EXCE,FTION TO SF 30, APPROVED BY NARS 5/79 -@T-AHL,ARP FORM 30, JULY 1966 --XNERAL StAVICES Pa"d PAGE OF FED'PROC, REG. (41 CF ) - 16. 101 1 5 - I. AMENDMENT/MODIFICAVON NO. 2. EFFECTIVE DATE 3. REGUISITIOm/PURCHASE REQWST No. PROJECI NO. afePpUeabie) . P00002 30SEP81 12o8/5702/81 T 5. ISSUED BY CODE HIASA7 i.7-ADMINISTERED BY al "her Am Week 5) CODE I S0507A Virginia Contracting Activity DCASNA San Francisco ATTN: RS-Q2 1250 Bayhill Drive Washington, DC 20301 San Bruno, CA 94066 7. CONTRACTOR CODE 0 652 TY CODE. a. j FA 3 HAW AND ADMSS Ei AW04I)MENT Of _ SOUCTFATI10H HO SRI International 333 Ravenswood Avenue A look 9) (Street, ft`t'&*`te ' Menlo Park CA 94025 unt c o MODIF]CATION OF y, Mo. . CONTRACT/01111DIER , MDA903-81-C-0292 and ZIP Code) L DATED 06APR81 _p%ewwkjj) 9. THIS BLOCK APPLIES ONLY TO AMENDMENTS OF SOLICITATIONS El the above numbered solicitation is amended as set forth in block 12. Tfso hour and dole specified far of Offors 11 is exhoded, El is not extended. Off*rors must ockno@lodqe receipt of this amendment prior to the hour and dole specified in the, tolicilation,or as ameastled. by oven of dw following neWhod (0) By signing and returning- copies of this amendment; (b) By acknowledging receipt of this on socls copy of dw offer A Ahe ; or (c) By separate letter or tologrom which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWIEDGMEN'T TO BE RECEr4W AT TW 15SUING, OFFICE PRIOR TO THE H04JR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If, by virt" of this amendment you dmsioe to dwonge an offer abootly --1 1 - , such change may be I, by selegram, or letter. provided such telogrom or letter makes reference to the solicitation and this amendment, and is socei prior to dso opening how and dorse, specifted. 10. ACCOUNTING AND APPROPRIATION DATA (If required) ACRN: AB 2112020 25-2037 P381321.03250-2572 s18128 2P29 $189p892.00 11. THIS BLOCK APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS (a) 1:1 This Change Order is issued pursuant to The Changes set forth in black 12 ore mode to the above numbered controct/order. (b) El the above numbered controct/order is modified to reflect the administrative cbon ""' ' - " (such as di n i l f * i bl k o ces s among c ato, ek.) to a, n oc 12. g I F F (c) M This Supplemental Agreement is entered into pursuant to authority of 10 U.S.C. 2304(a')'(11) It modifies the above numbered contract as W forth in block 12. 12. DESCRIPTION OF AMENDMENT/MODIFICATION A. Delete any and all references to Contract No. NDA903-81-C-0292 and substitute therefor Contract No. NDA908-81-c-ooo4. B. Add the following as task number 2.1.10 to the Statement of Work (Classified) dated 19MAR 81: (U) 2.1.10 Continue development and evaluation of CRV training program. C. Add task numbers 2.1 and 2.2 of the Contractor's technical proposal number ESU 81-60 (Classified), dated 23MAR81,. to the Statement of Work (Classified) dated 19MAR81. These tasks shall be rem=bered 2.3 and 2.4 respectively. D. Add an additional paragraph or section to the quarterly and final reports specified in paragraph C.2 of the contract to cover the tasks added by this modification. E. Add the following as paragraph H.9 of the contract: (continued) Except as provided heroin, all terms and conditions of " document reforencod in black 8, as horessfons choopsti, resessin anchoaged and ilk Sum 60M ond effect. o CONTRACTOR/OFFEROR IS NOT REWIRED CONTXACTOR/OFFEROR IS REOUIRED TO SIGN TIES DOCtWZW AND RETURN 2 COWS TO ISSUING OFFICE TO SIGN THIS DOCUMENT 14. NAME OF CON 17. UNITED TATES, OF AMERISIk , W By my IVAA@ JS.9-4.ro of p.,,oo to ig-aT V-@ 15 NAME Of TITL IGNERre or 16, DATE 10. NAME 19, DATE print) SIGNED OF CONMACTING SIGNED It KCt4o- 10b OFFICE* (7!lve or "-1/ edov-, CIANROR9648MR001 81SEP29- 201? 5001100 2 112- Approved For Release 2001/04/02: CIA-RDP96-00788ROO1500110012-2 contract MDA903-81-C-0292 Modification P00002 (New Contract NDA908-81C-0004) Page 2 of 5 11-9 VSE OF HV?tAN SUBJECTS (1978 -Aug) The following definitions are used In this clause: (1) At risk means that the human subject my be exposed to the possibility of hysical, biological# psychological, sociological, or other - an a consequence of an act or omission that goes beyond the applica- tion of those established and accepted methods or procedures which are In his best interests. or that Increases ordinary risks of daily life, including the recognized risks Inherent in his chosen occupation or field of service. (2) Human Subject means any human being who$ know'ngly or unkowingly, is subjected to an act or'OW15810n, ubether at rtak or not, the object of which 19 to contribute to knowledge to be gained go a part of work to be performed under the scope of this contract& (b) The contractor, before undertaking to perform any study Involving human subjectst whether at risk or not, shall Insure that the following minimum conditions are complied with: (1) The proposed study has been reviewed and approved by a committee meeting the requirements set forth in Chapter 46 of Title 45 of the Code of ,-Federal Regulations- (2) The Inum;ber of hu@nan subjects used will be kept to the minimum number that will reasonably achigve the required results. (3) The study must be such as to contribute significantly toscientific knowledge and have reasonable prospects of yielding important results essential to an Army research programe (4) The study Will be conducted only by persons possessing the requisite scientific qualifications- The highest degree of skill and care will be required during all stages of study of persons who conduct or assist In the study* (5) The human subject will be informed that at any time during the course of his participation he has the right to revoke his consent and withdraw from participation without prejudice to himself* (6) Participation by subjects will be immediately terminated If It sub- sequently appears that the risk to the subjects is significantly greater than anticipated at the time review and approval was granted. (7) There shall be no greater Intrusion into the privacy of the human subject than Is absolutely necessary for the conduct of the study involved. Ex- cept for the submission of reports and other data required by this contract, any information obtained about human subjects as a result of their participation shall be held an confidential as the law allows- (8) The study will be conducted 80 419 to ovoid all unnecessary Physical or mental suffering or Injury. Approved For Release 20011944QZ- fia[A-RDP96-00788 ROO 1500110012-2 Approved For Release 2001/04/02 : CIA-RDP96-007@8ROO1500110012-2 Contract MDA903-81-C-0292 Modification P00002 (New Contract MDA908-81-c-ooo4) Page 3 Of 5 (9) No study will be conducted If there Is any Inherent reason to believe that death or disabling Injury Is likely to occur. Sufficient animal or laboratory experiments, or other evaluations-, must have been completed to give assurance of acceptable kisks prior to the use of human subjects. (10) The degree of risk to be taken will never exceed that which is justified by the benefit to the subject and/or the humanitarian Importance of the knowledge to be gained. (11) A physician will be responsible for the medical care of subjects.. Even If not the project leader, the physician idll have authority to terminate the study at any time that he believes death, injury or bars to likely to result. (12) Proper preparations mill be made, and adequate facilities provided, to protect the subject against all foreseeable possibilities of Injury, disability, or death, This Includes but is not limited to hospitalization and medical treatmen as way be required. In addition, all apparatus and Instruments necessary to deal with likely emergency situations will be available. (13) Human subjects will have no physical or mental conditions which will make participation more hazardous for them than It would be for normal healthy persons, unless such condition is a necessary prerequisite for the particular study involved. In any such case, the use of human subjects with such pro-existing conditions must have been specifically described and justified :in the scope of the work to be performed under this,contracto % (14) The scientifically qualified person conducting the study, and each member of his research teams will be prepared to terminate the subject's partici- pation at any stage If he has reason to believe, In the exercise of the good faith, superior skill, and careful judgment required of hing that continuation In likely to result in Injury, disabilityg or death to the human subject. , (c) The Contractor, before permitting any person to participate an a human subject, whether at risk or not, shall Insure that the following minimum conditions are complied with: (1) Legally effective informed conse .nt will be obtained by adequate and appropriate methods In accordance with the provisions of this clause. (2) All consent must be voluntary* It must be the imowing consent of the Individual or his legally authorized representative, so situated as to be able to exercise free power of choice without there having been any use of forces fraud, deceit, dureses constraint, coercion* or lawful or improper Inducement. The ele- mouts of information necessary to such consent Include: . (1) A fair explanation of the procedures to be followed$ and their purposes, Including Identification of any procedures which are experimental. i (U) A description of any attendant discomforts or risks reasonably to be anticipated* Approved For Release 2001/O4M2t:LQ&PZDP96-OO788 ROO 1500110012-2 Approved For Release 2001/04/02: CWRDP96-007@8 ROO 1500110012-2 Contract MDA903-81-C-0292 Modification P00002 (New Contract No. mA9o8-8i-c-ooo4) Page 4of 5 (lit) A description of any benefits reasonably to be anticipated. (1v) A disclosure of any appropriate alternative procedurect that night be advantageous to the subject. (v) An offer to answer any questions concerning the procedure. (vi) An Instruction that the subject Is free to revoke his consent end to discontinue participation at any time without prejudice to himself. (d) Exculpatory language through which the subject is made to 41aive, or appear to wive, any of his legal rightse Including any release from liability for uegligence, Is prohibited* (e) Prior consent by a subject or his legally authorized representative shall be obtained In all cases. Such consent shall be to writing wbenever It Is reasonably possible to do so. The consent form my be read to the subject ar his legally authorized representatives but In any event he Or his legally authorized representative must be given adequate opportunity to read it and to ask questions they night have* This consent form should then be signed by the subject or his legally authorized representative and by a witness not directly Involved In the study* Oral consent my be used only when it has been specifi- cally described and justified In the scope of the work to be performed under this contract or approved In writing by the contracting officer. When so author- Ized and used# oral consentAs subject to all the same standards as apply to written consento except that the signature of the subject or his legally author- Ized representative to not required. (f) Prior to co uduct of the studyt the contractor *ball submit for approval to the contracting officer & detailed description of the mans by which informed consent will be obtained, to Include any forms to be used. Upon completion of the study, the contractor will submit to the contracting officer detailed report demon- strating compliance with paragraph (c), to include copies of the written consent If such was obtained. (g) The Contractor shall not undertake to conduct either the clinical pharmacology or clinical trails of an investigational drug unless this contract contains the clause entitled "Clinical Study of investigational Drugs." (h) Prisoners of war will not be used under any circumstances* F. Add the fo" owing as paragraph H.10 of the contract: H.10 All persons participating as human subjects, as defined by paragraph H.9(a)(2) hereof, shall be known to possess the abilities and qualities which will be observed and analyzed during the conduct of this contract. Approved For Release 2001104/02: CIA-RDP96-00788ROO1500110012.2 Approved For Release 2001/04/02 : CIA-RDP96-00788f,001 500110012-2 Contract No. MDA903-81-C-0292 Modification P00002 (New Contract No. MDA908-81-c-ooo4) Page 5 of 5 SGFOIA2 Approved For Release 2001/04/02': CIA-RDP96-00788ROO1500110012-2 G. Military security requirements in the Performance of contract NDA908-81-C-Ooo4 as modified shall be maintained in accordance with the revised DD Form 254 attached hereto. The highest classification involved in the performance of this contract as modified is TOP SECRET. 4 e, _FO01500110012 Approved For Rel ' ase 2001104102: CIA-RCIP96-0078 -2 DEPARTMENT OF I. DEFENSE 'THE REQUIREMENTS OF THE DOD INDUSTRIAL SECURITY MANUAL CONTRACT SECURITY APPLY CLASSIFICATION TO SPECIFICATION ALL SECURITY ASPECTS OF THIS EARANCE REQUIRED Isjop Secret RT ITY C FF T E FAC I . H IL L E O 2. 3. CONTRACT NUMBER 4. 3. THIS SPECIFICATIONOR OTHER DATE THIS IDENTIFICATION TO SPECI NUMBER BE FICATiON IS: IS FOR: contracts must COMPLETED (See be shown "NOrEll ,- below. r It * item IP b ot, c is -4jVcr#. , subcontracts) (Estimated) also I. enter , date ,, for item &) A. PRIME CONTRACT A. a. DATE NUMBER PRIME CONTRACT ORIGINAL x 8-81-c-ooo4 82APRO5 (Complete 81APRo6 NDA90 I date in all 40008) b. FIRST TIER b. DATE b. sue, SUBCONTRACT No. 0 REVISION CONTRACT(Use b. NO. Item IRIE ad.- 15 for subcontracting x a 1 BlATJG21 nd ti b d r) e n seco ay n I C. PtEOUEST DUEDATE C. DATE FOR $10. C IDENTI FICATION NUMBER REQUEST FOR FINAL PROP(@ISALJ ., 101CO FOR CUOTA1 G. this *.(*).low-on.co.ntrscI.? Is Yet No. If YES, complete the following: --,MDA903-81-C-0292 c. _ b. Accountability for classified material on preceding contract PRECEDING CONTRACT ETED NUMBER DATE COMPL Olt 17] Is not, transferred to this follow-on contract. 7a. . c. Name, FOC Name, Address Number Address & & Zip Zip Code Code of of Prime Cognizant Contractor Security b Office SRI International DCASR Los Angeles, ATTN: Directorate of -Tfidustrial 333 Ravenswood Security Ave . llQ99-S.La Cienga Menlo Park, Blvd.., CA 11a Aa4eles, CA 90045 Ga. b. c. Name, FrSC Name, Address Number Address & Go, Zip Zip Code Code of of First Cognizant Tier Security Subcontractor Office Sa. b. c. Name, PSC Name. Address Number Address L & Zip Zip Code Code of of Second Cognizant Tier Security Subcontractor, Office at facility associated with IFS, RFP OR RFQ When actual performance Is at a location other then that specified, identify such other'lecation in Item 15. iOa.General Identification cation b. of the Procurement upplies DoDAAD for which this Number specifi of Procuring Activity S&7 identified Intelligence in Study/Analysis Item 16d. c. Are there additional security requirements established in accordance with paragraph 1-114 or 1-215. ISR? [:3 Yes No. If YES, identify the pertinent contractual documents in Item 15. d. bility Are of any the elements cognizant of security this office? contract M outside Yes the No. !nspection If responsi YES, explain to Ite In 15 and identify specific areas or elements. It.ACCESS REOUIREMENTS ESNO ACCESS YESNO Y REQUIREMENTS (Continued) a 'Access J. x to Access Classified to Information SENSITIVE Only COMPARTMENTED at INFORMATION. other . c ontractor /Government It. activities. Access x to other Special Access Program information b (Specify Recei in t Item of 15). classified docurnews or oth r m t ri l . 1. e Access a to e U. a S. p classified for information reference outside nrily the (Incr U. generation). S. x Panama X Canal Zone, Puerto Rico, U. S. Possessions c. and Receipt Trust and Territories. generation of classified docu ments x or in. other Defense material. Documentation Center or Defense information d. x Analysis x Fabric Center at Services ion/Modificat may Ion/St be or requested. age Of classified hardware. c. n. Graphic Classified arts ADP services processing only. will be involved. f. REMARKS: Access to.IPO information. g. Access DOD to DIR RESTRICTED 5200 DATA. 17 " . h. Access to classified COMSEC information. DOD DIR 5200AR L. x Cryptographic Access Authorization required. 12. Refer *11 questions pertaining to contract security classification specification to the official named below (NORMALLY. thru ACO (item l6e), EMERGENCY, direct with written record of Inquiry and ilospons& to ACO) (thru prime contractor for subconfracge). a. The classification guidance contained in this specific o u attachments referenced herein is complete and adeq ate. b. vvird name title c. T and slanaliore, Activity nfonrA-n-/nr name. address. Zip Code, telephone n'mber and office symbol Defense Intelligence Agency Deputy ATTN: Directorate D7-lA Or ScieAific and Technical Intelligence Washinaton. SG1J D.r. 7nini SG1j De ense Intelligence A NOTE: Original Specification (Item 5a) is authority for contractors to mark clszslf@ ...... wjj. o-wasum mjw a join, apv--ptions (Items 5b and C) are authority for formation. contractors Such to remark the actions regraded classified by in contractors &hall be taken In accordance with the provisions of the Industrial Security Manuel. Approved For Release ZU011041UZ : UA-RUFUD-IIJ U-7-8-0-r-1% V.0 1500 1 160 12-2 FORM DD I JAN 7e 254 EDITION OF I APR 71 IS OBSOLETE. ALSO REPLACES DO FORM 254c WHICH 15 OBSOLETE Approved For Release 2001/04/b2 : CIA-RDP96-0078JR001 500110012-2 13m. 'Inf*r%ation pertaining to classified contracts or projects, even though such information is considered unclassified, shall not be released forpublic dissemination except as provided by the Industrial Security Manuel (paragraph So and Appendix IX). _J Direct [:J Through (Specify): b. Proposed public releases shall be submitted for approval prior to release r- Public Release of SCI is not Authorized. to the Directorate rot Freedom of Information and Security Review, Office of the Assistant Secretary of Defense (Public Affairs) 0 for review in accordance with paragraph So of the Industrial Security Manual. 0 In the case of non-DoD User Agencies,, see footnote, paragraph So, Industrial Security Manual. N. security ciaskirication Specifications for this solicitation 'contract are identified below ('*X" applicable box(es) and supply attachments as required). Any narrative or classification guide(&) furnished shall be annotated or have information appended to clearly and precisely Identify each element of Wormation which requires a classification. When a classification guide is utilized, that portion of the guide(s) pertaining to the specific contractual effort may be extracted and furnished the contractor. When a total guide(&) is utilized , each individual portion of the guide(s) which pertains to the contractual effort shall be clearly identified in item 14b. The following information must be provided for each item of classified information identified in an extract or guide: (1) Category of classification. (11) Date or event for doclassification or review for declassification. and (111) The dote or event for downgrading (71 applicable). The official named In Item 12b, is responsible for furnishing the contractor copies of all guides and changes thereto that are made a part of this specification. Classified Information may be attached or furnished under separate cover. a. A completed narrative is.(i) CD attached. or (2) (M transmitted under separate cover and mode a part of this specification. C-j b. The following classification guide(s) is made a part of this specification and Is (1) [D attached, or (2) E] transmitted under separate cover. (Liat guides under Item JS or in an attachment by title, r*t*ronc* number and date). C-j c. Service-type contract /subcontract. (Specify instructions In accordance with ISRIISM, as appropriate.). d, $1X11 only If this Is a final specification and Item 6 Is a -'NO" answer. In response to the contractors* request dated retention of the identified classified material is authorized for a period of r7 c. Annual review of this DD Form 254 Is required. 11 54X'd", provide date such review Is due: IS. Remarks ("@never possible, Illustrate proper classification, docles a III cation, and It applicable, downgrading instructions). The Defense Intelligence Agency has exclusive t SCI i . o res access a This contract requ security responsibility for such information released to the contractor or developed under this contract. DIAM 50-5 provides the necessary guidenace for physical, personnel and information security measures and is a part of the security specifications for this contract. DCASR is relieved of responsibility for all SCI material or information released to the contractor under this contract. b. Foreign national employees of the Contractor or subcontractor(s) are not authorized access to classified information resulting from or use in the performance of this Contract. c. The Contractor shall notify the COTR in writing no later than five (5) days after rec 'eipt of the contract of the following information regarding the individuals assigned to work on this contract. (1) Name (2) Date and Place of Birth (3) Social Security Number (SEE CONTINUATION SHEET) 16 a. C. ntr ct Security Classification Specifications for Subcontracts issuing from this contract will be approved by the Office named in Item l6e bela or o ecification and attachments referenced herein are approved by thwe' User ific tion S Cl C S i : a ecur ass ontract ty p prime contractor, so; authorized. This b y th Agency Contracting Officer or his Representative named in Item l6b below. REQUIRE15 DISTRIBUTION: b USA Deputy Prime Contractor atom 7s) SG1J , ' Director ffor-7becurity Services Asst Security Office (Item 7c) . 5D Cognizant ED Adm@'Tistrsitlve Contracting Office 7 atom J6@) SG1J CK3 Quality Assurance Rep"sentative M Subcontractor (Item So) Cognizant Security Office atom Sc) d. d Zip Pods Program/Project Manager (Item J2b) Defens"kdllig64 Agency M U. S. Activity Responsible for OverseasThe Pentagon, RSS Security Administration Washington, D.C. 20301 ADDITIONAL DISTRIBUTION: a. Name, address and Zip Code of Administrative Contracting Office DCASMA San Francisco M Approved For Release 2001/04/01 W.A='b* 012-2 "kpoi 500110 9F 71 O Approved For Release 2001/04/02 : CIA-RDP96-007 R001500110012-2 DD Form 254 (Continued) (4) Certification of clearance investigation and clearance, date clearance granted,.and name of agency granting clearance. c. Final classification of the information generated under this Contract is the responsibility of DIA"(DT-lA). Information generated under this Contract is subject to the guidelines contained in DoD Regulation 5200.1R, dated 2 November 1978, which implements EO 12065 which became effective I December 1978. Technical reports classified as.high as TOP SECRET SI/SAO will be provided the Contractor by DIA and other DoD activities, and other DoD contractors for use in connection with this Contract. These reports may be retained for t 'he duration of this Contract unless no longer needed. Upon termination of this Contract, the reports shall be returned to the sender (if required) or destroyed in accordance with current security regulations. If these documents are to be retained beyond the ending date of this Contract, written justification must be forwarded to and authorization given by the Contracting Officer. e. All copies of final documents generated by the Contractor under this Contract will be transmitted to DIA (DT-lA) for dissemination to the Grill Flame Committee. No other distribution is authorized. f. Use of the ARFCOS system is required. I Approved For Release 2001/04/02 : CIA-RDP96-00788ROO1500110012-2