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######## TABLE OF CONTENTS

# I. INTRODUCTION 1

# 

# II. APPLICATION AND REVIEW PROCESS 2

# 

# Pre-application Process and Letter of Intent 2

# Application Procedure 2

# Review Process 3

# Center Evaluation Procedure 3

**III. CONTENT OF THE APPLICATION 5**

**III.A. Narrative Sections 5**

> **Overview 5**
>
> **Qualifications of the Center Leadership 5**
>
> **Research Base for the Core Center 6**
>
> **Institutional Environment and Resources 6**
>
> **Progress Report (if applicable) 7**
>
> **Pilot and Feasibility Program Management 7**

**III.B. Budgeted Components 9**

> **Administrative Unit 9 Research Cores 10**
>
> **Pilot and Feasibility Projects** **13**

**IV. APPLICATION FORMAT 16**

**General Information and Appendix Material 16**

**Content Order for the Core Center Application 16**

# V. REPORTING REQUIREMENTS AND ANNUAL EVALUATION 19

EXHIBIT I \-- Format & Table Of Contents 21

EXHIBIT II \-- Grants Supporting The Research Base 24

EXHIBIT III \-- Distribution Of Core Unit Costs 25

EXHIBIT IV \-- Use Of Core Facilities 26

EXHIBIT V\-- Sample of Information Useful to Reviewers 27

EXHIBIT VI -- Composite 1^st^ Year Budget 28

EXHIBIT VII -- Composite 5 Year Budget 29

EXHIBIT VIII \-- Consolidated Budget For 1st Year Of Requested Support
30

EXHIBIT IX -- Animal & Human Subjects Assurance Tables 31

**GUIDELINES FOR RESEARCH CORE CENTERS**

**NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES**

# I. INTRODUCTION

This document provides administrative guidelines for the NIAMS Core
Center (P30) program. Applications for Core Centers are sought through
Requests for Application (RFA) and the topic areas for the focus of the
Core Center are listed in the RFA.

The overall goal of a Core Center is to provide shared facilities and
services to groups of established, currently funded investigators in
order to improve efficiency, accelerate the pace of research, and ensure
greater productivity. Any institution or consortium with an active
program of excellence in basic and clinical biomedical research in an
area suggested by the Request for Applications may qualify for support
through a Core Center. A strong biomedical research base is the
prerequisite for establishment of a Core Center and an important
component in considering continuing funding of an established center.

A Core Center must be an identifiable organizational unit either within
a single university medical center or representing a consortium of
cooperating institutions that includes an affiliated university. Greater
scientific productivity is an ultimate objective of the Core Center.
Applicants should clearly demonstrate the ways in which the Core Center
will build the local research program, will support on-going projects
and will attract both senior and new investigators to the research base.

The Core Center will provide funding for both biomedical research
components and an administrative unit to support the research
components. The research components are either Research Core facilities
or Pilot and Feasibility Projects. Research Cores are defined as shared
resources that enhance productivity or in other ways benefit a group of
investigators working in areas related to the stated goals of the Core
Center. Two or more core facilities must be proposed in a Core Center.
The Pilot and Feasibility Program provides modest support for new
initiatives or for feasibility studies for established or new
investigators who are engaged in research of direct relevance to the
Core Center. Up to \$100,000 direct costs per year may be requested to
support two to five projects budgeted @ \$20,000 - \$50,000 for 1 -- 3
years. An Administrative Unit coordinates Core Center activities and
promotes collaborative research through the Cores. Limited funds for
program enrichment such as seminars and visiting scientists may also be
requested.

**II. APPLICATION AND REVIEW PROCESS**

## Preapplication Process and Letter of Intent 

Core Center applications are solicited by Requests for Applications
(RFAs) published in the NIH Guide for Grants and Contracts. See the
NIAMS website for current funding opportunities:
<http://www.niams.nih.gov/Funding/Funding_Opportunities/filter.asp>

Individuals from institutions with potential interest in applying for a
Core Center grant are encouraged to contact the NIAMS staff as early as
possible after the RFA has been issued. 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.

To facilitate Institute planning, applicants are requested to submit a
letter of intent on the date listed in the RFA. This letter should
provide a descriptive title of the research projects and cores requested
and the key participants. The letter of intent, and any inquiries about
the program, should be directed to the Scientific/Research Contact
identified in the RFA.

## Application Procedure

The PHS 398 application instructions are available at
<http://grants.nih.gov/grants/funding/phs398/phs398.html> in an
interactive format. Applicants must use the currently approved version
of the PHS 398. For further assistance contact GrantsInfo, Telephone
(301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-0088.

Because of their specialized nature, Core Center applications require
modifications of the standard PHS 398 format. The recommended format is
described in detail below, and illustrated in the sample Table of
Contents provided as Exhibit I. Briefly, a Core Center application
consists of three sections. First, a **General Material** section
includes a brief description of the Core Center, and provides overall
budgets, biographical sketches, and other basic information. Second, a
series of **Narrative Sections** describes the Core Center in terms of
its leadership, research base, institutional environment, recent
progress (if previously supported), and management of Pilot and
Feasibility projects. Finally, each **Budgeted Component** of the Core
Center (such as the Administrative Unit, individual Cores, and Pilot and
Feasibility Projects) is described in PHS 398 format. For each Budgeted
Component, the key sections, corresponding to Specific Aims, Background
and Significance, and Research Design and Methods, together may not
exceed a total of 15 pages.

Receipt dates for Core Center 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 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:

Chief, Review Branch

NIAMS/NIH

6701 Democracy Blvd., Suite 800 -- MSC 4872

Bethesda, MD 20892-4872

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

Telephone: (301) 594-4952

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 V.B.9).

## Review Process

Applications for Core Center 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, in accordance with NIH peer review
procedures (<http://grants1.nih.gov/grants/peer/>), 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.

## 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 core and pilot project (including the administrative
unit) will be individually reviewed for scientific merit and assigned a
rating by committee consensus. Merit ratings will also be determined for
the center elements: qualifications of the center leadership, the
research base, the institutional environment and resources. If this is
an application for competitive renewal, the progress during the last
funding cycle will also be evaluated. To be funded, there must be two or
more highly meritorious research cores.

As part of the scientific peer review, all applicants will undergo a
selection process in which only those applicants deemed to have the
highest scientific and technical merit will be discussed and assigned an
overall priority score. This score will reflect not only the individual
quality of the cores, administration and pilot projects, but also the
quality of the research base and how the proposed Core Center will
enhance the research base. The overall score may be higher or lower than
the "average" of the descriptors based on the assessment of whether the
"whole is greater than the sum of its parts."

In addition to the standard criteria of significance, approach,
innovation, investigators, and environment, the following elements will
be evaluated for the overall priority score:

> The scientific excellence of the Core Center\'s research, since the
> existence of a base of established independently supported biomedical
> research of high quality is a prerequisite for establishment of a Core
> Center.

The application must convey how the proposed Core Center will enhance
significantly the established research base of the host institution. In
a competing continuation application, the application should document an
impact of the Core Center. This includes the qualifications, experience,
and commitment of the Core Center investigators and their willingness to
interact with each other. This also includes efficient and effective use
and/or planned use of enrichment funds including the contribution of
these activities in enhancing the realization of the Core Center
concept.

The appropriateness, quality and relevance of the proposed cores, and
the modes of operation, facilities, and potential for contribution to
ongoing research.

The proposed management of the pilot and feasibility program and the
scientific merit of the pilot and feasibility projects for which funds
are requested from the Core Center grant. The effectiveness of the
proposed program will serve as a basis for recommendations concerning
the level at which pilot and feasibility studies will be supported
throughout the project period.

The overall environment for a Core Center. This includes the
institutional commitment to the program, including lines of
accountability regarding management of the Core Center, and the
institution\'s partnership with the Core Center, and the institutional
commitment to individuals responsible for conducting essential Core
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.

# III. CONTENT OF THE APPLICATION 

This section describes the required components of the proposed Core
Center and the review criteria to be applied. The suggested content
order for the overall application will be covered in Section V. Note
that these applications will be reviewed by a committee that will have
three or more applications to review. Having a uniform format and using
cross- references in each application greatly assists the reviewers in
finding information and therefore giving a more favorable review. 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.

## III.A. Narrative Sections 

**Overview**

Each application should have an OVERVIEW - a narrative section that
serves as a synopsis of the key elements of the proposed Core Center,
the qualifications of the Center Director, Associate Director and
executive committee, the research base, and the resources and
environment for the Center. The Overview serves to introduce the
proposed program, to state the Center objectives, and to identify the
scope of research addressed in the proposed 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.

## Qualifications of the Center Leadership

The emphasis in this section should be on the qualifications of the
Center leaders. The details of the administrative structure should be
presented in the budgeted component for the Administrative Unit (see
Section IV.F.) The Director of the Core Center, aided by an Associate
Director and an executive committee, is expected to provide leadership
for the research base of the proposed center. Describe the
qualifications of the Center Director and Associate Director to lead the
Core Center. Describe the qualifications of each member of the executive
committee and the rationale for including these individuals in the
leadership of the Center. Reviewers will be instructed to judge whether
the Director and Associate Director have the leadership and research
qualifications to lead a Center, and whether the leadership team
(Director, Associate Director, and executive committee) have the
collective expertise to assure focused development and implementation of
the Core Center.

## Research Base for the Core Center 

A strong research base is a fundamental requirement for, and a major
factor in, establishment of a Core Center**. The most important point to
be made in the application is how establishment of a Core Center will
improve efficiency, accelerate the pace of research, and ensure greater
productivity within the research base.** This section should present an
overview of current research conducted at the institution(s)
participating in the Core Center, in sufficient detail to allow
reviewers to judge its extent and the interrelationships of ongoing
research.

Begin with a brief summary of the research base, and continue with a
descriptive narrative of research activities related to Core Center
focus at the primary and any collaborating institutions. This narrative
presentation should be organized to address the focus and
interrelationships of research conducted by Core Center investigators.
Since most, if not all, of the research base will have undergone
separate peer review, the quality of the individual funded projects will
be established.

To document the research base of the proposed Core Center, it is helpful
to prepare a table listing the grants, their duration, the current year
direct dollars, and their principal investigators. It is helpful to
group the grants into aggregates of projects with similar overall goals
and objectives. Give the bottom line current year dollar amount for
research grant support in the research base of the Core Center. A
suggested format is given in Exhibit II.

Criteria for designating an investigator as a Core Center investigator
should be defined in terms of the responsibilities and privileges
associated with a Core Center investigator. Relevance of research to the
objectives of the Core Center will be evaluated by the initial review
group. Biographical sketches of those investigators can be included in
the application in the center biographical sketch section.

Provide a brief narrative of the proposed cores and their expected
impact on the research base. The more important aspects will be: (1)
interactions and interrelationships of the research efforts; (2) uses
and benefits of core services; and (3) plans to develop productive
collaboration among Core Center investigators. Indicate if any of the
proposed cores will utilize or expand cores already existing at the
institution. Provide a table of those core costs that are estimated for
support of pilot and feasibility projects (see Exhibit III for suggested
format.)

### 

Reviewers will be instructed to address the following review criteria:
Is there a substantial productive and funded research base? Is the
research base sufficiently broad to foster new research? Will the
proposed cores enhance the research base? Is there a definition of who
will be a Center investigator and what this designation might mean?

## Institutional Environment and Resources 

Briefly describe the features of the institutional environment that are
relevant to the effective implementation of the proposed Core Center. 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. Campus maps and floor plans of space for the
cores of the Core Center are helpful. Include a list of who occupies
specific space, the square feet and equipment in that space, and a
designation of the Core Center functions associated with the spaces
designated. What institutional commitments for space or other resources
are there for the proposed Core Center? Include any letters of support
for the proposed Center by appropriate institutional officials,
including Directors of a General Clinical Research Center (GCRC) or
Clinical Translational Science Award (CTSA) funded by the NIH National
Center for Research Resources, if applicable.

Reviewers will be instructed to address the following review criteria:
Is there evidence of a supportive institutional environment for the
proposed Core Center? Will the Core Center add an important research
element to the institutional environment? Does the proposed Core Center
utilize available resources well? Is there support and commitment from
the institutional authorities?

## Progress Report (if application is a Renewal or Competing Continuation Application)

All applications for competitive renewal must provide the following
information in the progress report:

-   A description of the changes that have resulted from the presence of
    the Center (e.g., increased numbers of research grants and research
    papers);

-   A description of the activities before the existence of the Center
    (or at the beginning of the last award period) compared with any
    changes brought about by the Center\'s activities;

-   The results of each core supported by the Center during the previous
    grant period;

-   The results of each pilot project supported by the Center over the
    past 10 years (if applicable); and

-   A list of publications that have resulted specifically supported
    with Center funding.

Reviewers will be instructed to judge whether the progress report
reflects significant accomplishments that were derived from the Core
Center, as reflected in publications and new research directions.

## Pilot and Feasibility Program Management 

The Administrative Unit will oversee the use of funds for the proposed
Pilot and Feasibility Program. A management plan for the Pilot and
Feasibility Program should be described. This plan should include
designating a director who is an established investigator. There should
be a committee to assist the director in the management of the program.
The major responsibilities of the director and the committee will be to:

\(1\) Prepare and ensure appropriate distribution of announcements of
the availability of pilot and feasibility funding;

\(2\) Arrange and preside over the scientific merit review of pilot
proposals submitted;

\(3\) Make recommendations to the Core Center Executive Committee (or
equivalent) for final decisions;

\(4\) Maintain oversight and review of ongoing pilot and feasibility
studies;

\(5\) Make recommendations regarding termination or other actions to the
Core Center Executive Committee (or equivalent); and

\(6\) Maintain, insofar as is possible, a record of subsequent status of
the research developed (funding and manuscripts) and the further career
development of each pilot and feasibility study recipient.

**Using the management plan described, an initial set of pilot and
feasibility proposals should be solicited and evaluated for inclusion in
the Core Center application.** All reviewers should assign priority
scores in accordance with the NIH system. At least one reviewer from
outside the applicant institution must be used for each proposal
selected. Other details on handling the internal review will be left to
the Core Center.

Review of the Core Center application will include review of the
selected pilot and feasibility proposals. The quality of the proposals
submitted and the management plan described are major criteria in
evaluating the Core Center application. A dollar amount up to \$100,000
in direct costs yearly will be recommended for supporting future pilot
and feasibility studies.

Since pilot and feasibility studies may be awarded for any period of
time up to three years, studies may be ending at various times during
the overall duration of the grant. In addition, studies may also be
terminated by the Core Center administration before their approved time
limit for various reasons: (1) the investigator may receive outside
funding for the project; (2) the project is found not to be feasible;
(3) the investigator may leave the Core Center institution; etc. When
such situations result in the termination of the study, the Core Center,
using the mechanism described, may make new awards for pilot and
feasibility studies with the remaining funds. After the initial review
of pilot and feasibility proposals, responsibility for review and
decisions for funding of individual pilot and feasibility studies during
the remainder of the project period will reside within the Core Center
itself. Future pilot and feasibility studies to be identified should be
budgeted as a block under \"Other expenses\" in the Administrative unit.

Reviewers will be instructed to judge whether the management plan
described is appropriate and adequate for reviewing proposals for, and
administering funds in, the Pilot and Feasibility Program.

**III.B.** **Budgeted Components**

Each budgeted component should be presented in PHS 398 format, without
page 1 (Face Page). Text corresponding to sections 2 through 5 of the
standard PHS Table of Contents (Specific Aims, Background and
Significance, Preliminary Studies, and Research Design and Methods) must
not exceed 15 pages for a given budgeted component. Comprehensive
budgetary justifications should be given for all items.

## Administrative Unit

In place of a research plan, this part of the application should
discuss:

(1) The roles of the Director and Associate Director;

(2) Relationships and lines of authority and sanction by appropriate
    institutional officials;

(3) Committee structure (including the committee for the Pilot and
    Feasibility Program).

The functions assigned to the Administrative Unit should be described.
These functions may include:

\(1\) Coordination and integration of the Core Center components and
activities;

\(2\) Reviewing the utilization of funds for pilot and feasibility
studies and for cores;

\(3\) Advising the Core Center Director about the activities of the Core
Center;

(4) Implementing an enrichment program.

The use of outside consultants for the Core Center is strongly
encouraged. Such consultants may play a role in reviewing progress of
cores and pilot studies and be a part of the enrichment program of the
center. It is helpful to have a diagram of the interactions to be
fostered by the Core Center. The Administrative Unit may request support
for personnel, administrative functions, enrichment activities, and
travel.

Personnel should include the Center Director, who is responsible for the
organization and operation of the Center, and an Associate Director, 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. An Executive Committee representing the research base for the
Center should also be identified. Their collective expertise should
reflect the research breadth included in the research base of the
Center. (Their qualifications are to be presented elsewhere in the
application in a section on Qualifications of the Center Leadership -
see Section IV.B.1.) Administrative support personnel may be budgeted at
no more than one full time equivalent (FTE) that may be divided among
one or more positions. This FTE must be fully justified.

The Core Center grant may also include limited funds for program
enrichment (i.e., seminars, visiting scientists, etc); these should be
included in the description and the budget of the Administrative Unit.

Travel of the Core Center Director and one Co-Director to and from the
Washington, D.C. area should be included in the Administrative Core for
attendance at an annual Core Center meeting.

Future pilot and feasibility studies to be identified should be budgeted
as a block under \"Other expenses\" in the Administrative Unit.

Reviewers will be instructed to address the following review criteria:

> Does the proposed Core Center document coordination of ongoing
> research between the separately funded projects and the Core Center
> including mechanisms for internal monitoring? Is there a plan for the
> establishment and maintenance of internal communication and
> cooperation among the Core Center investigators, core leaders and an
> executive committee? Are there plans for outside review and input?
>
> Is the management proposed appropriate for fiscal administration,
> procurement, property and personnel management, planning, budgeting,
> etc.? Are the Core Center budgets appropriate for the proposed and
> approved work to be done in core facilities, for pilot and feasibility
> studies, and for enrichment in relation to the total Core Center
> program?
>
> Is there a plan for an enrichment program (e.g., a seminar series with
> outside and internal speakers)?
>
> Is there scientific and administrative leadership, commitment and
> ability, and adequate time commitment of the Core Center Director and
> Associate Director for the effective management of the Core Center
> program? Have institutional lines of authority and sanction been
> documented for the Core Center?

## 

## Research Cores

To be funded, a core center must have two or more highly meritorious
research cores.

### [Definition]{.underline}

A research core in a Core Center is a shared facility that provides a
service that enables Core Center investigators to conduct their
independently funded individual research projects more efficiently or
more effectively. Cores should be designed to furnish a group of
investigators some service, technique, assay, or instrumentation in a
manner that will enhance the research in progress, consolidate manpower
effort, and contribute to cost effectiveness in terms of providing a
service at less cost or of higher quality than if each investigator were
to attempt the same thing individually. A core should also attract new
investigators to an area of research by offering specialized services
not easily duplicated in an individual laboratory.

Cores may be proposed in relation to any acceptable research activity of
the Core Center, but usually fall into one of four categories: (1)
provision of a technology that lends itself to automation or preparation
in large batches (e.g., histology and tissue culture); (2) complex
instrumentation (e.g., electron microscopy); (3) animal preparation and
care; and (4) service (e.g., molecular biology, biostatistics, patient
data base).

In addition to providing a product or a service, a core must maintain
appropriate quality control. Training in complex techniques and
methodologies for Core Center investigators is also an important
function of these cores. The cores are not intended to supplant
investigator capabilities, but rather are intended to enhance their
opportunities to learn and become proficient in the core technologies.

Limited developmental research is also an appropriate function of a core
facility so long as it is directly related to enhancing the functioning
or utility of the core and is not an undertaking that should be funded
through other mechanisms.

Note that NIH has policies for animal and human subjects, including the
inclusion of women, minorities and children which **must** be addressed
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}

### [Justification for proposing a core]{.underline}

State the reasons a core is needed. What value will be added to the
research base? This is an especially important point to document if the
proposal is to buy into an existing institutional core.

The establishment of research cores within a Core Center may be
justified only on the basis of use by [independently funded Core Center
investigators]{.underline}. The minimum requirement for establishment of
a core facility is significant usage by two or more investigators with
peer reviewed projects that are independently funded. How the core will
enhance the research productivity of these investigators should be
described. While investigators holding awards from the Core Center pilot
and feasibility program may be appropriate users of the core facilities,
their use does not contribute to justification for establishment or
continued support of a core. Additionally, the minimum of two funded
investigator users does not in itself provide sufficient justification.
Establishment of a core with a minimal number of users calls for
particular justification on the part of the applicant and will receive
close scrutiny during review.

### [Personnel]{.underline}

A director should be named for each core. Core directors may be
acknowledged experts with an independently funded research program that
will use the core services. In such cases, the percent effort on the
grant is usually relatively low. Alternatively, a core director may be a
more junior scientist with reasonable expertise who may devote a greater
effort to the core. Rarely would a core director devote 100 percent
effort; justification for this would be given very close scrutiny. In
the case of a core director who is not yet an established investigator,
an established expert must be included as a consultant to the core. The
career potential and institutional commitment to junior scientist core
directors will be considered in the review. A technician is allowable as
a participant in accordance with the volume and type of work in the
core, but a technician cannot be a core director.

### [Facilities, space, and special arrangements]{.underline}

The description of the physical arrangements and instrumentation for the
cores should be given special attention. Institutional commitment to
provide space or to cost share in equipment should be documented if
possible. In renewal applications, any changes should be carefully
documented. Whenever possible, Core Centers are encouraged to enter into
cooperative arrangements with established cores in other centers or
resource grants offering a similar type of service at the applicant
institution.

### [Management of the core]{.underline}

The organization and proposed mode of operation of each core should be
presented. Included should be a plan to prioritize investigator use of
the core as well as a definition of qualified proposed and potential
users. This need not be a narrow definition, since some use of a core
might be an enticement to established investigators in other fields to
lend their expertise to the research base. If the core is used to train
investigators in special techniques, the extent of, and approach to,
this training should be included.

It is expected that center investigators using the core will provide
some reimbursement to the core. This reimbursement plan will offset some
of the costs specific for a project using the core.

The reimbursement plan should be described.

### [Research Core Format Guidelines]{.underline}

Present each core separately using Form PHS 398 without page 1.

Descriptive page: Use PHS form 398 page 2. Include a description and key
personnel.

Budget: It is important to provide comprehensive budgetary
justifications; and to discuss mechanisms for reimbursing core services.
To assist reviewers in understanding how the core budget will be
distributed to pilot and feasibility studies within the Core Center, it
is helpful to provide a table of supplies and expenses in the core
budget associated with each pilot and feasibility study (see Exhibit
III). Avoid duplication of budget items in the cores and the pilot and
feasibility studies.

Resources and Environment**:** Special attention should be given to
describing the space and resources available for the core service(s)
proposed.

Specific aims: Describe the broad, long-term objectives, and describe
concisely the specific aims to be accomplished by the core. Include
developmental research or training, if proposed.

Background and Significance: Describe the background information and
gaps that lead to the proposal of the core. A table such as that in
Exhibit IV is helpful to describe for reviewers the projected use of the
proposed core by funded investigators.

Research Design and Methods: Each proposed technique or service should
be described in enough detail to allow the reviewers a comprehensive
evaluation. Include how the core will be organized and how use will be
prioritized. Where applicable, include sections on quality control and
data analysis. See Exhibit V as an example for the kind of information
that would be helpful to the reviewers.

Other**:** Include the sections on Human Subjects, including the
inclusion of women and minorities, Vertebrate Animals,
Consultants/Collaborators, Consortium/Contractual Arrangements, and
Literature Cited. If not applicable, mark them N/A.

Reviewers will be instructed to address the following review criteria:

**Significance:** Will the core have utility to the Core Center research
base (minimum: two independently funded investigators)?

**Approach:** Is the quality of services high? Are there procedures for
quality control? Is the core cost effective? How is cost reimbursement
proposed?

**Innovation:** Are unique services offered?

**Investigators:** Are the personnel appropriate?

**Environment:** Are the facilities and equipment adequate? Is there
institutional commitment to the core?

## Pilot and Feasibility Projects

Research projects associated with a Core Center will be funded from
other resources, most notably individual research grants (R01) or
program project grants (P01) from NIH and similar project funding from
other Federal agencies or non-Federal sources. Exceptions to this
outside support are pilot and feasibility studies funded as part of the
Core Center.

Up to \$100,000 direct costs yearly may be budgeted for pilot and
feasibility studies.

### [Definition]{.underline}

The pilot and feasibility program provides modest research support
(\$20,000 to \$50,000 yearly) for a limited time (1 to 3 years) to
enable investigators to explore the feasibility of a concept related to
the research supported by the Core Center and obtain sufficient data to
pursue it further through other funding mechanisms. Pilot and
feasibility study support is [not]{.underline} intended for large
undertakings of established investigators for which it would be
appropriate to submit separate research grant applications. Pilot and
feasibility funds are also not intended to support or supplement ongoing
supported research of an investigator. A given investigator can receive
pilot and feasibility funds no more than once every 5 years.

### [Eligibility and related guidelines]{.underline}

Investigators eligible for pilot and feasibility funding generally fall
into three categories:

> \(1\) New investigators without current or past NIH research project
> support (e.g., R01 or P01) as a principal investigator to engage in
> innovative research (see
> <http://grants1.nih.gov/grants/new_investigators/resources.htm#definition>
> for the definition of a new investigator). In addition, they should
> not have extensive research experience. However, although
> investigators should be clearly independent with clear potential to be
> a productive independent investigator, they do not need to have a
> faculty appointment. Serving as a PI of a pilot and feasibility
> project will not change one's status as a new investigator.

\(2\) Established investigators with no previous work in research
related to the focus of the Core Center who are willing to test the
applicability of their expertise on a problem related to the Core Center
focus; and

\(3\) Established investigators in the Core Center with a proposal for
testing the feasibility of a new or innovative hypothesis that is
related to the research focus of the Core Center, but represents a clear
and distinct departure from the investigator\'s ongoing research
interest.

**Each pilot and feasibility study proposal should state clearly the
justification for eligibility of the investigator under one of the above
three criteria at the beginning of the proposal**. Indicate why this is
a pilot study and where it might lead. A pilot and feasibility study
should present a testable hypothesis and clearly delineate the question
being asked, detail the procedures to be followed, and discuss how the
data will be analyzed. It must be on a topic related to the research
base. Items 2 -- 5 of the Research Plan (Specific Aims, Background and
Significance, Research Design and Methods) may not exceed a total of 15
pages. This page limitation does not apply to subsections 6 -- 17. Note
that preliminary studies are not required. Each project should be
submitted using Form PHS 398.

Note that NIH has policies for the use of vertebrate animals and for
human subjects, including the inclusion of women, minorities and
children which **must** be addressed in **each** pilot proposal, 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}

### [Pilot and Feasibility Project Format Guidelines (see Exhibit I)]{.underline}

Present each study separately using Form PHS 398 without page 1 (unless
from a consortium institution). Follow the instructions and include:

\(1\) Description page, using PHS form 398 page 2.

(2) Budget with justifications;

(3) **Justification of eligibility of the principal investigator and
    also of the study as a pilot study (including where the project
    could lead);**

(4) Scientific proposal as outlined in form PHS 398 (including
    justification for core use if applicable); note that items 2 - 5 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 is exclusive of subsections 6 -- 17;

(5) Include the sections on Human Subjects, including the inclusion of
    women and minorities, Vertebrate Animals, Consultants/Collaborators,
    Consortium/Contractual Arrangements, and Literature Cited. If not
    applicable, mark them N/A.

> .

Reviewers will be instructed to address the following review criteria:

**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 promotes innovative new
research related to the Core Center?

**Investigators:** Does the investigator meet one of the criteria for
P&F investigators? (If not, the project should not be considered
further.)

**Environment:** Is the project appropriate to the research base of the
Core Center? Does one or more of the cores offer needed
materials/assistance?

**IV. APPLICATION FORMAT (see Exhibit I)**

## General Information and Appendix Material

It is desirable for Core Center 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.

PHS 398 is required for all applications. Each Budgeted Component
(Administrative Unit, Research Core, or Pilot and Feasibility Project)
should be written as an individual project using form PHS 398. For pilot
projects, items 2 -- 5 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 is exclusive of subsections 6 --
17.

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.

### **Appendix Material.**

Include key reprints and other supporting material. See instructions on
appendices in the instruction manual for Form PHS 398. Different
sections of the Core Center application may be reviewed by different
reviewers. Appendices are not required, but if submitted, each piece of
appendix material should be labeled with the Center Director and the
project, core, or other category to which it belongs. EXAMPLES: Appendix
1 -- John Doe -- Project 1; Appendix 2 -- John Doe -- Core B. All 5
copies of appendices should be sent to:

Chief, Review Branch

NIAMS/NIH

6701 Democracy Blvd., Suite 800 -- MSC 4872

Bethesda, MD 20892-4872

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

> Telephone: (301) 594-4952

## Content Order for the Core Center Application

### **Face Page of Form PHS 398.** 

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

### **Page 2, Description:** 

Describe the proposed program indicating the goals and objectives of the
projects. Do not exceed the space allowed. Key personnel are those
doctoral level investigators with a percent effort on the grant:
component/core Directors or Co-Directors, principal investigators of
pilot and feasibility studies, and consultants.

### **Table of Contents.** 

Discard this page from Form PHS 398 and write a Table of Contents
appropriate for the Core Center grant application. This 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 pilots and cores for which
funding is sought. See Exhibit I for a suggested format. Each pilot and
feasibility study 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, other support, and bibliographic sketches.

### **Budgets.** 

For budget pages, see Exhibits VI, VII and VIII Use the forms found as
form pages 4 and 5 in PHS Form 398 for all budgets. Justify and document
all costs for current and future years throughout.

The overall Center budget, \"Summary Center Budget,\" is to be presented
first using PHS Form 398 page 4 entitled \"Detailed Budget for First
12-Month Period\" (see Exhibit VI). Note that no details need be given
for the individual categories. Page 5 of PHS Form 398, \"Budget
Estimates for All Years of Support Requested Direct Costs Only\", should
then follow, summarizing all individual budgets (see suggested format in
Exhibit VII). 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 VIII is suggested. For
the purpose of establishing future year budget requests, the applicant
should use cost escalations specified in the RFA or less. However, **the
direct cost budget cannot exceed \$400,000 in any year**. This does not
include the indirect costs of subcontracts. (See NOT OD-04-040:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html> )

Individual budgets, both first 12 month and 5 year, should be included
later, *with each pilot and feasibility study (1 to 3 years) and core (5
years) for which funding is sought*. Details and justifications for all
budget items must be part of the individual budgets. Read carefully the
instructions for PHS 398 on how to prepare budget pages and
justifications.

-   This grant mechanism is not intended for the acquisition of
    equipment. Costly items of equipment should be funded through other
    sources. Under unusual circumstances, where costly items of
    equipment are requested, the application must document available
    equipment within the institution and provide clear justification in
    terms of core service to be provided by the Core Center
    investigators.

### **Biographical Sketches.** 

Biographical sketches are required for all professional level personnel
who are listed with a percent effort (including consultants) in the Core
Center application. Biographical sketches are also desirable for those
investigators designated as Core Center Investigators without a
dedicated percent effort. The forms found in Form PHS 398 should be
used. Begin with the Center 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.

### **Assurance Documentation.** 

See sample suggested table, Exhibit IX. 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.

### **Narrative Sections.** 

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

-   **Overview**

-   **Qualification of the Center Leadership**

-   **Research Base for the Core Center and Impact of Proposed Research
    Cores**

-   **Institutional Environment and Resources and Impact of Proposed
    Research Cores**

-   **Progress Report (if a Renewal or Competing Continuation
    Application)**

-   **Pilot and Feasibility Program Management**

### **Budgeted Components**

See Section IV for content information. Present each individual core and
pilot study in the following order using the PHS 398 forms. Text
corresponding to sections 2 through 5 of the standard PHS Table of
Contents (Specific Aims, Background and Significance, Preliminary
Studies, and Research Design and Methods) must not exceed 15 pages for a
given budgeted component. This page limitation is exclusive of
subsections 6 -- 17.

-   **Administrative Unit**

-   **Research Cores (minimum of 2)**

-   **Pilot and Feasibility Studies**

# V. REPORTING REQUIREMENTS AND ANNUAL EVALUATION

Annual progress reports, submitted as part of the annual noncompeting
continuation application are due two months before the anniversary date
of the award. These reports are used by the NIAMS and advisory
committees to review the Core 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 annual reports, planning programs, and
communicating scientific accomplishments.

A progress report containing the following information is to be
submitted with the annual continuation application. The report should
include the following:

1\. A summary (equivalent to no more than 2-4 single-spaced pages) of
the goals and significant activities of the Core Center. This summary
should be prepared for a general audience;

2\. A discussion of the effectiveness of the Core Center in furthering
the goals of the Core Centers Program. This should include a summary of
the specific accomplishments that can be attributed to the Center grant.
List what has been accomplished with the Core Center and what would not
have been done without it; e.g., new research funding, persons educated,
changes in curricula, patients seen, or organizational improvements
within the institution;

3\. A discussion of any problems which impede accomplishment of the
stated goals in the administration of the Core Center grant;

4\. Itemize all collaborative efforts which the Core Center has
established and is conducting with other Core Centers. This should
include a description of each activity, identification of the other Core
Center(s) involved, and any results obtained so far;

5\. **A copy of each new pilot and feasibility application to be funded
by the Core Center.** These applications should be complete and should
follow the guidelines for pilot studies in Section IV.H.of these
guidelines. [IACUC and IRB approvals should be included]{.underline}.

6\. A detailed summary of each Core Center activity and project
including the title, principal investigator and key personnel, their
percent efforts, budgets, description, progress and evaluation. This
progress report should include all Core Center supported projects
initiated during the budget period, all continuing Core Center supported
projects, and any Core Center supported projects terminated during the
budget period. It is especially important that the significance and
ultimate utility of each project be discussed in the summary
description;

7\. A budget of the estimated use of funds for each core and project. In
conjunction with the programmatic description, this report will describe
allocations in the usual budget categories (i.e., personnel, equipment,
travel, etc.) as well as the total expenditures. Separate budget pages
should be used for each project and core in addition to a composite
budget for the entire Core Center;

8\. An updated table of assurances. (See Exhibit IX);

9\. A table showing all support associated with the Core Center. This
should include both federal and non-federal support. At a minimum, this
would include all individual research grants, program projects, training
grants, National Research Service Awards, Clinical Investigator Awards,
etc. The table should list, for each source of support, the title of the
project, name of the principal investigator, identifying number of the
grant, percent effort of the investigator, dates of support, current
annual support, and total support. If the Core Center has no other
associated support, state this fact;

10\. Other information that, from year-to-year, may be requested by
NIAMS staff.

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

In addition to the annual progress report, the NIAMS Centers Program
Director may conduct site visits to gain added insight into the various
aspects of the Core Center operations. The NIAMS will hold a meeting at
various intervals for the Core Center Directors and Co-Directors to
review the operation of the Core Center program as a whole.

EXHIBIT I \-- Format & Table Of Contents

***Sample of Suggested Format***

ABC University

Application for a Research Core Center

Table of Contents

###### Page \#

## General Material  {#general-material .Style1}

## Face Page  {#face-page .Style1}

## Description  {#description .Style1}

## Performance Site and Key Personnel  {#performance-site-and-key-personnel .Style1}

## Table of Contents  {#table-of-contents-1 .Style1}

## Detailed Overall Budget for Initial Budget Period -- See Exhibit VI  {#detailed-overall-budget-for-initial-budget-period-see-exhibit-vi .Style1}

## Overall Budget for Entire Proposed Period of Support -- See Exhibit VIII  {#overall-budget-for-entire-proposed-period-of-support-see-exhibit-viii .Style1}

## Detailed Summary (Composite) Center Budget -- See Exhibit VII  {#detailed-summary-composite-center-budget-see-exhibit-vii .Style1}

## Biographical Sketch -- Principal Investigator (not to exceed 4 pages)  {#biographical-sketch-principal-investigator-not-to-exceed-4-pages .Style1}

## Other Biographical Sketches -- for Key Personnel in alphabetical order  {#other-biographical-sketches-for-key-personnel-in-alphabetical-order .Style1}

## Table of Assurances (See Exhibit IX)  {#table-of-assurances-see-exhibit-ix .Style1}

## Human Subject Education Certifications  {#human-subject-education-certifications .Style1}

## Overall Resources  {#overall-resources .Style1}

## Narrative Sections {#narrative-sections .Style1}

## Overview of the Core Center  {#overview-of-the-core-center .Style1}

## Qualifications of the Center Leadership  {#qualifications-of-the-center-leadership-1 .Style1}

## Research Base for Core Center and Impact of Proposed Cores  {#research-base-for-core-center-and-impact-of-proposed-cores .Style1}

## Table of Grant Support for Research Base -- See Exhibit II  {#table-of-grant-support-for-research-base-see-exhibit-ii .Style1}

## Institutional Environment and Resources and Impact of Proposed Cores {#institutional-environment-and-resources-and-impact-of-proposed-cores .Style1}

## Letters of Support  {#letters-of-support .Style1}

## Progress Report (if applicable)  {#progress-report-if-applicable .Style1}

## Pilot and Feasibility Management Program  {#pilot-and-feasibility-management-program .Style1}

## Budgeted Components {#budgeted-components-1 .Style1}

## Title page -- Core A: Administrative Unit: John Doe, M.D.  {#title-page-core-a-administrative-unit-john-doe-m.d. .Style1}

## Description, Performance Site, and Personnel  {#description-performance-site-and-personnel .Style1}

## Table of Contents  {#table-of-contents-2 .Style1}

## Detailed Budget for Initial Budget Period  {#detailed-budget-for-initial-budget-period .Style1}

## Budget for Proposed Period of Support  {#budget-for-proposed-period-of-support .Style1}

## Budgets Pertaining to Consortium/Contractual Arrangements.  {#budgets-pertaining-to-consortiumcontractual-arrangements. .Style1}

## Resources  {#resources .Style1}

## Research Plan (limit 15 pages excluding subsections c-g)  {#research-plan-limit-15-pages-excluding-subsections-c-g .Style1}

## Specific Aims  {#specific-aims .Style1}

## Structure to Accomplish Aims  {#structure-to-accomplish-aims .Style1}

## Leadership and Organizational Structure  {#leadership-and-organizational-structure .Style1}

## Advisory Committee  {#advisory-committee .Style1}

## Enrichment Program {#enrichment-program .Style1}

## Bibliography and References Cited *(if applicable)*  {#bibliography-and-references-cited-if-applicable .Style1}

##  {#section-4 .Style1}

## Human Subjects *(if applicable)*  {#human-subjects-if-applicable .Style1}

## Protection of Human Subjects  {#protection-of-human-subjects .Style1}

## Inclusion of Women  {#inclusion-of-women .Style1}

## Inclusion of Minorities  {#inclusion-of-minorities .Style1}

## Inclusion of Children  {#inclusion-of-children .Style1}

## Data Safety and Monitoring Plan  {#data-safety-and-monitoring-plan .Style1}

## Target enrollment table  {#target-enrollment-table .Style1}

## Vertebrate Animals *(if applicable)*  {#vertebrate-animals-if-applicable .Style1}

## Consortium/Contractual Arrangements *(if applicable)*  {#consortiumcontractual-arrangements-if-applicable .Style1}

## Letters of Support {#letters-of-support-1 .Style1}

## Letters of Support {#letters-of-support-2 .Style1}

## Title Page: Research Core B: Core Name, Jane Case, Ph.D.  {#title-page-research-core-b-core-name-jane-case-ph.d. .Style1}

## Description, Performance Site, and Personnel  {#description-performance-site-and-personnel-1 .Style1}

## Table of Contents  {#table-of-contents-3 .Style1}

## Detailed Budget for Initial Budget Period  {#detailed-budget-for-initial-budget-period-1 .Style1}

## Budget for Entire Proposed Period of Support {#budget-for-entire-proposed-period-of-support .Style1}

## Budgets Pertaining to Consortium/Contractual arrangements  {#budgets-pertaining-to-consortiumcontractual-arrangements .Style1}

## Resources {#resources-1 .Style1}

## Research Plan (limit 15 pages excluding subsections d-i)  {#research-plan-limit-15-pages-excluding-subsections-d-i .Style1}

## Specific Aims  {#specific-aims-1 .Style1}

## Background and Significance  {#background-and-significance .Style1}

## Research Design and Methods  {#research-design-and-methods .Style1}

## Distribution of Costs among Projects  {#distribution-of-costs-among-projects .Style1}

## Use Of Core Facilities (see Exhibit IV) {#use-of-core-facilities-see-exhibit-iv .Style1}

## Bibliography and References Cited  {#bibliography-and-references-cited .Style1}

## Human Subjects  {#human-subjects .Style1}

## Protection of Human Subjects  {#protection-of-human-subjects-1 .Style1}

## Inclusion of Women  {#inclusion-of-women-1 .Style1}

## Inclusion of Minorities  {#inclusion-of-minorities-1 .Style1}

## Inclusion of Children  {#inclusion-of-children-1 .Style1}

## Data Safety and Monitoring Plan  {#data-safety-and-monitoring-plan-1 .Style1}

## Target enrollment table  {#target-enrollment-table-1 .Style1}

## Vertebrate Animals  {#vertebrate-animals .Style1}

## Consortium/Contractual Arrangements  {#consortiumcontractual-arrangements .Style1}

## Letters of Support {#letters-of-support-3 .Style1}

## Repeat for additional cores {#repeat-for-additional-cores .Style1}

## Title Page -- Pilot and Feasibility Project 1: Novel signaling pathway for inflammation; Chin-Mei Lee, M.D.  {#title-page-pilot-and-feasibility-project-1-novel-signaling-pathway-for-inflammation-chin-mei-lee-m.d. .Style1}

## Description, Performance Site, and Personnel  {#description-performance-site-and-personnel-2 .Style1}

## Table of Contents  {#table-of-contents-4 .Style1}

## Detailed Budget for Initial Budget Period  {#detailed-budget-for-initial-budget-period-2 .Style1}

## Budget for Entire Proposed Period of Support {#budget-for-entire-proposed-period-of-support-1 .Style1}

## Budgets Pertaining to Consortium/Contractual arrangements  {#budgets-pertaining-to-consortiumcontractual-arrangements-1 .Style1}

## Resources {#resources-2 .Style1}

## Research Plan (limit 15 pages excluding subsections e-h)  {#research-plan-limit-15-pages-excluding-subsections-e-h .Style1}

## Justification of PF Eligibility  {#justification-of-pf-eligibility .Style1}

## Specific Aims  {#specific-aims-2 .Style1}

## Background and Significance  {#background-and-significance-1 .Style1}

## Research Design and Methods  {#research-design-and-methods-1 .Style1}

## Bibliography and References Cited  {#bibliography-and-references-cited-1 .Style1}

## Human Subjects  {#human-subjects-1 .Style1}

## Protection of Human Subjects  {#protection-of-human-subjects-2 .Style1}

## Inclusion of Women  {#inclusion-of-women-2 .Style1}

## Inclusion of Minorities  {#inclusion-of-minorities-2 .Style1}

## Inclusion of Children  {#inclusion-of-children-2 .Style1}

## Data Safety and Monitoring Plan  {#data-safety-and-monitoring-plan-2 .Style1}

## Target enrollment table  {#target-enrollment-table-2 .Style1}

## Vertebrate Animals  {#vertebrate-animals-1 .Style1}

## Consortium/Contractual Arrangements  {#consortiumcontractual-arrangements-1 .Style1}

## Letters of Support  {#letters-of-support-4 .Style1}

## Repeat for additional Pilot and Feasibility Projects  {#repeat-for-additional-pilot-and-feasibility-projects .Style1}

## Checklists  {#checklists .Style1}

##  {#section-5 .Style1}

## EXHIBIT II \-- Grants Supporting The Research Base

**Sample Of Suggested Format**

+-------------+-----------+---------------+-------------+-------------+
| *           | **Key     | **Title**     | **Project   | **Current   |
| *Supporting | Pe        |               | Period**    | Annual      |
| O           | rsonnel** |               |             | Amount**    |
| rganization |           |               |             |             |
| &**         |           |               |             |             |
|             |           |               |             |             |
| **Grant     |           |               |             |             |
| Number**    |           |               |             |             |
+-------------+-----------+---------------+-------------+-------------+
| NIH 5 R01   | Chen,     | New           | 3/1/2004 -- | \$467,000   |
| ARnnnnn     | Chin-Mei  | Therapeutic   | 2/28/2009   |             |
|             | (PI)      | Agents for    |             |             |
|             |           | Autoimmune    |             |             |
|             | Doe, John | Disease       |             |             |
+-------------+-----------+---------------+-------------+-------------+
|             |           |               |             |             |
+-------------+-----------+---------------+-------------+-------------+
|             |           |               |             |             |
+-------------+-----------+---------------+-------------+-------------+
|             |           |               |             |             |
+-------------+-----------+---------------+-------------+-------------+
|             |           |               |             |             |
+-------------+-----------+---------------+-------------+-------------+
|             |           |               |             |             |
+-------------+-----------+---------------+-------------+-------------+
|             |           |               | **TOTAL**   |             |
+-------------+-----------+---------------+-------------+-------------+

## EXHIBIT III \-- Distribution Of Core Unit Costs Among Research Projects

***Sample of Suggested Format***

  ------------ -------------- -------------- -------------- --------------
  PROJECTS     CORE A         CORE B         CORE C         CORE D

  P&F 1        \$ 3,000                      \$ 1,500       

  P&F 2        \$ 4,000       \$ 6,000       \$ 1,500       

  P&F 3        \$ 3,000                      \$ 2,500       \$ 5,500

  P&F 4        \$ 10,000      \$ 6,000       \$ 1,500       \$ 2,500

  TOTALS       \$ 20,000      \$ 12,000      \$ 7,000       \$ 8,000
  ------------ -------------- -------------- -------------- --------------

Only those supply costs and other expenses specific to a project are to
be listed. Personnel and equipment maintenance costs should
[not]{.underline} be prorated.

## EXHIBIT IV \-- Use Of Core Facilities 

**Sample Of Suggested Format**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

CORE: *NAME*

[Determinations/Services Rendered]{.underline}

A.

B.

Funded Projects with Period of Estimated Use

[Users]{.underline} [Identifying Number]{.underline} [Core
Use]{.underline} [Determinations/Services]{.underline} [&
Comments]{.underline}

1\.

2\.

3\.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

#### EXAMPLE

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

CORE: Cell Culture

##### Determination/Services Rendered

A. Fibroblast Cell Cultures

B. Cell Isolations

C. Special Media Preparation

D. Isotopic Labeling

Funded Projects with Period of Determinations/Services Estimated Use

[Users]{.underline} [Identifying Number]{.underline} [Core
Use]{.underline} [A]{.underline} [B]{.underline} [C]{.underline}
[D]{.underline} [& Comments]{.underline}

1\. J.F. Smith R01AR42846-02 3/06 - 2/09 X X B. 4 per mo

C. 15 per mo

2\. S.R. Jones K01AR41654-04 6/06 - 5/09 X X A. 2 per mo

D. 6 per mo

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

##  {#section-6 .Style1}

## EXHIBIT V\-- Sample of Information Useful to Reviewers

Sample of information useful to reviewers in evaluating a core. This
example was developed for a tissue acquisition core.

I. What types of samples are needed?

A. Diseases

B. Numbers of samples

C. Source of samples

D. Age

E. Sex

F. Tissues

II\. What patient population is available? Is it sufficient?

III\. What tissues are potentially available?

A. Neonatal foreskins

B. Surgical specimens of normal skin

IV\. Ability to communicate needs with clinicians:

> A. Is there regular contact between the core director and clinicians?
> A Ph.D. core director may be less desirable because of lack of patient
> contact and lack of regular contact with clinicians, especially
> clinicians not part of the research effort.
>
> B. How will needs be communicated to clinicians, especially residents
> and clinicians not engaged in research?

V. Ability to harvest tissues and transport tissues and supplies:

> A. Who will harvest tissues? (Same clinician who sees patients in a
> busy clinical setting; Residents; designated member of the tissue
> acquisition core)
>
> B. Will these be biopsies required for patient care or will the
> biopsies be only for research purposes? Is it feasible to expect
> additional biopsies to be performed in a busy clinic?
>
> C. How will the clinicians obtain needed special supplies required for
> harvesting certain tissues (flash freezing or special fixatives for
> EM)? Who will either transport these supplies to the clinic or
> maintain a stock in the clinic?
>
> D. Who will transport tissues to the core? This is especially critical
> with frozen tissues and tissues requiring viability.

VI\. Proof of previous ability to obtain similar samples:

> A. Publications and preliminary data demonstrating success at sample
> collection.
>
> B. Was it necessary to pay donors?

Justify budget and required technician effort by estimating volume of
samples and slides.

## EXHIBIT VI -- Composite 1^st^ Year Budget

<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"><strong>EXHIBIT VI</strong></td>
</tr>
<tr class="even">
<td colspan="16"></td>
</tr>
<tr class="odd">
<td colspan="10" rowspan="2"><p><strong>DETAILED BUDGET FOR INITIAL
BUDGET PERIOD</strong></p>
<p><strong>DIRECT COSTS ONLY</strong></p></td>
<td colspan="2">FROM</td>
<td colspan="4">THROUGH</td>
</tr>
<tr class="even">
<td colspan="2">4/01/2006</td>
<td colspan="4">3/31/2011</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">161,272</td>
<td colspan="4">48,311</td>
<td>209,583</td>
</tr>
<tr class="odd">
<td colspan="15"><p>CONSULTANT COSTS</p>
<p>     </p></td>
<td>6,000</td>
</tr>
<tr class="even">
<td colspan="15"><p>EQUIPMENT <em>(Itemize)</em></p>
<p>     </p></td>
<td>0</td>
</tr>
<tr class="odd">
<td colspan="15">SUPPLIES <em>(Itemize by category)</em></td>
<td>84,994</td>
</tr>
<tr class="even">
<td colspan="15"><p>TRAVEL</p>
<p>     </p></td>
<td>2,515</td>
</tr>
<tr class="odd">
<td rowspan="2">PATIENT CARE COSTS</td>
<td colspan="2">INPATIENT</td>
<td colspan="12">     </td>
<td>     </td>
</tr>
<tr class="even">
<td colspan="2">OUTPATIENT</td>
<td colspan="12">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td colspan="15"><p>ALTERATIONS AND RENOVATIONS <em>(Itemize by
category)</em></p>
<p>     </p></td>
<td>     </td>
</tr>
<tr class="even">
<td colspan="15"><p>OTHER EXPENSES <em>(Itemize by category)</em></p>
<p>     </p></td>
<td>34,223</td>
</tr>
<tr class="odd">
<td colspan="13">SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD</td>
<td colspan="2">$</td>
<td>337,315</td>
</tr>
<tr class="even">
<td colspan="7" rowspan="2">CONSORTIUM/CONTRACTUAL COSTS</td>
<td colspan="7">DIRECT COSTS</td>
<td colspan="2">62,686</td>
</tr>
<tr class="odd">
<td colspan="7">FACILITIES AND ADMINISTRATIVE COSTS</td>
<td colspan="2">55,791</td>
</tr>
<tr class="even">
<td colspan="13">TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD <em>(Item
7a, Face Page)</em></td>
<td colspan="2">$</td>
<td>455,791</td>
</tr>
<tr class="odd">
<td colspan="14">SBIR/STTR Only: FEE REQUESTED</td>
<td colspan="2">     </td>
</tr>
</tbody>
</table>

PHS 398 (Rev. 05/01) Page **Form Page 4**

## EXHIBIT VII -- Composite 5 Year Budget

<table style="width:100%;">
<colgroup>
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 9%" />
<col style="width: 16%" />
<col style="width: 0%" />
<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="6">Principal Investigator/Program Director (Last, First,
Middle):</td>
<td colspan="8"><strong>EXHIBIT VII</strong></td>
</tr>
<tr class="even">
<td colspan="14"></td>
</tr>
<tr class="odd">
<td colspan="14"><strong>BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD<br />
DIRECT COSTS ONLY</strong></td>
</tr>
<tr class="even">
<td colspan="3" rowspan="2">BUDGET CATEGORY<br />
TOTALS</td>
<td colspan="2" 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">2nd</td>
<td>3rd</td>
<td colspan="4">4th</td>
<td colspan="2">5th</td>
</tr>
<tr class="even">
<td colspan="3">PERSONNEL: <em>Salary and fringe benefits. Applicant
organization only</em>.</td>
<td colspan="2">209,586</td>
<td colspan="2">166,932</td>
<td>166,932</td>
<td colspan="4">166,932</td>
<td colspan="2">166,932</td>
</tr>
<tr class="odd">
<td colspan="3">CONSULTANT COSTS</td>
<td colspan="2">6,000</td>
<td colspan="2">6,000</td>
<td>6,000</td>
<td colspan="4">6,000</td>
<td colspan="2">6,000</td>
</tr>
<tr class="even">
<td colspan="3">EQUIPMENT</td>
<td colspan="2"></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 colspan="2">84,994</td>
<td colspan="2">51,144</td>
<td>51,144</td>
<td colspan="4">51,144</td>
<td colspan="2">51,144</td>
</tr>
<tr class="even">
<td colspan="3">TRAVEL</td>
<td colspan="2">2,515</td>
<td colspan="2">2,515</td>
<td>2,515</td>
<td colspan="4">2,515</td>
<td colspan="2">2,515</td>
</tr>
<tr class="odd">
<td rowspan="2">PATIENT CARE<br />
COSTS</td>
<td colspan="2">INPATIENT</td>
<td colspan="2">     </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 colspan="2"></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 colspan="2"></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 colspan="2">34,223</td>
<td colspan="2">110,723</td>
<td>110,723</td>
<td colspan="4">110,723</td>
<td colspan="2">110,723</td>
</tr>
<tr class="odd">
<td colspan="3">SUBTOTAL DIRECT COSTS</td>
<td colspan="2">337,315</td>
<td colspan="2">337,313</td>
<td>337,313</td>
<td colspan="4">337,313</td>
<td colspan="2">337,313</td>
</tr>
<tr class="even">
<td colspan="2" rowspan="2">CONSORTIUM/<br />
CONTRACTUAL<br />
COSTS</td>
<td>DIRECT</td>
<td colspan="2">62686</td>
<td colspan="2">62,686</td>
<td>62,686</td>
<td colspan="4">62,686</td>
<td colspan="2">62686</td>
</tr>
<tr class="odd">
<td>F&amp;A</td>
<td colspan="2">55791</td>
<td colspan="2">55,791</td>
<td>55,791</td>
<td colspan="4">55,791</td>
<td colspan="2">55791</td>
</tr>
<tr class="even">
<td colspan="3">TOTAL DIRECT COSTS</td>
<td colspan="2">455791</td>
<td colspan="2">455,790</td>
<td>455,790</td>
<td colspan="4">455,790</td>
<td colspan="2">455,791</td>
</tr>
<tr class="odd">
<td colspan="10">TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT PERIOD
<em>(Item 8a, Face Page)</em></td>
<td><strong>–––––</strong></td>
<td colspan="2">$</td>
<td>2,278,950</td>
</tr>
<tr class="even">
<td colspan="3"><p>SBIR/STTR Only</p>
<p>Fee Requested</p></td>
<td>     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="3">     </td>
</tr>
<tr class="odd">
<td colspan="11"><p>SBIR/STTR Only: Total Fee Requested for Entire
Proposed Project Period</p>
<p>(Add Total Fee amount to “Total direct costs for entire proposed
project period” above and Total F&amp;A/indirect costs from Checklist
Form Page, and enter these as “Costs Requested for Proposed Period of
Support on Face Page, Item 8b.)</p></td>
<td colspan="2">$</td>
<td>     </td>
</tr>
<tr class="even">
<td colspan="14"><p>JUSTIFICATION. Follow the budget justification
instructions exactly. Use continuation pages as needed.</p>
<p>     </p></td>
</tr>
</tbody>
</table>

PHS 398 (Rev. 05/01) Page **Form Page 5**

+--------------+------+------+------+------+-------+-------+----------+
| #            |      |      |      |      |       |       |          |
| # EXHIBIT VI |      |      |      |      |       |       |          |
| II \-- Conso |      |      |      |      |       |       |          |
| lidated Budg |      |      |      |      |       |       |          |
| et For 1st Y |      |      |      |      |       |       |          |
| ear Of Reque |      |      |      |      |       |       |          |
| sted Support |      |      |      |      |       |       |          |
|              |      |      |      |      |       |       |          |
| **Sample Of  |      |      |      |      |       |       |          |
| Suggested    |      |      |      |      |       |       |          |
| Format**     |      |      |      |      |       |       |          |
|              |      |      |      |      |       |       |          |
| ##           |      |      |      |      |       |       |          |
|              |      |      |      |      |       |       |          |
| ##           |      |      |      |      |       |       |          |
|              |      |      |      |      |       |       |          |
| ##           |      |      |      |      |       |       |          |
|              |      |      |      |      |       |       |          |
| ##           |      |      |      |      |       |       |          |
|              |      |      |      |      |       |       |          |
| ##           |      |      |      |      |       |       |          |
|              |      |      |      |      |       |       |          |
| ##           |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| BUDGET       | Pro  | Pro  | Pro  | Core | Core  | Core  | TOTAL    |
| CATEGORY     | ject | ject | ject | A    | B     | C     |          |
|              | 1    | 2    | 3    |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Personnel    |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Consultant   |      |      |      |      |       |       |          |
| Costs        |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Equipment    |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Supplies     |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Domestic     |      |      |      |      |       |       |          |
| Travel       |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Foreign      |      |      |      |      |       |       |          |
| Travel       |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Patient Care |      |      |      |      |       |       |          |
| Costs        |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Alteration   |      |      |      |      |       |       |          |
| and          |      |      |      |      |       |       |          |
|              |      |      |      |      |       |       |          |
| Renovation   |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Contractual  |      |      |      |      |       |       |          |
| Costs        |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| Other        |      |      |      |      |       |       |          |
| Expenses     |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+
| **Total      |      |      |      |      |       |       |          |
| Direct       |      |      |      |      |       |       |          |
| Costs**      |      |      |      |      |       |       |          |
+--------------+------+------+------+------+-------+-------+----------+

## EXHIBIT IX -- Animal & Human Subjects Assurance Tables

**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}: This table may need updating. 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        | 8/3/2006   | 9/5/2006     | Yes          |   |
+--------------+----------+------------+--------------+--------------+---+
| Dr. B        | 2        | 4/8/2006   | 9/5/2006     | Yes          |   |
+--------------+----------+------------+--------------+--------------+---+
| Dr. C        | 3        | 6/7/2006   | 8/5/2006     | Yes          |   |
+--------------+----------+------------+--------------+--------------+---+
| Dr. E        | 5        | 7/7/2006   | 9/5/2006     | Yes          |   |
+--------------+----------+------------+--------------+--------------+---+
| Dr. B        | Core A   | 8/3/2006   | NA           | NA           |   |
+--------------+----------+------------+--------------+--------------+---+
| Dr. D        | Core B   | 4/8/2006   | NA           | NA           |   |
+--------------+----------+------------+--------------+--------------+---+

+--------------+----------+------------+--------------+--------------+---+
| 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        | 4/15/2006  | 9/6/2006     | Yes          |   |
|              | (sub     |            |              |              |   |
|              | project) |            |              |              |   |
+--------------+----------+------------+--------------+--------------+---+
| Dr. D        | 4        | 4/15/2006  | 8/5/2006     | Yes          |   |
+--------------+----------+------------+--------------+--------------+---+
| Dr. Y        | Core B   | 4/15/2006  | NA           | NA           |   |
|              | (sub     |            |              |              |   |
|              | project) |            |              |              |   |
+--------------+----------+------------+--------------+--------------+---+

\* Attach certification letter