2011-10813. Advisory Committee; Medical Imaging Drugs Advisory Committee; Reestablishment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the reestablishment of the Medical Imaging Drugs Advisory Committee in the Division of Advisory Committee and Consultants Management, Center for Drug Evaluation and Research.

FOR FURTHER INFORMATION CONTACT:

Minh Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2424, Silver Spring, MD 20993-0002, 301-796-9001, FAX: [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Federal Advisory Committee Act of October 6, 1972 (Pub. L. 92-463 (5 U.S.C. app. 2)); section 904 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 394), as amended by the Food and Drug Administration Revitalization Act (Pub. L. 101-635); and 21 CFR 14.40(b), FDA is announcing the reestablishment of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). A notice announcing a request for nominations for members and representatives on the committee as well as a final rule adding the committee to the current list of committees in 21 CFR 14.100 will be published at a later date.

The Medical Imaging Drugs Advisory Committee 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 and makes appropriate recommendations to the Commissioner.

The Medical Imaging Drugs Advisory Committee shall consist of a core of 12 voting members including the chair. Members and the chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of nuclear medicine, radiology, epidemiology or statistics, and related specialties. Almost all non-Federal members of this committee serve as special Government employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the committee may include one nonvoting member who is identified with industry interests.

This notice is given under the Federal Advisory Committee Act and 21 CFR part 14, relating to advisory committees.

Dated: April 28, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.