00-18829. Request for Nominations for Working Groups Under the Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutical Science

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting nominations for qualified persons to serve on two fact-finding working groups being formed to support the Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutical Science. The working groups will identify and report on scientific issues that may benefit from focused nonclinical research and collaboration.

FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees, and therefore, encourages nominations of qualified candidates from these groups. Final selections from among qualified candidates for each working group will be based on the expertise demonstrated for the specific focus areas and previous experience working in these areas.

DATES:

All nominations should be received by September 29, 2000.

ADDRESSES:

Please submit nominations to Docket No. 00N-0930, Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

David C. Morley, Center for Drug Evaluation and Research (HFD-358), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5684, FAX [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is requesting nominations for qualified persons to serve on two fact-finding working groups being formed to support the Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutical Science. The working groups will identify and report on scientific issues that may benefit from focused nonclinical research and collaboration.

FDA is forming the following two working groups:

• A multidisciplinary working group to identify promising areas of nonclinical scientific research to develop biomarkers and/or other evolving molecular technologies to identify or predict drug-induced cardiac tissue injury, and
• A multidisciplinary working group to identify promising areas of nonclinical scientific research to develop biomarkers and/or other evolving molecular technologies to identify or predict drug-induced vasculitis.

Criteria

Persons nominated for the working groups shall have exceptional accomplishments and expertise in the scientific fields appropriate to the working group. In particular, expertise in genomic and proteomic technologies is desired.

Nomination Procedures

Any interested person or organization may nominate one or more qualified persons for one or more of the working groups. Self-nominations are also accepted. Nominations should include appropriate biographical material, a brief (one-half page maximum) endorsement, a list of scientific publications relevant to the working group, and a statement that the nominee is aware of the nomination and is willing to serve on the working group if selected.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

Dated: July 18, 2000.

Linda A. Suydam,

Senior Associate Commissioner.