Notice Number: NOT-GM-08-125

Key Dates
Release Date: March 31, 2008
Response Due By:  April 30, 2008

Issued by
This is a time-sensitive Request for Information (RFI) issued by a Trans-NIH Project Team, on behalf of the Trans-NIH Pharmacogenomics Working Group.  The information from this RFI will be collected by NIGMS and shared with the Working Group members from across the NIH, in order to ascertain the needs of the field.

Information Requested

PURPOSE

We are requesting community input on challenges and barriers to pharmacogenomics (PGx) research.  The targeted questions asked are intended to reveal gaps and highlight the opportunities, and to aid in identifying specific, achievable goals that will advance and transform the field overall.  NIH wants to consider research needs from discovery-based efforts to validation and applied research, in order to accelerate the translation of pharmacogenomics knowledge into the clinical practice setting.

This RFI is for planning purposes only, and should not be construed as a solicitation for applications or proposals and/or as an obligation in any way on the part of the United States Federal Government.  The Federal Government will not pay for the preparation of any information submitted and/or for the Government’s use of that information.  All submitted information shall remain with the Federal Government and will not be returned.

BACKGROUND

NIH invites responses from the scientific community, scientific organizations, pharmaceutical companies, Federal Agencies, and other interested parties well-versed in the areas of pharmacogenetics and pharmacogenomics, to help identify crucial needs, gaps and roadblocks to PGx research.  Collectively, we want to identify ways in which NIH can effectively and efficiently address these barriers.

As you formulate responses, please consider that NIH is interested in replies that suggest transformative ideas and approaches.  The best ideas will have great potential to dramatically affect how biomedical research is conducted over the next decade, yet will be concrete and achievable tasks.  Moreover, NIH wants to leverage existing research mechanisms and resources.  Ideas for enabling research efforts of interest would be those challenges for PGx that:  (1.) are activities that no other entity is likely to be able to successfully conduct, (2.) will generate knowledge that can be made publicly accessible, and (3.) are of clear benefit to public health.

NIH wants to broadly advance the field, and in keeping with the missions of the individual institutes and the NIH and DHHS as a whole, to benefit and improve the health of the nation (see the report of the Secretary’s Advisory Committee on Genetics, Health, and Society entitled Realizing the Promise of Pharmacogenomics: Opportunities and Challenges).  The ultimate goal is to facilitate PGx discoveries and enable the most rapid transfer possible into the clinical realm.

Responses

Responses must be submitted electronically at: http://www.nigms.nih.gov/Initiatives/NIH-RFI, and will be accepted through April 30, 2008.  Replies to any individual elements of the webform are optional, and the site will permit anonymous responses.  The information provided will be analyzed and may appear in various reports.  Additionally, the government cannot completely guarantee the confidentiality of the information provided.

Inquiries

Specific questions about this RFI should be directed to the contact listed below:

Rochelle M. Long, Ph.D.
Chief, Pharmacological & Physiological Sciences Branch
Pharmacology, Physiology, & Biological Chemistry Division
NIGMS, NIH
45 Center Dr., Rm. 2AS-49G
Bethesda, MD  20892-6200
tel:  (301) 594-3827
fax:  (301) 480-2802
e-mail:  rochelle.long@nih.gov

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