The Health Department is offering a grant to conduct a PK/PD study in ADHD patients to evaluate the therapeutic equivalence of generic methylphenidate extended release products. This study aims to identify additional PK metrics that may impact treatment efficacy, contributing to scientific and regulatory standards in the field. Applicants have the opportunity to advance understanding of methylphenidate’s effects in ADHD patients. Closing date for submissions is Jun 11, 2014.
Opportunity ID: 254474
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-015 |
| Funding Opportunity Title: | Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 29, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 11, 2014 |
| Current Closing Date for Applications: | Jun 11, 2014 |
| Archive Date: | Jul 11, 2014 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | $950,000 |
Eligibility
| Eligible Applicants: | State governments County governments Private institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts City or township governments Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Special district governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this project is to conduct a prospective PK/PD study in attention deficit hyperactivity disorder (ADHD) patients to link the PK profiles to the time-course of PD activity of methylphenidate extended release products in order to identify additional PK metrics (if any) that may impact the therapeutic equivalence of methylphenidate extended release products. The findings from the PK/PD study will help establish scientific and regulatory standards for assuring therapeutic equivalence of generic methylphenidate extended release products. |
| Link to Additional Information: | FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Martin Bernard
Grants Management Specialist Phone 240-402-7564 Email:Martin.Bernard@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 254474 Full Announcement-1 -> sf424_rr_guide_general_adobe_verc1.pdf
Folder 254474 Full Announcement-1 -> rfa-fd-14-015_ pharmacokinetic_pharmacodynamic (pk_pd) studies of methylphen.pdf
Packages
| Agency Contact Information: | Martin Bernard Grants Management Specialist Phone 240-402-7564 Email: Martin.Bernard@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | ADOBE-FORMS-C | RFA-FD-14-015 | PKG00195888 | Apr 29, 2014 | Jun 11, 2014 | View |
Package 1
Mandatory forms
254474 RR_SF424_2_0-2.0.pdf
254474 PHS398_ResearchPlan_2_0-2.0.pdf
254474 PHS398_CoverPageSupplement_2_0-2.0.pdf
254474 RR_Budget_1_3-1.3.pdf
254474 RR_KeyPersonExpanded_2_0-2.0.pdf
254474 RR_OtherProjectInfo_1_3-1.3.pdf
254474 PerformanceSite_2_0-2.0.pdf
Optional forms
254474 PlannedReport-1.0.pdf
254474 PHS398_CumulativeInclusionReport-1.0.pdf
254474 RR_SubawardBudget30_1_3-1.3.pdf
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