2011-19067. Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs Advisory Committee

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting nominations for 12 members to serve on the Medical Imaging Drugs Advisory Committee in the Center for Drug Evaluation and Research.

FDA has a special interest in ensuring that women, minority groups, and individuals with physical disabilities are adequately represented on advisory committees and, therefore, extends particular encouragement to nominations for appropriately qualified female, minority, or physically challenged candidates. Final selection from each vacancy will be determined by the expertise required to meet specific Agency needs and in a manner to ensure appropriate balance on membership.

DATES:

Nominations should be received before September 27, 2011.

ADDRESSES:

All nominations for membership, except for consumer-nominated members and industry representatives members, should be sent to Minh Doan (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT:

Minh Doan, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 31, rm. 2417, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9001, Fax: [phone], E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is requesting nominations for voting members on the Medical Imaging Drugs Advisory Committee (the Committee). (Elsewhere in this issue of the Federal Register is a final rule adding the Medical Imaging Drugs Advisory Committee to the list of FDA standing advisory committees in 21 CFR 14.100 as well as a request for nominations of nonvoting industry representatives, and a request for nominations of voting and nonvoting consumer representatives.)

I. Function

The Committee advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee also reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology.

II. Criteria for Members

Persons nominated for membership on the Committee must have adequately diversified research and/or clinical experience appropriate to the work of the committee in such fields as nuclear medicine, radiology, epidemiology or statistics, and related specialties.

The specialized training and experience necessary to qualify the nominee as an expert suitable for appointment is subject to review, but may include experience in medical practice, teaching, research, and/or public service relevant to the field of activity of the committee. The term of office is up to 4 years.

III. Nomination Procedure

Any interested person may nominate one or more qualified persons for membership on the Committee. Self-nominations are also accepted. Nominations must include a current, complete resume or curriculum vitae for each nominee, current business and/or home address, telephone number, and e-mail address if available. Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination, unless self-nominated. Potential candidates will be required to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest.

This document 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 22, 2011.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.