Convener of Discussions on Medical Policy Issues Impacting Drug Development

Post Date

March 31st 2014

Application Due Date

June 2nd 2014

Funding Opportunity Number

RFA-FD-14-003

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Education
Health
Science and Technology and other Research and Development

Number of Awards

5

Eligibility Categories

Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)

Funding

• Estimated Total Funding:

  $600000

• Award Range:

  $550000 - $600000

Grant Description

The Office of Medical Policy (OMP) provides CDER oversight and leadership in the development of medical policy, procedures, and policy initiatives pertaining to drug development, drug approval, bioresearch monitoring, human subject protection and post market surveillance processes. When developing and implementing policy, a key step is often to create a broad public forum with a variety of stakeholders to identify key issues that will need to be addressed before, during, and after implementation of any initiative. These discussions can help focus many of the policy and procedural needs of an evolving initiative. The goal of such meetings is not to obtain advice relating to regulatory actions or to make decisions. Nor is the goal to reach a consensus among the participants on any of the issues discussed. Rather, it is to hear the opinions of experts in the field and other individual stakeholders. In addition, it is important to maintain transparency. The goal of these meetings is to be as inclusive as possible, while still limiting participation to a number that supports the meetings goals and objectives. However, it is important to ensure that information from these meetings and working groups must be described, managed, and made available to the public using a transparent and open approach.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Gladys Melendez-Bohler
  Grants Management Specialist
  Phone 301-827-7175

• Agency Mailing Address:

  FDA Office

• Agency Email Address:

  gladys.bohler@fda.hhs.gov

• More Information:

  NIH Guide for Grants and Contracts