Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01)

Quick Facts

Due DateJune 11, 2014 (Wednesday)
Award Amount$ 950,000 - $ 1,000,000
Category of Funding ActivityHealth
Science and Technology and other Research and Development
Eligible Applicants
  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others - FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY
  • Unrestricted (i.e., open to any type of entity below) - FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY

Program 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.

General Information

Funding Opportunity NumberRFA-FD-14-015
Funding Opportunity TitlePharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01)
Opportunity CategoryHealth
Science and Technology and other Research and Development
Funding Instrument TypeCooperative Agreement
Category ExplanationNot Available
Number of Awards1
Cost Sharing or Matching RequirementNo
Posted DateApril 29, 2014 (Tuesday)
Application Due DateJune 11, 2014 (Wednesday)
Application Archive DateJuly 11, 2014 (Friday)
Total Program Funding$ 1,000,000
Award Amount$ 950,000 - $ 1,000,000
CFDA Number
  • 93.103 - Food and Drug Administration_Research

Eligible Applicants

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others - FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY
  • Unrestricted (i.e., open to any type of entity below) - FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY

Contact Information

Agency NameDepartment of Health and Human Services
Program Information WebsiteFULL ANNOUNCEMENT
ContactOffice: Food & Drug Administration
Martin Bernard
Grants Management Specialist
Phone 240-402-7564
FDA OFFICE

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