Notice of Limited Competition Request for Competing Applications: NHLBI Blood and Marrow Transplant Clinical Research Network

Notice Number: NOT-HL-05-119

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

Key Dates
Release Date: July 6, 2005
Application Receipt Date: September 18, 2005

Issued by
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)

The NHLBI and NCI are requesting competing renewal applications from the 17 cooperative agreements currently funded as part of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). These awards resulted from RFA-HL-01-004, Blood and Marrow Transplant Clinical Research Network (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-01-004.html). This Network provides a unique collaborative structure for clinical studies. The extensive time and processes involved in establishing the collaboration essential for efficient development and implementation of protocols as a network warrants this limited re-competition for one renewal cycle. If the grant applications receive favorable scores, the current Network will continue for five more years, depending on the availability of funds.

Four expanded activities in the BMT CTN will be emphasized in the renewal period: (1) procedures to monitor and manage core and non-core center performance, funding, and status within the Network; (2) the conduct of Phase II trials that provide a basis for Phase III studies on transplantation methodologies aimed at improving long-term outcome following transplantation; (3) the conduct of Phase II/III clinical trials addressing the needs of pediatric patients and those with rare diseases; and (4) the development of procedures for protocol development, conduct, and data management that will enable collaboration with other NIH-funded cooperative research programs and increase the efficiency of conducting trials in blood and marrow transplant.

Mechanism of Support

The Network uses the cooperative agreement (U01) administrative and funding mechanism of support. Under the cooperative agreement, the NIH assists, supports, and/or stimulates, and is substantially involved with recipients in conducting studies by facilitating performance of the effort in a "partner" role. Details of the responsibilities, relationships, and governance of a study funded under this cooperative agreement will be the same as in the current terms and conditions of the award. General Organization, Operation, and Oversight remain unchanged from the original RFA.

Submitting an Application

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Supplemental Instructions

Only competing renewal applications funded as part of RFA-HL-01-004, Blood and Marrow Transplant Clinical Research Network, will be considered. For each Clinical Core Center, the Research Plan will include the description of two well-developed proposed clinical trials with the full protocols attached as addendum. In addition, two to three concept proposals for studies desired in another period of funding should be briefly described. Only one application (the Master application) must contain the Research Plan (sections a. through d. outlined in the PHS 398). Each of the other applications in the program will have the same Research Plan as the Master application and should specify “See the application from Dr. X” (Principal Investigator for the Master Plan application for the Research Plan), but will have unique Budget pages, Biosketches, Resources, and Checklist. The application from the DCC should include a review of the progress made by the BMT CTN, a plan to monitor and manage core and non-core center performance, funding, and status within the Network, and a plan to develop procedures for protocol development, conduct, and data management that will enable collaboration with other NIH-funded cooperative research programs and increase the efficiency of conducting trials in blood and marrow transplant. The Principal Investigators of the Data Coordinating Center and Clinical Core Centers will work collaboratively with the NHLBI and NCI Project Officers and staff to obtain Institute approval when required and implement approved changes to Organization, Operation, and Oversight of the Network Research Program. Each applicant is allowed to submit a budget that includes a 10% increase in the first year of the renewal funding period. In addition, in order to enable the conduct of research in children by increasing the utilization of clinical sites within the Pediatric Blood and Marrow Transplant Consortium (PBMTC), the PBMTC (U01 HL069254) is allowed to submit a budget that includes a 37% increase in the first year of the renewal funding period.

For every application, Item 2 on the Face Page should be checked "Yes"; after "Number:" enter "NOT-HL-05-119," and after "Title:" enter "Competing Applications for Blood and Marrow Transplant Network."

For the Checklist at the end of the application, mark the box "Competing Continuation," and fill in the grant application number.

Application Procedure

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
Bethesda, MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application plus all five collated sets of appendix material must be sent to:

Chief, Review Branch Division of Extramural Affairs, NHLBI
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0270
FAX: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Application Processing

Applications must be received on or before the application receipt date listed in the heading of this Notice. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgment of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks.

Review Criteria

One single overall score for the application will be based on the scientific merit of the Clinical Core Center applications and the Data Coordinating Center application, as well as the overall synergy and integration of these components, the effectiveness and adequacy of plans for past and future development and management of BMT CTN, the overall program organization and capability of the associated personnel, the plans for expansion through addition of new research activities, and the extent to which the proposed clinical studies will contribute to the overall mission of the BMT CTN, as indicated in RFA-HL-01-004.

Criteria and Attributes to Consider for Evaluation of the Individual Application Components

Review Criteria for Clinical Core Center Applications:

Research plan. Is a clinical trials network required to accomplish the proposed protocols? Will the proposed studies advance, extend or challenge existing paradigms in blood and marrow transplantation for malignant diseases, non-malignant diseases, and either rare diseases or pediatric diseases? Will the results of the proposed studies develop critical, new knowledge about blood and marrow transplantation leading to advances in clinical practice and improved outcomes for patients undergoing blood or marrow transplantation? Do the preliminary results justify the proposed end points and sample size, and indicate that accrual could be accomplished in four years?

Qualifications and experience. Are the expertise, training, and experience of the investigators and staff well suited to carry out blood and marrow transplantation clinical trials?

Institutional resources for patient care and follow-up. Will the institutional resources, including personnel, space, and special laboratory facilities, contribute to the probability of success of the Network? Do the proposed studies benefit from the unique scientific environment created by the Network?

Review Criteria for Data Coordinating Center (DCC) Application:

Research plan. Does the administrative framework have clear lines of authority and responsibility? Does the leadership have a clear understanding of the scientific, statistical, logistical, and technical issues underlying multi-center studies, including issues relating to treatment and management of transplant subjects? Is leadership demonstrated in study design and statistics, data acquisition and management, data quality control, data analysis, handling and quality control of laboratory specimens, and the coordination of inter-institutional activities? Is there feasibility and clarity of plans for prioritizing the use of shared resources, for allocating availability to the proposed research activities, and for ensuring that the scientific resources and facilities are used to their fullest extent? Are the plans to develop industry sponsorship/partnership of Network trials feasible and adequate? Are resources (Network, NIH and industry) leveraged so that Network-initiated trials can be completed?

Qualifications and experience. Are the expertise, training, and experience of the investigators and staff well suited for the effective coordination of the Network? Is adequate time and effort devoted to the program for effective Network functions? Do the investigators and staff demonstrate an understanding of randomized, multi-center trials?

Study management. Does the DCC provide administrative, supervisory, and collaborative arrangements necessary for achieving the goals of the program, including willingness to cooperate with the participating NIH Clinical Centers and the NHLBI and NCI? Does the DCC assist with recruitment problems, identify and subcontract with non-Core clinical centers so that the Network is able to meet accrual goals? Are effective strategies in place to select concepts to develop into full protocols?

Patient access and study population. Are there sufficient numbers of patients eligible for the proposed Network protocols? Are the plans for recruitment and retention of subjects feasible? If competing protocols exist, is the proposed strategy for allocating patients between them practical and feasible?

Willingness and past evidence to participate in the Network. Is the DCC committed to a collaborative environment and work with other NIH Network and Cooperative Groups, NHLBI, and NCI? Do the proposed studies benefit from collaborative arrangements within and outside of the Network? During the previous funded period, have the clinical core principal investigators collaboratively developed Network protocols, contributed to Network infrastructure through committee participation, and accrued patients for Network protocols?

Environment . Are the facilities, equipment, and organizational structure suitable for coordinating Clinical Research Network activities effectively, assisting Clinical Centers in implementing the Clinical Research Network protocols, providing specialized laboratory testing, and collecting and analyzing data generated by the Network? This includes but is not limited to development and/or utilization of repositories, conduct of lab tests and studies, and obtaining study drugs or investigational agents.

Additional Review Criteria

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

Inquiries

Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from applicants is welcome.

Direct inquiries regarding programmatic issues to:

Jean Henslee-Downey, MD
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Diseases
6701 Rockledge Drive, Room 10042
Bethesda, MD 20892-7950
Telephone: 301-435-0065
FAX: 301-480-1060
E-mail: downeyj@nhlbi.nih.gov

Nancy DiFronzo, PhD
Division of Blood Diseases and Resources
National Heart, Lung and Blood Diseases
6701 Rockledge Drive, Room 10042
Bethesda, MD 20892-7950
Telephone: 301-435-0065
FAX: 301-480-1060
E-mail: difronzon@nhlbi.nih.gov

Roy Wu, PhD
Chief, Clinical Grants and contracts Branch
Cancer therapy Evaluation Program, DCTD
National Cancer Institute
6130 Executive Boulevard
Bethesda, MD 20892
Telephone: 301-496-8866
FAX: 301-480-4663
E-mail: wur@ctep.nci.nih.gov

Direct inquiries regarding review matters to:

Chief, Review Branch Division of Extramural Affairs, NHLBI
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0270
FAX: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Authority and Regulations

This program is described in the Catalog of Federal Domestic Assistance No. 93.837. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Las 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CRF 52 and 45 CRF Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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.


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