ࡱ> sur_ bjbj .bb(((((<<<<$`<y{{{{{{$V(((333:((y3y335EkfɃ"9e0?3E(E 33 : ANNEX II INFORMATION TO IBSC/ RCGM TO CARRY OUT RESEARCH FOR DEVELOPMENT OF R-DNA PRODUCTS Application for clearance by IBSC/ RCGM to carry out research involving genetic engineering activity for the development of r-DNA products. 1.Name of the ApplicantDesignation(a) Address (Registered Office)Telephone No.Telex No.Fax No.e-mail(b) Address (Research Station)Telephone No.Telex No.Fax No.e-mail2.Application for :2.1Purpose2.2NewYesNo2.3Ongoing ProjectYesNoIf yes, No. & Date of LOI issued :No. & Date of Permit issued :2.4If yes, briefly state the purpose for which permission was granted.2.5 Category of experiments as per the Guidelines of DBT3.Objectives of the proposal 4.Description of the GMOs employed in the research proposal (in scientific terms; for new application only)4.1Description of GMOs4.2Description of the target gene(s)4.3Number of copies of the genes incorporated4.4Description of the target product(s)5.Details on:5.1Source of nucleic acid(s) :5.2Nucleic acid sequence (Please enclose the nucleic acid sequence map of the target gene) :5.3Vector(s) (Please enclose the map of the vector gene) :5.4Host(s) that carrying the vector(s)/ target gene(s) :5.5Manipulative procedures :5.6Anticipated functions of Product(s)  6.Summary of the proposed work plan utilizing GMOs (please check it from the following areas and provide the details of work plan).6.1Basic transformation and laboratory work to assess the expression of the target gene6.2Standardization of fermentation procedures below 20 It. capacity (if applicable)6.3Assessment of toxicity and allergenicity of the product (if yes, please provide the following information)i) Production/ fermentation procedures adoptedii) Purification procedures adopted; state briefly the processing chemicals used in the purification steps.iii) Physico-chemical characterization of the product; please provide limits of residues with there characterization!/ identification.iv) Biochemical/immunological characterization of the productv) Information on Five batches production datavi) Toxicity and Allergenicity protocols and the address of the lab where these studies are proposed to be conducted.vii) Institutional Animal Ethics Committee's Approval.6.4Acceptability criteria of the bulk and the formulated material wherever ready for animal experiments.7.Site/ Location of the research work :8.Proposed containment facility (Please indicate the level of containment proposed) :9.Decontamination and disposal mechanisms10.Risk management (Emergency plan) 11.Any other relevant information12.Declaration :I declare that the information provided in the above format is correct and accurate to the best of my knowledge. The "Safety Guidelines" brought out by the Department of Biotechnology, Ministry of Science & Technology, Govt. of India will be and is being strictly followed. 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