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

The summary for the Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food Drug Administration, which is the U.S. government agency offering this grant.

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

Federal Grant Title:	Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01)
Federal Agency Name:	Food Drug Administration
Grant Categories:	Health Science and Technology
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-14-015
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	Jun 11, 2014
Original Application Deadline:	Jun 11, 2014
Posted Date:	Apr 29, 2014
Creation Date:	Apr 29, 2014
Archive Date:	Jul 11, 2014
Total Program Funding:	$1,000,000
Maximum Federal Grant Award:	$1,000,000
Minimum Federal Grant Award:	$950,000
Expected Number of Awards:	1
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
For profit organizations other than small businesses
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
City or township governments
Private institutions of higher education
Native American tribal governments (Federally recognized)
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Special district governments
Public housing authorities/Indian housing authorities
State governments
Additional Information on Eligibility: FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY
Link to Full Grant Announcement: FULL ANNOUNCEMENT
Grant Announcement Contact: Martin Bernard Grants Management Specialist Phone 240-402-7564
FDA OFFICE

Food & Drug Administration 301-443-5869
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