Part I Overview Information


Department of Health and Human Services

Participating Organizations 
U.S. Food and Drug Administration (FDA), (http://www.fda.gov)

Components of Participating Organizations
Office of Orphan Products Development (OC, FDA), (http://www.fda.gov/orphan)

Title: Pediatric Device Consortia Grant Program (P50)

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

Announcement Type
New  

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

Request For Applications (RFA) Number: RFA-FD-09-007

Catalog of Federal Domestic Assistance Number(s)
93.103

Key Dates  
Release Date: April 30, 2009
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Date: June 15, 2009
Peer Review Date(s): July 2009   
Council Review Date: August 2009
Earliest Anticipated Start Date: September 2009
Expiration Date: June 16, 2009

Due Dates for E.O. 12372  

Not Applicable  

Additional Overview Content

Executive Summary  

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The development of pediatric medical devices currently lags five to ten years behind the development of devices for adults.  Children differ from adults in terms of their size, growth, development, and body chemistry, adding to the challenges of pediatric device development.  There currently exists a great need for medical devices designed specifically with children in mind.   Such needs include the original development of pediatric medical devices, as well as the specific adaptation of existing adult devices for children.  Thus, as part of the 2007 FDAAA legislation, Congress passed the Pediatric Medical Device Safety and Improvement Act of 2007.  Section 305 of this Act requires the Secretary to provide demonstration grants or contracts to nonprofit consortia to promote pediatric device development.

The FDA definition of “pediatric” devices, for purposes of device development, refers to devices intended to be used for patients who are 21 years of age or younger at time of diagnosis or treatment. The FDA’s Center for Devices and Radiologic Health defines “pediatric use” as any use of a medical device in a pediatric population in which there is a primary pediatric indication OR a more general indication where significant pediatric application is anticipated.

Research Objectives

The goal of FDA's Pediatric Device Consortia Grant Program is to support nonprofit consortia in stimulating projects which will promote pediatric device development.   The consortia will facilitate the development, production, and distribution of pediatric medical devices by

1)  encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;

2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;

3) connecting innovators and physicians to existing Federal and non-Federal resources;

4) assessing the scientific and medical merit of proposed pediatric device projects; and

5) providing assistance and advice as needed on business development, personnel training, prototype development, and post-marketing needs.

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

Section II. Award Information


1. Mechanism of Support

Support will be in the form of a Specialized Center Project Grant (P50). The P50 grant mechanism supports any part of the full range of research and development in a given field of study.  The P50 grant mechanism supports a wide spectrum of activities which together comprise a multidisciplinary approach to a specific biomedical problem area.  The rationale for funding  these P50 grants is to create a critical mass of interdisciplinary researchers all focused on the common problem of advancing the availability of pediatric medical devices.

The Project Director/ Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007 (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm), including the provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92. The regulations issued under Executive Order 12372 do not apply to this program. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

All grant awards are subject to applicable requirements for clinical investigations imposed by sections 515 and 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e, and 360j), regulations issued under any of these sections, and other applicable HHS statutes and regulations regarding human subject protection.  FDA’s research program is described in the Catalog of Federal Domestic Assistance (CFDA) No. 93.103.

2. Funds Available

The estimated amount of funds available for support of one to four consortia awarded as a result of this announcement is $2 million for fiscal year 2009. Grants will be awarded on a competitive basis up to $2,000,000 in total (direct plus indirect) costs per year for up to 2 years. Future year amounts will depend on annual appropriations.  It is anticipated that funding for the non-competing continuation awards in FY 2010 will be similar to FY 2009.

Because the nature and scope of the proposed activities will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the FDA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

The grants are available to any domestic, public or private, nonprofit consortium (including State and local units of government). Federal agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply.  Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards.

1.B. Eligible Individuals

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

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for the consortium. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi.

When multiple PDs/PIs are proposed, FDA requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the FDA, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The FDA review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This grant program does not require the applicant to match or share in the project costs if an award is made.

3. Other-Special Eligibility Criteria  

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions.  Not Applicable. 

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

Section IV. Application and Submission Information


1. 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 Camille Peake, Telephone (301) 827-7175, Email: Camille.Peake@fda.hhs.gov.

Telecommunications for the hearing impaired: TTY 301-480-0434.

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://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form and registered in the Central Contractor Registration (CCR) database.

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.

Consortium/Contractual Arrangements: If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required as per the PHS 398 research grant application instructions.

For all P50 applications submitted in response to this FOA, the standard PHS 398 instructions are modified.  In particular, Research Plan (Items 2-5 per Revision 11/07 of the PHS 398 Table of Contents, previously known as “Sections A-D”) is altered as follows:

Other sections of the standard PHS 398 Research Plan (Sections E-L) remain unchanged and must be completed following the PHS 398 instructions (see http://grants.nigh.gov/grants/funding/phs398/phs398.html).

Section 1.  Overall Consortium Description (up to 20 pages suggested).

This section should be used to present both the overall vision and specifics for the consortium.  This summary should contain the long- and short-term objectives, specifically how activities supported by the consortium will advance pediatric device development. 

Of importance is the discussion of the business, regulatory, and medical/ scientific expertise of the consortium leaders and members.  Established relationships between the consortium and manufacturers and academic institutions should be explained.  The consortium leadership’s familiarity with the Federal system and obtaining funding through Federal and non-Federal

resources should be explained. Relevant background information on the consortium leadership’s accomplishments pertinent to the goals of pediatric device development should be described. 

Section 2. Portfolio of Proposed Projects (up to 10 pages per project)

The consortium should provide a list of all projects it currently supports and the stage of development of each of these projects.

For purposes of evaluating this application, the consortium should present a description of no fewer than two and no more than five pediatric medical device projects that it plans to manage or provide mentorship for over the next two years. 

The proposed projects must all be designed to obtain results that are directly relevant and useful in clinical practice and in advancing pediatric device development.

Each project should be described in sufficient detail to enable reviewers to judge the merit from the written application.  Each project should have a single theme related to pediatric medical devices and a described budget.  See section V.2 for review criteria.

Each proposed project must contain the following elements:

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. FDA requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the activities plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the proposed projects should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

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

3.A.Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: Not Applicable
Application Receipt Date:  June 15, 2009
Peer Review Date: July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date(s): 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, eight signed photocopies, and appendices on CD-ROM, in one package to:

Division of Acquisition Support and Grants
Office of Acquisitions & Grant Services
5630 Fishers Lane, Room 2141
Rockville, Maryland  20857
Phone:  301- 827-7175

3.C. Application Processing
Applications must be post-marked on or before the application receipt date described above (Section IV.3.A.). If an application is post-marked after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness and for responsiveness by the FDA.  Incomplete and/or non-responsive applications will not be reviewed.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

6. Other Submission Requirements

None

Research Plan Page Limitations

For page limits and content of Research Plan, see Section IV.2  Content and Form of Application Submission of this FOA

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. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

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

Resource Sharing Plan(s)

Not applicable.

Foreign Applications 

Not applicable.

Protection of Human Research Subjects

All institutions engaged in human subject research financially supported by HHS must file an assurance of protection for human subjects with the OHRP (45 CFR Part 46).  Applicants are advised to visit the OHRP Internet site at http://www.hhs.gov/ohrp for guidance on human subject protection issues.

The requirement to file an assurance applies to both ”awardee” and collaborating ”performance site” institutions. Awardee institutions are automatically considered to be ”engaged” in human subject research whenever they receive a direct HHS award to support such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the awardee institution bears the responsibility for protecting human subjects under the award.

The awardee institution is also responsible for, among other things, ensuring that all collaborating performance site institutions engaged in the research hold an approved assurance prior to their initiation of the research. No awardee or performance site institution may spend funds on human subject research or enroll subjects without the approved and applicable assurance(s) on file with OHRP. An awardee institution must, therefore, have its own IRB of record and assurance. The IRB of record may be an IRB already being used by one of the ”performance sites,” but it must specifically be registered as the IRB of record with the OHRP.

For further information applicants should review the section on human subjects in the application instructions as posted on the grants.gov application website.  The clinical protocol should comply with ICHE6 ”Good Clinical Practice Consolidated Guidance' which sets an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. All human subject research regulated by FDA is also subject to FDA's regulations regarding the protection of human subjects (21 CFR Parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and Good Clinical Practice available on the Internet at http://www.fda.gov/oc/gcp/.

Key Personnel and Human Subject Protection Education

The awardee institution is responsible for ensuring that all key personnel receive appropriate training in their human subject protection responsibilities. Key personnel include all principal investigators, co-investigators, and performance site investigators responsible for the design and conduct of the projects. HHS, FDA, and OPD do not prescribe or endorse any specific education programs. Many institutions have already developed educational programs on the protection of research subjects and have made participation in such programs a requirement for their investigators. Other sources of appropriate instruction might include the online tutorials offered by the Office of Human Subjects Research, NIH at http://ohsr.od.nih.gov/  and by OHRP at http://ohrp.osophs.dhhs.gov/educmat.htm.

Within 30 days of the award, the consortium director should provide a letter to the FDA grants management office that includes the names of the key personnel, the title of the human subjects protection education program completed for each key personnel, and a one-sentence description of the program. This letter should be signed by the principal investigator and cosigned by an institution official and sent to the Grants Management Specialist whose name appears on the official Notice of Grant Award (NGA).

Informed Consent

This section applies for any clinical studies or studies involving humans that are conducted under this RFA.  Consent forms, assent forms, and any other information given to a subject are part of the grant application and must be provided, even if in a draft form. The applicant is referred to HHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details regarding the required elements of informed consent.

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

FDA grants management and program staff will review all applications sent in response to this notice. To be responsive, an application must be submitted in accordance with the requirements of this notice.  Applications found to be non-responsive will be returned to the applicant without further consideration.

Applicants are strongly encouraged to contact FDA to resolve any questions about criteria before submitting their application. Please direct all questions of a technical or scientific nature to the OPD program staff and all questions of an administrative or financial nature to the grants management staff (see Agency Contacts in section VII of this document).

Responsive applications will be reviewed and evaluated for merit by an ad hoc panel of experts in pediatrics and device development. Consultation with the proper FDA review division may also occur during this phase of the review to determine whether the proposed consortia projects may provide acceptable data that could contribute to product approval. Responsive applications will be subject to a second review by the National Cancer Institute, National Cancer Advisory Board (NCAB) for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of Food and Drugs or his designee.

A score will be assigned based on the review criteria. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the Pediatric Device Consortia Grant Program.

As part of the peer review, all applications will:

The following will be considered in making funding decisions:

The goal of the FDA’s Pediatric Device Consortia Grants Program is to support the development of medical devices designed for pediatric use through consortia which in turn support pediatric device projects.  In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed consortium will have a substantial impact on pediatric device development.

2.A. CORE REVIEW CRITERIA

Reviewers will assign scores based on 1) the Consortium’s Organization/ Capability to Develop Pediatric Devices and 2) the Likelihood of Success of the Consortium’s Proposed Device Development Projects.  Both of these core criteria will be weighted equally.  Please see below for how each of these core criteria will be scored.

2.A.1.  Consortium Organization/ Capability to Develop Pediatric Devices

In evaluating the Consortium ’s Organization/ Capability to Develop Pediatric Devices reviewers will provide an overall score to reflect their assessment of the likelihood for the consortium to exert a sustained, powerful influence on the field of pediatric device development, in consideration of four review criteria below.

Reviewers will consider each of the four review criteria below in the determination of merit evaluation and will give a separate evaluation for each review criterion.   An application does not need to be strong in all aspects of the following four review criteria to have effective organization and capability to develop pediatric devices. 

1. Significance.  Does the consortium address an important problem or a critical barrier to progress in the field of pediatric device development?  If the aims of the consortium are achieved, how will pediatric device development be advanced?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive pediatric device development?   Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the consortium?

2. Consortium Leadership and Membership.  Do the consortium leadership and members have complementary and integrated expertise; is the leadership approach, governance and organizational structure appropriate for the consortium?  Does the consortium leadership have established relationships with device manufacturers and academic centers?  Does the consortium leadership demonstrate established business experience, specifically in device development and with regulatory processes?  Does the consortium leadership have knowledge of Federal government agencies and resources; and have experience in obtaining both Federal and non-Federal resources?  Does the consortium include members with adequate scientific and medical expertise to judge the merit of proposed pediatric device projects?  Does it include members knowledgeable in engineering, statistics, clinical trial design, and regulatory experience?

3. Budget.  Are the budget and requested period of support fully justified and reasonable in relation to the proposed work of the consortium and its proposed projects?

4. Environment/Resources.  Will the scientific environment in which the work is done contribute to the probability of success?  Is there institutional commitment to establishing and supporting a pediatric device consortium?  Are the institutional support, equipment, physical, or other resources available to the investigators adequate for the projects proposed?  Will the consortium benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there access to pediatric patients and populations for conducting current and projected clinical research?

2.A.2. LIKELIHOOD OF SUCCESS OF THE CONSORTIUM’S PROPOSED DEVICE DEVELOPMENT PROJECTS

In evaluating the Likelihood of Success of the Consortium ’s Proposed Device Development Projects,  reviewers will provide an overall score to reflect their assessment of the quality and practicality of proposed projects in consideration of the five review criteria below.

Reviewers will consider each of the five review criteria below in the determination of merit evaluation, and will give a separate evaluation for each review criterion.   An application does not need to be strong in all aspects of the following five review criteria to have an appropriate likelihood of success.

1. Significance:  Do the projects address important pediatric clinical device needs?  If the aims of the projects are achieved how will clinical practice be advanced?  What will be the effect of these projects on the technologies, treatments, services, or preventative interventions that drive the field of pediatrics?

2. Approach:  Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the projects?  Does the applicant acknowledge potential problem areas and consider alternative tactics?  Is the proposed project plan appropriate for the state of knowledge, current capabilities and resources for the pediatric population or group of diseases?  Are the questions being asked most likely to advance the development of products for pediatric patients?  Are the clinical designs appropriate to address the objectives of the project plan?

3. Likelihood for marketing success:  Are the projects likely to advance product development towards market approval?  What stage of development are the products in?  Are the proposed projects in an early stage of concept development (product identification and prototype design) or in a later stage of development (device development and marketing) ?  How likely is it that the consortium will be able to provide effective assistance in forwarding the development of these products?

4. Project Leaders:  Are the project leaders appropriately trained and well suited to carry out this work?   Do they have experience in product design or conducting clinical research?  Is the work proposed appropriate to the experience level of the project leader and other researchers?

5. Environment/Resources:  Does the scientific environment in which the work will be done contribute to the probability of success?  Is there evidence of institutional support?

2.C. Additional Review Criteria 

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

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

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

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

Vertebrate Animals.  The adequacy of the plans for care and use of vertebrate animals to be used in the project will be assessed.  See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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.

Resource Sharing Plans.  Not applicable.

3. Anticipated Announcement and Award Dates

Mid to Late September 2009

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).

If the application is under consideration for funding, FDA may request information from the applicant prior to making the award. For details, applicants may refer to the HHS Grants 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 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 FDA grant awardees must adhere to the requirements stated in the Request for Application, the NoA, associated Terms and Conditions, as well as any relevant FDA or HHS statutory or regulatory requirements. For these terms of award, see the HHS Grants Policy Statement, DHHS Grants Policy Statement  Link: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

3.A.  Oversight Activities

The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer or specialist and the consortium.  Information including but not limited to information regarding project progress, problems, adverse events, changes in consortium leadership and planned activities, and any applicable regulatory compliance will be requested.  Periodic site visits with officials from the consortia organizations may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the consortia must comply with all special terms and conditions of the grant.

3.B.  Reporting Requirements

The grantee must file a final program progress report, Financial Status Report (FSR) and invention statement within 90 days after the end date of the project period as noted on the notice of grant award. Section 305 requires an annual report on the status of pediatric device development, production, and distribution that has been facilitated by the consortium.  The report should be sent to the Office of Orphan Products Development.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement, dated October 1, 2006, (http://www.hhs.gov/grantsnet/adminis/gpd/). Also, all new and continuing grants must comply with all regulatory requirements.

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

A listing and a justification for any study changes that occurred in the past year must be included in the Non-Competing Continuation Grant Progress Report (PHS 2590).

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Linda C. Ulrich, M.D.  or  Debra Y. Lewis, O.D., M.B.A
Pediatric Device Consortia Grants Program
Office of Orphan Products Development
Food and Drug Administration
5600 Fishers Lane, Room 6A-55, HF-35
Rockville, MD  20857
Telephone: (301) 827-3666
FAX: 301-827-0017
Email: Linda.Ulrich@fda.hhs.gov or Debra.Lewis@fda.hhs.gov

2. Financial or Grants Management Contacts:

Camille Peake
Grants Management Specialist
Division of Acquisition Support and Grants
Office of Acquisitions & Grant Services
5630 Fishers Lane, Room 2139
Rockville, Maryland  20857
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FAX:  301-827-7101
Email:  Camille.Peake@fda.hhs.gov

Section VIII. Other Information


1. Required Federal Citations

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

1.B.  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).

1.C. Data and Safety Monitoring Plan:
Data and safety monitoring may be required for certain types of clinical trials.  The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials.  Although Phase I and Phase II clinical trials may also use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.

1.D. 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 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.

1.E. Access to Research Data through the Freedom of Information Act:
The Freedom of Information Act (FOIA), 5 U.S.C. 552, provides individuals with a right to access certain records in the possession of the Federal government, subject to certain exemptions. The government may withhold information pursuant to the exemptions and exclusions contained in the FOIA. The exact language of the exemptions can be found in the FOIA. 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) and FDA regulations implementing the FOIA (21 CFR part 20). (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 relevant statutes and implementing regulations. FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law.

1.F.  Inclusion of Women And Minorities in Clinical Research:
Applicants for PHS clinical research grants are encouraged to include minorities and women in study populations so research findings can be of benefit to all people at risk of the disease or condition under study. It is recommended that applicants place special emphasis on including minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy applies to research subjects of all ages. If women or minorities are excluded or poorly represented in clinical research, the applicant should provide a clear and compelling rationale that shows inclusion is inappropriate.

1.G.  Inclusion of Children as Participants in Clinical Research:
FDA regulations at 21 CFR part 50, subpart D contain additional requirements that must be met by IRBs reviewing clinical investigations regulated by FDA and involving children as subjects. FDA is part of HHS; accordingly, the research project grants under this program are supported by HHS, and HHS regulations at 45 CFR part 46, subpart D also apply to research involving children as subjects.

1.H. Standards for Privacy of Individually Identifiable Health Information:
HHS 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 HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Web site http://www.hhs.gov/ocr/ provides information on the Privacy Rule.

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

1.J  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.

1.K  Authority and Regulations: 
This program is not subject to the intergovernmental review requirements of Executive Order 12372. FDA's research program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103 http://www.cfda.gov/.

FDA will support the clinical studies covered by this notice under the authority of section 301 of the PHS Act as amended (42 U.S.C. 241) and under applicable regulations at 42 CFR Part 52 and 45 CFR Parts 74 and 92. All grant awards are subject to applicable requirements for clinical investigations imposed by sections 505, 512, and 515 of the act (21 U.S.C. 355, or 360e) or safety, purity, and potency for licensing under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262), section 351 of the PHS Act, including regulations issued under any of these sections.

All human subject research regulated by FDA is also subject to FDA's regulations regarding the protection of human subjects (21 CFR Parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and Good Clinical Practice available on the Internet at http://www.fda.gov/oc/gcp/.

The applicant is referred to HHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details regarding the required elements of informed consent.

All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007 (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm). 

1.L  Human Embryonic Stem Cells (hESC) Research and Cloning:
Section 498 of the PHS Act places certain restrictions on human fetal research.  In addition, under currently applicable executive orders, HHS funds may not be used to support human embryo research under any extramural award instrument. HHS funds may not be used for the creation of a human embryo for research purposes or for research in which a human embryo is destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204 and 46.207 and Subsection 498(b) of the PHS Act 42 U.S.C. 289g(b). The term human embryo includes any organism not protected as a human subject under 45 CFR part 46, as of the date of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

In addition, HHS is prohibited, by a March 4, 1997, Presidential memorandum, from using Federal funds for cloning human beings.  In implementing this program, FDA will comply with all applicable statutes, regulations, presidential memoranda and executive orders.

Criteria for Federal funding of research on hESCs can be found at http://www.hhs.gov/faq/research/stemcell/r-0006.html and http://stemcells.nih.gov/research/registry/eligibilityCriteria.asp.

1.M  Clinical Trials Data Bank
The Food and Drug Administration Amendments Act of 2007 (FDAAA) contains provisions that expand the current database known as ClinicalTrials.gov to include additional requirements for individuals and entities, including grantees, who are involved in conducting clinical trials that involve products regulated by FDA or that are funded by the Department of Health and Human Services (HHS), including FDA.  These additional requirements include mandatory registration of certain types of clinical trials, as well as reporting of results for certain trials for inclusion in the ClinicalTrials.gov database.  ClinicalTrials.gov, which was created after the Food and Drug Administration Modernization Act of 1997, provides patients, family members, healthcare providers, researchers, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Library of Medicine (NLM) has developed this site in collaboration with NIH and FDA. ClinicalTrials.gov is available to the public through the Internet at http://clinicaltrials.gov.

ClinicalTrials.gov contains information about certain clinical trials, both federally and privately funded, of drugs (including biological products) and medical devices.  The types of trials that are required to be registered, and for which results must be reported, are known as "applicable clinical trials."  FDAAA defines the types of clinical trials that are "applicable clinical trials" and, therefore, are subject to the registration and results reporting requirements.  The registry listing for each trial includes information such as descriptive information about the trial, patient eligibility criteria, recruitment status, location information on the clinical trial sites, and points of contact for those wanting to enroll in the trial.  The database also contains information on the results of clinical trials.  More detailed information on the definition of "applicable clinical trial" and the registry and results reporting requirements can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html and http://prsinfo.clinicaltrials.gov/fdaaa.html.

FDAAA also added new requirements concerning clinical trials supported by grants from HHS, including FDA.  Under these provisions, any grant or progress report forms required under a grant from any part of HHS, including FDA, must include a certification that the person responsible for entering information into ClinicalTrials.gov (the "responsible party") has submitted all required information to the database.  There are also provisions regarding when agencies within HHS, including FDA, are required to verify compliance with the database requirements before releasing funding to grantees.  OPD program staff will be providing additional information on these requirements, including the appropriate means by which to certify that a grantee has complied with the database requirements.


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