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- !A products" #" !ame of the Applicant esignation $a% Address $Registered &ffice% 'elephone !o" 'ele( !o" )a( !o" e-mail $b% Address $Research Station% 'elephone !o" 'ele( !o" )a( !o" e-mail *" *"# *"* *"/ Application for + ,urpose !e.es !o &ngoing ,ro0ect .es !o If yes1 !o" 2 ate of 3&I issued + !o" 2 ate of ,ermit issued + If yes1 briefly state the purpose for -hich permission -as granted" Category of e(periments as per the Guidelines of B' &b0ectives of the proposal escription of the GM&s employed in the research proposal $in scientific terms6 for ne- application only%

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escription of GM&s escription of the target gene$s% !umber of copies of the genes incorporated escription of the target product$s% etails on + Source of nucleic acid$s% + !ucleic acid se7uence $,lease enclose the nucleic acid se7uence map of the target gene% + 8ector$s% $,lease enclose the map of the vector gene% + 9ost$s% that carrying the vector$s%/ target gene$s% + Manipulative procedures + Anticipated functions of ,roduct$s%

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Summary of the proposed -or; plan utili<ing GM&s $please chec; it from the follo-ing areas and provide the details of -or; plan%" Basic transformation and laboratory -or; to assess the e(pression of the target gene Standardi<ation of fermentation procedures belo- *= It" capacity $if applicable% Assessment of to(icity and allergenicity of the product $if yes1 please provide the follo-ing information% i% ,roduction/ fermentation procedures adopted ii% ,urification procedures adopted6 state briefly the processing chemicals used in the purification steps" iii% ,hysico-chemical characteri<ation of the product6 please provide limits of residues -ith there characteri<ation>/ identification" iv% Biochemical/immunological characteri<ation of the product v% Information on )ive batches production data vi% 'o(icity and Allergenicity protocols and the address of the lab -here these studies are proposed to be conducted" vii% Institutional Animal ?thics Committee@s Approval" Acceptability criteria of the bul; and the formulated material -herever ready for animal e(periments"

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Site/ 3ocation of the research -or; + ,roposed containment facility $,lease indicate the level of containment proposed% + econtamination and disposal mechanisms Ris; management $?mergency plan%

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Any other relevant information eclaration + I declare that the information provided in the above format is correct and accurate to the best of my ;no-ledge" 'he DSafety GuidelinesD brought out by the epartment of Biotechnology1 Ministry of Science 2 'echnology1 Govt" of India -ill be and is being strictly follo-ed" In case any unto-ard incident occurs1 the Chairman of the msc and the Member-Secretary of the RCGM -ill be informed immediately" ate+ )or-arded+ 'he proposal set out above has been considered by the DInstitutional Biosafety CommitteeD on EEEEEEEEEEEEEEEEEEEE and is for-arded to RCGM for further necessary action" ate+ Signature of the Chairman1 IBSC $!ote+ ,lease submits *= copies of the application to the epartment of Biotechnology for placing the same in the meeting of RCGM% Signature of the Applicant