Advisory Committees; Industry Representation

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing its intention of adding one nonvoting representative of industry interests to the membership of its existing advisory committees that do not already have such nonvoting industry representation under the purview of the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Elsewhere in this issue of the Federal Register, FDA is publishing a notice to request nominations for nonvoting members of industry interests on public advisory committees.

FOR FURTHER INFORMATION CONTACT:

Donna M. Combs, Committee Management Office (HFA-306), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5496.

SUPPLEMENTARY INFORMATION:

Section 120 of the FDA Modernization Act (FDAMA) of 1997 (21 U.S.C. 355) requires that certain newly formed FDA advisory committees include representatives from the biologics and/or drug manufacturing industries. Although not required for existing committees, the agency intends to add nonvoting industry representatives to all its CBER and CDER advisory committees.

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.