Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

Office of Orphan Products Development (OSMP, OC, FDA)

Funding Opportunity Title

Pediatric Device Consortia Grant Program (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-FD-09-007

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-FD-11-002

Companion FOA

Not applicable

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103   

FOA 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.  FDA will provide grants to consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children.  The program does not support the development of single device projects.  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.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

Not Applicable

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

May 2, 2011

AIDS Application Due Date(s)

N/A

Scientific Merit Review

June, 2011

Advisory Council Review

September, 2011

Earliest Start Date(s)

September, 2011

Expiration Date

May 3, 2011

Due Dates for E.O. 12372

Not Applicable

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts in Section VII for additional information regarding page limits and the FDA Peer Review Process.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide http://grants.nih.gov/grants/funding/phs398/phs398.html except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description
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 Food and Drug Administration Amendments Act of 2007 (FDAAA), 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.

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.

The program supports the development of consortia; it does not support the development of single device projects.

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

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Approximately $2.5 million will fund two to four new awards.  It is anticipated that funding for the non-competing continuation awards in FY2012 will be similar to the amount made for new awards in FY 2011.  Note: The total amount awarded, and the number of awards will depend upon applications meeting the research objectives, costs of the project, and the availability of funds.

Award Budget

Grants will be awarded up to $1,500,000 in total cost (direct costs plus indirect costs) per year.

Award Project Period

Grants will be awarded for up to two years. 

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.  

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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 the following registration:

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.     

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, http://grants.nih.gov/grants/funding/phs398/phs398.html 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.

Application Submission

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 2128
Rockville, Maryland  20857
Phone:  301- 827-7175          

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

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:

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

The PHS 398 standard page limit for items 2-5 is replaced by a new limit of 30-35 pages for these sections plus additional allocation of 10 pages for each Proposed Project  (number of pages “suggested” below for individual sections are provided solely as a nonbinding guidance for applicants).

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.nih.gov/grants/funding/phs398/phs398.html

Research Plan

All instructions in the PHS398 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 (specified below).

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:

Project Face page containing project title, name of Project Leader, Project Summary and Key Personnel (listing percent of effort of each individual); and

Project Plan (analogous to Standard Sections 2-5 in the PHS 398 instructions); and

Phase of Development description of the project including where these projects currently are in development; a projection of where in development the projects might be after two years of support from the consortium; and how the consortium proposes to assist in moving the projects forward.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.  

Foreign Organizations

Not applicable.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

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 and Information

Applications must be postmarked received on or before the due dates in Part I. Overview Information. If an application is received 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 scientific and programmatic responsiveness by the FDA Program area Project Officers. Applications that are incomplete and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium 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 PHS398 Application Guide http://grants.nih.gov/grants/funding/phs398/phs398.html

Post Submission Materials

Not applicable.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

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. 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.

For this particular announcement, note the following:

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.

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.

A.  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?

B. 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?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines  http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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.      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

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 made in the last funding period.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not applicable.

Select Agent Research

       Not applicable.

Resource Sharing Plans

       Not applicable.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Office of Orphan Products Development using the stated review criteria.

As part of the scientific peer review, all applications will:

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by a National Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) via e-mail.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement available at: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

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 Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the award notice 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions for FDA Grants

2. Administrative and National Policy Requirements

All FDA grant awardees must adhere to the requirements stated in the Request for Application, the Notice of Grant Award, 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

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.

B.  Reporting Requirements

All new and continuing grants must comply with all regulatory requirements.

When multiple years are involved, awardees are required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) at http://grants.nih.gov/grants/funding/2590/2590.htm annually, and financial statements as required in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

Also, 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 Activity Report (PHS 2590) see above. 

In addition, "Section 305 of the FDAAA Act of 2007" 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.

At the end of a grant's project period, the grantee must submit the following three requirements: 1) A final progress activity report; 2) a final Financial Report, and 3) an invention statement within 90 days after the end date of the project period as noted on the notice of grant award. 

These requirements are also applicable when an award is relinquished prior to the grant's end of project period, when a recipient changes institutions, or when an award is terminated for cause.

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.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000.   

Section VII. Agency Contacts

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

Scientific/Research Contact(s)

Linda C. Ulrich, MD or Debra Y. Lewis, OD, MBA
Office of Orphan Products Development, OSMP, OC, FDA
Telephone: 301-796-8660
Email:  Linda.Ulrich@fda.hhs.gov  OR   Debra.Lewis@fda.hhs.gov

Financial/Grants Management Contact(s)

Kimberly Pendleton
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Service
Food and Drug Administration
FHSL Rm 2104, HFA-500
5630 Fishers Lane 
Rockville  MD 20857 
Telephone: (301) 827-9363
Fax: 301-827-7101
Email: Kimberly.Pendleton@fda.hhs.gov

Section VIII.  Other Information

1.  Required Federal Citations

1.A.  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.

1.B.  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 3 clinical trials. Although Phase 1 and Phase 2 clinical trials may also use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.

1.C.  Access to Research Data through the Freedom of Information Act (FOIA)

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/ and FDA Web site at http://www.fda.gov/RegulatoryInformation/FOI/default.htm

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.D.  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 as applicable 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

1.E.  Human Subjects Protection

Federal regulations (45 CFR 46) 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.F.  Inclusion of Women And Minorities in Clinical Research (Adopted by the FDA)

It is the policy of the NIH/DHHS that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH/DHHS staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.



1.G.  Inclusion of Children as Participants in Clinical Research (Adopted by the FDA)

The NIH/DHHS maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research conducted or supported by the NIH unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).



1.H.  Required Education on the Protection of Human Subject Participants (Adopted by the FDA)

NIH/DHHS policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.



1.I.  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.J. Healthy People 2010

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 Funding Opportunity Announcement 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.K.  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.L.  Authority and Regulation

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


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