http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
User fees and refunds for premarket approval applications
Center for Devices and Radiological Health (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Title from PDF title page (viewed on May 22, 2009).
"Document issued on: November 24, 2003".
Mode of access: Internet at the FDA CBER web site. Address as of 5/22/09: http://www.fda.gov/cdrh/mdufma/guidance/1224.pdf ; current access is available via PURL.