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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Cancer Institute (NCI) (http://www.nci.nih.gov/)

Title: Limited Competition: AIDS and Cancer Specimen Resource (ACSR) (U01)

Announcement Type
This funding opportunity announcement (FOA) is a reissue of RFA-CA-02-001, which was previously released on April 24, 2001.

Request For Applications (RFA) Number: RFA-CA-08-501

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 93.399

Key Dates
Release Date: November 19, 2007
Letters of Intent Receipt Date: Not Applicable
Application Receipt Date: January 15, 2008
Peer Review Date(s): March/April 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 2008
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 16, 2008

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Cancer Institute requests limited competition applications from the AIDS and Cancer Specimen Resource’s (ACSR s) East Coast, Mid-Region, and West Coast Biospecimen Repositories, and the Central Operations and Data Coordinating Center (CODCC) for the continued support of the collection, storage, and provision of HIV-related human tumor tissue with associated clinical, pathological, diagnostic, and demographic data.

The ACSR is currently funded through four U01 cooperative agreements (three of which are awarded to Regional Biospecimen Repositories and one to a single Central Operations and Data Coordinating Center, CODCC).

Background

In the United States alone, there are an estimated 988,000 people living with AIDS (2005 HIV/AIDS Surveillance Report, U.S. Centers for Disease Control and Prevention). The success of highly active anti-retroviral treatment (HAART) has led to a decrease in death due to opportunistic infections and has led to a reduced incidence of some AIDS-associated cancers such as Kaposi’s Sarcoma. However, the impact of HAART on the incidence of other malignancies such as Non-Hodgkin’s Lymphoma (NHL) has been marginal, and the incidence of some cancers, such as Hodgkin’s Lymphoma, appear to have increased in the HAART era. Despite the success of HAART, death due to cancer continues to rank as the second or the third cause of mortality among HIV-infected patients; as many as 28-30% of deaths in this population are attributed to cancer.

Prospective and longitudinal clinical samples collected across the time-line of the HIV/AIDS crisis are pivotal to understanding the epidemic and its impact on cancer incidence. Availability of such specimens also facilitates efforts to identify therapeutic targets and gain further insight into the pathogenesis and treatment of cancer in the HIV-infected population. Finally, these specimens are critical for highly needed studies of emerging non-AIDS defining cancers such as anogenital and lung cancers in HIV-positive patients.

The HIV/AIDS epidemic is a global issue. Developing countries face an increasing burden of HIV-associated cancers in their growing HIV positive populations. A goal of the resource will be to proactively develop tissue collections that include samples from other world regions with a large HIV burden. Through active international collaborations, the resource will be poised to capture the heterogeneity in types of cancer associated with HIV. These international links will help the scientific community better understand the biological basis of genetic and environmental factors that impinge upon ethnic and geographical differences in cancer incidence.

Organization and Goals of AIDS and Cancer Specimen Resource

The current structure of the ACSR consists of the East Coast, Mid-Region and West Coast Biospecimen Repositories and a Central Operations and Data Coordinating Center (CODCC). Each Regional Biospecimen Repository is composed of: (1) two or more member institutions who contribute biospecimens, biological fluids and data; and (2) a Regional Operations Office that provides the necessary coordination of specimen collection and data management. The CODCC is the administrative unit that coordinates the ACSR’s activities. The primary purpose of the ACSR is to acquire, store, and equitably distribute tumor tissues and biological fluids from patients with HIV-associated malignancies. This task is accomplished through the workings of two committees, the Steering Committee and the Research Evaluation and Decision Panel (REDP).

During the current project period, the ACSR took a number of fundamental steps to conform to The First Generation Guidelines for the NCI-Supported Biorepositories (now known as the NCI Best Practices for Biospecimen Resources, http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf). The ACSR was then evaluated by the NCI with respect to its performance and effectiveness based upon these guidelines. The evaluation clearly highlighted the strength of maintaining the ACSR in its current structure. However, this evaluation also suggested modifications to the FOA to assure the ACSR s adherence to NCI Best Practices, to establish a more effective means of tracking publications/patents/grants and contracts based on the analysis of biospecimens received from the ACSR, and to expand outreach programs to the patient advocacy community. In order to accommodate these and other modifications, three additional working groups will be added to the structural elements of the ACSR: Marketing, Outreach, and Tracking Working Group; Bioinformatics Working Group; and Auditing Working Group.

Based upon a competitive renewal mechanism, this initiative is designed to provide continued support for the specimen and data collection, storage, and distribution activities of the ACSR. Specimens are (and will continue to be) distributed to funded investigators working in the fields of HIV/AIDS, cancer, virology, immunology, pathology, epidemiology, assay/technology development, and many others. It is hoped that this broad distribution will encourage interdisciplinary HIV-related studies. This FOA also addresses specific objectives outlined in the FY08 Office of AIDS Research, NIH, Plan for HIV-Related Research (http://www.oar.nih.gov/public/pubs/fy2008/Preface.pdf).

The governing body of the ACSR is the Steering Committee. The Steering Committee’s membership will include: (a) the PI and one other investigator (also known as designee) from each Regional Biospecimen Repository; (b) the PI and a designee from the CODCC; (c) the NCI Program Official, (d) the NCI Project Scientist, (e) one or two external research scientist(s) with expertise in the field of HIV-associated malignancies but not affiliated with any of the Regional Biospecimen Repositories, the CODCC, or NIH; and (f) a patient advocate representing the HIV-infected patient community. The PI of the CODCC or his/her designee will serve as the Executive Secretary of the Steering Committee. (For details on the organization and responsibilities of Steering Committee, please see Section VI. 2.A. Cooperative Agreement Terms and Conditions of Award.)

Applications submitted in response to the Regional Biospecimen Repository component of this FOA must comply with the specific organizational and structural requirements as defined below.

(1) Steering Committee. Each Regional Biospecimen Repository will participate in the activities of the Steering Committee (as defined in Section VI. 2.A. Cooperative Agreement Terms and Conditions of Award) and implement its recommendations. Applicant teams must plan (and budget) for the participation of the PI and one other investigator/designee from each Regional Biospecimen Repository as Steering Committee members.

(2) Review and Evaluation Decision Panel (REDP). The REDP is an independent panel that evaluates all research proposing to use specimens and data from the ACSR. The panel will include six to eight scientists who have clinical/basic research expertise in the field of HIV-associated malignancies, but who are not affiliated with either the Regional Biospecimen Repositories or the CODCC. Investigators affiliated with the Regional Biospecimen Repositories as well as investigators from the research community-at-large may request the biospecimens and data of the Resource for research purposes by submitting appropriate Letters of Intent (LOIs). The PI and key investigators who comprise the applicant teams must agree (and plan accordingly) that all such LOIs will be evaluated by REDP according to the evaluation and review criteria established by the Steering Committee. Through their participation in the activities of the Steering Committee, the leadership of each proposed Regional Biospecimen Repository will be expected to work towards establishing standardized evaluation and review criteria for the REDP.

(3) Marketing, Outreach and Tracking Working Group. Each of the Regional Biospecimen Repositories will appoint a representative from their Regional Operations Office to participate on this Working Group that will also consist of: (1) the NCI Program Official; (2) the CODCC PI or his/her designee; (3) one of the PIs from the Regional Biospecimen Repositories (selected and appointed by the Steering Committee); and (4) a Patient Advocate from the HIV community. The Marketing, Outreach, and Tracking Working Group will plan and propose strategies to promote the resource to the research and patient community, to work towards educating the patient community about the existence and value of the ACSR, and to establish more effective means of tracking publications, patents, grants, and contracts that have been generated based upon the analysis of biospecimens received from the ACSR. Most meetings of the Working Group will be held via conference calls. However, applicant teams should plan (and budget) for the participation of their representatives in face-to-face meetings that will be held in conjunction with Steering Committee Meetings or other meetings (site visits, scientific conferences) where a majority of members can/will be present.

(4) Bioinformatics and Data Working Group. The Database Administrator from each of the Regional Biospecimen Repositories and one of the PIs of the Regional Biospecimen Repositories (selected and appointed by the Steering Committee) will serve on this Working Group that will also consist of: (1) the NCI Program Official; (2) the CODCC PI or his/her designee; (3) the CODCC Programming Consultant; and (4) the CODCC Database Administrator. The Bioinformatics and Data Working Group will be charged with the task of revising the ACSR informatics systems to bring the Resource closer to standards outlined in the National Institute of Standards and Technology Risk Management Guide for Information Technology Systems (http://csrc.nist.gov/publications/nistpubs/800-30/sp800-30.pdf) and the NCI Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf). The Bioinformatics and Data Working Group will be expected to design and propose strategies and plans for: (a) establishing interoperable systems to facilitate the process of obtaining clinical data; (b) attaining best practices status in data entry, security, and accessibility; and (c) increasing the compatibility of the Resource with the Cancer Bioinformatics Grid (caBIG). The PI and key investigators who comprise the applicant teams must be willing to participate in the creation and implementation of these strategies. In particular, the applicant teams should acknowledge that the Resource and its Regional Biospecimen Repositories are expected to reach the bronze level of caBIG compliance by 2009, with attempts to achieve silver level compatibility in the following years (https://cabig.nci.nih.gov/guidelines_documentation). Most meetings of the working group will be held via conference calls. However, applicant teams should plan (and budget) for the participation of their representatives in face-to-face meetings that will be held in conjunction with Steering Committee Meetings or other meetings (site visits, scientific conferences) where a majority of members can/will be present.

(5) Auditing Working Group. Each of the PIs from the Regional Biospecimen Repositories will serve on this panel that will also include: (1) the NCI Project Scientist; (2) the NCI Program Official; (3) the CODCC PI or his/her designee; (4) a Biostatistician; and (5) two research scientists whose expertise includes biorepository operations, but who are not affiliated with any of the Regional Biospecimen Repositories or the CODCC. The non-affiliated research scientists will be appointed by mutual agreement between the NCI Program Official and the PIs. The Auditing Working Group, in consultation with the NCI s Office of Biorepositories and Biospecimen Research, will establish reliable mechanisms to assess adherence to standard operating procedures (SOPs), manual of operations (MOO), NCI Best Practices, quality control/quality assurance (QC/QA) tests, etc., of the ACSR Regional Biospecimen Repositories and their sub-sites. The Auditing Working Group will propose changes and updates that will bring the Resource closer to compliance with NCI Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf ) and will propose processes to assess adherence of the Regional Biospecimen Repositories (including their sub-sites) to these changes. The PI and key investigators who comprise the applicant teams must agree to follow these processes. Most meetings of the working group will be held via conference calls. However, applicant teams should plan (and budget) for the participation of their representatives in face-to-face meetings that will be held in conjunction with Steering Committee Meetings or other meetings (site visits, scientific conferences) where a majority of members can/will be present.

Applications submitted in response to the Central Operations and Data Coordinating Center (CODCC) component of this FOA must comply with the specific organizational and structural requirements as defined below.

(1) Steering Committee. The CODCC will participate in the activities of the Steering Committee (as defined in Section VI. 2.A. Cooperative Agreement Terms and Conditions of Award) and implement its recommendations. Applicants must plan for the CODCC PI or his/her designee to act as the Executive Secretary for the Steering Committee.

(2) Marketing, Outreach and Tracking Working Group. The CODCC PI or his/her designee will coordinate the activities of this Working Group. For details on other members, goals, and anticipated activities for this Working Group, please see the description above under the requirements for the Regional Biospecimen Repository applications.

(3) Bioinformatics and Data Working Group the CODCC PI or his/her designee will coordinate the activities of this Working Group. The CODCC’s Programming Consultant and Database Administrator will be members of this Working Group. For details on other members, goals, and anticipated activities for this Working Group, please see the description above under the requirements for the Regional Biospecimen Repository applications.

(4) Auditing Working Group The CODCC PI or his/her designee will coordinate the activities of this Working Group. For details on other members, goals, and anticipated activities for this Working Group, please see the description above under the requirements for the Regional Biospecimen Repository applications.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH U01 cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator (PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

This FOA is a one-time solicitation. At this time, the NCI has not determined whether or how this solicitation will be continued beyond the present FOA.

2. Funds Available

The National Cancer Institute is providing 3.6 million dollars for the first year (total costs) for the ACSR on the basis of a competitive renewal. These funds will support up to four awards, which may include the three Regional Biospecimen Repositories and a single CODCC. A total of 18 million dollars (total costs) have been set aside to fund the four awards for 5 years. Applicants should request a project period of 5 years.

In the current funding period, the individual site awards have ranged from $300,000 1,000,000 (direct costs). A similar range is expected for the renewal awards.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Eligible organizations include: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education). Only those organizations funded under RFA-CA-02-001 (U01 ACSR) are eligible to apply for both Regional Biospecimen Repository awards and the CODCC award. The single CODCC will be located at the same site as one of Regional Biospecimen Repositories. Therefore, any of the eligible applicants may apply for the CODCC award.

1.B. Eligible Individuals

Eligible individuals include the current principal investigators of the ACSR and/or any designee/approved individual(s) from the current awardee institutions with the skills, knowledge, and resources necessary to carry out the proposed research.

3. Other-Special Eligibility Criteria

Not Applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

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) 710-0267; Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Additional Materials to Include in Application:

It is critical that applicants clearly describe plans to accommodate stated criteria and staff involvement as listed in the Terms and Conditions of Award, and in the Review Criteria section.

Requirements for the Regional Biospecimen Repository applications

The Regional Biospecimen Repository applicants should provide an overview of the structure of the proposed Regional Biospecimen Repository and state how the applicant team will maintain and enhance their capabilities. The Regional Biospecimen Repository applicants should describe the productivity of their regional repository during the current 5 years of funding. This description should include documenting the types, quantities, and quality of specimens and clinical/demographic data that have been obtained and distributed for each year of the current project period. Also, the Regional Biospecimen Repository applicants should summarize the number of research projects that have utilized their resources, types of these projects, and progress accomplished. The Regional Biospecimen Repository applicants should list the projects proposed, the biospecimens that were provided for the projects, and a full list of publications and meeting presentations that have resulted from such projects. The Regional Biospecimen Repository applicants should provide an estimate of the number of specimens stored in the Regional Biospecimen Repository over the current project period.

The applicant team should take into account the number of specimens acquired, stored and distributed by the Regional Biospecimen Repository in the current 5 years of funding and provide an estimate of the cost per specimen per year s funding.

Each applicant team should discuss their recent research endeavors that incorporate NCI-sponsored clinical groups such as: the AIDS Malignancy Consortium; NCI-sponsored Clinical Trials Cooperative Groups; NCI-sponsored Epidemiology Cohorts; and the NIH-sponsored VA Aging Cohort Study. The application should list the collaborations made, the specimens/data that have been obtained or provided, and projects that have ensued from these attempts to better integrate and leverage these NCI-sponsored initiatives. Each site should provide information regarding their contribution to resource-wide enhancement projects, such as the development of Tissue MicroArrays.

Each applicant team should state how they propose to enhance their existing Regional Biospecimen Repository; these proposed improvements should include the Operations Office, the database, plans to incorporate new research opportunities, as well as to describe future contributions of specimens in the upcoming years of funding. This latter description should include: (1) estimates of the types, quantity, and quality of specimens that may be accrued; (2) projections of the clinical/demographic data to be obtained; and (3) discussions of how feedback from the investigators who have acquired both biospecimens and data will be used to strategically focus future acquisitions and distributions (of both specimens and data). The applicants should address the recent NCI-solicited evaluation of the resource. Based upon this evaluation, the applicants must identify areas in which the resource must be strengthened at both the applicant institution and sub-site levels, and they must propose ways in which the applicant institution and sub-sites can improve the resource at the Regional Biospecimen Repository level. Special emphasis must be given to the following areas:

Applicants should provide the name (and list qualifications) of a second investigator (also known as designee) who, in addition to the PI, has been designated to become a member of the future Steering Committee. The applicants should also list the name and qualifications of the proposed head of the Regional Operations Office.

Travel funds for two investigators to attend two Steering Committee meetings per year should be included in the budget.

In addition, applicants must be prepared to identify non-affiliated experts as potential appointees to the REDP and as external members of the Steering Committee. The applicants should describe the desired scientific profiles of such external advisors. However, in order not to adversely affect the process of peer review of the applications, names of such individuals must not be provided in the application. Moreover, the applicants must not contact these individuals unless their application is selected for funding after the completion of the peer review process.

Requirements for the Central Operations and Data Coordinating Center (CODCC) application

In addition to the current CODCC awardee, any of the two other eligible ACSR applicants may compete for the single CODCC award. The CODCC application by the incumbent applicant should contain an overview of the entire ACSR in its current form. The incumbent CODCC application should also document productivity during the current funding period, summarizing: (i) activities performed solely by the CODCC (administrative responsibilities, promotion of the resource, tracking, creation and updates of a central database); and (ii) those activities that have been spearheaded or coordinated by the CODCC but which comprise a collective ACSR effort (development and updates to SOPs, MOO, Compliance with NCI Best Practices, adherence to Office of Human Research Protection Regulations).

The non-incumbent CODCC applicants should describe activities during the current 5 years of funding, where the PI and/or key investigators were highly involved in joint CODCC/Regional Biospecimen Repository efforts, such as: development and updates for SOPs and MOO; development and improvement of bioinformatics systems; compliance with NCI’s Best Practices and CaBIG initiatives; etc. The non-incumbent CODCC applicants should describe the reasons for, and the benefits of changing the regional location of the CODCC. The non-incumbent CODCC applicants should also include a detailed plan for the physical relocation of the CODCC offices and staff members.

Both incumbent and non-incumbent CODCC applicants should address the recent NCI-solicited evaluation of the resource, identify areas in which the resource (and CODCC) must be strengthened, and then propose ways in which the CODCC can make tangible improvements and better serve its role in coordinating the Regional Biospecimen Repositories. For details on areas of emphasis, see the description above under the requirements for the Regional Biospecimen Repository applications.

Both the incumbent and non-incumbent CODCC applicants should budget for all administrative duties listed under Definitions and Terms of Award, for computer needs and software upgrades and for REDP and ACSR Advisors travel expenses. Both the incumbent and non-incumbent CODCC applicants should budget for biostatistical support staff to serve on the Auditing Working Group, and to provide ad hoc statistical support for ACSR projects and in evaluating Letters of Intent (LOIs) from investigators requesting specimens.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: Not Applicable
Application Receipt Date: January 15, 2008
Peer Review Date(s): February/March 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 2008

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for non-USPS delivery)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional paper copies of the application and one copy of the appendix material in paper or pdf format must be sent to the address below

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the National Cancer Institute (NCI). Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application that was originally submitted as an investigator-initiated application, has to be submitted in response to a funding opportunity, it needs to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project; and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

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

Specific to this FOA:

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

Specific to this FOA:

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

Specific to this FOA:

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

Specific to this FOA:

Specific to this FOA

Progress of the Regional Biospecimen Repository Applicant

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and athttp://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in Item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Throughout these Terms and Conditions of Award, the AIDS and Cancer Specimen Resource (ACSR or Resource ) refers to all individual ACSR awardees forming together the ACSR resource. The organizational structure of the ACSR is expected to maintain three Regional Biospecimen Repositories (East Coast, Mid-Region, and West Coast) and a single Central Operations and Data Coordinating Center (CODCC). All the awardee institution(s), principal investigators (PIs) and other key personnel must agree to collaborate on goals of the ACSR.

2.A.1. Awardees and Principal Investigators Rights and Responsibilities

The Awardee and the Principal Investigator will have primary and lead responsibilities for their project as a whole but will also have to participate in the activities of the entire ACSR and its Steering Committee. Specific responsibilities will include the following:

2.A.2. NIH Responsibilities

NCI staff members will serve as the NCI Program Official and Project Scientist for ACSR. Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award. The NCI Project Scientist and the NCI Program Official may be the same person. In that case, the Program Official/Project Scientist will seek an NCI waiver according to the NCI procedures for management of conflict of interest to enable her/him to attend peer review meetings of renewal (competing continuation) and/or supplemental applications when necessary.

The NCI Project Scientist and Program Official will have substantial scientific-programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NCI Program Official and Project Scientist will participate as members of the Steering Committee and as observers on the REDP. The NCI Program Official/Project Scientist will cast a single, collective NCI vote on the Steering Committee. Additional NCI representatives may attend Steering Committee meetings as non-voting observers. The Program Official/Project Scientist will serve as the ex officio (non-voting) member and Executive Secretary of the REDP. In his/her role as Executive Secretary, the NCI Program Official/Project Scientist will advise the ad-hoc REDP members on the procedures of the Steering Committee for reviewing the proposals requesting biological specimens and clinical data. The NCI Program Official/Project Scientist will also participate in meetings for the Marketing, Outreach, and Tracking Working Group, the Bioinformatics and Data Working Group, and the Auditing Working Group.

The NCI Program Official and Project Scientist will provide technical assistance, advice and coordination, assure that the Steering Committee and the REDP follow the NIH Guidelines on conflict of interest issues and play critical roles in promoting the availability and use of the banks. The roles of the NCI Program Official and Project Scientist are to assist and facilitate, but not to direct activities of the ACSR.

The NCI Program Official and Project Scientist will act as liaisons between the ACSR and the NCI’s Office of Biorepositories and Biospecimen Research (OBBR) as the ACSR works towards compliance with NCI’s Best Practices (http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf). The NCI Program Official and Project Scientist will, in conjunction with the OBBR, organize internal and external evaluations of the ACSR.

The NCI Program Official and Project Scientist will act as liaisons between the ACSR and the NCI’s Cancer Biomedical Informatics Grid (caBIG) initiative, to help facilitate the ACSR’s attempts to achieve bronze level and silver level compatibility.

The NCI Program Official and Project Scientist will act as liaisons between the ACSR and the following NCI-supported groups: The AIDS-Malignancies Consortium; The Clinical Trials Cooperative Groups; and other NCI-sponsored epidemiology cohort studies.

The NCI Program Official and Project Scientist will serve as an information resource on relevant NCI extramural awardees likely to require the resources of the proposed Regional Biospecimen Repositories, those awardees willing to contribute specimens to the repository, and NCI awardees who may have received grant funding based upon research conducted with specimens from the ACSR.

The National Cancer Institute reserves the right to reduce the budget, to withhold support, and to suspend, terminate, or curtail a study or an award in the event of substantial shortfall in specimen accrual, data reporting, inadequate quality control in specimens or clinical data collection, non-adherence to biohazard precautions, refusal to carry out the recommendations of the REDP and Steering Committee, or substantial failure to comply with the terms of award.

2.A.3. Collaborative Rights and Responsibilities

Steering Committee

The Steering Committee will serve as the governing board of the AIDS and Cancer Specimen Resource.

The Steering Committee s membership will include: (a) the PI and one other investigator (also known as designee) from each Regional Biospecimen Repository; (b) the PI and a designee from the CODCC; (c) the NCI Program Official; (d) the NCI Project Scientist; (e) one or two external research scientist(s) with expertise in the field of HIV-associated malignancies but not affiliated with any of the Regional Biospecimen Repositories, the CODCC or NIH; and (f) a patient advocate representing the HIV-infected patient community.

The Steering Committee will have primary responsibility for developing and evaluating policies for quality control of the specimens, and uniformity of procedures across institutions; for promoting the availability and the uses of the specimen repository; and for developing an algorithm for review and prioritization of research proposals, to be used by the REDP, utilizing the stored specimens and clinical data (e.g., based on scientific merit with high priority awarded to investigators with funded, peer-reviewed grants). The NCI Program Official and Project Scientist will assist the other members of the Steering Committee in all these tasks. Furthermore, the NCI Program Official and Project Scientist will serve as the scientific liaisons between the awardees and other program staff of NCI who have previous experience in the establishment of tumor repositories.

Each member of the Steering Committee will have one vote except for the NCI Program Official and Project Scientist, who will collectively have one vote and the CODCC PI and his/her designee who will collectively have one vote.

The PI of the CODCC or his/her designee will serve as the Executive Secretary of the Steering Committee.

One Chairperson (who may not be an NCI employee and/or representative) will be selected by the Steering Committee. The Chairperson, together with the CODCC is responsible for coordinating the Steering Committee’s activities, for preparing meeting agendas, for scheduling and chairing meetings, and preparing an annual progress report, which will include individual reports from each Awardee. Each Awardee is responsible for timely preparation of this report, which will be submitted to the CODCC. The CODCC is responsible for providing documentation as to the availability and accessibility of specimens and data for scientific investigations (e.g., the PI of the CODCC will send the Principal Investigator of an REDP-reviewed, high priority proposal a letter as to the availability of the specimens, with a final letter to be sent stating that specimens and/or data will be made available as requested when funding for the REDP-reviewed, high priority proposal is documented -- if the proposal is already funded at the time it is submitted to the REDP and reviewed as high priority, then the ACSR PI will send the final letter at that time). The only situation in which the Steering Committee can overturn the recommendations of the REDP is when specimens and/or data are not available.

Subcommittees and Working Groups will be established by the Steering Committee, as it deems appropriate. The NCI Program Official and Project Scientist will serve on Subcommittees and Working Groups as appropriate.

The Steering Committee will meet at a minimum of twice per year in conjunction with the NCI Program Official and Project Scientist, to map strategies to fulfill the objectives of their function, to develop operation procedures and to evaluate progress. The initial meeting will occur immediately after funding.

The Steering Committee will select members of the REDP. The Steering Committee in the conduct of all business matters will pay particular attention to conflict of interest issues, especially in actions regarding recommended prioritizations of the REDP.

Research Evaluation and Decision Panel (REDP)

The REDP will serve the Steering Committee by reviewing and evaluating all research proposals submitted by the research community at-large as well as those proposals submitted by the Awardees requesting use of the specimen and clinical data banks. A recommendation in terms of priority of the proposed research will be provided to the Steering Committee. The only situation in which the Steering Committee can overturn the recommendations of the REDP is the unavailability of the requested specimens and/or clinical data.

The REDP will be composed of the NCI Program Official, Project Scientist and six to eight scientists with clinical/basic research expertise in the field of HIV-associated malignancies. The members of the panel will evaluate all research (those of the awardees as well as proposals from the research community-at-large) proposing to utilize the specimen and data banks according to the evaluation and review criteria provided by the Steering Committee. The panel will provide a recommendation to the Steering Committee as to the priority of the proposed research. The membership of the REDP may vary depending on the scientific areas of the proposed research to be reviewed and evaluated. Ad-hoc members will be appointed by the NCI Program Official to provide expertise for those proposals that lie outside the scope of HIV-associated malignancies. All members will be selected by the Steering Committee. The Chairperson of the REDP may not be an NCI (or NIH) employee.

The review of proposals can be conducted either in person, by conference call or by mail at a minimum of twice per year. All reviews will be conducted according to rules pertaining to conduct of reviewers for NIH grants, contracts, and cooperative agreements, paying special attention to issues of conflict of interest, whether real or apparent. The NCI Program Official/Project Scientist will serve as the Executive Secretary (non-voting role) for the review and will forward the final recommendation to the CODCC for distribution to the Steering Committee. The NCI Program Official/Project Scientist, in the role of Executive Secretary of review will inform and advise the ad-hoc REDP members on the Steering Committee’s algorithm for review and prioritization of proposals; will provide information to the ad-hoc REDP members on the studies that have already been approved and on other relevant, on-going NCI activities so that redundant studies are not performed; and will help answer any programmatic issues. The NCI Program Official/Project Scientist will also play an important role in the whole review process by lending a degree of continuity with the Steering Committee, as the ad-hoc REDP composition may change depending on the expertise required to review the submitted research proposals.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

In addition, the CODCC Awardee must collect site specific tissue acquisition and distribution information, track such information, and provide it to the NCI Program Director/Project Scientist as a quarterly progress report indicating site specific contributions to tissue acquisitions and tissue distribution in response to approved Letters of Intent.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research; peer review; and financial or grants management issues.

1. Scientific/Research Contacts

Rebecca Liddell Huppi, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6120 Executive Boulevard, Room 6119, MSC 8337
Bethesda, MD 20892-8337 (for U.S. Postal service express of regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 402-3920
FAX: (301) 480-4137
Email: [email protected]

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal service express of regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

3. Financial or Grants Management Contacts:

Ms. Eileen M. Natoli
Office of Grants Administration
National Cancer Institute
Executive Plaza South, Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8791
Fax: (301) 496-8601
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The Loan Repayment Program (LRP) is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov.

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