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U.S. Department of Health and Human Services

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Clinical Trials Transformation Initiative (U19)

pdf version  

 

Part I Overview Information



Department of Health and Human Services

Issuing Organization

Food and Drug Administration

Participating Organizations

Office of the Commissioner (http://www.fda.gov/oc/)

Components of Participating Organizations

Office of Critical Path Programs (http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm)


Title
: Clinical Trial Transformation Initiative (U19)

 

Note:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type:  New

Request For Applications (RFA) Number


Catalog of Federal Domestic Assistance Number(s)
: 93.103

Key Dates

Release Date: June 19, 2009
Letters of Intent Receipt Date(s):  N/A
Application Receipt Dates(s):  July 6, 2009
Peer Review Date(s): July 2009
Council Review Date(s): September 2009
Earliest Anticipated Start Date: September 2009

Additional Information To Be Available Date (Url Activation Date): http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIProjects/ucm083241.htm
Expiration Date: July 7, 2009

 

Due Dates for E.O. 12372
Not Applicable

 

Additional Overview Content


Executive Summary

  • Purpose.  To support modernization of the clinical trial enterprise by identifying practices that will enhance human subject’s protection, boost the quality of information derived from clinical trials, and make the research process more efficient.
  • Mechanism of Support. This FOA will use the Cooperative Agreement grant mechanism (U19).
  • Funds Available and Anticipated Number of Awards. FDA anticipates providing up to $1.5M (direct and indirect costs combined) during fiscal year (FY) 2009 to support research and related efforts of identified projects that are part of the Critical Path Initiative. This is a sole source funding opportunity.  Only one award will be made to the Duke Translational Medicine Institute to support the Clinical Trial Transformation Initiative (CTTI) at Duke University.
  • Budget and Project Period.  Subject to the availability of Federal funds and successful performance, an additional 4 years of support up to $1.5M (direct and indirect costs combined) per year may be available.
  • Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
  • Resubmissions. Resubmission applications are not permitted in response to this FOA.   
  • Renewals.Renewal applications are not permitted in response to this FOA. 
  • 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 and Information

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


1. Research Objectives

The Food and Drug Administration (FDA), Office of the Commissioner (OC) is announcing its intent to accept and consider a single source application for the award of a Cooperative Agreement to the Duke University’s Duke Translational Medicine Institute (DTMI) to support the Clinical Trial Transformation Initiative (CTTI).

FDA anticipates providing up to $1.5 M (direct and indirect costs combined) during fiscal year (FY) 2009 to support research and related efforts for the Clinical Trials Transformation Initiative (CTTI).

Subject to the availability of Federal funds and successful performance and if the Funding Opportunity Announcement (FOA) stated objectives are met, an additional 4 years of support of up to $1.5M (direct and indirect costs combined) per year may be available.

This Cooperative Agreement ensures substantial FDA involvement in this program and will include, but not be limited to, co-development of CTTI’s priorities, decision-making, reports, and publications at specified program milestones related to outcomes of projects. 

1.         Background

The Critical Path Initiative, launched by FDA in 2004, has the objective of helping modernize the development, evaluation, manufacture, and use of FDA-regulated products. Through nationwide collaboration with other Federal, academic, scientific, industry organizations, and other stakeholder organizations, the Initiative seeks to develop new tools to facilitate innovation in FDA-regulated product development, manufacture, and use. Examples of tools include novel biomarkers, laboratory assays, genetic tests, and state-of-the art information technologies, etc.  A memorandum of understanding (MOU) between FDA and Duke University was published in the Federal Register on November 23, 2007 to establish the CTTI.  The objective of CTTI is to systematically modernize the clinical trial process, a goal shared by FDA’s Critical Path Initiative.  CTTI comprises a broad representation of member organizations including government, industry, patient advocacy groups, professional societies, and academia.  The participants will work together to identify practices that through broad adoption will increase the quality and efficiency of clinical trials.

This award will be made to Duke University in support of CTTI under the DTMI to provide some of the direct and indirect costs associated with the organization and related to CTTI projects.  CTTI undertakes projects proposed by members and the public, with the goal of identifying practices with the potential to increase the quality and efficiency of clinical trials.  In this context quality is characterized by the ability to effectively and efficiently answer the intended questions about the benefits and risks of a medical product (therapeutic or diagnostic) or procedure, while ensuring protection of trial participants.

CTTI will generate evidence about how to improve the design and execution of clinical trials. Projects about design will address principles generally applicable to clinical trials to ensure that they are fit to accomplish their intended purpose.

While CTTI focuses on clinical trials, it may study other types of clinical research (e.g., registries) that can provide data to regulatory agencies. Although CTTI will concentrate initially on the design and conduct of clinical trials in the United States, it seeks to identify practice improvements that can be applied worldwide.

As part of its Critical Path Initiative, FDA recognizes the need for collaborations established under the terms and conditions of a cooperative agreement, whereby existing resources and expertise can be used to the fullest extent possible.

The DTMI is Duke University’s academic home for the clinical and translational research community. It is an integrated support structure that provides resources and training and facilitates collaborative research in clinical and translational research. The mission of the DTMI is to create a seamless continuum from scientific discovery to care delivery to global health.

2. Program Research Goals

The goals of this program are to develop an administrative and scientific infrastructure to support the creation and execution of a series of projects under the auspices of the CTTI initiative, to complement the goals of FDA’s Critical Path Initiative according to congressional mandate.

The following activities will be supported by this cooperative agreement.  The applicant must demonstrate the ability to (1) establish an adequate administrative and scientific infrastructure to implement all related projects under this collaborative effort;(2) identify and/or hire a sufficient number of qualified personnel to conduct the necessary research and project-management of all related activities, including review of project milestones for degree of completion, preparation/reporting of project findings, periodic and final reports, and for subsequent distribution in the public domain; (3) develop plans for the conduct of identified research projects (4) identify and/or build, and effectively leverage other resources for the conduct of identified projects; and (5) upon completion of a given project, propose related studies/projects, if needed, to build on the findings of the project and continue to leverage established resources and personnel.

3. Examples of Research Topics

  • Design Principles - The principles that govern the design of clinical trials are important in determining the quality of clinical trials. A quality trial is designed in such as way as to obtain reliable answers to the clinical questions being asked and to do so in an effective and efficient manner.

Project Examples:

  1. Assess existing approaches to the development of study plans, and to the extent practicable, identify best practices for a plan that ensures a clinical trial is fit for purpose or meets the intended needs of the study and is conducted effectively and efficiently.
  2. Evaluate the decision-making process for identifying inclusion and exclusion criteria, and propose standards to ensure that criteria are appropriate (not overly broad or narrow) to achieve the study objectives.
  •  Data Quality and Quantity - It is unclear whether current methods for ensuring data quality are appropriate and useful in all study settings. Issues related to case report forms (CRFs) and monitoring impact the quality of data collected within a clinical trial. Projects will assess possible approaches for more efficient data collection and assessment.

Project Examples:

  1. Assess existing approaches to monitoring (e.g. on-site monitoring, central statistical controls to identify problems or target on-site monitoring) and, to the extent practicable, propose standards for approaches to monitoring that take into account the specifics of study design, study population, and clinical setting.
  2. Identify best practices for trial oversight committees in carrying out their respective responsibilities for monitoring the conduct of the study and for evaluating the data.
  •  Study Start-up - Recently available data suggest that in the United States the time from a site receiving a multi-center, clinical trial protocol to that site being ready to enroll subjects often exceeds 6 months. The investigational review board (IRB) review of a protocol often exceeds 4.5 months, and contract negotiations take an equally long time. These delays in trial initiation are a substantial concern. Projects will analyze reasons for delays in trial initiation and identify best practices and metrics to help minimize those delays.

Project Examples:

  1. Explore options for an accreditation program for research sites and a credentialing program for clinical investigators and support personnel. Currently, research organizations that coordinate large, multi-site clinical trials are required to assess and document the qualifications of each investigator and the quality of each research site participating in a clinical trial. In the current system, a single site is typically subjected to an evaluation of its quality by multiple research organizations or sponsor companies.
  2. Review traditional methods of informed consent and explore development of newer methods, such as video-interactive electronic informed consent, with the objective of improving patient understanding and information, and assisting investigators in explaining the protocol.
  •  Adverse Event Reporting - Adverse event reporting is an important means of communicating potential safety concerns about a product or class of products. The existing system for adverse event reporting appears overly complex and can be overwhelming for investigators and IRBs. Projects will assess current practices for adverse event reporting and identify strategies to improve the sharing of information about potential safety issues.

Project Examples:

  1. Assess approaches for investigators to report adverse events to sponsors, and identify best practices for submitting complete and timely reports, where possible leveraging electronic data sharing technology.
  2. Evaluate the impact of the different adverse event reporting standards required for investigators and for sponsors.

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



Section II. Award Information


1. Mechanism of Support

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism (U19). 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 FDA staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."


2. Funds Available

It is anticipated that FDA will fund this Cooperative Agreement at up to $1.5M (direct and indirect costs).  Subject to the availability of Federal funds and successful performance of the FOA stated goals and objectives, four (4) additional years of support may be available depending on annual appropriations.

Appropriated funds will be obligated in fiscal year 2009.  Funding beyond the first year will be noncompetitive and will depend on (1) satisfactory performance during the preceding year and (2) the availability of Federal fiscal year funds.

This award will be funded based on the quality of the application received and is subject to availability of Federal funds to support the program. 

Facilities and administrative costs requested by consortium participants are included in the total cost limitation.

FDA grants policies as described in the DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the application submitted and the award made in response to this FOA.


Section III. Eligibility Information



1. Eligible Applicants

1. A. Eligible Institutions 
Duke Translational Medicine Institute located within Duke University.

 

2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current in the DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

 
3. Other-Special Eligibility Criteria

Resubmissions. Resubmissions applications are not permitted in response to this FOA. 

Renewals. Renewal applications are not permitted in response to this FOA.  

 

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.  Forms are available at http://grants.nih.gov/grants/forms.htm  For further assistance contact the FDA Grants Management Specialist listed under contacts in this FOA.
Telecommunications for the hearing impaired: TTY 301-451-0088.

2. Content and Form of Application Submission
Applications must be prepared using the most 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://fedgov.dnb.com/webform. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
Applicants must also register in the CCR database.  This database is a government wide warehouse of commercial and financial information of all organizations conducting business with the Federal Government.  Registration can be completed via the web at http://www.ccr.gov  You must have a DUNS number before registering in CCR.

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.

 

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

Application Receipt Dates(s):  July 6, 2009
Peer Review Date(s): July 2009
Council Review Date(s): September 2009
Earliest Anticipated Start Date: September 2009

 

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the FDA
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 five signed photocopies in one package to:

Gladys M. Bohler

Office of Grant and Contracts

Food and Drug Administration

5630 Fishers Lane; Rm. 2105

Bethesda, MD 20857

(301) 827-7168

FAX: 301-827-7101

Email: gmbohler@fda.hhs.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 FDA and for responsiveness by the reviewing panel. Incomplete and/or non-responsive applications will not be reviewed.

The FDA 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.

 

4. Intergovernmental Review

This initiative is not subject to intergovernmental review (see http://www.whitehouse.gov/omb/grants/spoc.html

5. Funding Restrictions
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement. The Grants Policy Statement can be found at

http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

Pre-award costs are allowable. A grantee may, at its own risk and without FDA 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 award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without FDA prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain FDA approval before incurring the cost. FDA 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 renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on FDA 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. FDA 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 DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm).   

6. Other Submission Requirements and Information

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Research Plan Page Limitations

As stated in the current PHS 398 application package and instructions.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. 

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.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

  • Data Sharing Plan. Not Applicable
  • 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 FDA’s Office of Critical Path Programs in accordance with FDA peer review procedures and to the extent applicable, the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), and the DHHS Awarding Agency Grants Administration Manual shall govern the establishment and operation of peer review groups, using the review criteria stated below.
As part of the scientific peer review, all applications will:

  • Receive a written critique.
  • Receive a second level of review by National Cancer Institute, National Advisory Board

Scientific/Technical Review Criteria

  1. The application clearly demonstrates an understanding of the purpose and objectives of the Cooperative Agreement.
  2. The application clearly describes the steps involved in a proposed schedule for planning, implementing, and accomplishing the activities to be carried out under the Cooperative Agreement. The application presents a clear plan and schedule of steps to accomplish the goals of the Cooperative Agreement.
  3. The application establishes the applicant’s ability to perform the responsibilities under the Cooperative Agreement including the availability of appropriate staff and sufficient funding.
  4. The application specifies the manner in which interaction with FDA will be maintained throughout the lifetime of the project.
  5. The application specifies how the DTMI will monitor progress of the work under the Cooperative Agreement and how progress will be reported to FDA.
  6. The application shall include a detailed budget that shows: (1) anticipated costs for personnel, travel, communications and postage, equipment, and supplies; and (2) the sources of funds to meet those needs, if other than FDA.

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
  • Relevance to program priorities

FDA’s mission is to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.As part of this mission, applications submitted to FDA for grants or cooperative agreements to support the protection and promotion of public health are evaluated for scientific and technical merit through the FDA peer review process.  

Overall Impact. Reviewers will provide an overall impact 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 are 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 PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

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? 

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.

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 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.

 

3. Anticipated Announcement and Award Dates
Notice of Award will follow within two weeks of the scheduled second level review by the National Cancer Institute, National Advisory Board.

 
Section VI. Award Administration Information



1. Award Notices
After the peer review of the application is completed, the PD/PI will  receive his or her Summary Statement (written critique) via e-mail from the Project Officer, or Grants Management Contact.

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant. For details, applicants may refer to the DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.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 Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award 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 FDA grant and cooperative agreement awards include the FDA Grants Policy Statement as part of the Notice of Award. For these terms of award, see the DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm


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

2. A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA 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 FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA 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 FDA as defined below.

2. A.1. Principal Investigator Rights and Responsibilities
Principal Investigator will have the primary responsibility for directing and overseeing the project and ensuring its completion in accordance with this cooperative agreement.
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 FDA policies.

2. A.2. FDA Responsibilities
An FDA Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below under collaborative responsibilities.

Additionally, an agency program official or OC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.


2. A.3. FDA Collaborative Responsibilities 
CTTI is comprised of an Executive Committee that serves as the decision-making body for the initiative.  This body will set the strategic direction and areas of priority for the initiative.  The composition of the Executive Committee will be as follows:

  • FDA – 2 members, one of whom will serve as Co-Chair
  • Duke – 1 member, who will serve as Co-Chair
  • NIH – 1 liaison
  • Non-US regulatory authority- 1 liaison
  • Pharmaceutical industry – 1 member
  • Device manufacturer industry – 1 member
  • Biotechnology industry – 1 member
  • Academia / research institutes – 1 member
  • Contract research organization – 1 member
  • At-large (non-industry) – 1 member
  • Patient representative – 1 member

The CTTI Executive Director, an employee of Duke, oversees the daily management of the CTTI and ensures compliance with all decisions made by CTTI’s Executive Committee.

In addition, a Steering Committee has been formed to develop project plans and teams to carry out the mission of the initiative.  The Steering Committee includes representatives from CTTI members and government agencies, to include FDA, CMS, NIH, and OHRP.  The responsibilities of Steering Committee members are:

  • Based on priorities defined by the Executive Committee, propose specific projects for approval by the Executive Committee
  • Appoint individuals to develop a formal project plan for approved project concepts
  • Assemble project teams for approved projects
  • Provide a workgroup with balanced public and private membership to review conflicts of interest for projects and white papers
  • Communicate to Executive Committee recommended shifts in priority for CTTI, should they arise
  • SC members should communicate progress on CTTI back to their respective member organizations
  • Keep abreast of and communicate with parallel initiatives in other arenas, e.g., CTSAs, other public private partnerships, other Critical Path Initiatives
  • Develop strategies to synthesize recommendations resulting from completed projects and to promote adoption of these recommendations within the clinical research enterprise
  • Nominate individuals to serve on the Executive Committee to replace members rotating off
  • Choose individuals to serve as the two at-large patient representatives and the one additional at-large member on the Steering Committee
  • Propose expectations and responsibilities of its members to the Executive Committee for ratification

CTTI's activities will be implemented primarily through the work of project teams doing research on the processes of clinical trials.  Representatives from Duke, FDA, and others will be members of the various projects being conducted by CTTI.  Teams are comprised of volunteers from member organizations and other interested expert volunteers to carry out the work identified and developed in project plans. 

Finally, DTMI and FDA provide project management support to assist in the creations and overall management of CTTI.

 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 DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

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/Review Contacts:

 

Melissa Robb

Office of Critical Path Programs

Office of the Commissioner

Food and Drug Administration

5600 Fishers Lane, Room 14B-45

Rockville, MD 20857

(301) 827-1516

FAX:

Email:  Melissa.robb@fda.hhs.gov

 

 2. Financial or Grants Management Contacts:

Gladys M. Bohler

Office of Grant and Contracts

Food and Drug Administration

5630 Fishers Lane; Rm. 2105

Bethesda, MD 20857

(301) 827-7168

FAX: 301-827-7101

Email: gmbohler@fda.hhs.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).

 

Access to Research Data through the Freedom of Information Act:
The Freedom of Information Act, U.S.C. 552, provides individuals with a right to access certain records in the possession of the Federal government.  The government may withhold information pursuant to the exemptions and exclusions contained in the act.  The exact language of the exemptions can be found in the act.  Additional guidance on the exemptions and how they apply to certain documents can be found in the HHS regulations implementing the FOIA (45 CFR Part 5).  Also see the HHS Web site http://www.hhs.gov/foia/

 

Data included in the application may be considered trade secret or confidential commercial information within the meaning of the Freedom of Information Act (5 U.S.C. 552) and FDA’s statute and implementing regulations.  FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law. See http://www.fda.gov/foi/default.htm for additional information.

 

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”.


URLs in FDA Grant Applications or Appendices:
All applications and proposals for FDA 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 (93.103) 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 DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

Smoke-Free Workplace:  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.