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hfo Action hfo Action DIR, SPECIAL PROGRAMS FORWARD ALL RESPONSES TO CONGRESSIONALACTIONS AND INTERNAL REPORTS CAIR DIVISION AP/PI 0 Prepare draft DOD reports to LRS (Forwnrcl reply THRU: CAIR Division APPI) 0 Review and provide comments to CAIR Division, APPI. Phone simple concurrence for negative response to CAIR Division, ~73459.Written comments must be rovided when comments are extensive. When more than one office has been tasked for comment, forward oraBwritten comments to CAIR for consolidation and 0 *Prepare comments on the attached LRS action. CAIR will consolidate comments when there is more than one action agency, and coordinate the entire package with OGC&). o For info don and integration into your response to LRS. ALL draft DoD Reporb and written comments on legislation packages MUST BE COORDINATED WITH OGC not be forwarded by action officers dinctlv to OMB.
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DEPARTMENT OF DEFENSE OFFICE OF THE GENERAL COUNSEL LEGISLATIVE REFERENCE SERVICE Experimentation - More ENERGY Questions and Answers SUSPENSE: 1300, FRIDAY, 18 MAR 94 OMJ3 has requestedthe views of the Department of Defense on the enclosed subject matter. ACTION AGENCY: Please advise upon receipt of name of action officer and phone number. Please review and respond by the suspense date or request an extension. OSD agency comments require DGC coordination. Please advise us in advance ifcomments will be provided. STAFF'INGANDINpylRMATIONAGENCIES: Hease review the enclosed request and respond appropriately. If staf€hg agencies do not respond by the suspense date or request an extension, we will assume you have no interest. Information agencies need not respond unless comments are necessary. OSD agency comments require DGC coordination. Please advise us in advance ifcomments will be provided. A response sheet is enclosed for your convenience. PO NOT C A y OMB. Department of Dehse response. LRS will consolidate all responses and n o w OMB of the LRS FILE.#: 7 Medical Research & Medical Other
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PSSPONSE TO DOD LEGISLATIVE REFERENCE SERVICE you may rospond to this requost in on. o f tho following ways : Comploto tho following information: Mark your tosponro on tho appropriato U n o following: Stat. tho nunrbor o f pager attached:
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Legislative Llaieon fficer -. Assistant D rector for ECT : ENERGY Qs and A s on Human Radi a tio i lino for LRM YM 1212 i a urndad: requests thevi we af your agency on theiabc s i n g on its re1 tioqehip to the program of i so rdvime urn i f Chia ita will affoot dirml ipt. for purp0m.m of tho tha **~ap-m-You-m~ Ou do not romp0 d by t h 8 daadlina, If. wibl 4 apmnay haul no onmaat. I re subject before le President, in
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Answer : Uith t h e Departmi that all types o f on human subjects there may be situ; subjects may still Iff ice: Energy Research OM SENATOR GLENN J ost open fashion, whll Bre o f any bases forc aday, it i s important Ions i n which such res be necessary 1 t h e in > tion should ni be co arch. All aspects o f 111 have to be fulfill ,e reviewed by the Inte and i hould all man subjects be arch on human zderal repulat ons agency Adv t sory
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IQUESTIONS FROM SENATOR GLEMN ase provide for tho r word the follow Oepartment which involve the use of h ai A s promlsed on January 25, 1994, by Secretarf I a . The total number o f grants o r contrac Comnlttee an Government Affairs, a computerizel current 006 human subjects projects wtll be pri 1994. The Informatton will contaln the total I adminlstered by the Department. b. The dollar amount of these contracts. A s promised on January 25, 1994. by Secretary ,Comnlttee on Gqvernment Affairs, a camputeri e.( human subjects projects will be provided on pi lnformatlon will contaln the tgtal dollar amoui e . The number of FTEs devoted to assurance i regulatlan d governtng the use of humans i A great nunrber o f people spend some o f their t . assurance and compl lance wl th regulations gover human sutJj ect s in research. This includes nqmt t h e various institutions conducting human subjc database on DOE ri compllanca with jocts in research. inq the use o f r s of the IRE o f
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many o f each. What were t h contractor support and some WE staff tlme. estimate i5not currently available. d . The number of compliance Invest lg at lons c Department over the past3years. No camp1 lance Invest lg at lons have been conduct8 over the past3 years. Compliance Invest ig at lo by complaints. Complaints may come fram human investigations, or other staff and may be direc agency and institution as well a s the ZRB. In .time,there were no comglatnts. ow miiny and what correctfve act lons were There were no fn vest lg at lons conducted by the D past3years because no formal complaints were Yes. The Department has made one announc S and fa National Laboratory last year toe wlth the regulation. Sandia was vlslted by the Oepartment i would be driven taken based on is lte vis lt at
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recently proposed + t s flrst human subjec 1 frnplmnted t h e 1RB process and received Iff 1 ce phone : lfftce: Energy Rerorrc b its first DOE
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OIJESTIONS FROM SENATOR GLENN ppa red by: Or. A rl Patrloot fflce : Energy Research Question tl1.d. L Has the experimental use o f accelerators using human human subject studies. These studies ha( Inrtitutlonal Review Boards. As long as a research effort, Food and Orug Administ not required. I f the approach should bec diagnostfc procedure, Food and Drug Adaln uauld be required. The Brookhaven National Synchrotron l i g h Source and the Stanford Synchrotron Radiatlon Laborator are t h e only two Ap ropriate Institutfonal Review Board an procedures are i n place for all studies1 experimental use o f accelerators using hu t been approved by .he stud fes remain