to whom the Center Director reports and the
administrative structure as it relates to the investigators responsible
for the research projects and core units.

**CORT Advisory Group**. A CORT advisory group representing scientific
expertise and lay persons relevant to the disease theme should be
identified. Their collective expertise should reflect key issues
addressed in the disease theme. (Their qualifications are to be
presented elsewhere in the application in a section on Qualifications of
the Center Leadership - see Section III.B.) Describe the structure for
using the advisory group to provide scientific oversight for all active
CORT research studies. Describe how lay input from the advisory group
will be incorporated.

**Enrichment Program.** The Administrative Core may include limited
funds for program enrichment (i.e., seminars, visiting scientists, etc).
Plans for an enrichment program should be included in the application
and in the budget of the Administrative Core.

**Data Sharing Plan.** The NIH expects investigators supported by NIH
funding to make their research data available to the scientific
community for subsequent analysis based on a data sharing plan approved
as part of the award; see the NIH Data Sharing Policy website at
<http://grants.nih.gov/grants/policy/data_sharing/>. A data sharing plan
for the research data from the CORT should be included in the
Administrative Core.

**Time Commitment**. The CORT director is expected to make a commitment
of at least 15 percent effort to the overall administration of the
program plus 20 percent effort as a principal investigator of a CORT
project. The CORT Associate Director is expected to commit at least 10%
effort to administration. Administrative support personnel may be
budgeted in at no more than one full time equivalent (FTE) which may be
divided among one or more positions. This FTE must be fully justified.

**CORT Travel**. Applications should include \$2,500 yearly travel
expenses in the Administrative Core to pay for two individuals to attend
one 2 day meeting related to the CORT program.

*Review Criteria for the Administrative Core:*

-   []{#OLE_LINK2 .anchor}Is there scientific and administrative
    leadership, commitment and ability, and adequate time commitment of
    the CORT Director and Associate Director for the effective
    management of the CORT? Is either the Center Director or Associate
    Director a clinical investigator who will be responsible for the
    translation of basic research to clinical research?

-   Is the management proposed appropriate for scientific administration
    as well as fiscal administration, procurement, property and
    personnel management, planning, budgeting, etc.?

-   Is there a plan for the establishment and maintenance of internal
    communication and cooperation among the CORT investigators? Are
    there plans for effective use of the CORT advisory group?

-   Is the management program proposed appropriate for soliciting,
    reviewing and prioritizing pilot and feasibility project
    applications for submission to NIAMS?

III.H. Projects

Using Form PHS 398, name and number each project sequentially so that it
can be readily distinguished from other projects in the program. Each
research project should be clearly identified by the same title as that
provided in the Table of Contents. The project should begin with the
abstract and budget pages and should follow the instructions for Form
PHS 398. Describe each section in the same detail and format as required
for a regular research grant application so that the scientific merit
can be judged on the basis of the written proposal. Adhere to the page
restrictions indicated in the instructions for Form PHS 398.

**For each project begin Section B, Background and Significance, with a
paragraph that clearly states how that project contributes to the theme
of the CORT as a whole, and the translational nature of each project. If
it is a clinical research project, describe the rationale of including
it as a clinical research project within the theme of the CORT.**

The budget for each research project should reflect the instructions for
Form PHS 398. A detailed budget is required for the first year; budget
estimates are required for all subsequent years of support. Explicit and
detailed budget justifications must be included for all years. Budget
pages must be labeled so that they can be readily associated with the
particular projects to which they apply.

The project principal investigator should devote at least 20 percent
effort to the research.

Each project using human subjects must include a detailed plan for
protection of human subjects and inclusion of women, minorities, and
children as described in the PHS 398 instructions.

If the proposed project is a clinical trial, a data safety and
monitoring plan must be included in the project proposal. The following
activities should be included in a monitoring plan:

-   Overview of the research protocol with emphasis on data integrity
    and patient safety issues.

-   Monitoring of adverse effects and determining stopping rules for the
    trial.

-   Protecting the confidentiality of the trial data and the results of
    monitoring.

-   Twice yearly review of recruitment and adverse events by a Safety
    Officer or a Data Safety and Monitoring Board (DSMB).

Note that the NIAMS will determine at the time of award whether a Safety
Officer or a DSMB will be appointed for each clinical trial. NIAMS will
appoint the Safety Officer or DSMB members in consultation with the
principal investigator. The Safety Officer or DSMB members must not be
affiliated with the host institution. NIAMS will provide logistical
support when a DSMB is required and will provide any travel funds or
consultant fees for DSMB members.

If the proposed project will use vertebrate animals, a complete
description of their use and care must be included as found in the
instructions for the PHS 398 application.

*Review Criteria for projects:*

-   Significance\
    Does this study address an important problem? What will be the
    effect of these studies on the concepts, methods, technologies,
    treatments, services, or preventative interventions that drive this
    field? Does this study clearly address the theme of the CORT? Will
    the outcomes inform the other projects in the CORT? If the aims of
    the application are achieved, how will scientific knowledge be
    advanced? What will be the effect of these studies on the concepts
    or methods that drive the field? Does the project advance the theme
    of the CORT and inform the other projects?

-   Approach

> Are the conceptual framework, design, methods, and analyses adequately
> developed, well integrated, and appropriate to the aims of the
> project? Does the applicant acknowledge potential problem areas and
> consider alternative tactics?

-   Innovation\
    Is the project original and innovative? For example: Does the
    project challenge existing paradigms or clinical practice, and
    address an innovative hypothesis or critical barrier to progress in
    the field? Does the project develop or employ novel concepts,
    approaches, methodologies, tools, or technologies for this area? Are
    the aims original and innovative? Does the project challenge
    existing paradigms or develop new methodologies or technologies?

-   Investigators

> Are the investigators appropriately trained and well suited to carry
> out this work? Is the work proposed appropriate to the experience
> level of the principal investigator and other researchers? Does the
> investigative team bring complementary and integrated expertise to the
> project (if applicable)?

-   Environment

> Does the scientific environment in which the work will be done
> contribute to the probability of success? Do the proposed studies take
> advantage of unique features of the scientific environment, or subject
> populations, or employ useful collaborative arrangements? Is there
> evidence of institutional support?

[]{#__RefHeading___Toc82583664 .anchor}III.I. Research Core(s)

Each core must be written using Grant Application Form PHS 398. Name and
assign a letter designation to each unit. An abstract must be written
for each core.

A core may be a unit designed just for the CORT projects or may be an
institutional core unit. However, funds may only be requested for CORT
use, and the core must serve a minimum of two projects within the CORT,
with no project dominating use of the core.

The core principal investigator should devote at least 15 percent effort
to the core.

Describe the core unit and the various services it would provide. The
justification for the core must include the value added by having
services provided through the core rather than within the individual
projects.

Describe the personnel, facilities, management and any special
arrangements such as cooperation with other established cores. The
techniques to be used and the quality control procedures should be
documented and justified. Indicate which core services each project
would utilize.

It is helpful in presenting the scope of the core to prepare a table
indicating the research projects each core unit will serve and the
estimated proportion of the cost (in dollars) of the core unit
associated with each research project.

Each core using human subjects must include a detailed plan for
protection of human subjects and inclusion of women, minorities, and
children.

If the core proposes to use vertebrate animals, a detailed description
of animal care and use must be included (see the PHS 398 instructions).

*Review Criteria for research cores:*

 Will the core have utility to at least two of the CORT projects?

 Is the quality of services high? Are there procedures for quality
control? Is the core cost effective?

 Do the services offered best fit within a core structure? If this is
an add on to a preexisting core, what is the benefit to the CORT over
direct purchase of services from the existing core?

 Are the personnel appropriate?

 Are the facilities and equipment adequate? Is there institutional
commitment to the core?

[]{#__RefHeading___Toc82583665 .anchor}III.J. Review Criteria for the
Overall Application

After the review of the individual components of the application, an
overall priority score will be assigned to the application. This score
will reflect not only the individual quality of the projects, cores, and
administration, but also how the proposed CORT will bring together all
these elements in a workable unit. The overall score may be higher or
lower than the Aaverage@ of the descriptors based on the assessment of
whether the Awhole is greater than the sum of its parts:@

-   The scientific excellence of the Center\'s research base as well as
    the relevance and interrelation of these separately-funded research
    projects to the goals of the Center and the likelihood for
    meaningful collaboration among Center investigators. The application
    must convey how the proposed Center will enhance significantly the
    established research base of the host institution.

-   The overall environment for a Center. This includes the
    institutional commitment to the program, including lines of
    accountability regarding management of the Center, and the
    institution\'s partnership with the Center, and the institutional
    commitment to individuals responsible for conducting essential
    Center functions. This also includes the academic environment and
    resources in which the activities will be conducted, including the
    availability of space, equipment, facilities, and the potential for
    interaction with scientists from other departments and schools to
    enhance a multidisciplinary approach.

-   The overall priority score assigned to the application will also
    reflect how well the policies regarding (a) the inclusion of women,
    minorities and children in study populations, and (b) the protection
    of human subjects from research risks.

[]{#__RefHeading___Toc82583666 .anchor}IV. Suggested content order for
application

[]{#__RefHeading___Toc82583667 .anchor}IV.A. General Information

It is desirable for CORT applications to be arranged in a specified
format. This not only makes it easier for NIAMS staff and reviewers to
find all the center components to be reviewed, but it can also serve as
a checklist for the applicant institution in preparing the application.

Form PHS 398 is required for all applications. (See II.B. for how to
obtain this form). Each budget unit (project or core) should be written
in the style and within the page limitation described in the PHS 398
instruction kit. To aid in the review of these applications, the
applicant should assemble the component units following the format
described below. Applicants may also consult with NIAMS staff concerning
the technical aspects of preparing the application.

[]{#__RefHeading___Toc82583668 .anchor}IV.B. Content Order for the CORT
Application

[]{#__RefHeading___Toc82583669 .anchor}**IV.B.1. Face Page of Form PHS
398**.

Complete all items on the face page as directed. In the title block,
item 1, put \"NIAMS: CORT.\" Mark item 2 \"yes\" and write in the RFA
code as listed in the NIH Guide to Grants and Contracts and \"NIAMS:
CORT\" for the title.

[]{#__RefHeading___Toc82583670 .anchor}IV.B.2 Page 2, Description

Describe the goals and objectives of the CORT overall and of the
component projects and cores. Do not exceed the space allowed. Key
personnel are those doctoral level investigators with a percent effort
on the grant: Director and Associate Director, investigators on the
projects and cores, and consultants.

[]{#__RefHeading___Toc82583671 .anchor}IV.B.3. Table of Contents

Discard this page from Form PHS 398 and write a Table of Contents
appropriate for the CORT grant application. See Exhibit I for a
suggested format. The Table of Contents is paginated to follow the list
of Key Personnel. **Do not use letters (e.g., 4a, 4b, 4c, etc.)** The
Table of Contents should list all components. Each project and core
should be listed by the title and Principal Investigator. Specifically
list the locations of the checklist and the various requested supporting
documents, e.g., animal and human subject assurances.

[]{#__RefHeading___Toc82583672 .anchor}IV.B.4. Budgets

For budget pages, see Exhibits III, IV, and V. Use form pages 4 and 5 in
PHS Form 398 for all budgets. Justify and document all costs for current
and future years throughout.

To provide budget information in a format that is clear to reviewers and
therefore provides the most positive review possible, presentation of a
consolidated budget for the first 12 months in a tabular form such as
the sample shown as Exhibit III is suggested. The overall Center budget,
\"Summary Center Budget,\" is presented first using form PHS 398 page 4
entitled \"Detailed Budget for First 12-Month Period\" (see Exhibit IV).
Note that no details need be given for the individual categories. Page 5
of form PHS 398, \"Budget Estimates for All Years of Support Requested
Direct Costs Only,\" should then follow a composite like that in Exhibit
IV, summarizing all individual budgets (see suggested format in Exhibit
V). For the purpose of establishing future year budget requests, the
applicant should use cost escalations as specified in the RFA or less.
However, **the direct cost budget cannot exceed \$1,000,000 in any
year**. For purposes of establishing the \$1,000,000 direct cost limit,
the F&A (indirect) costs of subcontracts will not be counted. (See NOT
OD-04-040:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html> )

Both first 12 month and 5 year individual budgets should be included *in
the sections for each project and core.* Details and justifications for
all budget items must be part of the individual budgets.

-   This grant mechanism is not intended for the acquisition of
    equipment. Costly items of equipment should be funded through other
    sources.

-   A separate, detailed budget for each project subcontracted to a
    consortium institution is required as well as a form PHS 398 face
    page signed by the principal investigator and appropriate officials
    in the consortium institution.

-   It is not the purpose of a CORT grant to provide funding for
    alterations or renovations.

-   Support for research training positions is not to be included.

-   The production of audiovisual material with CORT grant funding is
    not appropriate.

### 

[]{#__RefHeading___Toc82583673 .anchor}IV.B.5. Biographical Sketches

Biographical sketches are required for all doctoral level personnel who
are listed with a percent effort (including consultants) in the CORT
application. The forms found in Form PHS 398 should be used. Begin with
the CORT Director and place the remaining individual sketches in
alphabetical order after the budget pages. These pages should not be
duplicated in the individual component projects and cores.

[]{#__RefHeading___Toc82583674 .anchor}IV.B.6. Assurance Documentation

See sample suggested table, Exhibit VI. In addition to the assurance
pages, a master table listing the status of vertebrate animals and human
subject approval dates and the human subjects education requirement
certification will aid in the timely processing of your application.

[]{#__RefHeading___Toc82583675 .anchor}IV.B.7. Narrative Sections

See Section III for content information. Present in the following order
using continuation pages:

-   **Overview**

-   **Qualifications of the Center Leadership**

-   **Research Base for the CORT**

-   **Institutional Environment and Resources**

-   **Pilot and Feasibility Project Program**

[]{#__RefHeading___Toc82583676 .anchor}IV.B.8. Budgeted Components

See Section III. for content information. Present each individual
project and core in the following order using the PHS 398 forms.

-   **Administrative Core**

-   **Translational Projects (minimum of 3)**

-   **Research Cores (optional)**

Each component should be written as a separate unit following these
guidelines and the instructions accompanying form PHS 398. It is
important that each component include a section on vertebrate animals
and on human subjects, gender and minority inclusion, and inclusion of
children as participants in research involving human subjects, even if
to indicate that a full discussion is not applicable. An individual
target enrollment table must be included with each project using human
subjects. Cores may cross reference detailed presentations to projects
and vice versa as appropriate to avoid lengthy repetitions of complex
arrangements.

 A cover page for an individual component is needed only when that
component will be administered through a subcontract to another
institution. Facilities and administrative (indirect) costs from these
subcontracts do not count against the \$1,000,000 cap for direct costs
for a CORT.

 An abstract and key personnel page must be included for each
component.

 A detailed budget for the initial budget period and budget for the
entire proposed period of support \[pages 4 and 5 of form PHS 398\] must
be included with each component. The budget justification should be
thorough. Do not assume that any item or percent effort is obvious. Note
that the following percent efforts are expected: CORT Director: 15% for
the Administrative Core, 20% as project principal investigator;
Associate Director: 10% for the Administrative Core; 20% as project
principal investigator: Other Core Directors: 15%.

 The biographical sketches are put centrally in one location (see IV.
B.) and should not be duplicated in the individual component.

 A resources page should be included for each component.

 The checklist page needs to be included with each institutional face
page.

[]{#__RefHeading___Toc82583677 .anchor}IV.C. Appendices

See the instructions in the PHS 398 booklet for appropriate appendix
materials.

Following these suggestions will insure that correct appendix material
can be sent to the appropriate reviewers:

-   Each piece should be marked with (1) the name of the CORT Director -
    not the name of the component PI and (2) a **single** component of
    the application to which it pertains - CORT Leadership, Research
    Base, Resources and Environment, Administrative Core, or individual
    cores and projects.

-   The marked materials should be grouped by the identified components.
    Thus, all five copies of appendices pertaining to a given project or
    component should be grouped together.

-   The five sets of all appendix material, and a CD including all
    appendices, should be sent directly to the NIAMS and **NOT** to the
    Center for Scientific Review:

Madeline Turkeltaub, CRNP, Ph.D., FAAN

Deputy Director, Extramural Program

NIAMS/NIH

> 6701 Democracy Blvd., Suite 800 -- MSC 4872
>
> Bethesda, MD 20892-4872
>
> \[Bethesda, MD 20817 (for express/courier service)\]
>
> Phone: (301) 594-2463

FAX: (301) 402-7478

[]{#__RefHeading___Toc82583678 .anchor}V. Noncompeting Applications:
Annual Reporting Requirements

Annual progress reports, submitted as part of the noncompeting
continuation application, are due two months before the anniversary date
of the award. These reports are used by the National Institute of
Arthritis and Musculoskeletal and Skin Diseases to review the Center and
its progress. They serve to verify in detail the achievement of the
objectives outlined in the initial application and award and are an
important source of material for program staff in preparing reports,
planning programs, and communicating scientific accomplishments.

The application for continuation of a PHS Grant, PHS Form 2590, is used
to file the annual report. In addition, an overall progress report
containing the following information should be included:

• A summary (equivalent to no more than four single space typewritten
pages) of the goals and significant activities of the CORT. This summary
should be prepared for a general audience. Honors and/or promotions of
professional personnel should be mentioned.

• A discussion of the effectiveness of the CORT grant in furthering the
goals of the CORT program. This should include a summary of the specific
accomplishments that can be attributed to the CORT grant, e.g., new
research funding, changes in curricula, or organizational improvements
within the institution and in the community.

• An itemization of collaborative efforts the CORT established.

• A list of publications relevant to CORT funding should be provided.

• A discussion of problems that impede accomplishment of the stated
goals in the administration of the CORT grant and plans to overcome
them.

• The administrative component report should include a list of
administrative meetings held, evaluations from advisory groups, speakers
or symposia sponsored. These may be included as appendix material.

• A table listing the assurance dates for IACUC, IRB and certifications
education for the protection of human research participants for key
personnel for all CORT funded projects is optional, but will assist the
timely processing of the award. (See Exhibit VI). The notice describing
the requirement for education for the protection of human subject
participants may be found at
<http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html>.

• A detailed summary of each CORT funded component (including the
Administrative Core) and project, including the title, principal
investigator and key personnel, their percent effort, proposed budgets,
description, progress, and evaluation. This progress report should
include all CORT supported projects. It is especially important that the
significance and ultimate utility of each project be discussed in the
summary description and that this discussion be in terms understandable
to an informed nonscientist.

• A budget page for the coming year for each component and project
funded by the CORT.

• The timely review of the application will be facilitated by the
inclusion of a composite budget for the entire CORT as illustrated in
Exhibit IV.

• Other information that, from year to year, may be requested by the
NIAMS staff.

The expanded progress report is in addition to, and does not replace,
other management reports required by PHS policy.

[]{#__RefHeading___Toc82583679 .anchor}VI. Guidelines for Pilot and
Feasibility Projects

See Section III.F. for a discussion of the Pilot and Feasibility Project
Program. Pilot and feasibility projects are NOT to be included in the
CORT grant application.

Present each study separately using Form PHS 398. Follow the
instructions and include:

\(1\) Face page, signed by the business office, and the description
page, page 2;

(2) Budget with justifications (An individual application may request up
    to \$50,000 direct costs and for no more than two years.);

(3) **Justification of eligibility: How does this project relate to the
    CORT theme? Where can the project lead?** This information should be
    included as part of the Background and Significance Section.

(4) Scientific proposal using form PHS 398 (including justification for
    core use if applicable); Note that items a - d of the Research Plan
    **(Specific Aims, Background and Significance, and Research Design
    and Methods) may not exceed a total of 15 pages.** This page
    limitation does not apply to subsections e -- i; and

(5) Sections on Human Subjects, including the Inclusion of Women
    Minorities, and Children; Vertebrate Animals;
    Consultants/Collaborators; Consortium/Contractual Arrangements; and
    Literature Cited. If not applicable, mark them N/A.

Applicants are advised to include sufficient information to address the
following review criteria:

*Review Criteria for a Pilot and Feasibility Project:*

Significance: Will the proposed work likely yield meaningful preliminary
data leading to a research proposal?

> Approach: Are the experimental approaches adequate?

Innovation: Is the research topic one that advances the translational
theme and promotes innovative new research related to the CORT?

Investigator: Is the investigator qualified to carry out the work
proposed?

Environment: Is the project appropriate to the CORT and its resources?

[]{#__RefHeading___Toc82583680 .anchor}**[VII. Guidelines for
Supplemental Applications]{.smallcaps}**

Applications submitted for supplemental projects to an NIAMS CORT
program must have prior approval of the NIAMS CORT Program
Scientific/Research Contact. Applications submitted without prior
approval will be withdrawn and returned to the applicant. Approval will
be based upon the following:

 A component research project was recommended for less time than was
the rest of the CORT in order to permit an early assessment of progress;

 A persuasive case can be made that an alternative, additional or
expanded project is important for the CORT program AND the new total
direct cost budget for the CORT will not exceed the budget cap.

Supplemental applications will undergo a competitive review by an
Initial Review Group (IRG) convened by the NIAMS Review Branch. In
general, applications should be submitted so that at least two years
remain on the parent grant at the time of award of the supplement. Major
factors to be considered in the evaluation of a supplemental application
will include:

1\. The relevance of the proposed research to the CORT concept outlined
in these guidelines;

2\. If a request for continuation, what findings have been developed
that justify additional years;

3\. Scientific merit of the proposed project, including significance,
approach and innovation;

4\. Competence of the investigators to accomplish the proposed research
goals, their commitment, and the time they will devote to the research
program;

5\. How the CORT environment enhances the project;

6\. Appropriateness of the budget for the proposed program; and

7\. Appropriateness of plans to include children, women, and minorities
in the study populations.

A supplemental project will be assigned a priority score based on its
merit as an individual research project. The review will also comment on
how the proposed project fits with the CORT program. Funding will be
based on merit, program relevance and availability of funds.

[]{#__RefHeading___Toc82583682 .anchor}Exhibit I Sample Table of
Contents

ABC University

Application for a Center of Research Translation

SAMPLE \-- Table of Contents

Page \#

I.  General Material

    A.  Face Page

    B.  Abstract

    C.  Key Personnel

    D.  Table of Contents

    E.  Detailed Summary (Composite) Center Budget -- See Exhibit III

    F.  Detailed Overall Budget for Initial Budget Period-- See Exhibit
        IV

    G.  Overall Budget for Entire Proposed Period of Support-- See
        Exhibit V

    H.  Biographical Sketch -- Principal Investigator

    I.  Other Biographical Sketches -- for Key Personnel in alphabetical
        order

    J.  Table of Assurances (See Exhibit VI)

    K.  Human Subject Education Certifications

    L.  Overall Resources

II. Narrative Sections

    A.  Overview

    B.  Qualifications of the Center Leadership

    C.  Research Base for CORT

        1.  Table of Grant Support for Research Base -- See Exhibit II

    D.  Institutional Environment and Resources

        1.  Letters of Support

    E.  Future Pilot and Feasibility Project Program

III. Budgeted Components

     A.  Title page - Administrative Core: CORT Director, degrees.

         1.  Abstract/Performance Site/Key Personnel

         2.  Table of Contents

         3.  Detailed Budget for Initial Budget Period

         4.  Budget for Proposed Period of Support

         5.  Budgets Pertaining to Consortium/Contractual Arrangements.

         6.  Resources

         7.  Research Plan

             a.  Specific Aims

             b.  Structure to Accomplish Aims

                 1.  Leadership and Organizational Structure

                 2.  CORT Advisory Group

                 3.  Administrative/Leadership Goals

                 4.  Enrichment Program

         8.  Consortium/Contractual Arrangements

         9.  Letters of Support

     B.  Title Page - Project 1: Title; Principal Investigator,
         degree(s)

         1.  Abstract/Performance Site/Key Personnel

         2.  Table of Contents

         3.  Detailed Budget for Initial Budget Period

         4.  Budget for Entire Proposed Period of Support

         5.  Budgets Pertaining to Consortium/Contractual arrangements

         6.  Resources

         7.  Research Plan

             a.  Specific Aims

             b.  Background and Significance

             c.  Preliminary Studies

             d.  Research Design and Methods

             e.  Human Subjects

                 1.  Protection of Human Subjects

                 2.  Inclusion of Women

                 3.  Inclusion of Minorities

                 4.  Inclusion of Children

                 5.  Data Safety and Monitoring Plan

                 6.  Target Enrollment Table

             f.  Vertebrate Animals

             g.  Literature Cited

             h.  Consortium/Contractual Arrangements

             i.  Letters of Support

     C.  Project 2: see above example

     D.  Project 3: see above example

     E.  Title Page: Research Core: Title; Principal Investigator,
         degree(s).

         1.  Abstract/Performance Site/Key Personnel

         2.  Table of Contents

         3.  Detailed Budget for Initial Budget Period

         4.  Budget for Proposed Period of Support

         5.  Budgets Pertaining to Consortium/Contractual Arrangements.

         6.  Resources

         7.  Research Plan

             a.  Specific Aims

             b.  Background and Significance

             c.  Preliminary Studies

             d.  Research Design and Methods

             e.  Human Subjects

                 1.  Protection of Human Subjects

                 2.  Inclusion of Women

                 3.  Inclusion of Minorities

                 4.  Inclusion of Children

                 5.  Data Safety and Monitoring Plan

                 6.  Target Enrollment Table

             f.  Vertebrate Animals

             g.  Literature Cited

             h.  Consortium/Contractual Arrangements

             i.  Letters of Support

IV. Checklists

[]{#__RefHeading___Toc82583770 .anchor}Exhibit II Grants Supporting the
Research Base

*SAMPLE OF SUGGESTED FORMAT*

+------------+----------+----------------+-----------+----------------+
| **         | **Key    | **Title**      | **Project | **Current      |
| Supporting | Per      |                | Period**  | Annual         |
| Or         | sonnel** |                |           | Amount**       |
| ganization |          |                |           |                |
| &**        |          |                |           |                |
|            |          |                |           |                |
| **Grant    |          |                |           |                |
| Number**   |          |                |           |                |
+------------+----------+----------------+-----------+----------------+
| NIH 5 R01  | Chen,    | New            | 3/1/2004  | \$467,000      |
| ARnnnnn    | C        | Therapeutic    | --        |                |
|            | hing-mei | Agents for     | 2/28/2009 |                |
|            | (PI)     | Autoimmune     |           |                |
|            |          | Disease        |           |                |
|            | Doe,     |                |           |                |
|            | John     |                |           |                |
+------------+----------+----------------+-----------+----------------+
|            |          |                |           |                |
+------------+----------+----------------+-----------+----------------+
|            |          |                |           |                |
+------------+----------+----------------+-----------+----------------+
|            |          |                |           |                |
+------------+----------+----------------+-----------+----------------+
|            |          |                |           |                |
+------------+----------+----------------+-----------+----------------+
|            |          |                |           |                |
+------------+----------+----------------+-----------+----------------+
| **TOTAL:** |          |                |           |                |
+------------+----------+----------------+-----------+----------------+

+--------------+------+------+------+-------+------+-------+----------+
| []{#__       |      |      |      |       |      |       |          |
| RefHeading__ |      |      |      |       |      |       |          |
| _Toc82583771 |      |      |      |       |      |       |          |
| .ancho       |      |      |      |       |      |       |          |
| r}**[Exhibit |      |      |      |       |      |       |          |
| III]{.       |      |      |      |       |      |       |          |
| smallcaps}** |      |      |      |       |      |       |          |
| Consolidated |      |      |      |       |      |       |          |
| Budget for   |      |      |      |       |      |       |          |
| 1^st^ Year   |      |      |      |       |      |       |          |
| of Requested |      |      |      |       |      |       |          |
| Support      |      |      |      |       |      |       |          |
|              |      |      |      |       |      |       |          |
| ***SAMPLE OF |      |      |      |       |      |       |          |
| SUGGESTED    |      |      |      |       |      |       |          |
| FORMAT***    |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| BUDGET       | Pro  | Pro  | Pro  | Admin | Core | Core  | TOTAL    |
| CATEGORY     | ject | ject | ject | Unit  | B    | C     |          |
|              | 1    | 2    | 3    |       |      |       |          |
|              |      |      |      | Core  |      |       |          |
|              |      |      |      | A     |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Personnel    |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Consultant   |      |      |      |       |      |       |          |
| Costs        |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Equipment    |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Supplies     |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Domestic     |      |      |      |       |      |       |          |
| Travel       |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Foreign      |      |      |      |       |      |       |          |
| Travel       |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Patient Care |      |      |      |       |      |       |          |
| Costs        |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Alteration   |      |      |      |       |      |       |          |
| and          |      |      |      |       |      |       |          |
|              |      |      |      |       |      |       |          |
| Renovation   |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Contractual  |      |      |      |       |      |       |          |
| Costs        |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| Other        |      |      |      |       |      |       |          |
| Expenses     |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+
| **Total      |      |      |      |       |      |       |          |
| Direct       |      |      |      |       |      |       |          |
| Costs**      |      |      |      |       |      |       |          |
+--------------+------+------+------+-------+------+-------+----------+

[]{#__RefHeading___Toc82583772 .anchor}Exhibit IV Initial Budget Period

<table>
<colgroup>
<col style="width: 18%" />
<col style="width: 6%" />
<col style="width: 4%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 1%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 11%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="6">Principal Investigator/Program Director (Last, First,
Middle):</td>
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="16"></td>
</tr>
<tr class="odd">
<td colspan="10" rowspan="2"><h1
id="detailed-budget-for-initial-budget-period">DETAILED BUDGET FOR
INITIAL BUDGET PERIOD</h1>
<h1 id="direct-costs-only">DIRECT COSTS ONLY</h1></td>
<td colspan="2">FROM</td>
<td colspan="4">THROUGH</td>
</tr>
<tr class="even">
<td colspan="2">7/1/2006</td>
<td colspan="4">6/30/2007</td>
</tr>
<tr class="odd">
<td colspan="4">PERSONNEL <em>(Applicant organization only)</em></td>
<td></td>
<td colspan="3">%</td>
<td></td>
<td colspan="7">DOLLAR AMOUNT REQUESTED <em>(omit cents)</em></td>
</tr>
<tr class="even">
<td colspan="2">NAME</td>
<td colspan="2">ROLE ON<br />
PROJECT</td>
<td>TYPE<br />
APPT.<br />
<em>(months)</em></td>
<td colspan="3">EFFORT<br />
ON<br />
PROJ.</td>
<td>INST.<br />
BASE<br />
SALARY</td>
<td colspan="2">SALARY<br />
REQUESTED</td>
<td colspan="4">FRINGE<br />
BENEFITS</td>
<td>TOTAL</td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="2">Principal<br />
Investigator</td>
<td>     </td>
<td colspan="3">     </td>
<td>     </td>
<td colspan="2">     </td>
<td colspan="4">     </td>
<td>     </td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="3">     </td>
<td>     </td>
<td colspan="2">     </td>
<td colspan="4">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="3">     </td>
<td>     </td>
<td colspan="2">     </td>
<td colspan="4">     </td>
<td>     </td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="3">     </td>
<td>     </td>
<td colspan="2">     </td>
<td colspan="4">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="3">     </td>
<td>     </td>
<td colspan="2">     </td>
<td colspan="4">     </td>
<td>     </td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="3">     </td>
<td>     </td>
<td colspan="2">     </td>
<td colspan="4">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="3">     </td>
<td>     </td>
<td colspan="2">     </td>
<td colspan="4">     </td>
<td>     </td>
</tr>
<tr class="even">
<td colspan="9"><blockquote>
<p>SUBTOTALS</p>
</blockquote></td>
<td colspan="2">443,180</td>
<td colspan="4">137,525</td>
<td>580,705</td>
</tr>
<tr class="odd">
<td colspan="15"><p>CONSULTANT COSTS</p>
<p>     </p></td>
<td>15,000</td>
</tr>
<tr class="even">
<td colspan="15"><p>SUPPLIES</p>
<p>     </p></td>
<td>212,485</td>
</tr>
<tr class="odd">
<td colspan="15"><p>TRAVEL</p>
<p>     </p></td>
<td>6,500</td>
</tr>
<tr class="even">
<td rowspan="2">PATIENT CARE COSTS</td>
<td colspan="2">INPATIENT</td>
<td colspan="12">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td colspan="2">OUTPATIENT</td>
<td colspan="12">     </td>
<td>     </td>
</tr>
<tr class="even">
<td colspan="15"><p>ALTERATIONS AND RENOVATIONS <em>(Itemize by
category)</em></p>
<p>     </p></td>
<td>     </td>
</tr>
<tr class="odd">
<td colspan="15"><p>OTHER EXPENSES <em>(Itemize by category)</em></p>
<p>     </p></td>
<td>28,595</td>
</tr>
<tr class="even">
<td colspan="13">SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD</td>
<td colspan="2">$</td>
<td>843,285</td>
</tr>
<tr class="odd">
<td colspan="7" rowspan="2">CONSORTIUM/CONTRACTUAL COSTS</td>
<td colspan="7">DIRECT COSTS</td>
<td colspan="2">156,715</td>
</tr>
<tr class="even">
<td colspan="7">FACILITIES AND ADMINISTRATIVE COSTS</td>
<td colspan="2">139,487</td>
</tr>
<tr class="odd">
<td colspan="13">TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD <em>(Item
7a, Face Page)</em></td>
<td colspan="2">$</td>
<td>1,139,487</td>
</tr>
</tbody>
</table>

[]{#__RefHeading___Toc82583775 .anchor}Exhibit V Budget for Entire
Proposed Project Period

<table style="width:100%;">
<colgroup>
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 9%" />
<col style="width: 16%" />
<col style="width: 10%" />
<col style="width: 5%" />
<col style="width: 15%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 11%" />
<col style="width: 0%" />
<col style="width: 1%" />
<col style="width: 13%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="5">Principal Investigator/Program Director (Last, First,
Middle):</td>
<td colspan="8"></td>
</tr>
<tr class="even">
<td colspan="13"></td>
</tr>
<tr class="odd">
<td colspan="13"><h1
id="budget-for-entire-proposed-project-period-direct-costs-only">BUDGET
FOR ENTIRE PROPOSED PROJECT PERIOD<br />
DIRECT COSTS ONLY</h1></td>
</tr>
<tr class="even">
<td colspan="3" rowspan="2">BUDGET CATEGORY<br />
TOTALS</td>
<td rowspan="2">INITIAL BUDGET<br />
PERIOD<br />
<em>(from Form Page 4)</em></td>
<td colspan="9">ADDITIONAL YEARS OF SUPPORT REQUESTED</td>
</tr>
<tr class="odd">
<td colspan="2">2<sup>nd</sup></td>
<td>3rd</td>
<td colspan="4">4th</td>
<td colspan="2">5<sup>th</sup></td>
</tr>
<tr class="even">
<td colspan="3">PERSONNEL: <em>Salary and fringe benefits. Applicant
organization only</em>.</td>
<td>580,705</td>
<td colspan="2">580,705</td>
<td>580,705</td>
<td colspan="4">580,705</td>
<td colspan="2">580,705</td>
</tr>
<tr class="odd">
<td colspan="3">CONSULTANT COSTS</td>
<td>15,000</td>
<td colspan="2">15,000</td>
<td>15,000</td>
<td colspan="4">15,000</td>
<td colspan="2">15,000</td>
</tr>
<tr class="even">
<td colspan="3">EQUIPMENT</td>
<td></td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="4">     </td>
<td colspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="3">SUPPLIES</td>
<td>212,485</td>
<td colspan="2">212,485</td>
<td>212,485</td>
<td colspan="4">212,485</td>
<td colspan="2">212,485</td>
</tr>
<tr class="even">
<td colspan="3">TRAVEL</td>
<td>6,500</td>
<td colspan="2">6,500</td>
<td>6,500</td>
<td colspan="4">6,500</td>
<td colspan="2">6,500</td>
</tr>
<tr class="odd">
<td rowspan="2">PATIENT CARE<br />
COSTS</td>
<td colspan="2">INPATIENT</td>
<td>     </td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="4">     </td>
<td colspan="2">     </td>
</tr>
<tr class="even">
<td colspan="2">OUTPATIENT</td>
<td></td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="4">     </td>
<td colspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="3">ALTERATIONS AND<br />
RENOVATIONS</td>
<td></td>
<td colspan="2">     </td>
<td>     </td>
<td colspan="4">     </td>
<td colspan="2">     </td>
</tr>
<tr class="even">
<td colspan="3">OTHER EXPENSES</td>
<td>28,595</td>
<td colspan="2">28,595</td>
<td>28,595</td>
<td colspan="4">28,595</td>
<td colspan="2">28,595</td>
</tr>
<tr class="odd">
<td colspan="3">SUBTOTAL DIRECT COSTS</td>
<td>843,285</td>
<td colspan="2">843,285</td>
<td>843,285</td>
<td colspan="4">843,285</td>
<td colspan="2">843,285</td>
</tr>
<tr class="even">
<td colspan="2" rowspan="2">CONSORTIUM/<br />
CONTRACTUAL<br />
COSTS</td>
<td>DIRECT</td>
<td>156,715</td>
<td colspan="2">156,715</td>
<td>156,715</td>
<td colspan="4">156,715</td>
<td colspan="2">156,715</td>
</tr>
<tr class="odd">
<td>F&amp;A</td>
<td>139,487</td>
<td colspan="2">139,487</td>
<td>139,487</td>
<td colspan="4">139,487</td>
<td colspan="2">139,487</td>
</tr>
<tr class="even">
<td colspan="3">TOTAL DIRECT COSTS</td>
<td>1,139,487</td>
<td colspan="2">1,139,487</td>
<td>1,139,487</td>
<td colspan="4">1,139,487</td>
<td colspan="2">1,139,487</td>
</tr>
<tr class="odd">
<td colspan="9">TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT PERIOD
<em>(Item 8a, Face Page)</em></td>
<td><strong>–––––</strong></td>
<td colspan="2">$</td>
<td>5,697,435</td>
</tr>
<tr class="even">
<td colspan="3"><p>SBIR/STTR Only</p>
<p>Fee Requested</p></td>
<td>     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="3">     </td>
</tr>
<tr class="odd">
<td colspan="10"><p>SBIR/STTR Only: Total Fee Requested for Entire
Proposed Project Period</p>
<p>(Add Total Fee amount to “Total direct costs for entire proposed
project period” above and Total F&amp;A/indirect costs from Checklist
Form Page, and enter these as “Costs Requested for Proposed Period of
Support on Face Page, Item 8b.)</p></td>
<td colspan="2">$</td>
<td>     </td>
</tr>
</tbody>
</table>

[]{#__RefHeading___Toc82583777 .anchor}Exhibit VI Approval Dates

***SAMPLE OF SUGGESTED FORMAT***

**HUMAN SUBJECTS APPROVAL DATES**

**HUMAN SUBJECTS EDUCATION REQUIREMENT**

**ANIMAL SUBJECTS APPROVAL DATES**

[General:]{.smallcaps}

1\. [Initial application]{.underline}: IRB approval and certification is
not required with the submission or prior to review and may be listed as
pending prior to the review. The certification of IACUC approval must be
submitted with the application or within 60 days after the application
receipt date.

2\. [Initial funding]{.underline}: Additional information may be
required prior to funding. The NIH no longer requires IRB approval and
certification prior to NIH review. This information will be required
when a decision is made to fund the application. Certifications for the
Human Subjects Education Requirement may be submitted at the time of
application but are not required until a funding decision is made. If
the Human Subjects Education Requirement certification is not included
in the application, please mark Apending@.

3\. [Yearly progress reports]{.underline}: This table should be updated
and included with each yearly progress report. Human Subjects Education
Requirement Certifications are needed only for investigators new to the
grant. Mark Apreviously submitted@ for continuing investigators.

[Specific]{.smallcaps}:

Please make a table for each Performance Site. If there is only one
performance site, then only one table is needed. A certification letter
must be attached for each project using Human Subjects. Each letter
should include the registered IRB number from the Office of Human
Research Protections.

+--------------+----------+------------+--------------+--------------+
| Performance  |          |            |              |              |
| Site:        |          |            |              |              |
| University A |          |            |              |              |
+--------------+----------+------------+--------------+--------------+
| *            | **P      | **IACUC    | **IRB        | **Human      |
| *Principal** | roject** | Approval   | Approval     | Subjects     |
|              |          | Date\***   | Date\***     | Education    |
| **In         |          |            |              | Requirement  |
| vestigator** |          |            |              | \***         |
+--------------+----------+------------+--------------+--------------+
| Dr. A        | 1        |            |              |              |
+--------------+----------+------------+--------------+--------------+
| Dr. B        | 2        |            |              |              |
+--------------+----------+------------+--------------+--------------+
| Dr. C        | 3        |            |              |              |
+--------------+----------+------------+--------------+--------------+
| Dr. E        | 5        |            |              |              |
+--------------+----------+------------+--------------+--------------+
| Dr. B        | Core A   |            |              |              |
+--------------+----------+------------+--------------+--------------+
| Dr. D        | Core B   |            |              |              |
+--------------+----------+------------+--------------+--------------+

+--------------+----------+------------+--------------+--------------+
| Performance  |          |            |              |              |
| Site:        |          |            |              |              |
| University B |          |            |              |              |
|              |          |            |              |              |
| Human        |          |            |              |              |
| Subjects     |          |            |              |              |
| assurance    |          |            |              |              |
| number:      |          |            |              |              |
|              |          |            |              |              |
| Animal       |          |            |              |              |
| welfare      |          |            |              |              |
| assurance    |          |            |              |              |
| number.      |          |            |              |              |
+--------------+----------+------------+--------------+--------------+
| *            | **P      | **IACUC    | **IRB        | **Human      |
| *Principal** | roject** | Approval   | Approval     | Subjects     |
|              |          | Date\***   | Date\***     | Education    |
| **In         |          |            |              | Req          |
| vestigator** |          |            |              | uirement\*** |
+--------------+----------+------------+--------------+--------------+
| Dr. X        | 1        |            |              |              |
|              | (sub     |            |              |              |
|              | project) |            |              |              |
+--------------+----------+------------+--------------+--------------+
| Dr. D        | 4        |            |              |              |
+--------------+----------+------------+--------------+--------------+
| Dr. Y        | Core B   |            |              |              |
|              | (sub     |            |              |              |
|              | project) |            |              |              |
+--------------+----------+------------+--------------+--------------+

\* Attach certification letter or mark NA if not applicable