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.cancer.gov/)

Title: Limited Competition: Support for Human Specimen Banking in NCI-Supported Clinical Trials - Cooperative Group Banks (CGB) (U24)

Announcement Type
This funding opportunity announcement (FOA) is a reissue of RFA-CA-05-017.

Request For Applications (RFA) Number: RFA-CA-09-504

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

Key Dates
Release Date: July 24, 2009 
Letters of Intent Receipt Date: Not Applicable
Application Receipt Date: November 17, 2009
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: November 18, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary 

Purpose. This limited competition Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), solicits renewal applications for the support of the Cooperative Group Banks (CGBs). CGBs were established to collect, store, and distribute well-annotated human specimens from patients with cancer who are participating in NCI-funded Phase III and large Phase II clinical treatment trials. This FOA is designed to continue support of the infrastructure of the CGBs and to provide access for qualified investigators to the specimens with associated high-quality, clinical, treatment and outcome data that are critical for developing and validating biomarkers for diagnoses, prognoses, and predictions of responses of cancer patients to therapies.

• Mechanism of Support. This FOA will utilize the NIH U24 cooperative agreement mechanism.
• Funds Available and Anticipated Number of Awards. The NCI intends to commit $8.75 million per year (total costs set aside) in fiscal years 2010-2015, for a total allocation of $43.75 million over the indicated 5 years. Up to nine awards are projected to be made under this FOA.
• Budget and Project Period. Applicants should request a project period of 5 years.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Only the organizations representing the current nine Cooperative Oncology Group Banks with CGBs funded under RFA-CA-05-017 are eligible to apply. (Current awards eligible for renewal under this FOA include: 5U24CA114737; 5U24CA114748; 5U24CA114725; 5U24CA114734; 5U24CA114740; 5U24CA114732; 5U24CA114736; 5U24CA114766; and 5U24CA114793).
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Eligible PIs must be the current PI and/or any other individual(s) designated/approved by the Cooperative Group with the skills, knowledge, and resources necessary to carry out the proposed research. 
• Number of PDs/PIs. Only one PD/PI per application is allowed.
• Number of Applications. Each eligible applicant institution may submit only one renewal application in response to this FOA.
• Resubmissions. Resubmission applications are not permitted in response to this FOA.
• Renewals. Only renewal applications from the current CGB U24 awardees will be accepted in response to this FOA. 
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review, and Anticipated Start Dates Application Materials. See Section IV.1 for application materials.
• Hearing Impaired.  Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    D.  Application Assignment
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. Resource Sharing Plan(s)
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

Purpose

Through this limited competition funding opportunity announcement (FOA), the National Cancer Institute (NCI) requests competing renewal applications from the NCI-supported Clinical Oncology Cooperative Group Banks (CGBs) for the continued support of the infrastructure for collection, storage, and distribution of well-annotated specimens from cancer patients entered into NCI-funded phase III and large phase II clinical treatment trials.

The CGBs are currently funded through nine U24 cooperative agreement awards. The role of the existing CGBs is to (a) collect and store the clinical trial specimens with associated high quality, clinical, treatment, and outcome data; and (b) distribute these specimens to qualified investigators. CGB-accumulated human specimens can be a crucial resource to new research efforts aimed at understanding of how to diagnose and treat a variety of cancers. This resource is thus critical for developing personalized medical care and treatment in the future. The objective of this FOA is to continue support for the CGBs to ensure that biospecimens collected in the course of NCI-supported cancer clinical trials are available to interested, qualified members of the scientific community.

Background

The CGBs were established to collect, store, and provide to researchers well-annotated human specimens from cancer patients, who participate in NCI-funded phase III and large phase II clinical treatment trials. Specimen collections from such patients offers several advantages that may not be available outside the context of clinical trials. These advantages include, for example, (a) uniform information on medical history and treatment details; (b) quality control; and (c) favorable costs (due to economies-of-scale). These specimen collections are unique because they have detailed treatment histories and recurrence data based on careful follow-ups of patients over long periods.

CGB Resource Organization and Operation

CGBs are part of the NCI-sponsored Clinical Trials Cooperative Groups (http://www.nci.nih.gov/cancertopics/factsheet/nci/clinical-trials-cooperative-group).

The nine CGBs that are currently supported by the NCI are formed by: American College of Surgeons Oncology Group (ACOSOG); Cancer and Leukemia Group B (CALGB); Children’s Oncology Group (COG); Eastern Cooperative Oncology Group (ECOG); Gynecological Oncology Group (GOG); North Central Cancer Treatment Group (NCCTG); National Surgical Adjuvant Breast and Bowel Project (NSABP); Radiation Therapy Oncology Group (RTOG); and Southwest Oncology Group (SWOG).

Specimen Collection.  All CGBs receive and store  biospecimens of solid tumors that include all organ systems represented in trials carried out by their parent Cooperative Groups (i.e., brain, breast, gastrointestinal, genitourinary, gynecological, head and neck, melanoma-skin, peripheral nervous system, liver, lung, soft tissue sarcoma, and thyroid gland). Several groups also have hematological malignancy banks, including leukemia, lymphoma, and multiple myeloma banks as well as serum banks. In years 2000-2007, the CGBs maintained collection of 807,767 solid tumor specimens, 143,047 serum specimens, and 49,491 leukemia specimens.

The specimens are collected by Cooperative Group member hospitals, member and affiliated member institutions, including Community Clinical Oncology Program (CCOP) hospitals, generally using special collection kits provided by the CGBs. The specimens are sent to the designated clinical trial biorepositories from participating hospitals. The clinical, treatment, and outcome data linked to the CGB biospecimens are stored in Statistical Data Centers of the Cooperative Oncology Groups. Specimens from clinical trials conducted by several Cooperative groups are currently stored in the bank of the lead group for that trial. This centralized approach has improved the quality of the banking efforts and broadened the availability of the specimens to investigators. All CGBs collect formalin-fixed, paraffin-embedded (FFPE) blocks and histological slides from diagnostic biopsies and surgical resections from patients with cancer. Seven of the nine banks also collect fresh frozen specimens in at least some of their trials. Other specimen types include (but are not limited to): serum, plasma, whole blood, white blood cells, bone marrow, urine, skin, and sputum/buccal samples as defined in the trial protocol. Many of the CGBs also prepare relevant biomolecules (such as nucleic acids) from the collected biospecimens .

The CGBs provide specimens to interested, qualified investigators from the same Cooperative Group that forms a CGB, other Cooperative Groups, as well as other academic, non-profit, and for profit entities outside of the Cooperative Groups. Access to the CGB biospecimens requires a “correlative science” application, which is reviewed for scientific merit outside the CGBs (by the NCI Correlative Science Committees and Cooperative Group Bank Review boards). The CGBs are establishing harmonized procedures for investigators to request and obtain specimens after their application for scientific merit has been approved. 

Group Banking Committee. Since 2006, CGBs are governed by the Group Banking Steering Committee (a.k.a. Group Banking Committee). The Group Banking Committee consists of three representatives appointed by the PDs/PIs from each of the 10 Cooperative Groups and three NCI representatives. The Group Banking Committee defines and coordinates the harmonization efforts of the CGBs and facilitates the integration of banks into a harmonized system, in which all the components adhere to the highest standards for the collection, storage, and distribution of specimens. The Group Banking Committee develops policies and milestones for implementation of CGB activities following the NCI Best Practices for Biospecimen Resources created by the NCI Office of Biorepositories and Biospecimen Research (OBBR).

Four subcommittees (Best Practices and Operations, Informatics, Regulatory and Access, and Marketing) have been formed by the Group Banking Committee to facilitate harmonization of CGB operations.

Specific Objectives and Scope

CGB applicants must adequately address the main objective of this initiative to maintain and improve the functioning of CGBs as a national resource  and describe how their efforts will fit into the overall program, including easier access to the banked specimens and associated data.

Applicants are expected to propose comprehensive activities necessary to operate well-developed banks.  The range of activities that can be supported under this FOA includes :

• Collecting and shipping specimens from the collection sites to the central banks;
• Overseeing receipt of specimens;
• Processing specimens at the central bank (including conducting pathology reviews and providing histology services); and
• Maintaining Informatics tracking system;
• Training for staff personnel in the areas listed above.

Applicants may also request support for the costs of equipment, supplies,, storage (e.g., liquid nitrogen), shipping, travel (e.g., for attendance of funded investigators at required meetings), informatics (e.g., for recording/tracking specimens), and miscellaneous items and/or services (e.g., maintenance contracts and subcontracts to participating institutions).

Additional support can be requested to cover other costs associated with review and processing of requests for specimens and data, including special handling costs that may be incurred (e.g., return of biospecimen blocks to the collecting institution). The costs of organizing new data centers will NOT be covered. Applicants may request in the budget a partial coverage of those data center operating costs that are directly associated with storage and manipulations of CGB data.

Requirements for CGB Applicants.

Only the organizations representing the current nine Cooperative Oncology Group Banks with CGBs funded under RFA-CA-05-017 are eligible to apply.

Moreover, at the time of CGB application submission, eligible Cooperative Groups must have: (a) current NCI funding for conducting phase III cancer clinical trials and (b) one or more operating specimen banks (funded under RFA-CA-05-017); and (c) continued access to detailed demographic, clinical, treatment, and outcome data for the patients whose specimens are in the bank.

To assure that there is coordination of banking activities among groups conducting trials, applicants must plan (to the maximal extent possible) for common collection and storage practices to be implemented.

Applicants are required to agree to work with the Group Banking Committee to develop policies with milestones for implementation.

In particular, the applicants must agree with and plan for the role of the Group Banking Committee that shall include, (but will not be limited to) the oversight in the following areas:

a. Coordination of all CGB activities;

b. Best practices for collection and storage and exchange of specimens;

c. Common data structures for banking and data exchange;

d. Principles for utilization of banked specimens and data;

e. Researcher application and review processes;

f. Taking advantage of relevant emerging technologies; and

g. Coordination of implementation of developed policies.

The Group Banking Committee will establish a timeline for developing and implementing the policies listed, with specific milestones and dates when they are to be completed. Progress will be evaluated annually by the NCI and substantial progress towards implementation of developed policies is expected. Failure to make substantial progress will be grounds for discontinuing funding.

The CGBs will work, as much as possible, to comply with the recommendations by NCI Best Practices for Biospecimens Resources (http://biospecimens.cancer.gov/practices/).

The CGBs will be expected to address compatibility with the Cancer Biomedical Informatics Grid (caBIG) program (https://cabig.nci.nih.gov).

The CGBs must meet the requirements of the Federal Human Subjects Regulations 45CFR46 (i.e., the Common Rule; https://grants.nih.gov/grants/oprr/humansubjects/45cfr46.htm). Federal requirements to protect human subjects apply to a much broader range of research than many investigators realize, including research that uses biospecimens (e.g., cells, blood, urine, and saliva), residual diagnostic biospecimens, and medical information. Information on Office for Human Research Protections (OHRP) Policy on Coded Specimens and Data can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf.

The CGBs are expected to address the evolving legal, ethical, and human subjects policy issues related to the use of human biospecimens for research purposes. These issues addressed in the NCI Best Practices for Biospecimen Resources and the OHRP website (http://www.hhs.gov/ohrp/).

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH U24 cooperative agreement award mechanism.
The Project Director(s)/Principal Investigator(s) (PD/PI or PDs/PIs) will be solely responsible for planning, directing, and executing the proposed project.

The NIH U24 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the PI retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NCI staff member(s) being substantially involved as a partner with the PI, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

This FOA uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions, see https://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.

2. Funds Available

The NCI has committed $8.75 million (total costs) for Fiscal Year 2010 to fund up to nine awards based on a limited competition renewal of the current CGB U24 awards. A total of $43.75 million (total costs) have been set aside for years 2010-2015. In general, annual budgetary requests are expected to not exceed the average annual total costs for the current funding period. Applicants should request a project period of 5 years.

Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the RFA-CA-05-017 are eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Eligible individuals include the current principal investigators of the Cooperative Group Banks 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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Each eligible applicant institution may submit only one renewal application in response to this FOA.

Resubmission. Resubmissions are not allowed.

Renewals. Only renewal applications from the current CGB U24 awardees will be accepted.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at https://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: GrantsInfo@nih.gov.

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 modified as outlined below. 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

The exceptions from the PHS398 instructions and detailed information on the application structure and components are provided in Section IV.6. Other Submission Requirements. All applicants must follow the specific instructions in that section.

Appendix Materials

All the applicant CGBs should work together to prepare one set of appendix materials (identical for each application) that are pertinent to harmonization and progress of the entire CGB resource.

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html).

For details on what items are generally allowed as Appendix materials, see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Applications with Multiple PDs/PIs: Not applicable.

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: November 17, 2009
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010

3.A.1. Letter of Intent:

Letters of Intent are not required for this FOA.

3.B. Sending an Application to the NIH

Applications must be prepared using the forms 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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

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 regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or 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, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is 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 PD/PI or PDs/PIs 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 NIH Grants Policy Statement.

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 renewal 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 NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

Instructions for the Preparation of RESEARCH PLAN: The standard PHS398 Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents) is altered as follows: 

• Standard Items 2-5 of the PHS 398 Research Plan are replaced by the following sections: 1) Progress Report; 2) Organizational Structure and Operations; and 3) CGB Harmonization Process. 
• The PHS 398 standard page limit for Items 2-5 is replaced by a new limit of 40 pages for the new Sections 1-3. Note: Applicants are encouraged to use the minimum number of pages necessary to describe the research plan clearly and succinctly.
• Other items of the PHS398 Research Plan remain unmodified.

Specific Sections 1-3 to be included in Research Plan are described below. (Table of Contents should be modified accordingly.)

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.

Section 1.  Progress Report).  The applicants should discuss the productivity and specific contributions of their CGB (2003-2008). At a minimum, this report should summarize the progress in the following aspects for the applicant’s CGB:

Bank Activity:

a) Collection, processing, storage and distribution of biospecimens;

b) Tracking of investigators served;

c) Tracking of publications that resulted from specimen use; and

d) Tracking of clinical trials.

Scientific Impact that resulted from specimen use:

a) Publications;

b) Patents; and

c) Ongoing research using CGB specimens (i) within your Cooperative Group (intragroup); (ii)between other Cooperative Groups (intergroup), and (iii) by researchers outside of the Cooperative Group program.

Section 2. Organizational Structure and Operation.

a) Describe organizational structure of the your CGB and its relationship to the Cooperative Group structure (include organizational chart, define lines of authority and individual responsibilities);

b) Outline your vision how the operation of your CGB might be improved and how the activities of your CGB will harmonize with those of the other CGBs. This outline should address the needs of the scientific community and explain how the applicants intend to simplify investigators’ access to biospecimens and associated data; and

c) Describe the services that your CGB intends to provide and how those services will address the needs of the scientific community and current investigator access to your CGB human specimens for cancer research, including the number and types of specimens with associated histopathologic and demographic and other data that could be made available.

Section 3. CGB Harmonization Process

The applicants should describe the strengths of their Cooperative group and its representatives and the role they are playing in collaborative work of the Group Banking Committee and its Subcommittees (Regulatory, Access and Marketing, Best Practices and Operations, and Informatics) towards harmonization. The harmonization process involves CGB policies and priorities, standardization and harmonization of Standard Operating Procedures (SOPs), promotion of the resource in the scientific community, improving information systems to manage the CGB, monitoring progress, and developing new strategies. Plans should be outlined to ensure that the resource remains responsive to researcher’s needs, and compatible with CaBIG informatics grid. The progress towards harmonization goals during the current funding period (2005-2008) should be described.

Other Requirements

Applicants are required to agree that, if funded, they will designate three individuals from their group to participate as members of the Group Banking Committee as described in the Section VI.2.A. ‘Cooperative Agreement Terms and Conditions of Award.’  They must also agree to abide by the decisions of the Group Banking Committee and to achieve milestones developed by the Group Banking Committee within the established time-lines (subject to the Arbitration clause in the ‘Cooperative Agreement Terms and Conditions of Award’ section).

Applicants must budget funds in their applications for the three members from their group to attend the Group Banking Committee face-to-face meetings (twice per year) each year. Applicants should assume that the meetings will alternate among the various participants’ repository sites (Midwest, West coast, and East coast).

Applicants must agree to provide information about their specimen and data collections to the NCI Specimen Resource Locator (http://pluto3.nci.nih.gov/tissue/default.htm)after receipt of this award and on a regular basis thereafter (at least once per year) to allow interested researchers to locate biospecimens they may need.

Applicants must establish policies to make appropriate patient demographic, clinical, outcome and treatment data available to users of the specimen bank. Commitment to establish a common CGB portal that will provide information on CGB specimens with minimal clinical data annotation to research community is required. Data policies can and in most cases should be established in collaboration with group statisticians and other investigators involved in the clinical trial(s) in which the specimens were collected.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CD only, and include five identical CDs in the same package with the application (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

At the minimum, the items to be submitted should include:

1)     Selected Local Standard Operating Procedures or Manual of Operation of your CGB

2)     Central Manual of Operation (draft) developed by the Group Banking Committee

3)     Other harmonized documents developed by the Group Banking Committee

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

Sharing Model Organisms: Not Applicable

Genome-Wide Association Studies (GWAS): Not Applicable

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

• Receive a full review;
• Receive a written critique; and
• Receive a second level of review by National Cancer Advisory Board.

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review;
• Availability of funds; and
• Relevance of the proposed project to program priorities.

The goal of NIH-supported human specimen resources is to facilitate research that advances the understanding of biological systems, improves the control of disease, and enhances health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed resource would have a substantial impact on the pursuit of these goals. 

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). 

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the qualifications of the resource leader(s) and key personnel well suited to organize and maintain the resource, maintain quality control and equitable access, and manage record keeping? Is the relationship between the PD/PI or PDs/PIs and the resource leaders clearly defined?

Innovation. Does this application propose a resource not otherwise available to the researcher users? Has the applicant proposed improved methods, such as more effective means of collection from distributed sites, improved practices for specimen processing and transfer of specimens, specimen tracking and/or encouraging utilization of the resource?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for: 1) protection of human subjects from research risks; and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.

Progress:

• How significant was the contribution of this CGB to cancer research? Is there evidence from published studies that specimens from this CGB facilitated scientific progress?
• How effective was this CGB in terms of collection, processing, storage, and utilization of specimens and collaboration with other CGBs?
• How well did this CGB fulfilled its obligations regarding the activities of Group Banking Committee and harmonization effort across the CGBs?

Additional Review Criteria.  As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (Not Applicable); and 3) Genome Wide Association Studies (GWAS) (Not Applicable).

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.

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 the 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 (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the PD/PI or PDs/PIs 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 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, “Cooperative Group Banks” (CGBs) refers to all individual CGB awardees participating together in the CGB Resource.  The individual “Cooperative Group Bank” (CGB; i.e., each individual CGB awardee) comprise the organizational structure which is composed of the awardee institution(s), principal investigators (PIs) and other key personnel, all of whom agree to collaborate on research goals of the CGB Resource.

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

Awardees will be required to work jointly towards the overall CGBs goals.

Awardees must accept and implement policies and recommendations made by the Group Banking Committee..

The CGB Principal Investigators will have the following main responsibilities:

• Overseeing the operation of the CGB;
• Participating in the work of Group Banking Committee (both directly and through designated representatives).
• Implementing policies and recommendations developed by the Group Banking Committee.(in areas such as defining best practices or operating policies, marketing the banks, access procedures, fiscal arrangements such as setting charges for the use of bank specimens, and quality assurance measures for all aspects of the operation of the banks.  The PI must also assure that designated banked tissues remain available and that the relevant clinical data are obtainable in accordance with the policies developed by the Group Banking Committee.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Program Director serving as a Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The Project Coordinator will have substantial scientific-programmatic involvement in CGB awards through:

• Serving as a liaison between the CGB awardees and the NCI;
• Serving as a voting member of the Group Banking Committee and on any subcommittee as deemed appropriate;
• Providing technical assistance, advice, and coordination of CGB activities.
• Coordinating activities of the Group Banking Committee between meetings.
• Working closely with the Chair of the Group Banking Committee (who cannot be the NCI representative) to develop agendas and monitor progress toward developing policies and milestones and adhering to the time-lines set by the Committee.
• Providing technical advice regarding the development of best practices for collection, processing, storage, retrieval, and shipping of specimens;
• Providing consultation and advice regarding the development of appropriate processes for assuring access to the banked specimens, legal and ethical issues such as implementation of the DHHS Health Information Portability and Accountability Act (HIPAA) Privacy Rule, the ‘common rule’ (45 CFR 46) and Institutional Review Board (IRB) interactions, as well as other issues for which the Group Banking Committee will develop policies.
• Attending CGB meetings.

 The NCI reserves the right to adjust funding, withhold support, suspend, terminate, or curtail an individual CGB award in the event of unacceptable performance or a failure to comply with the Terms and Conditions of Award.

Substantially involved NCI staff members will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice.  A Program Official may also have substantial programmatic involvement (as a Project Scientist]/Coordinator).  In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications, or will seek NCI waiver.

2.A.3. Collaborative Responsibilities

The cooperative agreements (U24) will require cooperation between the NCI representative (the NCI Project Coordinator) and members of the Group Banking Committee (described below) to assure the success of the project and to ensure smooth interactions among the cooperating organizations. The NCI Project Coordinator participates as a voting member of the Group Banking Committee and assists in coordinating the activities of the awardees and facilitating communications. Each participating organization has one vote on the Group Banking Committee. The Chair of the Group Banking Committee is responsible for developing agendas, ensuring progress, facilitating cooperation among participants, and chairing meetings. These responsibilities are described more fully below.

Group Banking Committee

The Group Banking Committee will serve as the steering committee for the CGB program. The Committee will consist of the following voting members:

• Three representatives from each CGB (appointed by PI), all of whom will collectively have one vote as a group; and
• Up to three NCI Program representatives (e.g., Project Coordinator and up to two other substantially involved NCI staff members, all of whom will collectively have one vote as a group),

Group Banking Committee will select one of the awardee representatives as its chairperson (NCI staff members cannot serve in this role).

Subcommittees may be established by the Group Banking Committee as deemed appropriate and the NCI participants may serve on any subcommittee.

As the program main governing board, Group Banking Committee will be primarily responsible for developing policies and recommendations to coordinate and harmonize the efforts of the participating CGBs and milestones for the implementation of these policies. These policies will include (but will not be limited to) the following areas:

i) Coordination of CGB activities;

ii) Best practices for collection and storage of specimens;

iii) Common data structures for banking;

iv) Rules of utilization of banked specimens and data;

v) Researcher application and review processes; and

vi) Adapting emerging technologies for the needs of CGBs.

The Group Banking Committee will also establish a uniform format for CGBs in which information must be reported in the non-competing (Type 5) grant progress report (PHS 2590).

The Group Banking Committee will meet twice a year in a face-to-face meeting.

Other NCI staff members will be asked to attend meetings to ensure that the necessary areas of expertise are represented, but they will not be designated as voting members of the Committee.

2.A.4. Dispute Resolution

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. A Dispute Resolution Panel 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 dispute resolution procedure does not alter the awardee's rights 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

PHS 2590 reports shall follow the format established by the Group Banking Committee and shall include (but not be limited to) the following information:

i) Outreach efforts to popularize the resource;

ii) The number of requests received (report total numbers, and separately list the number of requests from investigators not served previously and those from investigators outside your institution, cooperative group, or cancer center);

iii) The number of investigators who received specimens (report total numbers, and separately list the number of investigators not served previously and the number of investigators from outside your group);

iv) The number and types of specimens provided to researchers; and

v) The study from which the requested specimens were collected.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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:

Irina A. Lubensky, M.D.
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 6032, MSC 7420
Bethesda, MD 20892-7420 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7147
FAX: (301) 402-7819
Email: lubenskyi@mail.nih.gov

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 regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

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: Natolie@gab.nci.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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 (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local 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.

Policy for Genome-Wide Association Studies (GWAS):NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see https://grants.nih.gov/grants/gwas/.

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 https://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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://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 (https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 https://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 FOA 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. 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 https://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 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 two years to the research. For further information, please see: http://www.lrp.nih.gov.