Applications are submitted on Grant Application Form PHS-398. All information requested in the instruction booklet should be provided. In addition, the application should be responsive to the information requested below.

In lieu of the Table of Contents outline presented on page 3 of the "398," a table of contents listing all of the major sections described in these guidelines should be prepared and paginated to enable reviewers to find specific information readily.

The Table of Contents will contain Section 1, Section 2- Research Plan, and Section 3- Appendix. The following guidelines will provide directions and descriptions for preparing each page. Major areas to be listed and paginated in the Table of Contents include Section 1, items 2 through 8, and Section 2, items 1 through 4.

Complete all items on the face page of the application. This is page 1 of the application; number succeeding pages consecutively.

In Item number 2, enter the appropriate title, SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH, and RFA number, and check the YES box.

On page 2, describe briefly the composite research program, indicate the emphasis of the component research projects, and identify the purpose of the proposed core units. DO NOT EXCEED THE SPACE PROVIDED.

Prepare the table of contents as noted above.

Prepare a series of composite budget tables for the U54 grant as requested below. A detailed budget is also required for each component research project and core unit. The latter not be repeated elsewhere in the application.

A. Composite Budget

Use page 4, "DETAILED BUDGET FOR FIRST 12-MONTH BUDGET PERIOD," of Form PHS-398 to present the total budget for all requested support for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., give only the aggregate amount requested for each component research project and each core unit with subtotals.

If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the "CONTRACTUAL COST" category. Costs for purchased services should be itemized under the "OTHER EXPENSES" category.

Use page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS-398 to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must also be justified in the individual component research project and core unit budgets (see below).

B. Individual Component Research Project and Core Budgets (*)

1) First year (use page 4 of the PHS 398 for each)

2) Total project period years 02-05 (use page 5 of the PHS 398 for each)

Budget Justifications & Explanations: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases in any category over the first 12-month budget period. Identify such significant increases with asterisks against the appropriate amounts. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3 percent.

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* Consortium budget (if applicable) same as B. Total direct and indirect costs of sub-awardee to be shown under Consortium/Contract costs in the individual component budget and a detailed sub-awardee budget to be placed behind project/core budget.

To aid in the review of your application, information on all current and pending research support of key personnel may be presented in tabular form such as shown in Sample Format I. Please indicate by an asterisk, research support that overlaps with projects proposed in the subject U54 applications. For all key personnel named on page 2 (except consultants), beginning with principal investigator/program director and in alphabetical order thereafter, list in two separate sections: 1) Current Support and 2) Applications Pending Review and/or Funding.

Biographical sketches are required for all professional and key personnel participating in the component research projects and core units (i.e., personnel listed on page 2). Begin with principal investigator/program director, and in alphabetical order thereafter, submit biographical sketches as directed in the "Instruction Sheet" for Form PHS-398. Do not exceed two pages for each person.

Complete the "Resources and Environment" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be 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, geographical distribution of space and personnel, and consultative resources.

Provide copies of all letters pertaining to consortium agreements and consultancies.

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section 2. Identify each component research project and each core unit by title. Assign each component research project a roman numeral (I,II,III) and assign each core unit a capital letter (A,B,C) that reflects the order in which the research projects and core units are presented in the application. For each component research project and each core unit, provide the name of the responsible investigator, and biographical sketches for personnel not identified previously.

A. Purpose of the Center. Discuss the Center's objectives and general plans for the proposed grant period.

B. Administration, Organization, and Operation. Include information on the support and commitment of the parent institution for the Center, the authority of the director and space assignment. Describe the organizational framework including the establishment of or intent to establish any external and/or internal advisory committees, and provide an organizational chart.

C. Assurances and Collaborative Agreements. Any arrangements for collaborative endeavors or subcontracting should be highlighted.

Discuss the composite research program, highlighting its central theme. List by title and investigator the component research projects and core units, showing the interrelationship between the research projects and the core units and their relationship to the central theme. Applications should include a description of how the Center will meet the special cooperative terms and conditions of the award as set forth in RFA HD-99-009, including its potential interactions with other Centers, their component projects and the Research Coordinator.

For each component research project, a full description of the project is to be provided following the format presented in Form PHS-398. An individual progress report is required for each competing continuation (renewal) project.

A. Introduction

Discuss the overall objectives of the core units; present the organizational framework or chart; highlight the decision-making process for use of core unit services, plans for quality control, and identify the proposed core units by title. To aid in the review of your application, the proposed quantitative distribution of core usage may be indicated in a composite tabular form (see Sample Format II).

B. Administrative Core Unit

1. Objective;
2. Organizational Chart (if appropriate);
3. Staffing (Professional and Support);
4. Resources & Environment: provide description of space and physical resources;
5. Services Provided (current and projected use): describe services to other core units and research projects.

C. Technical Service Core Units

1. Objective;
2. Staffing (Professional and Support);
3. Resources & Environment;
4. Administration; include description of a chargeback system and priority management procedures if the core will be configured in an open access format.
5. Justification: describe services provided with their bearing on productivity and quality;
6. Use: indicate estimated needs for usage (e.g., assays performed, animals supplied, etc.).