Participating Organization(s)	U.S. Food and Drug Administration (FDA) The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Review Scoring Criteria. The FDA's page limitations for this RFA are outlined in Part 2, Section IV, 2. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Review Process.
Components of Participating Organizations	Office of Orphan Products Development (OSMP, OMPT, FDA)
Funding Opportunity Title	Pediatric Device Consortia Grant Program (P50)
Activity Code	P50 Specialized Center
Announcement Type	Reissue of RFA-FD-11-002
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-FD-13-010
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	This FOA, issued by Office of Orphan Products Development, FDA, solicits grant applications from nonprofit consortia to facilitate the development, production, and distribution of pediatric medical devices. While the pediatric device consortia are non-profit entities, their contacts and membership can include for-profit partners. FDA will provide grants to consortia which provide expert advising and support services to innovators of children's devices. These services should include business and regulatory consulting, as well as device testing capabilities. This program is intended to further the development of multiple pediatric devices; thus, grants are not awarded to support the development of a single device project. Although administered by the Office of Orphan Products Development, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.

Posted Date	March 19, 2013
Letter of Intent Due Date(s)	Not needed, unless requesting a direct cost budget > $500,000 in any year. See Section IV.6.
Application Due Date(s)	Postmark by June 1, 2013
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July 2013
Advisory Council Review	September 2013
Earliest Start Date	September 2013
Expiration Date	June 2, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this Request for Applications [RFA]). Conformance to all requirements (both in the Application Guide and the RFA) is required. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: FDA is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format. NIH is currently investigating solutions that will accommodate FDA's multi-project programs. FDA will announce plans to transition the remaining programs.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The development of pediatric medical devices currently lags behind the development of devices for adults. Pediatric patients often differ from adults in terms of their size, growth, development, body chemistry, and disease propensity, adding to the challenges of pediatric device development. There currently exists a great need for pediatric medical devices, including devices developed originally for pediatric patients as well as existing adult devices adapted for pediatric use. Recent passage of the FDA Safety and Improvement Act (FDASIA) reauthorized support of section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 which requires HHS to provide demonstration grants to nonprofit consortia to promote pediatric device development. While the consortia themselves are nonprofit entities, their contacts and membership can include for-profit partners.

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 goal of the Pediatric Device Consortia (PDC) Grant Program is to fund networks of pediatric medical device advisors who are able to provide a platform of experienced regulatory, business planning, and device development services (such as intellectual property advising; prototyping; engineering; laboratory and animal testing; grant-writing; and clinical trial design) to help foster and guide the advancement of medical devices for pediatric patients. A successful Pediatric Device Consortium brings together individuals and institutions that can support pediatric medical device progression through all stages of development concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization. The consortia are expected to support a mix of projects at all stages of development, particularly the later stages of clinical, manufacturing, and marketing.

The consortia are expected to provide counsel on how to access various Federal and non-Federal funding resources. Additionally, the consortia will also assess the scientific and medical merit of proposed pediatric device projects.

To accomplish this work, the consortia, at a minimum, should include individuals, groups, or institutions to provide all of the following capabilities: knowledge of the clinical needs for pediatric devices, business planning, regulatory advising, intellectual property protections and other legal expertise, as well as scientific, engineering, pre-clinical, and clinical capabilities.

Business leadership in a consortium should have experience with the following:

• Bringing pediatric medical devices to the market.
• Demonstrated success in medical device commercialization.
• Business planning for device development.
• Fostering relationships with and securing funding from the investment community.
• Demonstrated familiarity with Federal and non-Federal funding mechanisms.

Regulatory leadership in a consortium should have experience with the following:

• Interactions with the FDA at Pre-Submission, IDE, Filing, or Deficiency meetings.
• Involvement with preparation and submission of HUD, IDE, 510K, HDE, and PMA applications.

Legal and intellectual property leadership should have experience with the following:

• Preparation, filing, and prosecution of patent applications.
• Determining successful protection of developed intellectual property.

Scientific/engineering leadership in a consortium should have experience with the following:

• Medical device design and Prototyping.
• Hands on engineering.
• Bench testing.
• Understanding and application of Engineering Standards.
• Meaningful guidance on Good Manufacturing Practices (GMP) and Quality Assurance (QA) issues. such as Biocompatibility, Fatigue and Corrosion testing, and Sterilization.
• Access to facilities to complete Animal Testing according to Good Laboratory Practices (GLP).

Clinical leadership in a consortium should have experience with the following:

• Professional experience in direct pediatric patient care.
• Leadership and other professional participation in pediatric clinical trials.
• Participation and leadership in pediatric medical societies and organizations.
• Clinical trial design.
• Institutional Review Boards (IRB), Human Subjects Protection, and issues germane to pediatric clinical investigation.
• Patient registries.

Ultimately, the success of the PDC program will be judged by the market availability of medical devices for use in children. As such, the funds associated with this grant are to be used to support advising and consultative activities; infrastructure support; and limited financial assistance of projects on which they consult.

In this grant program, the consortia and their leadership work collaboratively with the Food and Drug Administration. The consortia leaders and PI’s function to effectively communicate and support existing laws and regulations governing pediatric device development. The agency acts as a resource to provide ongoing regulatory information and education to the consortia and their affiliated projects.

The consortia are Federally funded, national resources for pediatric device development-- consortia based out of either non-academic or academic centers are encouraged to apply. Consortia are expected to support any pediatric device development project and not be limited to projects generated by their own members.

Consortia leaders are expected to participate in agency supported meetings intended to enhance their regulatory expertise, as well as occasional agency- sponsored pediatric device outreach initiatives.

Funds are not intended to be used for general consortium educational initiatives such as university curriculum development, educational videos, or undergraduate, graduate, or fellowship classes.

Funding Instrument	Grant: support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal The OER Glossary and the PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	FDA intends to fund an estimate of 4 to 5 awards, corresponding to a total of $ 3 million, for fiscal year 2013. Future year amounts will depend on annual appropriations.
Award Budget	Application budgets are limited to $ 750,000 in total costs (direct costs plus indirect costs) per year, with a maximum of 10% indirect costs. This limitation on indirect costs will allow the Consortia receiving these awards to maximize efforts to advance the availability of medical devices for children within the overall amount of funds appropriated for this program. Up to one third of a consortium’s budget may be used at the group’s discretion to provide bridge funding to directly advance the pediatric device projects on which they consult. Activities supported by bridge funding may include activities such as prototyping and testing (laboratory and animal). The maximum amount allotted to any consortium-supported project shall not exceed $50,000 per year. Not more than one quarter of discretionary bridge funds are to be used towards the consortium's internally developed projects. The FDA will be kept informed of the progress made on these various projects through quarterly updates and annual reports (see Reporting Requirements under section VI). Spending of the bridge funding needs to be in compliance with existing Federal Regulations and Requirements.
Award Project Period	Five year award, contingent upon favorable annual review and an additional mid-cycle review after two and a half years of funding.

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

Both non-academic and academic centers are encouraged to apply for this program. Eligibility is not limited to any particular sector.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government, other than Health and Human Services
• U.S. Territory or Possession

Other

• Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

HHS/GPS available at: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

Applicant organizations may submit more than one application, provided that each application is conceptually distinct.

FDA will not accept any application in response to this RFA that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

All page limitations described in the PHS 398 Application Guide must be followed, with the following FDA exceptions and additional requirements:

For all P50 applications submitted in response to this RFA, 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 is altered as follows:

Standard items 2 - 5 of the PHS 398 Research Plan are replaced by the Sections 1, 2, and 3 (specified below).

Research Plan Item 8, "Targeted/ Planned Enrollment Date" is not applicable to this RFA, and should not be completed.

The PHS 398 standard page limit for items 2-5 is replaced by a new limit of 40 pages for Section 1; 20 pages for Section 2; and five pages for Section 3 (Section 3 to be completed by previously funded applicants only).

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

• The Biographical Sketch section of PHS 398 application should be used to highlight the relevant pediatric device development experience of the consortia leaders and key members. For consortia leaders or key members with a background in business, regulatory, or law, Sections C (Selected Peer Review Publications) and D (Research Support) should be replaced with a description of practical experiences related to pediatric or medical device development.

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and 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 2034
Rockville, Maryland 20857
Phone: 301- 827-7177

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

In addition to the Budget Pages included in the PHS 398 Application, applicants should include in response to Section 1, an explanation of the criteria that need to be met for projects to receive discretionary funding; and how they will determine how much bridge funding to distribute to each of their supported projects. Also, the consortium will need to explain how it plans to monitor the spending and activities of the recipients of bridge funding; and the methods by which they plan to hold recipients accountable to conduct the funded tasks.

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

• Standard items 2-5 of the PHS 398 Research Plan are replaced by the new Sections 1, 2, and 3 below.
• Standard item 8 of the PHS 398 Research Plan should not be completed as part of this application.

This section should be used to present a description and explanation of the regulatory, business planning, and other pediatric device development services (such as intellectual property advising; prototyping; laboratory and animal testing; grant-writing; and clinical trial design) provided by the consortium. A description of the consortium's expertise in understanding the clinical needs of pediatric medical devices should also be included.

The consortium’s method and approach to evaluating proposed projects should be explained.

The consortium leadership’s ability to provide counsel to innovators on how to obtain funding through Federal and non-Federal resources should be detailed.

Also, the consortium’s plan for determining how their discretionary bridge funds will be spent should be delineated. Applicants should include an explanation of the criteria that need to be met for projects to receive discretionary funding; and how they will determine how much money to distribute to each of their various projects. Also, the consortium will need to explain how it plans to monitor the spending and activities of the recipients of bridge funding; and the methods by which they plan to hold recipients accountable to conduct the funded tasks.

Relevant background information on the consortium leadership and key members' experience and accomplishments related to the goals of pediatric device development should be briefly highlighted.

Applicants should present the business, regulatory, intellectual property, engineering/scientific, and clinical expertise of the consortium leaders and key members. A more in-depth description of leadership and key members' professional experience should be presented in the Biographical Sketch Section of the PHS 398.

Established relationships between the consortium and device industry manufacturers, pediatric medical societies, and academic institutions should be described.

Consortia should document their affiliations with industry and regulatory specialists both in general and specific to the field of pediatrics, and present a plan for how to attract and support projects from outside of their specific group.

Finally, the consortium should present a brief description of its plans to attain self-sustainability upon the conclusion of this grant.

Applicants should describe their consortium’s approach to the following pediatric device scenarios, with no more than four pages dedicated to each response.

Include your analysis and advice for each proposed scenario, including what factors might make you inclined to encourage or discourage an innovator from developing a given device. Describe the contacts and resources your group could provide to advance the project to the next phase of development.

1. A would-be innovator comes to your consortium with a sketched idea for a new X-ray Imaging Device. How would you proceed?

2. A pediatric nurse practitioner needs help coming up with a physical model for an enhanced nebulizer to optimize the delivery of albuterol to toddlers with reactive airways disease.

3. A pediatric neurologist wants to know what type of animal testing might be needed for a device used to treat hydrocephalus, but lacks the resources and expertise to proceed to this phase of development.

4. A pediatric surgeon asks, What do I need to consider as I move my pediatric device, which may be used about six thousand times a year in the United States, into clinical trials?"

5. An innovator wants to develop a previously approved adult device for pediatric patients what needs to be considered?

Applicants who have previously received funds through the Pediatric Device Consortia Grant Program should provide a brief (not to exceed five page) summary highlighting their accomplishments. This summary should include the amount and length of time for which FDA funds were received, as well as progress and achievements in pediatric device projects.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Not Applicable

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be postmarked on or before the due dates in Part I. Overview Information.

Applications must be received on or before the due dates in Part I. Overview Information. Generally, if an application is postmarked after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Office of Acquisitions and Grant Services (OAGS); and for programmatic responsiveness by Office of Orphan Products' Development PDC Project Officers. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium Facilities & Administrative costs/ F&A) must contact FDA program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS 398 Application Guide.

Not Applicable

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 development 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.

The criteria that reviewers assign scores for are based on 1) An Overall Description of the Consortium, as demonstrated by: a) the Consortium s Organization and Approach to Developing Pediatric Devices; b) the Consortium's Leadership, Membership, and Affiliations; c) the Consortium's Plan for the Use of Discretionary funds and 2) the Consortium’s Ability to Effectively Advise and Assist on Pediatric Device Projects, as demonstrated by responses to scenarios presented in this RFA. 

A score will be assigned based on these criteria. Following their review of these 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.

Both of these two sections will be weighted equally.  Please see below for how each of these sections will be scored.

In evaluating a proposed consortium's ability to meet the criteria described in the subsections below, reviewers will provide an overall score to reflect their assessment of the likelihood for the consortium to exert a sustained, significant influence on the field of pediatric device development, in consideration of three review criteria below.

Reviewers will consider each of the three review criteria below (weighted independently) in determining a score for this (Overall Description of Consortium) section (Section 1). A score will be assigned for each criterion, and the sum of these scores will be added.

Is the consortium effectively organized to advance pediatric device development?

Is the consortium’s proposed method of evaluating and advising proposed projects logical and well thought out?

How effectively will the consortium consider and integrate scientific, business, and regulatory concerns at each stage of device development?

Does the consortium have knowledge of potential funding sources for device development and experience in advising innovators on how to apply for those funds?

Will the consortium’s organization and approach enable it to serve as a regional or national resource for pediatric device developers? Does the consortium present an achievable plan to encourage device development beyond projects from its own members?

Will the consortium benefit from unique features of its scientific environment, physical resources, or collaborative arrangements? Is there access to pediatric patients and populations for conducting current and projected clinical research?

Does the consortium have or plan to have an interactive website through which innovators can contact the group?

Does the consortium have a well-delineated plan on how it will achieve self-sustainability upon completion of this grant?

Does the consortium leadership have recent, relevant experience in bringing medical devices for children to the market?

Do the consortium leadership and members have complementary and integrated expertise?

Does the consortium have the expertise to effectively vet proposed projects?

Does the consortium have established relationships with device manufacturers and medical device

companies? 

Does the consortium have the capability and affiliations to assist device project development across all stages of development (i.e. clinical, manufacturing, marketing, commercialization), and not just early stages (i.e. concept, prototype, and preclinical)?

BUSINESS PLANNING/ FINANCIAL COMPONENT:

What is the relevant business experience of individual(s) handling this component of the consortium? In making this determination, consider the following:

• Number of pediatric medical devices successfully brought to market and level of involvement in these efforts?
• Number of overall medical devices successfully brought to market and level of involvement in these efforts?
• Relevant business experience in pediatric devices and overall device development?
• Experience with medical device start-ups?
• Experience with mid-size medical device companies?
• Experience with large-size medical device companies?
• How well thought out is the consortium’s approach to business planning?
• How well integrated is business planning in the various stages of device development?
• Does the consortium have ties to or relationships with the investment community? Do they have experience working with and procuring funding from angel investors or venture capitalists?
• Demonstrated familiarity and experience with Federal and non-Federal funding mechanisms.
• What is members track record in securing project funding?

REGULATORY COMPONENT:

What is the relevant regulatory experience of the individual(s) handling this component of the consortium? In making this determination, consider the following:

• Amount and quality of experience interacting with the FDA at Pre-Submission, IDE, Filing, or Deficiency meetings.
• Number and extent of involvement with prepared, submitted, and approved HUD applications.
• Number and extend of involvement with prepared, submitted, and approved IDE applications
• Number and extent of involvement with prepared, submitted, and cleared 510 K applications
• Number and extent of involvement with prepared, submitted, and approved of HDE applications
• Number and extent of involvement with prepared, submitted, and approved PMA applications.

SCIENTIFIC/ ENGINEERING COMPONENT:

What is the relevant scientific/engineering experience of the individual(s) involved with this component of the consortium? In making this determination, consider the consortium's ability to provide the following:

• Access to excellent prototyping
• Hands on engineering
• Bench testing
• Understanding and application of Engineering Standards
• Capability and experience with computational modeling and statistical evaluations
• Meaningful guidance on Good Manufacturing Practices (GMP) and Quality Assurance (QA) issues, such as biocompatibility, fatigue and corrosion evaluations and sterilization
• Access to facilities to complete preclinical and animal testing according to Good Laboratory Practices(GLP)

CLINICAL COMPONENT:

What is the relevant pediatric pre-clinical and clinical trials experience of the individual(s) involved with this element of the consortium? In making this determination, consider the following:

• The professional and direct patient care experience of pediatric practitioners affiliated with the consortium
• Experience of the clinicians in new product development
• The number, scope, and impact of pediatric pre-clinical and clinical trials that the consortia members led
• The number, scope, and impact of pediatric pre-clinical and clinical trials in which the consortia members have participated
• Relevant publications produced in association with pediatric clinical trials
• The experience of the individual providing assistance with trial design-- how many clinical protocols have they designed? What is their experience in designing small clinical trials?
• Is there an accomplished statistician associated with the consortium?
• Experience and familiarity with Institutional Review Boards (IRB), human subjects protection, and issues germane to pediatric clinical investigation
• Experience in formulating and tracking data in patient registries.

INTELLECTUAL PROPERTY COMPONENT:

What is the relevant legal experience of individual(s) involved with this component of the consortium? With regard to Intellectual Property protection issues, consider the following:

• Counsel's previous service as a patent examiner for the Patent and Trademark Office (PTO);
• Types of clients for whom the lawyer has worked (large v. small companies, academia, etc.);
• Number of applications prepared, filed, and prosecuted by the lawyer
• Whether any of the patents filed by the lawyer have ever been challenged/litigated and the result (i.e., patent found to be valid/invalid);
• Counsel's involvement in other areas of prosecution, including administrative appeals, petitions and protests, reissues, and reexaminations.

Is the plan for use of discretionary funds fully justified and reasonable in relation to supporting the consortium’s infrastructure, counseling/advising, and project support functions?

SPECIFIC SPENDING PLAN FOR DISCRETIONARY "BRIDGE FUNDING"

Is the consortium’s approach to distributing bridge funding well developed?

Is there a clear strategy to determine which projects will receive discretionary funds?

Is there a plan to assure that projects selected for consortium funding will be free from conflict of interest?

Is there a clear plan to decide how money will be allotted to various projects?

How will funded projects and tasks be monitored and held accountable for completion?

Is there a demonstrated understanding of engineering standards and an assurance that funded prototyping projects will be developed in accordance to these regulations and standards?

Is there a demonstrated understanding of Good Laboratory Practices and an assurance that funded preclinical projects will be conducted according to these regulations and standards?

Is there a demonstrated understanding of human subjects protections and an assurance that funded clinical projects will be conducted according to these regulations and standards?

In evaluating the consortium’s ability to effectively advise and assist on pediatric device projects, reviewers will provide an overall score to reflect their assessment of applicant's ability to provide guidance and assistance to individuals working on devices in various stages of development.

In all of the proposed scenarios, there are no predetermined answers. Rather, reviewers will consider applicant's understanding and response to all relevant considerations, and the resources they could bring to bear in managing these issues.

An applicant's response to each scenario will receive an individual score; and the sum of these scores will determine the overall score for this (Consortium's Ability to Effectively Advise and Assist on Pediatric Device Projects) section.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scores, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Renewals

For Renewals, the committee will consider the progress and contributions made by the consortium in relation to number of years funded and the amount of money previously awarded.

Budget and Period of Support

Apart from issues addressed in Section V, 1, Section1/ Criterion 1, 3 (Plan for Use of Discretionary Funds), reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to activities proposed by the applying consortium.

This grant supports the development of consortia to foster the development of multiple pediatric device projects.  Applications for the development of a single device will not be considered responsive to this funding opportunity announcement.

Responsive applications will be reviewed and evaluated for merit by an ad hoc panel of experts in pediatrics and device development, using the stated review criteria.

As part of the review, all responsive applications will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this RFA.

Applications will compete for available funds with all other responsive applications submitted in reply to this RFA. Following initial peer review, applications with a competitive score will receive a second level of review by a national advisory council for concurrence with the recommendations made by the first-level reviewers. Funding decisions will be made by the Commissioner of Food and Drugs or his designee. The following will be considered in making funding decisions:

• Merit of the proposed project as determined by the ad hoc pediatric and device development review panel.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review (ad hoc panel review) of the application is completed, the PD/PI will receive his or her Summary Statement (written critique).

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

The anticipated date for announcement and granting of awards is mid- to late- September 2013.

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 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 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.

Any application awarded in response to this FOA will be subject to the DUNS, System for Award Management Registration, and Transparency Act requirements as noted on the Award Conditions and Information for HHS Grants website.

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.

Not Applicable

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. An ongoing account and justification of how bridge funds are being spent will be provided on a quarterly basis. 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.

Grantees will provide accurate and timely updates on a quarterly basis according to the program-specified format. Grantees are required to meet and report their compliance with all applicable regulatory requirements.

Section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 requires an annual report on the status of pediatric device development, production, and distribution that has been facilitated by a consortium. The report should be sent to the Office of Orphan Products Development.

Submission of this annual report is in addition to the requirement that for multiple year grants, awardees must 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/).

Failure to fulfill any of the reporting requirements or failure to demonstrate substantial annual contributions by the consortium could result in termination of funding.

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

In addition to standard annual reporting, after two and a half years of funding, consortia grantees will undergo a mid-cycle evaluation. This evaluation will include the number of projects assisted, the depth and extent of the consortium's involvement in advancing pediatric device projects, and feedback from innovators who have received assistance. Continuation of funding for the final two years will be contingent upon a favorable review in this evaluation.

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.

Additionally, a grantee must file a final program progress report, Federal Financial Report (FFR) and invention statement within 90 days after the end date of the project period as described in the Notice of Award. A final progress report, invention statement, and FSR are required when an award is relinquished upon a recipient changing institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Linda C. Ulrich, M.D.
Pediatric Device Consortia Grants Program
Office of Orphan Products Development
Food and Drug Administration
WO 32-5271
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: (301) 796-8660
FAX: 301-847-8621
Email: Linda.Ulrich@fda.hhs.gov

Vieda Hubbard
Grants Management Specialist
Division of Acquisition Support and Grants
Office of Acquisitions & Grant Services
5630 Fishers Lane, Room 2034
Rockville, Maryland 20857
Telephone: 301-827-7177
Fax: 301-827-0505
Email: Vieda.Hubbard@fda.hhs.gov

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.