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)       
National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)

Title:  A Data Resource for Analyzing Blood and Marrow Transplants (Limited Competition U24)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-CA-07-506

Catalog of Federal Domestic Assistance Number(s)
93.226, 93.395, 93.839, 93.855

Key Dates
Release Date: May 29, 2007
Letters of Intent Receipt Date(s): June 25, 2007
Application Receipt Date(s): July 25, 2007
Peer Review Date(s): October/November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): March 1, 2008
Expiration Date: July 26, 2007

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

The National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Allergy and Infectious Diseases (NIAID) request a limited competition renewal application from the Center for International Blood and Marrow Transplant Research (CIBMTR) for the continued support of the established Data Resource for Analyzing Blood & Marrow Transplants.  This resource at the CIBMTR  is currently funded as a cooperative agreement (U24).

The CIBMTR collects consecutive transplant outcomes data from blood and bone marrow transplant centers throughout the world and includes data on approximately 60% of such transplants done in the United States (U.S.).  The CIBMTR database has information for more than 232,000 hematopoietic cell transplant (HCT) recipients (125,000 allogeneic and 107,000 autologous transplants).  Approximately 85% of allogeneic and greater than 99% of autologous transplants performed are for treatment of human malignancies.  Approximately 50% of the allogeneic data is of research quality, with the remaining 50% containing basic information.  Approximately 25% percent of the autologous data is of research quality, with the remaining 75% containing basic information.  More than 450 hematopoietic cell transplant (HCT)  centers in 47 countries are currently submitting data to the CIBMTR.  The CIBMTR has a proven system for facilitating the use of its database for research and a record of collaboration with government agencies, professional groups, international partners, and patient organizations via 18 scientific/research working committees.

This limited competition RFA will use the NIH U24 cooperative agreement mechanism to continue the support of a research quality data resource for analyzing blood and marrow transplants.  The CIBMTR database is available to investigators and health policy makers.  Studies that involve utilization of the CIBMTR registry will: help define the usefulness of transplants in various clinical situations; identify prognostic factors; compare transplant regimens; compare transplant and non-transplant therapies; assess inter-transplant center variability in diagnosis, practice, and outcome; evaluate transplant costs and cost-effectiveness; plan new clinical trials or treatment protocols; and develop approaches to evaluating transplant outcomes.  Furthermore, this Limited Competition RFA will partially fulfill the legislative requirements of the United States (U.S.) Congress in establishing the national C.W. Bill Young Cell Transplantation Program for the purpose of collecting outcomes data on every related and un-related transplant done in the U.S. (Stem Cell Therapeutics and Research Act of 2005 – Public Law 108-129, 12/20/2005).

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity announcement (FOA) involves use of the NIH (U24) cooperative agreement award mechanism.  In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/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 PD/PI, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."  The NIH assists, supports, and/or stimulates, and is substantially involved in but not directing the activities proposed by the awardee.  Details of the responsibilities, relationships, and governance will be the same as in the current terms and conditions of the award.  Plans beyond the current funding opportunity are indefinite.

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.

2. Funds Available

Total amount of funding to be awarded over 5 years will be $15.5 million (total cost).  The annual budget is capped at the current level of support ($3.1 million per year total cost).  One award will be made.  The earliest start date will be March 1, 2008.

The participating NIH institutes, the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), intend to commit funds approximately as follows:  the NHLBI will contribute $750,000/yr for 5 years; NIAID will contribute $350,000/yr for 5 years towards this funding opportunity but in one lump sum (of $1.75M) in fiscal year 2008. The balance towards the grand total of $15.5 million (total cost) over 5 years will be contributed by the NCI.

The applicant may request a project period of up to 5 years from March 1, 2008, through February 28, 2013.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

This FOA is a limited competition and only the Center for International Blood and Marrow Transplant Research (CIBMTR) is eligible to apply.

1.B. Eligible Individuals


The current PD/PI and/or any designated/approved individual(s) from the current awardee institution with the skills, knowledge, and resources necessary to carry out the proposed research is (are) invited to work with CIBMTR to develop an application.  Underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

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) 435-0714; 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.  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.

3. Submission Dates and Times

Applications must be received on or before July 17, 2007.

3.A. Receipt, Review, and Anticipated Start Dates
Letter of Intent Receipt Date(s): June 25, 2007
Application Receipt Date(s): July 25, 2007
Peer Review Date(s): October/November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): March 1, 2008

3.A.1. Letter of Intent

Prospective applicant is asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff members to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Dr. Roy S. Wu
Clinical Grants and Contracts Branch
Clinical Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 7009 , MSC 7432
Bethesda, MD 20892-7432 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: 301-496-8866
Fax: 301-480-4663
Email: wur@ctep.nci.nih.gov

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 express/courier delivery; non-USPS service)
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 (pdf format encouraged) must be sent to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncidearefof@mail.nih.gov

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.  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 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, 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 PI 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

The renewal application must include a section that addresses progress made during the previous grant funding period.

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 NCI 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, peer 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 RFA: Can this statistical and data resource serve the needs of patients, physicians, and researchers in the area of hematopoietic stem cell transplantation?  Will this resource have a significant impact on research in the field of hematopoietic transplantation?

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 RFA: Are the methods of data collection adequately developed, well integrated, well reasoned, and appropriate for the field of hematopoietic transplantation?  Does the applicant propose ways to use the data resource to advance the field?  Does the applicant propose novel statistical methodologies to analyze the data?

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?


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? 

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 RFA:  Does the institutional environment enhance observational population studies?

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).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed activities.  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 may 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 funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing). 

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 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 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 (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, U.S. Department of Health and Human Services (DHHS) 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 DHHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U24), 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.

2.A.1. Awardee and Principal Investigator Rights and Responsibilities

The only potential awardee organization is the CIBMTR, an entity formed in July 2004 through an affiliation of the International Bone Marrow Transplant Registry of the Medical College of Wisconsin and the research arm of the National Marrow Donor Program.  As the awardee, the CIBMTR will be responsible for maintaining a resource of data and statistical expertise for clinical research in blood and marrow transplantation through the activities of many management committees including the Advisory Committee, the Executive Committee and 18 Working Committees.

Collective responsibilities of the members of the Advisory Committee include: 1) reviewing policies for use of CIBMTR data; 2) holding annual meetings; 3) assisting in grant application preparation and other fund-raising activities; and 4) reviewing all research reports and manuscripts that describe results ofCIBMTR-linked studies.  Collective responsibilities of the members of the Executive Committee include: 1) providing direction to the Chief Scientific Director for scientific activities and policy decisions; 2) establishing priorities for scientific studies after obtaining input from the Working Committees; 3) reviewing results of audits and recommending measures to correct deficiencies; and 4) reviewing and assisting in preparation of the agenda for annual Advisory Committee meetings.

Responsibilities of the members of the Working Committees include: 1) designing and conducting studies relevant to their subject area and involving CIBMTR data, statistical resources, networks, and/or centers; 2) considering proposals to use CIBMTR data for studies pertinent to their subject area; 3) periodically assessing and revising relevant sections of the CIBMTR data collections forms; and 4) planning and conducting workshops at CIBMTR meetings.  The efforts of the Working Committees are derived from the voluntary contributions of time and expertise by hundreds of physicians, basic scientists, and clinical research associates.  The CIBMTR plays a central role in these activities as well as in coordinating data collection and management and providing statistical and administrative support for studies involving use of data in the CIBMTR database.

The Principal Investigator or Principal Investigators (PI or PIs, respectively) will coordinate all the scientific and administrative decisions/agendas made by CIBMTR’s Committees, including those of the Advisory Committee, Executive Committee, and Working Committees, related to data management and statistical analyses.  The PI(s) will actively seek opportunities for collaboration with other investigators outside of the CIBMTR in order to enhance and extend the utility of the CIBMTR database.  The PI(s) shall assure that the CIBMTR establishes and implements mechanisms to ensure that data collection and management procedures are adequate for quality control and analysis and patient and donor privacy.  The CIBMTR must be in compliance with the assurance program of the Federal Office of Human Research Protection.  The PI(s) will be responsible for communication with the appropriate NIH staff members.

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 DHHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

The NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, including but not limited to the areas specified below.  Additionally, an NIH Institute or Center (IC) Program Official (i.e., IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award.  The NIH Project Scientist and the IC Program Official may be the same person.  In that case, Program Official/Project Scientist will seek NCI waiver according to the NCI procedures for management of conflict of interest to enable her/him to attend peer review meetings of renewal or supplemental applications when necessary. The NCI Program Official, in consultation with NIH staff members from NHLBI and NIAID, will review mechanisms established by CIBMTR for data management and analysis, when appropriate.

NIH staff members will coordinate with Health Resources and Services Administration/DHHS on activities in stem cell transplant outcomes data collection for the C. W. Bill Young Cell Transplantation Program especially to eliminate and avoid duplication in data collection and harmonizing computer systems.  NIH staff members will serve as ex officio members of the CIBMTR Advisory Committee.  NIH staff members will attend appropriate CIBMTR meetings and/or participate on appropriate CIBMTR conference calls.

Benchmarks of Performance:

For the portion of the funding provided by the NIAID, critical path milestones will be established, such that: 1) the CIBMTR will be required to evaluate and enhance the quality and scope of the database in areas relevant to the mission of the Division of Allergy, Immunology and Transplantation (DAIT), NIAID when appropriate; and 2) even though the purpose of the U24 mechanism is to establish and maintain a database that may serve as a resource rather than to initiate research and analysis, collaborations within the CIBMTR Working Committees relevant to the DAIT, NIAID, mission should and will generate research reports that are published in peer-reviewed biomedical journals.

Evaluation of Performance/Outcome:

NIH program staff members will review and evaluate progress reports and milestone achievements.  The NCI Program Director will be responsible for internal coordination of NIH activities involving this cooperative agreement.

2.A.3. Collaborative Responsibilities

The CIBMTR and NIH staff members will jointly develop methods to make this resource accessible to other investigators.  This joint development may occur through strategy meetings, development of datasets for publication on the Internet, and other mechanisms, as deemed appropriate.

The CIBMTR and NIH staff will jointly coordinate activities to eliminate and avoid duplication in data collection and harmonizing computer systems.

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, including: a designee of the CIBMTR 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 DHHS 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.

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:

Dr. Roy S. Wu
Clinical Grants and Contracts Branch
Clinical Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 7009 , MSC 7432
Bethesda, MD 20892-7432 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: 301-496-8866
Fax: 301-480-4663
Email: wur@ctep.nci.nih.gov

Dr. Nancy DiFronzo
Transfusion Medicine and Cellular Therapeutics Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute6701 Rockledge Drive, Room 10146, MSC 7950
Bethesda, MD 20892-7950
Telephone: 301-435-0065
Fax: 301-480-1046
Email: difronzon@nhlbi.nih.gov

Dr. Linda M. Griffith
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive, Room 3025, MSC 6601
Bethesda, MD 20892-6601
Telephone: 301-496-7104
Fax: 301-480-1450
Email: lgriffith@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express mail/courier delivery)
Telephone:  301-496-3428
Fax: 301-402-0275
Email: ncidearefof@mail.nih.gov

3. Financial or Grants Management Contacts:

Ms. Eileen Natoli
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243 , MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-7800
Fax:  301-496-8601
Email: natolie@mail.nih.gov

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 at 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 PA 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 (CFDA) 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 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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