JAPAN APPLIED MICROBIOLOGY
RESEARCH INSTITUTE LTD.
obiken
326 Otogum lkmaho-cho Nak&oma-gun Yamarrpshi 409-3812M?AN http://www.oubiken,co.jp E-mail:oversea@oubikcn.co.jp Tek(81)55-240-3511 Fax:f81)55-240-3512
March 8,2005 Barbara0. Schneeman,‘ Ph.D. Office of Nutritional Products,Labeling and Dietary Supplements (HIS-800) Cente.r Food Safety and Applied Nutrition for Food and Drug Administration 5 100 Paint Branch Parkway College Park, MD 20740 RE: Notification under Section8 of DSIIEA and 2 1 CFR 190!6
Re: Courier
This notification is filed in accordance with 21 U.S.C. 35Ob(a)(2)[$413(a)(2)of the Federal Food, Drug, and CosmeticAct] and 2 1 CFR 190.6,Requirementfor premarketnotification by JapanApplied Microbiology Research Institute, Ltd., (JAMRI) 326 Otoguro Tamaho-cho, Nakakoma-gun,Yamanshi,409-3812, Japan. The new dietary ingredient,ABPC@, an enzyme-treated is Agaricus blazei Murill mycelia mixed with Current Good with brewer’ yeast. The manufacturingprocessis in accordance s ManufacturingPracticeand IS0 900 1 for design,developing,and manufacturingof product. JAMRI has concludedthat ABPC@ safe for use as a new dietary ingredient,and has provided is the history of use of ABPCe and safetyinformation from ivl-vitro studiesand animal studiesthat supportthe safetyof ABPCe. Portionsof this notification are consideredcommercialconfidential and fall within the exemptionsestablished $20.61 (21 CFR 20.61) of the Code of FederalRegulations. in If there are any questions,pleasecontactClyde A. Takeguchi,Ph.D., PhoenixRegulatory Associates,Ltd. at (703) 406-0906or at phoenix@phoenixrising,com. Sincerely,
Takeru Suyama,Director JapanApplied Microbiology ResearchInstitute Ltd. Attachment: 75-Day notification (original and two copies)