Request for Information (RFI): Input on Present and Future Funding Strategies for NIDCD Drug Development Projects

Notice Number: NOT- DC-16-003

Key Dates
Release Date: April 27, 2016
Response Date: August 15, 2016

Related Announcements
None

Issued by
National Institute on Deafness and Other Communication Disorders (NIDCD)

Purpose

The purpose of this Request for Information (RFI) is to solicit community input on drug development projects (small molecule, biologic, pharmaceutical, etc) that would treat disorders within the NIDCD mission areas of hearing, balance, smell, taste, voice, speech and language.

Background

Drug development, from discovery to clinic, can be very costly. The probability of success is difficult to determine and often low. The NIDCD annual budget is approximately $400M. Thus, it is readily apparent that it is not fiscally feasible for the NIDCD to support all stages of drug development. However, NIDCD does encourage and support drug development to the greatest extent possible, and as such, this likely includes leveraging existing federal and private resources as well as engaging in collaborative activities.

With this goal of supporting drug development in mind, NIDCD seeks feedback from the research community on specific and targeted efforts that might accelerate research and development of novel drugs at various points along the development pathway. When appropriate, please relate past efforts that were unsuccessful and describe how specific changes in the funding mechanism or funding strategies available from NIDCD could have overcome the barriers experienced.

Information Requested

Below are topics that might help frame the replies but respondents are not limited to these areas:

  • major impediments to advancing drug development research that are not addressed by current funding opportunities sponsored by NIDCD;
  • gaps and underrepresented research areas that might be addressed to accelerate translation of existing compounds into novel therapies;
  • acceleration of the discovery process that directly leads to the acquisition of preclinical data that will support Investigational New Drug (IND) submissions to the FDA;
  • issues that hamper development efforts that are specific to the NIDCD mission area and what solutions could be implemented with grant support;
  • difficulty of accessing known drug development programs and resources when addressing projects within the NIDCD mission areas;
  • engaging mid-sized and large pharmaceutical companies as a potential partner for commercialization and leveraging NIDCD funding to accomplish;
  • specific aspects of the STTR/SBIR grant awards currently available from NIDCD that could be altered to accelerate research and development in this topic area;

Currently available NIH programs relevant to this RFI include:
Blueprint Neurotherapeutics (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm)
TRND (https://ncats.nih.gov/trnd/about/goals)
BrIDGs (http://ncats.nih.gov/bridgs)
NIDCD Translational Research Grants (https://grants.nih.gov/grants/guide/pa-files/PAR-14-009.html)
SBIR/STTR (SBIR.nih.gov)

How to Submit a Response

Comments will be accepted through August 15, 2016. All comments must be submitted electronically to the following email address: RFIdrug@mail.nih.gov You will receive an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback. Responses to this RFI are voluntary. Any identifiers (e.g., names, institution, e-mail addresses, etc.) will be removed when responses are compiled by NIDCD. Only the de-identified comments will be shared internally with NIDCD staff members and any scientific working groups convened by the NIDCD, as appropriate. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use any submitted technical information in any resultant solicitation(s).

This Request for Information (RFI) is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and/or the National Institute on Deafness and Other Communication Disorders (NIDCD). The NIH and/or the NIDCD does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information. Responding or not responding to this RFI does not preclude participation in any related future solicitations. NIDCD appreciates your input.

Inquiries

Please direct all inquiries to:

Nancy Freeman, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: RFIdrug@mail.nih.gov