Request for Information (RFI) Regarding Opportunities to Advance Clinical Research on Liver Cirrhosis in the United States

Notice Number: NOT-DK-13-018

Key Dates
Release Date: August 22, 2013
Response Due Date: November 8, 2013

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) seeks input through this Request for Information (RFI) from members of the liver disease research community and industry on opportunities that will advance clinical research on liver cirrhosis.  Specifically, the NIDDK is interested in learning of new state-of-the-science diagnostics and therapeutics for patients with liver cirrhosis.  This RFI is part of an effort to identify potential opportunities that address current challenges that face care providers in the management and treatment of patients with liver cirrhosis.

Information Requested

This RFI is intended to solicit both the community of clinical investigators who care for and treat patients with liver cirrhosis as well as with industry.  The NIDDK wishes to solicit these communities who are willing to share with the NIDDK new diagnostics (including non-invasive diagnostics) and new therapeutics for patients with cirrhosis of the liver.  Responses should also share their concepts on the approaches to study these new diagnostics and therapeutics.  Lastly, the NIDDK requests that liver disease researchers, professional organizations, clinicians, industry, and other interested members of the liver research community share their perspectives on clinical research opportunities that would address current deficiencies in the clinical management and treatment of liver cirrhosis.

Responses to the RFI may be used for consideration of clinical research priorities in liver cirrhosis.

How to Submit a Response

Responses will be accepted through November 8, 2013 and should note this RFI identifier, “NOT-DK-13-018” in the subject line.  Responses are preferred in electronic format, approximately 1-3 standard letter pages in length, and should be emailed to: cirrhosisrfi@mail.nih.gov.

Respondents will not receive individualized feedback.

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential or sensitive information should not be included in your response. Comments submitted may be taken into consideration by the NIDDK in the prioritization of liver disease research in cirrhosis. Any personal identifiers (names, e-mail addresses, etc.) will be removed when responses are compiled.

This RFI is for informational and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States (US) Government, the NIH or the NIDDK to provide support for any ideas submitted in response to it. Please note that the United States Government, NIH and NIDDK will not pay for the preparation of any information submitted, or for its use of that information.

Inquiries

Please direct all inquiries to:

Edward Doo, MD
Director, Liver Diseases Research Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Email: Dooe@niddk.nih.gov

or

Averell H. Sherker, MD, FRCP(C)
Scientific Advisor for Viral Hepatitis and Liver Diseases
Liver Diseases Research Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Email:  averell.sherker@nih.gov


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