Document 3NKQ9Ea8GvQM1bJMj95x09XOa

MEMORANDUM OF TELEPHONE CONVERSATION BETOKEN: John Raiggiero Pharmaceutical Manufacturers Association and Paul Fehnel Bureau of Drugs (HFD-30) On February 18, 1976 I received a phone call from Mr. John Raiggiero, of the Pharmaceutical Manufacturers Association who inquired as to the status of PMA's Petition submitted September 11, 1975 requesting that the final regulations relating to "Asbestos-Form Particles in Drugs for Parenteral Injection" published in the Federal Register of March 14, 1975 be amended. I informed him that the Agency was working on a reply and that they would be hearing fran us shortly. Mr. Raiggiero indicated that his primary reason for calling was to ascertain if the proposed "GMP's" published on February 13, 1976, which included the provisions that they were requesting be amended, was meant to serve as an answer to their petition. I assured him that it was not an answer to their petition but merely an incorporation of existing provisions concerning requirements for filters into the proposal. cc: HFA-226 C H F C - 2O/Hearing Clerk HFD-140/Dr. Armond Casola HFS-50/Dr. Constantine Zervos HFD-30 HFD-30/R HFD-30/C HFD-30/Mr. Fehnel osp-od-b/ MT!