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U.S. ARMYMEDICAL MATERIEL DEVELOPMENT ACTIVITY

19e9 ANNUAL REPORT

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64. NAME OF PERFORMING ORGANIZATION 6b. OFFICE SYMBOL 7s. NAME OF MONITORING ORGANIZATION* U.S. Amy Medical Materie.l (I .ppab) U.S. Auy Medical research a• _

DevelowTent Activity SGIT-W and Develognnt Can~andS.ADDRESS (Clty. Staft, mnW Co*) 7b. ADDRESS (Cty, Stafte and ZIP CC10)Fort Detrick Fort Detrick31iidiM T-622 bhlding 504Frederick, M 21701-5009 Frederick, MD 21701-5012

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-. " • U.S. Azry Medical Materiel Developmt APctivity 1989 Aknal report (U)

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. CMPL E. P. JR., , 1one: , MS, Ormvwni13,. TYPE OF REPORT 13b. TIME COVRfED 14. DATE OF REPORT (Y•"* *kon OAY) IS. PAGE COUNTAnnual Progress IFROM 17inVLTo21n891 1990 January 31.

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ii

U. S. ARMY MEDICAL MATERIEL DBVELOPMENT ACTIVITYFORT DETRICK

FREDERICK, MARYLAND 21701-5009

31 JANUARY 1990

ANNUAL REPORT FOR PERIOD 1 JANUARY 1989 - 31 DECEMBER 1989

APPROVED FOR PUBLIC RELEASE.DISTRIBUTION UNLIMITED

U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMANDFORT DETRICK

FREDERICK, MARYLAND 21701-5012

NOTICE

The findings in this report are not to be construed as anofficial Department of the Army position unless so designated byother authorized documents.

Destroy this report when it is no longer needed. Do notreturn it to the originator.

U. S. ARMYNED2CAL MATERIEL DEVELOPMENT ACTIVITY

1989 ANNUAL REPORT

TABLE OF CONTENTS

INTRODUCTION* ......... . ..........

PROGRAM MANAGEMENT ......... . .... . .o... 3

PROGRAM ACCOMPLISHMENT

APPLIED MEDICAL SYSTEMSTHE PROGRAM. .o. . . . . v e o . o o s o e # e o o o 9MAJOR ACCOMPLISHMENTS. . e . o * . o . . o . . e o 13PROJECTIONS. . o .. o. .. *. . . . .. o. . *. .o. .o . 16

BIOLOGICAL SYSTEMSTHE PROGRAM. e•.s s. o o .# . .o & e * e . . # o o 19MAJORACCOMPLISHMENTS. . . . . . . . . . . . . . . . 24

PHARMACEUTICAL SYSTEMSTHE PROGRAMeo . .. .. . . * * & a * o * * . e * * 31MAJOR ACCOMPLISHMENTS o . o e .. . o e o . a . o o 34PROJECTIONS. . . . . . . . . . . . . . . . . . .o. 37

PUBLICATIONS .o. . . . . .. .. . . . . . . . . . . . 41

PRESENTATIONS .. . . . . . . .* . . . . . . . . . . . . . 43

SEMINARS AFD MAJOR TRAINNG EVENTS. . . . . . . . . . . . 45

DISTINGUISHED VISITORS .................. 53

DISTRIBUTION LIST . . . . . . . . . . . . . . . . . . . 55

ANNEX A ORGANIZATION CHART ................. . -1

DYIl TA C#

Tv,a ll'"' /op,...

INTRODUCTION

Calendar Year 1989 was marked by frenetic activity as thesmall staff of the U.S. Army Medical Materiel DevelopmentActivity kept pace with the many changes in development regu-lations and mobile funding profiles. Shepherding progress ineach product under development by the three project managementoffices was never dull.

Accountability was the primary theme for our organizationduring the yeLr. Intensive reviews and antlyses, data baseupdates, a plethora of prioritization and concommitant fundingalignments, MAMP and MSRC deliberations, IPRs, and high-levelbriefings to the senior AMEDD leadership and the DA/DOD staffsall served to reinforce the credibility of our efforts as well asacknowledge the fact that we actively serve the best interests ofthe user community.

Several high visibility materiel products are on track forfielding in the early 1990's, notably the major hardware items.The AMEDD program will clearly deemphasize the Je hovedevelopment of medical materiel in the foreseeable future.Rather, modification of off-the-shelf items (NDI) will be theprincipal materiel development consideration in meeting AMEDDneeds. Any perceived void, however, will be readily filled withproducts maturing from within the biologics and pharmaceuticsside of the house. We have no shortage of requirements tosubstantiate our development program.

We are entering the final phase of our evaluation of theAMEDD acquisition system with a series of recommendations beingprepared for the AMEDD leadership. If accepted, these will haveprofound implications on how the AMEDD acquisition process isconducted and how to best manage it.

In 1990, we intend to conduct thorough scrubs of our majorsupport contracts which serve as the underpinnings for ourproducts. It will become even more necessary to control costgrowth in these areas as our development program resourcescontinue to be scrutinized. Competition among product prioritieswill become even more keen, and product managers will be forcedto use trade-offs which impact on cost drivers vis-a-vis need forproduct enhancements. "Better" may well become the worst enemyof "good enough."

The future looks both intriguing and challenging, and westand ready to fully support the AMEDD community during an era ofprojected dynamic change.

CARL E. PEDERSEY, JR.Colonel, MSCommanding

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2

PROGRAM•

INTRODUCTION

The Project Management Support Division (PMSD) providescentralized program-wide administrative, financial, contracting,and logistical support. Throughout 1989, the emphasis withinPMSD has been on enhancing the support provided to the ProjectManagement Divisions, and improving accountability for resourcesthroughout the AMEDD materiel development spectrum.

MAJOR ACCOMPLISWMENTS

* 1989 Medical RDA MAP: The FY89 Medical RDA Mission AreaMateriel Plan (MAMP) Conference (March 1989) conducted productassessments for evaluating the USAMRDC Research, Development, andAcquisition (RDA) Program with respect to medical-related combatrequirements. Representatives from USAMRDC, USAMMDA, USAMMA,Office of The Surgeon General (OTSG), U.S. Air Force, U.S. Navy,Academy of Health Sciences (AHS), and other Training and DoctrineCommand (TRADOC) schools evaluated 139 products against 35Medical Area capability issues (CI), and 11 medical-relatedBattlefield Development Plan (BDP) capability issues. AMEDDprioritization was developed and was approved by the CommandingGeneral, USAMRDC and the Commandant, AHS. The increasedparticipation by other AMEDD and non-AMEDD organizations, andother Services greatly enhanced conference effectiveness. Asbefore, overnight turnaround on the team scoring resulted in veryenlightening discussions in the final general session. Actionswere initiated to incorporate the old AMEDD CVs into theCapability Packages of the Modernized Concept Based RequirementsSystem (CBRS).

* 'Project anamuent ControiSv3ten !PMCS: Contractordevelopment of the Project Management Control System (PMCS) wascompleted in hay 1989 with the revision of the Schedule Module.The revision resulted in the following enhancements: streamlineduser interface, unified Oracle data management design, andcapability to perform cross-schedule queries. The Work BreakdownStructure (WBS) code in the Schedule Module was standardized andmandatory command-level tasks to be included in R&A briefingswere identified. Training on the Schedule Module and BPL wasprovided to USAMODA personnel as required.

3

o Ceneral Analysis/Priority System tGAPSI: The ResourcesManagement Branch, with contractor support, developed andimplemented GAPS, an automated resource management tool designedto assist in planning and prograumirg the cost of productdevelopment. GAPS contains vital product identification andfunding data concerning all products managed by USAMMDA. Phase Iimplementation of the system provides easy on-line access to allproduct data ("Z sheets") and a wide array of management reportswhich serve as invaluable tools in allocating limited dollarresources among competing products under development. Phase II,currently under development, will include an on-line Help Moduleas well as a Query Module to provide "what if" capabilities forthe user. Phase II is scheduled to be completed by 3Q90.

e Automatic Data Processina SuMDort: Additional softwarepackages (such as BMDP Statistical Software, Turbo C, and Windows286) increased specific user productivity. Macintosh SE's wereintroduced to more users to improve the quality of presentationgraphics and provide a totally supportive environment for allusers. With the conversion to Macintosh for graphics, andinstallation of a MAC II with a volor monitor, color printer andscanner, USAMMDA is able to produce high-quality graphics outputin-house; thereby eliminating the need to contract for suchservices. Work also began on installation of an ethernet localarea network'to speed data interchange.

e fj3Mra= rwmvge•n : USAMRDC experienced sionificantreductions in outyear program guidance during the 1989 Field LongRange Research, Development, and Acquisition Plan buildingprocesa during spring and summer. USAMMDA, as the agent forpreparation and defense of the development portion of the USAMRDCprogram, was heavily committed to preparing impact statements andprogram realignments to accommodate the reductions. Programreductions through FY95 averaged 15% then swelled to 48% fromFY96 through FY06. Significant realignment in both research anddevelopment priorities will be required to adjust to Departmentof Defense RDA downsizing.

e Configuratio NanAum niA:unDot: The ConfigurationManagement Branch at the U.S. Army Belvoir Research, Developmentano Engineering Center (ARDEC), Fort Belvoir, VA, has beenselected as the data repository for USJMMDA technical datapackages (TOP) resulting from development contracts for products.This past year, the TDP for the Military Transportable FieldRadiographic and Fluoroscopic System (MTFRFS) was delivered toBRDEC for reproduction and storage. Copies of these aperturecards will be provided to potential production contractors forthe MTFRFS. Changes to the TDP resulting from the production ofthe systems will be made by government-approved engineeringchange proposals and provided to BRDEC for update of the TDP tomaintain currency.

4

* Production Contract Prenaration: The Togistics ManagementBranch was designated as the tesponsible office for preparing,staffing and coordinating the Army Acquisition Plan, statementsof work for the production contracts for the PET Scope and theMTFRFS. Contract award is expected in mid-FY90.

* Najor Support Contracts: The PMSD acts as the ContractingOfficer's Representative for a majcr contract to provideapproximately 25 technical manyoars annually in support of theProject Manager's documentation requireaents. The contractobjective is to facilitate the timely and efficient execution ofmedical materiel development by providing a mechanism forpreparing and assembling the support documentation necessary forcoordinating and transitioning developmental medical product".To that end, 90 tasks were awarded during the year to provide 9In Progress Review participant packages, either a System Conceptand a Decition Coordinating Paper; 15 life cycle cost estimates;13 integrated logistical support plans, 7 transition plans withMemorandum of Notification for each, 4 test and evaluation masterplans, a logistics demonstration plan with contractor evaluation,a production readiress plan, a depot maintenance support plan,and a configuration management plan; 74 market investigations;several other incidental product-specific analyses and papers; aswell as s',pport for program-wide data collection and analysisefforts such as the General Analysis/Priority System and theMission Area Materiel Plan. The support contract was awarded toSherikon, Inc., in September based on a successful marketingpresentation. The 90 tasks were split between 2 contractors, 54to Engineering and Economics Research Inc., the exitingcontractor, and 36 to Sherikon Inc., after award.

a Produg i naag *nt SUpDgrt During the past year, thefollow-on award for phase II of the development of the FieldMedical Oxygen Generating and Distribution System (FMOGDS) waeawarded and the Logistics Management Branch has been designatedas the office to provide the contracting officer's technicalrepresentative for the contract. This resulted in arrangement ofpost contract award conferences, ILS Management Team meetings,Critical Design Reviews and various other meetings with thecontractor and manv outside Army agencies and officez. Severalchange orders to the contract have resulted, and the necessarymodifications to the contract statement of work have beenprepared and coordinated.

e IntgaMted Loa 'iais Eunort and.: As theresponsible organizational element for managing all ILS andMANPRINT related actions, all necessary documentation to supportthese programs has been accomplished within the requiredmilestone guidelines established for vach product. Thesedocuments include ILS plans, review and coorCination of XANPRINTmanagement plans, preparation, staffing and coordination of ILS

5

plans, transition plans, System Support Packages, Sasis of lisuePlan feeder data, and configuration management plans.

HUMAN RESOURCES

USAMNDA experienced an 80% turnover rate in clericalpositions during 1989. Efforts are underway to standardizeposition requirements for secretaries among the ProjectManagemert Divis.ons and to establish promotion ladders tostabilize clerical support.

Through novel and intensive recruiting efforts, three hard-to-fill civilian specialties were committed: a Regulatory AffairsSpecialist, a Pharmacologist, and a Toxicologist. Actionscontinue to resolve problems with recruiting and retainingcivilian Logistics Management Specialists and militaryLogisticians.

e USAMMDA Kev Personneal:

Commander COL C.E. Pedersen, Jr. 1 Jan 89 to 31 Dec 89

PM/AMSPMD COL B.A. Schiefer 1 Jan 89 to 31 Dec 89

PM/BSPMD Dr. W.E. Brandt 1 Jan 89 to 31 Dec 89

PM/PSPMD COL R.O. Pick 1 Jan 89 to 31 Dec 89

Dir/PMSD MAJ W.F. Heinemann 5 Sep 89 to 31 Dec 89LTC J.L. Chaffee 1 Jan 89 to 4 Sep 89

9 USA)=D 13 : As of 31 December 1989:

military Civilian tl

Required 25 51 76

Authorized 20 34 54

Actual 14 29 43

16

FISCAL PERFON(AMCZ

e JRWMf: USANNDA in-house fiscal execution exceeded DAestablished targets for FY 89, and exceeded FY88 performance by5% in obligations and 33% in disbursements. The improvement indisbursements was attributable to increased use of supportcontractor resources.

£U.QmDn Obltgio Disbursements

FY 89 Dollars ($000) 3,799 3,770 2,478

Target (%) 94 49

Actual (%) 99 65

e Z ajg3 Wide: Performance in the commnd-wide developmentprogram was not as successful as USAIIDA in-house, but much moresuccessful than FY 88. Both laboratory and extramural programperformance exceeded the obligation target. Criticaldisbursement targets were met in-house but not in the contractprogram although the total program performance increased by 70%over FY 88. Significant delays were encountered in applyingcontract modifications in two major projects (RErLUPS and DINS).

Allotment ZibgutgZy ZxiAZrAJ TotalProject (.000 . OQL 2ISM =•L D= OBL DM

836 7,837 99 72 94 76 95 74808 3,972 100 80 99 30 99 63809 5,000 100 77 96 42 97 55993 13,298 99 56 99 26 99 30

Total 6.3B 30,107 99 72 97 42 99 50

832 3,140 100 90 100 50 100 64847 6,134 100 81 100 44 100 50848 5,626 100 60 100 29 100 33849 2,365 100 66 100 52 100 58

Total 6.4 17,265 100 76 100 40 100 48

Total Program 47,372 100 73 98 41 99 49

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THIS PAGE InTENToNALLY LinT BLANK

APPLIED MEDICAL SYSTDPROJCT IM DIVISION

MR Pfdm

INTRODUCTION

The Applied Medical Systems Project Manaqgment Division is amultidisciplinary team with broad missioa responsibilities tocentrally manage the development and initial production ofapplied medical products, related diagnostic equipment, eyewearproducts, and pesticide delivery systems.

MILITARY RELEVANCE

Applied Medical Systems is committed to developing compact,lightweight, durable medical equipment to achieve both the Army'sdemanding Service-unique and multi-Service mission requir%aents.Diverse, multi-discipline technologies are integrated to create awide range of state-of-the-art systems. Equipment initiativesare directed toward addressing medical defense against chemicalwarfare agents, medical protection against military hazards, andthe ability to provide care to the combat casualty.

OBJECTIVES

Army readiness is predicated upon the timely and successfulexecution of programs by the Materiel Developer. To achievethis, Applied Medical Systems capitalizes on emerging Tech Baseefforts and aggressively manages the development component of theAMEDD Research, Development and Acquisition process to meet DAand Joint Services performance and supportability requirementsfor field-survivable medical equipment.

PRODUCT DESCRIPTIONS

e The h CaItv X-raw Svum is a radiographic andfluoroscopic unit incorporating state-of-the-art solid stateelectronics, composite materials for lightweight construction,and mil-spec zo nonts for system reliability that complies withall radiation health and safety standards and meets therequirements for military operation.

o The Piald ---•i4al v.n Generatim and Distributi2nSystem I7NOGD61 will provide both bedside and cylinder-refilloxygen capabilities within TO0 hospitals and medical logisticsorganizations. The system is designed to reduce the logisticsburden of acquiring medical grade oxygen.

9

o The jgmscitative Fluids Production and ReconstitutionSystem (REFLM;3 produces sterile Water for Injection from apotable water source, combines that water with concentratedelectrolytes to formulate parenteral solutions, and packages thesolutions in sterile IV bags.

o Ballistic-Laser Protective Spectacles (B-LPS) affordballistic protection against small mass (5.8 grain) low velocity(640-660 feet per second) fragments and directed energyprotection against two wavelengths (ruby and neodymium) lowenergy (0.1-1.0 joule per pulse) lasers. Two versions areavailable, one clear and one tinted. An optional prescriptionlens carrier provides vision correction for the ametropic wearer.

e Laser Protective Eyewear (Materiel Chanae) is a family ofpolycarbonate eyewear which consists of the spectacle frontsert,helmet visor, sprectacle lenses, mask outserts, and eyewrap.These eyewear products are designed to attenuate laser threats(three or moxe wavelengths) emitted from range finders, targetdesignators, and low energy laser weapons.

o The Steam Vacuum Pulse Sterilizer Syvste (SVPSS1 is amicrocomputer-controlled automatic steam sterilizer which employsa pressure/vacuum pulsing-conditioning principle for air removaland is designed to sterilize instruments, linens, and solutionsfor field hospitals.

o The Ethylene Oxide Sterilizer (XeSI is a stand-alonedevice for sterilizing non-heat sensitive devices as well asthose sensitive to moisture or heat or those damaged by steam orliquid chemical sterilization. Products that fall into thelatter categories include any plastic or rubber products such ascatheters, resuscitation bags, anesthesia masks, surgical gloves,and most fiber optic instruments.

e The SDecial ODerations Forces Sterilizer is a rugged,compact, lightweight, easy-to-use steam sterilizer for theSpecial Operations Forces medical personnel operating in mobileor unconventional warfare modes. This sterilizer can useelectricity, wood fires, or gasoline/kerosene stoves as a heatsource.

e The Field CauTmtd To =Rbahv Scanner is a compact x-rayscanning system which weighs about 1,600 pounds, requires lessthan ten kilowatts of power, can be deployed in a 1:1 ISOShelter, produces diagnostic quality CT information, and becauseof the thermal management design, can be operated continuously.

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0 The Filmless Diaital imagina Network System is the combatcasualty care incarnation of a battlefield filmless medicalimaging network. The focus is on image acquisition, networking,display, and archiving for the echelon III and IV theaterhospital environment. Peacetime variations of this technologyare also being developed along two other basic thrusts;teleradiology and intra-hospital digital imaging networks.

* The Miniature Dental X-Ray System (XRSBI) is a smeall.lightweight, hand-held dental x-ray system for field use. Thesystem consists of a hand-held x-ray generator subsystem(suitable for use with self-developing film or digital imager)and a digital imaging and storage subsystem for displaying imageswithout the use of film.

e The Powered Vnjilator is a lightwelght portable devicewhich uses an oxygen source or filtered ambient air toresuscitate and ventilate apneic casualties that are beingmedically evacuated. Ventilation can be administered througheither an oropharyngeal mask or a cricothyroid cannula.

e The Vital Sians Monitor (VSM1 is a noninvasive electronicdevice which will determine the heart rate and blood pressure ofa casualty in chemical protective clothing while in a battlefieldenvironment.

a The Life Detector is a hand-held device which provides anoninvasive method for detecting heart beat, respiration, or someother indicator of the presence of life, through chemicalprotective clothing without compromise to the protective ensembleor individual. It also determines the adequacy of priorantidotal treatment.

e M-40 CB Protective Mask Vision Correction (Mainstreaml isa vision correction device which uses the X-17 wire opticalinsert with modified supporting hoops and is internally mountedon the M-40 CB protective mask. Prescription lenses are mountedin the frame component of this eyewear.

9 M-40 CB Protective Mask Vision Correction (MaterielCnugj ia a vision correction device which uses the B-LPSprescription lens carrier and is internally mounted on the M-40CB protective mask. Prescription lenses are mounted in the framecomponent of this eyewear.

* M-17 and M-40 CB Protective Mask laser Protective Outsertsare made of polycarbonate with applied absorptive dyes whichafford laser eye protection from ruby and neodymium wavelengths.Additionally, the polycarbonate substrate serves to provideballistic eye protection against small mass and low valocityfragments.

11

//

e The Obtometrv Field Set is made up of field operationaloptometric equipment which is composed of an examinee chair,instrument pole, examiner-examinee stools, supportingaccessories, commercially available optometric instrumentation-equipment, and field chests.

e The Electronic Wet Bulb Globe Teumerature Monitor (WBGT1will be available for use in field units to measure Dry BulbTemperature (DBT), Wet Bulb Temperature (WBT), and GlobeTemperature.

e The Hand-held. Heat-stress Calculator contains aprediction algorithm capable of computing work and rest cyclesand associated water requirements for the individual soldierunder a variety of environmental conditions.

* The computer Assisted Post-Mortem Identification SystemjCMfl consists of computer hardware and a software routine thatcompares antemortem and postmortem dental records to yield a listof most probable matches for facilitating the process ofidentifying human remains.

e The Externally Mounted Rescue Hoist EMRMI will be mountedon UH-60A (Black Hawk) Medical Evacuation (MEDEVAC) helicopters.It will allow 25 to 33 percent more space inside the aircraftcompared to the current design with internally mounted rescuehoist. The additional cabin space can be used for patient care,medical equipment, and the MEDEVAC litter kit. Use of the EMRHwill decrease mission time required for extraction of casualtiesor personnel and decrease aircraft weight.

e The Field Dental OneratIna and TreatNent Unit (OTUDF is asmall, lightweight, mobile dental unit which will be used toprovide emergency, limited preventive, and sustaining dental carein the field. It consists of a light source, suction apparatus,water reservoir, and high and low speed drills.

e The Dggn2&--ble Folding Litter is capable of beingdecontaminated and providing a surface on which patients can beCWA decontaminated. It consists of aluminum poles and spreaderbars, polypropylene mash, retractable nylon handles, andethylene-propylune-dione-uonomor (EPDR) securing straps.

e The CK Resistant Field Dressinr Cover consists of a stripof cotton gauze sandwiched betweon two laminates of polyethylene/nylon/polyethylene (PNP). The cover is used over the fieldbattle dressing to protect open wounds and prevent penetration bychemical warfare agents.

9 The OIA Prot=etive Patient Ira- is a disposable fabriccontainer to protect decontaminated or uncontaminated patientsfrom chemical agents during evacuation in a field environment.

12

* The new Field Medical Refrigerator will replace thecurrent refrigerator, used to contain blood and biologics, whichhas become logistically unsupportable.

e The Individual Chemical Resuscitation Device (RDIC)provides manually operated positive pressure respiratoryresuscitation to assist in the restoration of normal breathing ofa battlefield casualty. The RDIC filters chemical warfare agentsfrom ambient air and is usable with an oropharyngeal mask orcricothyroid canula.

* The Molecular Sieve OxvQen Generatina Sstem (MSOGS) willbe used for trauma and chemical agent patient resuscitation onMedical Evacuation (MEDEVAC) aircraft.

e The Hiah Capacity X-Ray (Materiel Change) is a flywheelsystem which stores kinetic energy and produces short high powerbursts of electrical energy to enable a high capacity x-ray tooperate from a wide variety of power sources.

MAJOR ACCOMPLISHMENTS

e A validated Technical Data Package for the High CapacityX-Ray System was completed and procurement of 190 units wasinitiated.

e The Field Medical Oxygen Generatikn and DistributionSystem program continues on a dual track acquisition strategy(full scale development and a Nondevelopmental Item (NDI)approach). An Invitation for Bid (IFB) was advertised andawarded to MEPECC International for its Model Ml-C Medical Oxygenand Air Generating System early in April 1989. Phase II of theGuild contract was also awarded in April 1989. The NDIs weredelivered and accepted during August and Operational Testing wascompleted in November 1989.

e Deficiencies found during technical and user testing ofthe Resuscitative Fluids Production and Reconstitution System(PEFLUPS) advanced development models were corrected this year.The new designs incorporated in the engineering developmentmodels significantly improve performance and reduce life cyclecost.

e Ballistic-Laser Protective Spectacles (B-LPS) wererecommended for Type Classification - Limited Procurement(Urgent) by the Army Clothing and Equipment Board on 7 July 1989.

Upon final approval by the Chief of Staff of the Army, follow-onprocurement of product improved B-LPS will commence.

13

e Two and three wavelength Laser Protective Visors wereapproved for Type Classification - Limited Procurement (Urgent)by the SPH-4B Aviator Visor Type Classification Review Panel on1 August 1989. Currently, there are 20,000 laser protectivevisors (10,000 two wavelength protection and 10,000 threewavelength protection) being procured for delivery to highpriority aviation units.

* The Steam Vacuum Pulse Sterilizer System (SVPSS) wasmodified to include a variety of design enhancements to addressRAM criteria. These changes were proven through Technical andReliability Testing in mid-June 1989.

0 Technical, reliability, and environmental testing of theEthylene Oxide Sterilizer (OS) was completed this year.

9 The Imatron prototype Field Computed Tomography Scanner(CT) was tested at the factory on 26-27 February 1989. Thedevice passed all tests specified in the contract.

9 In January and February of 1989, a small size phosphorplate Filmless Digital Imaging Network System device wasclinically tested at the Fort Meade and Fort Bragg communityhospitals. The phesphor plate system was mated with the militaryhigh capacity x-ray device to produce the first militarydiagnostic quality digital x-ray image. In March, the DODhealth Council approved a teleradiology system for Fort Meade andits surrounding clinics on the basis of specifications developedthrough the DINS project. This is the first tangible"technology transition" resulting from the DINS project. In May1989, a teleradiology trial was conducted for the 18th MEDCOM inSouth Korea. Teleradiology images were moved between Osan AFBand the 121st Evacuation hospital in Seoul and from GeorgetownUniversity hospital in Washington, DC, across the Pacific toSeoul. In July 1989, a Filmless Digital Imaging System underwenta weeklong test at the Camp Bullis DEPMEDS site. This was thefirst operation of such a network under field conditions. Nofailures were experienced. In August, an In-Process Review (IPR)was chaired by MG Major, CG at HSC, to examine implementation ofDINS at the new Mriigan Army Medical Center. Issues from the IPRare under review within the AMEDD.

o The delivery of prototype units for the Miniature DentalX-Ray System was completed this year. A CEP test was conducted14-25 August 1989.

* The Powered Ventilator Draft JSOR was revised and staffedfor final review and comment in 4Q89. Modified Non-DevelopmentalItem ventilators were procured for Echelons I/I1 and III/IVmedical care and were tested in a Concept Evaluation Program(CEP) test 4-15 December 1989.

14

e Commercially available, Non-Developmental Item Vital SignsMonitors (VSM) identified within the Market Investigation uereobtained by the government for testing. A CEP test was conducted11-22 Septeiber 1989 by the U.S. Army Medical Departzjnt Board(USAYDDBD). A Technical Test involving determination of vitalsigns using these devices on human subjects in a high noise andhigh vibration environment was conducted by the U.S. ArmyAeromedical Research Laboratory (USAARL) in October 1989.

* Flash Reflectance Oximeter (FRO) and Personal Monitcr andCommunicator (PMC) prototypes for the Life Detectnr program weredelivered this year.

o Production of 75,000 M-40 CB Protective Mask VisionCorrections (Mainstream) was completed on 18 April 1989. Thesemask vision correction frames were shipped to Army depots atMechanicsburg, PA and Tracy, CA for requisitioning by themilitary optical fabrication laboratories.

o Fabrication of Optometry Field Sets was completed on6 October 1989. Tobyhanna Army Depot, PA, received these fieldsets for initial staging of fabricated items with standard Armyitems.

o The Computer-Assisted Postmortem Identification System(CAPKI) Mission Element Noeds Statement (MENS) was certified byTRADOC and is awaiting HQDA approval. Defense EligibilityEnrollment Reporting System (DEERS) Support Office (DSO) agreedto conduct a Pilot Study to verify the feasibility ofincorporating the CAPMI antemortem dental data base into DEERS.

o The concept of an Externally Mounted Rescue Hoist (EMRH)was technically tested by the U.S. Army Aeromedical ResearchLaboratory (USAARL) during July-November 1989. Test results arepending.

o A correspondence IPR tranoitioned the Field DentalOperating and Treatzent Unit (OTUDF) to USAMMA 30 January 1989.

o The National Stock Number 6530-01-290-9964 was assigned tothe Decontaminable Folding Litter on 25 January 1989. A contractwas awarded on 14 August 1989 to the National Industries for theBlind to conduct a Low Rate Initial Production.

o The Defense Personnel Support Center began formalacquisition procedures for the Field Medical Refrigerator in4Q89.

15

* A Milestone Ia In-Process Review (IPR) was held for theResuscitation Device, Individual, iamlical (RDIC) on13 April 1989. It was determined that additional prototypesshould be procured to incorporate the C2 canister filter into thedesign and to remove the PEEP valve. Prototypes were redesignedand tested at the Uniformed Services University of HealthSciences (USUHS) against soman poisoned swine.

* A Joint Working Group finalized the O& Plan for theMolecular Sieve Oxygen Generatirig System (NSOGS) on24 January 1989.

P20314ONS

e Procurement of the High Capacity X-Ray System will startearly in 1990.

* Developmental teuting of the Field Medical OxygenGeneration and Distribution System (FIOGDS) will begin April 1990and Operational Testing of the developmental item beginningFebruary 1991.

* The Resusitative Fluids Production and ReconstitutionSystem (REFLUPS) will move into the Full Scale Development Phasein March 1990. Life Cycle Cost estimates, determined from theAbbreviated Analysis, which are driven by the process consumableswill be substantially reduced.

* The Steam Vacuum Pulse Sterilizer System (SVPSS) contractis in its final year with delivery of the Technical Data Packageexpected 2Q90. The SVPSS contract will end in March 1990following support of the IOT&E II. A Milestone III IPR will beheld in 4Q90.

* The Ethylene Oxide Sterilizer System (EOSS) prototypes anda complete Technical Data Package for this effort will bedelivered in 2Q90. A Milestone III IPR will be held in 3Q90.

o Procurement of the Special Operations Forces Sterilizer(SOF) will start in 1Q90.

o Clinical and technicL.l tests for the Field ComputedTomography Scanner will begin in April of 1990. These tests willculminate in December 1990 prior to CEP testing which isanticipated in January 1991.

e Field trials will continue in 1990 for the FilulessDigital Imaging System (FDIS). A MS I/I will be held in 3Q90 tosustain a modified NDI approach. Teleradiology systems will beacquired for Fort Meada and Korea. DINS will be acquired for thenew M.adigan Army Medical Center.

16

e The Miniature Dental X-Ray System (XRSDB) developmentaltesting will be completed lQFY90. A Milestone I/II :PR will beconducted in early February 1990.

* After receiving the test report from the CP testing, aMilestone II Powered Ventilator IPR will be held in 2Q90.

e After receiving the Vital Signs Monitor CEP test reportand Independent Evaluation Report, a Milestone II IPR will beheld in early 2Q90 to decide if a Non-Developmental Item existsthat satisfies the Tri-Services' needs.

e A CEP test will be ccnducted in mid-2Q90 on the PersonalMonitor and CommunicatQr and Flash Reflectance Oximeterprototypes of the Lifb Detector project.

* Engineering development prototypes for the M-40 CBProtective Mask Vision Correction (Materiel Change) will undergotechnical and operational tests in 4Q90.

e Advanced development prototypes for the d-40 and M-17 CBProtective Mask Laser Protective Outserts will undergo limiteduser testing in 4Q90-1Q91.

o Fielding of the Optometry Field Set will coumence 2Q90.

* The Pilot Study for determining the feasibility ofincorporating the Computer-Assisted Postmortem Identification(CAPRI) dental data base into the Defense Eligibility EnrollmentReporting System will be conducted 2Q90.

* A Milestone .L IPR will be held for the Externally MountedRescue Hoist in 2Q90, and decisions will be made regarding an NDIor a developmental effort strategy.

* The Defense Personnel Support Center will award a contractto purchase the new Field Medical RPfrigerators in 3Q90.

o A Milestone II/III IPR will be held for the IndividualChemical Resuscitation Device (RDIC) in 2Q90.

e Delivery of off-the-shelf candidates for the MolecularSieve Oxygen Generating System will occur in October 1990.Technical testing will begin in December.

e The High Capacity X-Ray (Materiel Change) prototypes beingdeveloped by the US Army Biomedical Research and DevelopmentLaboratory will be delivered for technical testing in December1990.

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BIOLOGICAL SYSTMESPROJCT A"MNA DIVISION

T3E PROGMAK

INTRODUCTION

The Biological Systems Project Management Division managesthe development and acquisition of biological products to preventcasualties or loss of soldier effectiveness due to disease.These diseases may be naturally acquired (close contact,unsanitary conditions, contaminated environment, biting insects),or acquired by deliberate exposure to aerosols. Product Managersexploit domestic and foreign medical teoinology to remedydeficiencies identified by the Combat Developer and monitorresearch projects for their application to disease protectivemeasures.

MILITARY RELEVANCE

Casualties from disease have been a major cause of hospitaladmissions and ineffectiveness on the battlefield. Figures foradmission for soldiers during a year in Vietnam wer, as follows:disease - 70.6 percent; battle casualty - 15.6 percent; nonbattleinjury - 13.8 percent. Efforts to reduce the impact of diseaseon operations will make a significant contribution to soldiereffectiveness.

OBJECTIVES

This Division's directive is to develop effective preventivemeasures against diarrheal diseases; malaria; acute respiratorydiseases; hepatitis; insect-transmitted diseases such as dengueand Japanese encephalitis; hemorrhagic fevers and other diseasesspread by aerosol (and rapid methods to identify the cause ofillness); schistosomiasis; meningococcal disease; andopportunistic wound infections. Methods to address thesedeficiencies (some of which include treatment) are vaccines,immune enhancers, adjuvants, immune globulins, antiviral drugs,insect repellents, and rapid identification kits for clinicalspecimens.

PRODUCT DESCRIPTIONS

a Salk Vacicee Productlon Facility is a manufacturingfacility dedicated exclusively to the production of vaccines anddiagnostic reagents under Federal regulatory guidelines. Thefacility is managed by a task order contract for schedulingproduction of vaccines and reagents.

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* University of Nrla- Vaccine YestIM Facility is usedfor evaluating vaccines in human safety and efficacy trials. Thetrials are done either in the 32-bed isolation ward or on anoutpatient basis. Each trial is performed under a specific taskorder, with detailed protocols.

* Oxygen-CarriyM BL2od EXpander is a resuscitative fluidfor use in field medical units. Modified hemoglobin solutionsare currently under development in the commercial sector. TheArmy plans to evaluate these products to determine suitabilityfor military use.

* Ranid Identification vste for Biological Aaents is aportable, rugged, easily operated system designed to identifybiological agents in clinical materials. In the test, drops ofserum from soldiers exhibiting symptoms of disease are placed oncredit card sized blotters in plastic holders. After thereagents are added and absorbed, positive or negative results arevisible to the unaided eye in less than 30 minutes.

9 Rikoirin is an antiviral drug that has been tested forefficacy against Hemorrhagic and Sandfly Fevers. The Army isevaluating the clinical studies that will be a part of a New DrugApplication (NDA). The intravenous formulation could be used bymilitary physicians to treat diseases such as Korean HemorrhagicFever and Lassa Fever.

* J-5 Human Monoclonal Antibody is secreted by culturedhybridomas that were created by fusing myeloma cells with cellsfrom the spleen of a donor immunized with killed Z. ojle strainJ-5. The collaborative effort between Walter Reed Army Instituteof Research (WRAIR) and Centocor has shown that the monoclonalantibody, which reacts with the highly conserved lipid A regionof the lipopolysaccharide, binds to a wide variety of endotoxinsand to gram negative bacteria of many genera.

* Klebuiella/Pseudomonas Human =*e Globulins will treatopportunistic infections in burn and wound patients. The immuneglobulins will be obvained from the plasma of volunteersimmunized with Klebsi1lla and Pseudomonas vaccines. Each vaccinecontains antigens from multiple serotypes of the organism and wasshown to induce antibodies in volunteer studies involving acollaborative effort between WRAIR and the Swiss Serum andVaccine Institute (SSVI).

s Lassa Fever Immune Plasma is an immune globulin used totreat Lassa fever infections. The collection of human immuneplasma in Africa is an ongoing contract effort. USANRIIDperforms laboratory tests and selects the plasma units withsufficient antibody titers for fractionation into immuneglobulin.

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* ReBatitia a gnJM was produced at VRAIR by growing thevirus first in cultured monkey kidney cells and then in humanlung cells until antigen voncentrations reached a stationarylevel. The virus was inactivated with formalin, safety testedaccording to regulatory guidelines, and tasted in volunteers.Several inactivated vaccines, including a Smith, Kline andBeckman vaccine, vill be tested in order to obtain the mostimmunogenic product.

a Adenovirus Vectored HM"atitis B Vaccine was developed byWyeth Laboratories by using recombinant MA technoloqy toincorporate the Hepatitis B surface antigen gone into AdenovirusType 7. This bioengineered adenovirus produces both Hepatitis Band Adenovirus 7 antigens in infected cell culture and has passedregulatory safety tests. The Army will test the vaccine involunteers and use it in recruits if it can be licensed.

9 DenSMS Two 4 Live Vaccine is a non-disease producingstrain of dengue 4 virus developed at WRAIR by growing the virusin cultured primary dog kidney cells and then in fetal rhesusmonkey lung cells. The cell culture supernatant contains theattenuated virus which was lyophilized for long-term storage andshown to pass regulatory safety tests. After satisfactory h .u1anstudies, the live vaccine will be combined with live vaccincs forthe other dengue virus serotypes.

a Rift Valley Fver Vaccin is prepared by growing thevirus in cultured monkey lung cells at the U.S. Army MedicalResearch Institute of Infectious Diseases (USAMRIID) and ti. SalkInstitute, inactivating the virus with formalin, and storing itas a lyophilized product. This investigational vaccine ha, beenused in at-risk laboratory workers, United Nations peace-keoepingforces, and State Department missicn personnel. Licensure of thevaccine will be considered when nov production runs are requiredto replace current stocks.

a Vaccinia Vectare Venzuelan Khulna I ephadlii Vaccine(VERI will be produced by inserting into a live vaccinia viruscarrier the VEX genes that direct the production of immunizingVEE antigens. This vaccine, which should elicit antibodiesagainst both smallpox and VEX, is being developed under contractby the Centers for Disease Control (CDC) to replace a live VEEvaccine that is reactogenic in 15 percent of recipients. It willbe a contingency vaccine for biological defense.

* Vacna-etrdKrn e bai Favor (galI Vaccinewill be produced by inserting the J gene that controls theproduction of inmunoqenic MIF antigens into a live vaccinia viruscarrier (smallpox vaccine). The resulting recombinant vaccineshould elicit antibodies against both smallpex and XHF. This

21

vaccine, currently in the early stages of development, is beingprepared in a collaborative effort between USAHRIID and the SalkInstitute.

• Snailno Live VaccMn is a now cell culture producedanimal pox virus (vaccinia) that will be free of bacteriapresently found in the calf lymph vaccine. This should allowintramuscular rather than percutaneous administration.

0 Argentin X mrraaic Fever Live Vaccine (DgF is a live,attenuated vaccine for military personnel being deployed toendemic or potential threat areas with this agent. The vaccinewas prepared by growing the virus in fetal rheaus monkey lungcells in a collaborative effort between USAMRIID and the SalkInstitute. Following successful efficacy studies in Argentina, alicense application will be prepared.

0 a li~ts Vaccine is extracted and purifiedfrom infected mouse tissue by a Japanese company (Biken), and hasbeen shown to reduce the incidence of disease in endemic regionsof the world. It is currently being administered as aninvestigational vaccine since it is not licensed in this country.

o Chiknnaunva Live Vacine is a live attenuated virusvaccine obtained by growing the virus in cultured human lungcells at USAMIIID. The Salk Institute produced the experimentallots under regulatory guidelines for testing in humans and,following additional human testing, it will be stored in alyophilized form as a contingency vaccine.

0 _FalciJ•-en Mlaria Sgorozoite Vaccin, is a product ofr4.:ombinant DNA technoloqy and consists of the circumsporozoiteprotein of a &li D. The vaccine is produced undera no-cost aqrsement witu Smith, Kline and French Laboratories.The vaccine is being tested in combination with different typesof adjuvants in order to increase the antibody titers involunteers.

0 Vivax Nalaria Enorozoite Vaccin is a product ofrecombinant DNA technology and consists of the circumsporozoiteprotein of I1AsgJ= vJvaM. The vaccine is following thedevelopment of the falciparum malaria vaccine by collaborationbetween WRAIR and Samith, Kline and French Laboratories: the mosteffective adjuvant for the falciparum vaccine will be givenpriority for the vivax vaccine.

0 0 PMver Vacine filoroor etol Us -idue I(aR11 is aformalin inactivated vaccine prepared at the Salk Institute fromrickettsia that are qrown in embryonated eggs. The extractionwith chloroform-methanol was devised at the USAMRIID and was

22

shown to eliminate severe skin reactions seen in animalsinoculated with earlier vaccine. The vaccine is for biologicaldefense.

* Tularemia Live Vaccine is a live, attenuated vaccine formilitary personnel being deployed to an area where there is apotential threat use of racisfllA tareinis. New lots ofvaccine have been prepared at the Salk Institute under slightlymodified production protocols, and are currently being tested forsafety in volunteers at USAMRIID. There may be sufficientefficacy data for licensure.

o Botulinal Toxoids. TYpes F & G, will be used in apolyvalent product for military personnel being deployed to anarea where there is a potential threat use of Cori,b toxin. The toxins will be purified from cultures ofthe bacteria that produce either Types F or G toxin, inactivatedwith formalin to produce the toxoid, and tested separately andthen together for their ability to produce toxin neutralizingantibodies in humans.

* Shiaella Vaccines are oral products containing livebacteria with specific antigens to protect against diarrhealdiseases. These bioengineered vaccines are produced at WRAIR andtested at the University of Maryland Vaccine Testing Facility.

& N. meninaltidl (Group B) Vaccine is a protein-basedvaccine for use in conjunction with licensed polysaccharidevaccines to protect military personnel against epidemiccerebrospinal meningitis. The vaccine is a bacterial sub-capsular protein complexed to polysaccharide antigens. Theproduct is a collaborative effort between WRAIR and ConnaughtLaboratories, and is necessary to protect soldiers against alarger number of strains of this organism.

.9 Schlstosome Topical AntiDenetrant is a niclosamide-basedlotion originally designed at WRAIR and then formulated forapplication to human skin by Miles Laboratory. The niclosamidelotion prevents the penetration of free swimming schistosomallarva.

0 insect/lr ood RMaellant. Clothi Turenant is achemical treatment of permethrin to the Battle Dress Uniform toprovide protection of the covered areas from insect /arthropodbites. One treatment lasts for "e entire life of the uniform.Reports on permethrin toxicology, risk benefit analysis, and riskassessment have been prepared. Theme are conponents of aregistration application to the Environmpeital Protection Agency(EPA) for a Military Use Only label.

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./7

* Insect/Artht300d RESllent lotion (Nateriel chMeI is animproved, controlled release, topically applied insect repellentdesigned to provide protection from a broader spectrum of diseasevectors and pests, especially biting midges. This recentlyapproved effort will initially focus on selection of the bestcandidate repellent formulation for efficacy.

2 Body Louse Toxicant is a powder formulation of malathionwhich will replace lindane as the standard pediculicide.Technical tests were completed on a commercially availablepreparation and showed the need to add an anti-caking agent topermit compatibility with mass delousing equipment. Theprocurement specification is being revised to incorporate thechange.

NAJOR T. accwm IsMm s

* A pilot lot of inactivated Hepatitis A Vaccine wasproduced at the Salk Vaccine Production Facility. A master seedof vaccinia virus coutaining a removable marker gene (in aposition where genes coding for desired antigens could beinserted) was produced under regulatory guidelines for productionof recombinant live vectored vaccines. Completion of Q FeverVaccine preclinical testing showed that the new purified andinactivated product is nonreactogenic in animals, that it passedall safety tests, and that it is ready for testing in humans. Amaster and production seed was made for a new bacteria-fieesmallpox vaccine. A pilot lot was also made of a new candidatelive attenuated Rift Valley Fever (RVF) Vaccine. Over 20 lots ofinactivated RVF vaccine that had lost vacuum were pooled,filtered, and repackaged in 3 lots. The Johns Hopkinssubcontractor tested the ability of Pseudomonas Exotoxin A toenhance Malaria Vaccine immunogenicity and found a fivefoldincrease in antibody titers. The first liposome vaccine(containing recombinant malaria sporozoite antigen) was alsostarted in clinical trials.

* During this year, the University of Maryland VaccineTesting Facility completed a study comparing simultaneousadministration of K1niall and Ps do vaccines with analternate immunization schedule where the two vaccines were givenat a 2-week interval. Both sctedules produced similar results intiters in groups of 20 volunteers. Another study evaluatedimmunogenicity and safety of a V yTv21a TyphoidVaccine. Onlylow responses were seen to the Vi antqgen when volunteers weregiven one dose of vaccine (1x10 9 ). Additional work will evaluatetiters in volunteers given three doses. Another task conductedthis year was designed to evuluate safety of a candidateShicaa Vaccine derived by a mutation in the aromatic amino acidsynthesis pathway. Finally, the Adenovirus Vi&tne 1HiatUAU AVaccine was tested for safety and transmissibility.

24

6m\

/ Army intention to test commerical Oxygen Carrying BloodExpanders advertised in CoMerce Business Daily.

• Three companies submitted kits for the RapidIdentification System capable of detecting plague antigen in lessthan 30 minutes. Acquisition of 1000 kits for each of 4 agentsfrom the 3 companies is in progress.

a The clinical section of an NDA for Ribavirin describingthe field trials has been drafted.

o Five military medical centers are participating inclinical trials of the J-5 human Nonoclonal Antibody. Volunteerswith clinically diagnosed gram negative septic shock have beenenrolled in the treatment protocol.

o A Request for Proposal (RFP) has been issued to obtainimmune plasma to prepare Xlebsiella/Pludeudnas immune Globulinsfrom volunteers immunized with both vaccines simultaneously.

* A Phase 2 study was initiated at Fort Campbell, KY, withSmith, Kline and Beckman's Hepatitis A Vaccine.

* Adenovirus Vectored Hepatitis B Vaccine IND Applicationwas filed with the FDA in April 1989 by Wyeth Laboratories undera Cooperative Research and Development Agreement with the U.S.Army Medical Research and Development Command (USAMRDC). On12 October 1989, the initial human safety study was initiatedwhereby three volunteers received the vaccine and three a placeboat the University of Maryland.

• A Milestone III In-Process Review (IPR) in June 1989transitioned Rift Valley Fever Vaccine, as well as the threeEquine Encephalitis Vaccines (Eastern, Western, and Venezuelan),from development to the Office of The Surguon General. Thesevaccines are now on contingency deployment status.

• Horses vaccinated with recombinant Vaccinia Vectored VEXVaccine virus developed virus-specific antibodies and werecapable of surviving challenge with virulent virus.

* At USAMRIID, the gene coding for the two surface antigensof Korean Hemorrhagic Fever virus has been experimentallyinserted into the DNA of the smallpox vaccine virus (vaccinia)antecedent to production of the Vaccinia-Vectored WMF Vaccine.Concurrently, the Salk Institute ia preparing a certifiedvaccinia seed virus in cell culture to receive the antigen genesfor vaccine production.

o The master and production seed lots of a new cell culturederived Smallpox Live Vaccine have been made and certified.

25

e The Phase 3, double-blind field trial of the ArgentineHemorrhagic Fever Live Vaccine has been extended to allow forinclusion of a total of approximately 6000 at-risk Argentinevolunteers. Thus far, no vaccine related reactions have beennoted, and all vaccinees have seroconverted.

e An agreement was reached with the Food and DrugAdministration (FDA) to test three consecutive lots of theJapanese Encephalitis Vaccine in humans to facilitate licensure.

* Phase 1 studies indicated that a recombinant FalciparumMalaria Sporozoite protein covalently bound to Pseudomonas ToxinA generated a fourfold greater immune response than when admixedwith alum. An IND for the recombinant protein coupled toHepatitis B surface antigen has been submitted.

9 Preclinical testing of the candidate Q Fever IrradiatedVaccine was completed; the IND submission has been prepared andis in the final stages of in-house review.

* Review of clinical records of a Phase 1 clinical trial forTularemia Live Vaccine at USAMRIID, which was suspended in theface of transient, minor liver enzyme changes in two of ninevolunteers, has indicated that the apparent changes may not havebeen vaccine related. A new protocol has been submitted to theHumin Subjects Research Review Board for approval to continuesafety testing.

e Type F Botulinal Toxin has been purified and initialtoxoiding studies are in progress. Media selection andpurification techniques for Type G Botulinal Toxin are inprogress.

e Two candidate jiLg2JJL••Vaccines are currently undergoingrefinement and a third candidate vaccine, composed of a strain ofSicela flexneri genetically engineered to be avirulent, isready for tests in volunteers.

e The Investigational New Drug (IND) application for theSchistosome Topical Antipenetrant was filed with the FDA on1 June 1989. The Phase 1 protocol has been approved by TheSurgeon General's Human Subjects Research Review Board.

e Agreement was reached to field multiple methods ofpermethrin impregnation of the InsectWArthropod Repellent,Clothing Impregnant with an Individual Dynamic Adsorption Kit(for individual use), 2-gallon sprayer method (for company sizeunit use), and pad roll method (for industrial application).Continued technical testing showed negligible permethrin residue

26

in adsorption kit bags, and that perspiration and steam pressingof Battle Dress Uniforms (BDUs) had no degrading effect on thepermethrin. The registration application to the EPA has beencompleted.

e Technical tests concerning the compatihility of acommercially available Body Louse Toxicant (6alathion) withpowered delousing equipment permitted resolution of a cakingproblem. An effective anti-caking agent (silicon dioxide) wasidentified, which, when added to the deodorized Aalathion dust,will permit the introduction of an "off-the-shelf" product tomeet the Army's requirement.

PROJECTIONS

e A new lot of Eastern Equine Encephalitis Vaccine will beproduced at the Salk Vaccine Production Facility because ofexhaustion of the previous stockpile. A pilot lot of a new cellculture derived Smallpox Vaccine will be produced to replace thepresent commercial product (grown on calves and containingcontaminating bacteria) to allow parenteral rather thanpercutaneous administration. Clinical testing of the repackagedinactivated Rift Valley Fever Vaccine will be initiated, andclinical testing of the first Liposome Vaccine (Liposomal-Sporozoite Vaccine) should be completed.

e Future studies at the University of Naryland VaccineTesting Facility include safety and efficacy of a modified E.coli-Shicella fleneri vaclne, a follow-up study of thevolunteers from the Klebsiella-Pseudozonas Vacctne study todetermine longevity of immunity. and initial testing of a HbS R32recombinant malaria vaccine. Final results from the Hepatitis BVaccine study will be available, comparing intradermalimmunization with the subcutaneous route. New candidate ShicllaVaccines will be tested as they become available afterappropriate animal model testing.

* The Oxygen Carrying Blood Expander in-house program willbe returned to a tech base effort. A technology watch will bemaintained covering the development of blood substitutes by thecommercial sector.

e The 1000 test kits for each of four biological agents willbe procured and manufactured in 1990 and be available to starttesting the Rapid Identification System in 4Q90.

e Expanded clinical trials will be carried out with the J-5Human Monoclonal Antibody. Results of the trials from both thecivilian and military sector should enable licensure of theproduct by Centocor.

27

a Klebsiella/Pseud Ronam Roman Imune Globulin will beobtained from immunized volunteers.

* The IND for Lassw Fever Immune Globulin will be submittedand the Phase I trial conducted at USAMRIID.

"* WRAIR's Hepatitis A Vaccine will be safety tested.

"S The Phase 1 evaluation of safety and immunogenicity ofAdenovirus Vectored Hepatitis B Vaccine will be completed.

a A new study of Dengue Type 4 Live Vaccine will evaluateimmunogenicity in yellow fever immune individuals and expand thenumber of flavivirus naive vaccinees. Transmission by vectormosquitoes will also be evaluated in this study. An IND forDengue 4 Vaccine made in Thailand will be submitted, and thevaccine will be safety tested in the U.S.

9 A new Rift Valley Fever Live Vaccine requiring only oneinjection will transition into development, and an IND will besubmitted.

a Vaccinia Vectored Venezuelan Equine Encephalitis Vaccine(VEE) genes will be transferred into certified vaccinia virus anda pilot lot of vaccine will be produced at Salk Institute,Government Services Division.

* A master seed of Vaccinia-Vectored Korean HemorrhagicFever (KHF) Vaccine will be produced at the Salk Institute.

* A pilot lot of Smallpox Live Vaccine will be made andpurified according to USANRIID's protocol.

a The Phase 3 field trial of Argentine Hemorrhagic FeverLive Vaccine will continue in 1990, with vaccine beingadministered to an additional 1000 Argentine volunteers from theat-risk population. Clinical and serological data will beobtained for the first group of 5000 vaccinee. by 1990.

a Testing for immunizing conmsitency of three lots ofJapanese Encephalitis Vaccine will be performed in militarypersonnel in Hawaii.

* A study of C@ikumunya Vaccine will be conducted at FortBragg, NC, to gain additional immunogenicity data.

* Dengue 1 Vaccine will be transitioned to advanceddevelopment.

* Phase 1 studies of a new liposoma encapsulated FalciparumMalaria Sporosoite Vaccine will be completed.

28

* Extended safety and iumunogenicity studies of VivaxMalaria Sporosoite Vaccine will be carried out with additionalvolunteers.

o An IND application for Q Fever Irradiated Vaccine will besubmitted, and Phase 1 clinical trials will begin.

* The Phase 1 clinical trial for Tularemia Live Vaccine willresume in 1QCY90 as a result of the favorable review of theclinical records of the initial Phase 1 vaccinee.

o Types F and B Botulinal Toxoids will be prepared andtested in animals. Technical data package will be finalized forproduction and purification of these toxoids. IND* for eachtoxoid will be prepared.

o The genetically engineered fibigg2j Zimeri, Vaccine willbe tested in Phase 1 clinical trials.

o A new candidate N. meningitidis (Group B) Vaccine will gothrough Phase 1 testing at USAMRIID.

"e The Phase 1 study of the Schistosme Topical Antipenetrantwill be conducted at Johns Hopkins University.

"e Application for registration of Permethrin to be used as aClothing Imprognant for Battle Dress Uniforms will be submittedto the EPA.

. A Milestone II IPR will be convened during 1QCY90 totransition the Body Louse Toxicant as a Nondevelopmental Item tothe Defense General Supply Center for procurement.

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PHANDKTTCAL SYSTUPRO7CT MANAGDIEN]TDIVISIOK

INTRODUCTION

The Pharmaceutical Systems Project Management Divisioncentrally manages the development and the initial production ofpharmaceutical products (antidotes and drugs), related drugdelivery systems (autoinjectors and transdermal patches), anddecontamination products. These products are fielded aspreventive, protective, and therapeutic modalities for useagainst chemical and biological warfare threats, certain endemicdiseases, and the treatment of combat casualties.

MILITARY RELEVANCE

U.S. military forces must be prepared to serve anywhere inthe world against any threat. This could result not only inconventional injuries sustained during combat but exposure tochemical and biological warfare agents as well as exposure toendemic diseases not commonly found in the United States. Thedevelopment of products against these threats will help savelives, sustain the fighting force, and enhance return to duty.

OBJECTIVES

The objectives of this division are to developpharmaceuticals to be used for prophylaxis, immediate treatnent,and definitive treatment against a wide variety of naturallyoccurring aiseases, threat force use of chemical and biologicalagents, and combat-generated injuries. These pharmaceuticalsinclude those for use following expesure to organophosphoruscompounds, vesicants, &!id cyanide, and those to protect or treatsoldiers suffering from malaria, schistosomiasis, andleishmaniasis. In addition, a kit to decontaminate the skinfollowing exposure to chemical warfare agents or toxins isuz.dergoing development as is an antidote against the oralingestion of toxins. From a more conventional aspect, bloodreplacement fluids, and improved antimicrobial skin dressings areunder dovelopment.

PRODUCT DESCRIPTIONS

e The BSWu toZZ .. airs support contract, with ZER SystemsCorporation, provides a erhanism t2 facilitate the timel andefficient execution of the U.S. Army medical materieldevelopment program by preparing and assembling both generic andproduct specific Food and Drug Administration, and otherregulatory agency, related documentation. This includes thepreparation and assembly of Investigational New DrugApplications, Investigational Device Exemptions, New Drug

31

Applications, Biological License Applications, PremarketApprovals, Environmental Protection Agency Registrations, and allrelated documentation and support.

* The TgjxigJl support contracts, with the University ofIllinois at Chicago and Hazleton Laboratories, provide supportfor pharmaceutical products which are not included either in anin-house effort or under a contract. This support includes alltoxicology efforts from basic i mutagenicity :.creeningthrough long term (more than one year) chronic studies.

9 The Phase I Clinical PhaEbacoloaw support contract withJohns Hopkins University, provides the U.S. Army Drug DevelopmentProgram with those safety, tolerance, and pharmacokin"ticstudies, in humans, necessary to support the continueddevelopment of pharmaceutical products within the Command.

* The JQXJj•jtn support contract with the University ofIowa, provides formulated pharmaceuticals which are used inadvanced toxicology and clinical studies. The contractor has thecapability to provide, solid oral or parenteral dosage forms.

* The 11291 Skin Decontaminatina Kit (SDKQ is a resin-basedsystem being developed for Joint Service use. It will replacethe current M258Al Personal Decontamination Kit and the M58A1Training Aid. The 1291 is envisioned as a superior, safe andeffective skin decontaminating system for use against multiplepercutaneous chemical threat agents.

* A ,onvulsant Antidote for Nerve Aaent (CANA) is requiredto prevent or ameliorate convulsions in severe nerve agentcasualties. Anticonvulsants such as diazepam prevent theseconvulsions which can result in brain injury. An autoinjectorcontaining only an anticonvulsant will be issued to soldiers andadministered in conjunction with the Nerve Agent Antidote Kit, byBuddy-Aid to those individuals incapacitated by nerve agents.

* HRaloZmaxin is a 9-phenanthrenemethanol antimalarial thatis being jointly developed by the Walter Reed Army Institute ofResearch (WRAIR) and Smith, Kline, and French, as an alternativetreatment for use in Nefloquine-resistant fa ii a Mmalaria. The development of Halofantrine has been divided intotreatment and prophylactic indications. The prophylacticindication is in long-term preclinical toxi.cology.

* Mner r Malins Daxeran 18DI is a safe and effective,small-volume product suitable for rapid field administration thatcan be used to resuscitate and stabilize hypovolemic shockcasualties. A Collaborative Research and Development Agreement(CRDA) is on-qoing with Pharmacia for the development of thisproduct.

32

e A -nUlti bed AitoLAgijgctgr Ul. (single barrel) for theadministration of nerve agent antidotes (2 mg atropine, 600 mg2-PAM Cl) is being evaluated. The MA is a single autoinjectorwhich contains therapeutic drugs in separate chambers and injectsboth antidotes through a single needle. A clinical study at theDepartment of Clinical Investigation, Madigan Army MedicalCenter, suggested that the injection of atropine and 2-PAM Clinto the same injection site adversely affects the absorption ofatropine. Similar results were obtained in a sheep studyconducted at Battelle Laboratories. Based on this information,some of the vendors have modified their MAs which will need to betested.

e HMg nJf 2gaegaoing is required to provide an analgesicthat meets the field requirements of extended stability, greaterdurability and rapidity of use, and is tamper evident. Morphinestocks in the inventory are over 25 years old and are beginningto deteriorats.

9 PvridostiamIne Sustained Release is envisioned as asuperior pretreatment for use against nerve agent poiconing.When used in combination with atropine and 2-PAM, pyridostigmineis effective against all known nerve agents and is notablyeffective against soman.

e The Medical earosolized Nerve Aaent Antidote (MMnAA) is anatropine aerosol inhalant used by medical personnel for thesupplemental treatment of nerve agent casualties after adequateinjectable atropine has been given. The expected role of MANAAis to deliver atropine to the airway of spontaneously breathingand sufficiently lucid nerve agent casualties. The aerosol isintended for use at forward medical care facilities includingbattalion aid stations.

o R 238,602, is an S-amlnuquinoline derivative currently inthe concept exploration phase of development as an antimalarial.It is being developed as a replicement for primaquine for thetreatment of ZJugJ= yvivay malaria.

e An improved Antimicrabial Dermal Dressing (ADD) will becapable of providing sustained release of antimicrobial agents atthe site of dermal injury to prevent infection and enhance woundhealing.

• hJs0aa, sodium stibogluconate, is a drug produced andmarketed worldwide by Burroughs-Wellcome Foundation of GreatBritain. Pentostam is being studied under an IND application forthe treatment of visceral and cutaneous leishmaniasis.

33

* 2 analog is a sesquiterpene lactone produced bythe extraction and purification of the substance artemisian fromthe botanical arjjji nnuAa. This rapid acting bloodschizonticide is being developed for the treatment of cerebralmalaria.

a R 6026 is an 8-aminoquinoline being tested as an oraltreatment for visceral leishuaniasis.

o Mefg&Mine, a quinoline methanol, is an antimalarial drugindicated for use in multi-drug resistant Plasmum fAl12arummalaria.

e Toxin Antidote (Hiahlv Activated Charcoal) is acommercially available activated charcoal preparation with threetimas the surface area of Activated Charcoal USP. This productis being proposed as a broad spectrum antidote for the physicalbinding of chemicals and toxins.

e Li2osonal Pentstax is a formulation of Pentostamenripsulated in liposomes for the directed treatment of visceralleishmaniasis. The Burroughs-Wellcome Foundation and WRAIR,through a Cooperative Research and Development Agreement, areconducting preclinical studies.

MAJOR ACCOMPLISBNEHTS

o During this past calendar year, the Regulatory Affairscontractor prepared an IND for the Schistosomal TopicalAntipenetrant, a draft EPA Registration package for permethrin asa clothing impreqnant, a draft non-clinical section of an NDA f .rhypertonic saline dextran, and 18 other reports. They alsoprovided a review of the enpiroline clinical data collected todate which served as the basis for the Government's declsior tQterminate this program. The contractor also entered all of theclinical information from a ribavirin efficacy study aqair.3tLassa Fever into a data base; this would allow this data tcproperly analyzed and formatted for inclusion into the safetysection of an NDA. A new contract was competitively awarded toZER to prepare regulatory documents for not only pharmaceuticals,but biologicals and devices as well.

o The following Toxicology studies were completed:Subchxonic Toxicity Study of WR 46234 (Schistosome TopicalAntipenetrant Lotion) in two species; Subchronic Toxicity Studyof Halofantrins Hydrochloride: Photoallerqic Contact DermatitisStudy (WR 46234); Fertility and General Reproductive PerformanceStudy of Pyridostiqmine Bromide; Developmental Toxicity Study ofPyridostigmine Bromide; Perinatal and Postnatal Study of

34

Pyridostigmine Bromide; Developmental Toxicity Study ofPyridostiqmine: and Oral Toxicity Study of rR 238605. Thirteendraft reports were submitted.

* Under the Phase I Clinical Pharmacology contract, onestudy was completed evaluating "The Safety, Tolerance,Pharmacokinetics and Pharmacodynamics of Single Oral Doses ofPyridostigmine Administered by an Osmotic Delivery Module(Osmetr) Compared to Pyridostigmine Syrup in Healthy Men." Afinal report was delivered on the "Bioavailability of OralPyridostiqmine and Inhibition of Red Blood CellAcetylcholinesterase by Oral wul Intravenous Pyridostigmine."A protocol was prepared to "Assess the Irritancy, ContactSensitization and Contact Photoallergic Potential of Niclosamide-A Topical Anti-Schistosomal Aqent." An RFP was prepared andproposals were submitted for continuation of this effort.Discussions are ongoing between those still in the competitiverange and the Acquisition Activity.

e In the Formulation contract, studies were completed forthe formulation development of the 90 aq sustained releasepyridostigmine and it was manufactured under Good LaboratoryPractices for a clinical study. Five and 15 mq tablets of WR6026 were manufactured for the Phase II clinical study in Kenya.A Quinghaosu analog, arteether, was formulated in sesame oil fortoxicology studies.

e A section 510(k) notification of the Army's intent tomanufacture and field the 3291 Skin Decontaminating Kit (SDK) asa medical device for Department of Defense use was filed with theFDA and, subsequently, permission to market the device wasreceived. Low rate initial production and first article test ofthe M291, manufactured on two state-of-the-art Governmentprocured production lines, was completed 4Q89. A Milestone IIIIn-Process Reiew (IPR) was conducted 28 November 1989 with aunanimous decision to adopt the X291 SDK for production anddeployment. The technical data package for competitive follow-onproduction and fielding of the M291 was transitioned to the U.S.Army Armament, Munitions and Chemical Command.

e A Milestone I/IX IPR was conducted on 18 January 1989 withthe decision to transition the Comlulsazt Antidote for NerveAqsnts (CANA) into Full Scale Development (FSD). An lFSD contractieas awarded on 1 June. CANAs were produced for an InitialOp~rational Test and Evaluation (IOTAK) which was conducted at7ert Polk, Lk, in November. The FDA agreed that an NDA for theCANA was an acceptable regulatory approach.

* all preclinical and clinical studies required for the NDAfor Ham•vantrine, as a treatment for EAagi"malaria, were completed. Samth, Kline, and French is preparingan NDA for filing with the FDA.

35

* All non-clinical studies on Hypertonic Saline Dxtrmn,intended for inclusion in the New Drug Application (NDA) werecompleted by Letterman Army Institute of Research. The draft NDAwas prepared, in conjunction with Pharmacia, and review wasinitiated in December for an early 1990 submission to the FDA.

* The Joint Service Operational Requirement for theMultichambered Autoinjector (JR) was approved by HQDA.

* An Acquisition Decision Memorandum for the 10 mg MorphineAutoinjector was approved by the Commanding General, USAMRDC, andthe product was tran3itioned to the U.S. Army Medical MaterielAgency on 12 May 1989. Essential characteristics wereestablished and published by the Defense Medical StandardizationBoard on 9 August 1989. Two of three manufacturers involved inCRDAs have submitted paper NDAs to the FDA.

e Formulations of Sustained Release Pyridostigmine, obtainedunder contract or No-Dollar Agreement, underwent clinicalstudies. No formulation tested provided 20-40% cholinesteraseinhibition for 12 hours. Documentation for the InvestigationalNew Drug (IND) file at the FDA was updated, and the in-lifeportion of toxicological studies were completed to establish thesafety of pyridostignine with reference to its teratological andreproductive effects. Studies were begun and are currentlyonqoinq on the possible interaction of Pyridostigqine on humanthermoregulatory physiology under various conditions.

e A Clinical study was conducted on the Medical AerosolizedNerve Agent Antidote (HMA) which demonstrated that medicalpersonnel can effectively administer this product to persons whohave never received an oral inhalant previously. Preparation ofthe NDA was begun. Approval for MANAA airlift transportation wasob;ained.

"e Additional preclinical toxicology studies of WR 238,605were completed.

" Three CRDAs were established to evaluate AntimicrobialDerm&l Dressing products that could satisfy the militaryrequirements for a sustained release product. The RequiredOperational Capability (1OC) was approved by HQDA. Preclinicaltesting of antimicrobial agents in underway at the U.S. ArmyInstitute of Dental Research. A customer test of the adhesiveproperties of candidate dressings was completed at Fort Bragg bythe Airborne and Special Operations Test Board.

e A protocol was approved to allow PentAota to be used forthe treatment of U.S. Service Personnel. Studius are continuingin Panama and Guatemala to evaluate Pentostam against cutaneousleishmaniasis.

3'

e A protocol was drafted to evaluate the efficacy of WR 6026in Kenya against visceral leishmaniasis.

* The NDA for the antimalarial drug, NsfloquineHydrochloride, was approved by the FDA on 2 Kay 1989. Theindication contained in the NDA was for the prophylaxis andtreatment of chloroquine resistant Plasmodium fa iarum malaria.

• Efforts to identify alternative sources for the ToxinAntidote (Highly Activated Charcoal) were initiated. Theoriginal manufacturer no longer produces this product.

• Preclinical studies with Liposonal Pentostam identifi,6dtoxicity problems associated with the liposomes.

* A Capstone JSOR for antimalarial drugs was approved on17 April 1989.

a A Capstone JSOR was approved at HQDA for a Family ofVesicant Antidotes.

* A Capstone JSOR for Individual Protection againstSchistosoumasis was approved at HQDA.

PROJECTIONS

* Under the Regulatory Affairs contract, five to six IND'swill be prepared for vaccines and for pharmaceutical products(KHFvaccine, Live-attenuated Rift Valley Fever vaccine, topical skinprotectant, WR 238605, microencapsulated antibiotics, amongothers). One IND will be prepared for monoclonal antibody orimmune globulin. Task orders will be initiated for an NDA(pyridostiquine) for and for a BLA (Tularemia vaccine). Two510(k) 's will be prepared (for the RDIC and the litter).

a Under the Toxicology contracts, the following studies willbe conducted: a one year Ribavirin-induced testiculardegeneration and recovery study; a two week study on HI-6 andMMB-4, new oximes aqai.nst nerve agent poisoning; and a one yearchronic study of halofantrine: An RPP will be drafted andpublished in the Coumerce Businems Daily recoupeting thettoxicology contracts which expire in 1991.

a A clinical study will be conducted wider the Phase IClinical Pharanooloqy contract to evaluate the irritancy, contactsensitization and contact photoallergic potential of niclosamide.A study will be conducted to evaluate the 90 aq sustained releasepyridostiquine formulation prepared by the University of Iowa.Another study will be conducted to determine the pharmacokineticsof several multichambered autoinjectors (supplied by commercialfirms under CRDA.*) containing atropine and 2-PAM. A new

37

contract will be awarded to replace the current expiringcontract.

* The Formulation contractor will formulate WR 238605 infive and 15 mg tablets for phase I clinical studies. Additionalformulation efforts will be undertaken on the Quinghaosu analog(arteether, in sesame oil) to include stability studies.Preformulation studies (chemical characterization) on ribavirinand AVS 206 will be initiated. An RFP will be released torecompete the formulation contract.

9 A contract option (fixed price) will be awarded for theproduction and deployment of the first 1.5 million 1291 SkinDecontaminating Kits (SDK). Deployment will be completed 3Q90.

e A competitive contract for follow-on procurement of theSDK will be awarded by USAMCCOM.

e A clinical study to address FDW issues for the ConvulsantAntidote for Nerve Agent will be conducted 2-3Q90. A MilestoneIII IPR will be held during 3Q90.

* A Milestone I/III IPR for the antimalarial Halofantrinefor the treatment indication will be held 1Q90. An NDA will befiled in the United States by Smith, Kline, and French (SXF).

e A New Drug Application for Hypertonic Saline Dextran (HSD)will be submitted 1Q90. A Milestone 1/II IPR is scheduled for1Q90.

o A Milestone Ib IPR will be held for the NultichamberedAutoinjector 3Q90.

• Approval of NDAs for a Morphine Autoinjector iz.anticipated during FY90. Resolution of packaging and shelf-lifeissues will occur through coordination with the U.S. Army MedicalMateriel Agency and the FDA.

9 A Milestone II/III IPR will be held for Pyridostiguine3Q90.

o An NDA for the Nedical Aerosolized Nerve Agent Antidote isscheduled to be filed with the Food and Drug Administration inJanuary 1990. A Milcstone II/IIl IPR will be held 1Q90.

e A Milestone I IPR for the antimalarial drug MR 238,605will be held.

38

9 Results of preclinical testing of Antlicrobial DermalDressing candidates will provide data for selection of an optimalantimicrobial agent which includes antifungal activity.Evaluation of adhesive properties will produce informationimportant in determining overall effectiveneis of the dressingsystem,

o A Special IPR for the antileishmanial drug Pentostam willbe held 1Q90.

* Quinghaeou will be returned to the tech base foradditional studies to identify the most suitable analog forprogression into advanced development.

e A Phase II clinical study will be initiated in Kenya forthe antileishmanial drug MR 6026.

"* The Toxin Antidote (Highly Activated Charcoal) programwill be terminated due to a lack of manufacturing sources.

"* Liposomal Pentostam will be returned to the tech base toreformulate the liposome delivery system.

e A Milestone II/III IPR for the antimalarial drugEnpiroline will be held 1Q90.

e A Topical Skin Protectant will transition to advanceddevelopment.

39

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40

PUBLICATIONS

Calisher, C.H., Karabatsos, N., Dalrymple, J.X., Shope, R.E.,Porterfield, J.S., Westaway, E.G., and Bra= d, N-1- 1989.Antigenic relationships between flaviviruses as determined bycross-neutralization tests with polyclonal antisera. J. G.Virol. 70:37-43.

Kiiks, S.C., Nisalak, A., Bra=, N.E., Wahl, L., and Burke, D.S.1989. Antibody-dependent enhancement of dengue virus growthin human monocytes as a risk factor for dengue hemorrhagicfever. . a. . ==. Xd. &ag. 40:444-451.

Friedi, K.E., Hannan, Jr., C.J., Schadler, P.W., and J N.H.1989. Atropine absorption after intramuscularadministration with 2-pralidoxise chloride by two automaticinjector devices. J. PhM. So=. 78:728-731.

OQBrien, a., Thompson, W.L., and Pace, J.G. 1989. In VitroMetabolism of T-2 Mycotoxin. In Vitro T 2:139-150.

Perry, B.D., Schmidtmann, E.T., Mansen, J.W., and Ri&e, R.N.,Fletcher, M., Turner, E.C., Robl, M.G., and Hahn, N.E. 1989.Epidemiology of Potomac Horse Fever: An investigation intothe possible role of non-equine mammals. Vtrary Record125:83-86.

Oaks, E.V., Kelly, D.J., Rice, U.H., and Stover, K. 1989.Antigenic and Genic Relatedness of Eight Rickettiatsutsuaamushi antigens. I and Imunity 57:3116-3122.

Carroll, J.F., Schmidtmann, E.T., and ZJM, 3.N. 1989. White-Footed Mice-Tick Burdens and Role in Epizootiology of PotomacHorse Fever in Maryland. JournA1 21 Wildlife Dinsas25:397-400.

Hahn, N.E., Perry, B.D., Rim h.n., Hansen, J.M., and Turner,E.C. 1989. A study of the role of blackflies in theepidemiology of Potomac Horse Fever. VaznnXy Reacord 125:273-274.

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42

PRESENTATIONS

Brandt, Walter E. Briefing on Program Prioritization to WorldHealth Organization consultants, Fort Detrick, Frederick, MD,September 1989

Caldwell, Donald W. Briefing on the Resuscitative FluidsProduction System, Joint Services Medical LogisticsCoordinating Group Meeting, Fort Detrick, Frederick, MD,January 1989

Channing, Eugene S., COL "Ballistic-Laser Protective Spectacles(B-LPS) with Optional Prescription Lens Carrier (PLC),"Occupational Vision Consultants Course, U.S.Army Environmental Hygiene Agency, Brookshire Hotel,Baltimore, MD, September 1989

Clawson, Ronald E. Briefing on Development of an IndustrialFamiliarization Program to the Pharmaceutical ManufacturingAssociation, Washington, DC, January 1989

Goeringer, Fred, LTC Presentation and Demonstration on FilmlessMedical Imaging, Health Services Command CommandersConference, Seattle, WA, January 1989

Goeringer, Fred, LTC Medical Imaging in Military Medicine,Worldwide Image Management and Communications Conference,Washington, DC, June 1989

Goeringer, Fred, LTC Military Plans for Digital MedicineImaging, British National Health Authority, London, England,July 1989

Goeringer, Fred, LTC Briefing, Research and Developrent Statusand Plans for Computed Tomography and Technoloqy TransitionPlans for Digital Imaging Network Systems (DINS) to SeniorLeadership, AMEDD Technical Committee Meeting, Office of TheSurgeon General, Washington, DC, November 1989

Harrington, Donald G., LTC Briefing on M291 Skin DecontaminatingKit Development Program to Korean Army Delegation, FortDetrick, Frederick, MD, November 1989

Lehmann, Craig R., LTC Presentation on atropine for thetreatment of organophosphorum poisoning to the Division ofClinical Pharmacology, Uniformed Services University of theHealth Sciences, Bethesda, MD, March 1989

43

Lehmann, Craig R., LTC Information presentation on the statusof the CANA project to the U.S. Air Force Surgeon General'sOffice, Boiling AFB, DC, September 1989

Schiefer, Bernard A., COL Body Louse Toxicant, TriserviceEntomology Workshop, Jacksonville, FL, February 1989

Schiefer, Bernard A., COL Operational Entomology, 1989 AerospaceMedical Association Annual Scientific Meeting, Washington,DC, May 1989

Schiefer, Bernard A., LTC Briefing, Research and DevelopmentStatus and Plans for Field Medical Oxygen Generating andDistribution System, AMEDD Technical Committee, Office of TheSurgeon General, Waahington, DC, November 1989.

Schieferstein, George J. Poster, inabntia, "CarcinogenicEvaluation of 3,3' Dimethylbenzidine Dihydrochloride inBALB/C Mice," The Society of Toxicology Spring Meeting,Altanta, GA, February - March 1989.

44

SIMIUiRS AND MAJOR TRAINING ETLJ"ZS

Albright, Deanna W. Basic Supervisory Course, Fort Detrick,MD, January 1989

Albright, Deanna W. Manpower and Force Manarement, ALMC,Fort Lee, VA May 1989

Albright, Deanna W. Personnel Administration, FCC, Frederick,MD, January-May 1989

Albright, Deanna W. Files Improvement, Washington, DC, June 1989

Albright, Deanna W. Records Disposition, Washington, DCJune 1989

Albright, Deanna W. Principles of Management, FCC, Frederick,MD, August-December 1989

Baker, Rosalinda How to Get Things Done, Hagerstown, MDJanuary 1989

Boswell, Lydia L. The Secretarial Seminar, Frederick, MD,November 1989

Brandt, Walter E. National Vaccine Advisory Comaittee, InteragencyWorking Group, monthly, 1989.

Brandt, Walter E. Chairman, World Health Ozganization (WHO)Steering Committee on Dengue, Vienna, Austria, June 1989.

Brandt, Walter E. WHO Scientific Advisory Group of Experts,Geneva, Switzerland, July 1989.

Brandt, Walter E. American Society of Tropical Medicine andHygiene, Washington, DC, Scientific Program Committee, August1989.

Caldwell, Donald W. Basic Supervisory Course, Fort Detrick, MD,January 1989

Caidweli, Donald W. Memory Development and Effective Listening,Fort Detrick, MD, March 1989

Caldwell, Donald W. Personnel Management for Executives Program,Tamiment, PA, April 1989

Caldwell, Donald N. FDA Medical Device Update Seminar,Washinqton, DC, June 1989

45

Caldwell, Donald W. Army Streamlined Acquisition Program,Reston, VA, October 1989

Caldwell, Donald W. US/Israeli Defence Force ShoreshConference, Shoresh, Israel, November 1989

Chaffee, John L., LTC dBase III Plw, Fort Detrick, Frederick,MD, February 1989

Chaffee, John L., LTC Advanced dBase III Plus, Fort Detrick,Frederick, MD, June 1989

Channing, Eugene S., COL General end Ocular Pharmacology Course,State University of New York College of Optometry, New YorkCity, NY, April-May 1989

Channing, Eugene S., COL Occupational Vision Consultants Course,U.S. Army Environmental Hygiene Agency, Brookshire Hotel,Baltimore, MD, September 1989

Clawson, Ronald E. Annual Scientific Review, U.S. Army MedicalResearch Institute of Chemical Defense, January 1989

Clawson, Ronald E. Fourth International Symposium on RecentAdvances in Drug Delivery Systems, Salt Lake City, UT,February 1989

Clawson, Ronald E. Monitoring of Clinical Drug Studies, Centerfor Professional Advancement, East Brunswick, NJ, May-June 1989

Clawson, Ronald E. 1989 Medical Defense Bioscience Review,Columbia, MD, August 1989

Clavson, Ronald E. Boomerang (ZER Law for Supervisors), FortDetrick, Frederick, MD, October 1989

Cole, Francis Z., Jr. Symposium on Agents of Biological Origin,Baltimore, XD, March 1989

Cole, Francis Z., Jr. American Society for Microbiology Conferenceon Biotechnology, Orlando, FL, June 1989.

Cole, Janice M. Lotus 1-2-3 MS/DOS-Intro, Fort Detrick, MD,March 1989

Cole, Janice N. Contract Finance for Progam Managers Course,DSMC, Fort Belvoir, VA, Auqust-Sw)tsuber 1989

Cutsail, Cindy Z. Proofreading and Grammar, Fort Detrick,Fredeick, ND, Nay 1969

46

Delaplaine, Edward S. dBase III Plus, Fort Detrick, Frederick,MD, April 1989

Delaplaine, Edward S. Advanced dBase III Plus, Fort Detrick,Frederick, MD, June 1989

Delaplaine, Edward S. Program Management, The American GraduateUniversity, Alexandria, VA, October 1989

Doughty, David S. Fundamentals of Systems Acquisition ManagementCourse, DSMC, St. Louis, MO, May 1989

Doughty, David S. Contract Management for Program ManagersCourse, DSMC, Boston, MA, August 1.89

Doughty, David S. Program Management, The American GraduateUniversity, Alexandria, VA, October 1989

Doughty, David S. Contractor Performance Measurement Course,DSMC, Fort Belvoir, VA, December 1989

Eggert, Anna M. Budget Execution, Fort Detrick, Frederick,MD, July 1989

Eggert, Anna M. Systems Acquisition Funds Management, DSMC,Fort Belvoir, Vr., December 1989

Ferguson, Warren F. Army Streamlined Acquisition Program,Reston, VA, October 1939

Ferguson, Warren F. Prevention of Sexual Harrassment forSupervisors, Fort Detrick, Frederick, MD, October 1989

Fung, Kathleen P. dBase III Plus, Fort Detrick, MD, April 1989

Fung, Kathleen P. English Composition, FCC, Frederick, MDJanuary-May 1989

Goeringer, Fred, LTC Medical Imaging 11I, Society of Photo-Optical Instrumentation Engineers, Los Angeles, CA, January1989

Guessford, Kay X. Image and Communication Skills for Women,Hagerstovn, MD, January 1989

Guessford, Kay S. dBase III Plus, Fort Detrick, MD, March 1989

Guessford, Kay 5. Iffective Management Skills for AdministrativeAssistants and Secretaries, Fort Detrick, MD, August 1989

47

Harrington, Donald G., LTC Technical Data Package FundamentalsCourse, Chemical Research, Development and EngineeringCenter, Aberdeen Proving Ground, XD, March 1989

Harrington, Donald G., LTC American Association for LaboratoryAnimal Sciences Annual Meting, Little Rock, AR, November-December 1989

Johnson-Winegar, Anna. Botulism Antibody Study, Oakland, CA,January 1989.

Johnson-Winegar, Anna. Stroma Free Hemoglobin Review, SarFrancisco, CA, January 1989.

Johnson-Winogar, Anna. Advanced Biologics Regulations and LawWorkshop, Washington, DC, March 1989.

Johnson-Winegar, Anna. International Workshop on Anthrax,Winchester, England, April 1989.

Johnson-Winegar, Anna. American Society for Microbiology, NewOrleans, LA, May 1989.

Johnson-Winegar, Anna. International Symposium on Red CellSubstitutes, San Francisco, CA, May 1989.

Johnson-Winoqar, Anna. Second Annual Joint Israeli DefenceForces-U.S. Army Conference on Vaccines of MilitaryImportance, Tel Aviv, Israel, May 1989.

Johnson-Wineqar, Anna. Office of Personnel Management ExecutiveSeminar, Lancaster, PA, August 1989.

Johnson-Winegar, Anna. Army Streamlined Acquisition Program,Reston, VA, October 1989.

Johnson-Wineqar, Anna. Prevention of Sexual Harassment forSupervisors, Fort Detrick, Frederick, XD, October 1989.

Lehmann, Craig R., LTC Regulatory Affairs Management in thePharmaceutical Industry, Canter for Professional Advance-ment, East Brunswick, NJ, September 1989

Moore, Charles A., LTC Postgraduate Course in Clinical Pharma-coloqy, Drug Development, and Regulation, Tufts UuizversityCenter for the Study of Drug Development, Boston, MA,February-March 1989

Moore, Charles A., LTC Introduction to the Regulatory Process,University of Wisconsin, Madison, VW, June 1989

46

Moore, Charles A., LTC Research and Development OrientationCourse, ALMC, Fort Lee, VA, August 1989

Moore, Charles A., LTC Documentation and Good LaboratoryPractices, CPA, Fort Detrick, MD, October 1989

Morgan, Sharon L. Speedwriting Shorthand, FCC, trederick, MDJanuary-April 1989

O'Brien, John C., LTC Joint Meeting of the American Society forCall Biology, and the American Society for Biochemistry andMolecular Biology, San Francisco, CA, February 1989

O'Bcien, John C., LTC Basic Drug Law, Washington, DC, February1989

O'Brian, John C., LTC Practical Considerations in PreparingInvestigational New Drug and New Drug Applications,March 1989

O'Brien, John C., LTC Preparing Clinical Protocols and ManagingClinical Investigations, East Brunswick, NJ, March 1989

O'Brien, John C., LTC dBase III Plus, Fort Detrick, Frederick,MD, April 1989

O'Brian, John C., LTC Conference on Emerging Viruses: Evolutionof Viruses and Viral Disease, Washington, DC, May 1989.

O'Brien, John C., LTC Fundamentals of Systems AcquisitionManagement Course, DSMC, Fort Belvoir, VA, September 1989.

O'Brian, John C., ITC Xanprint Familiarization Seminar, FortDelvoir, VA, August 1989.

O'Brien, John C., LTC 38th Annual Meting of the AmericanSociety of Tropical Medicine, Honolulu, NI, December 1989.

Yedersen, Carl I., Jr., COL The Macintosh Seminar, Bunt Valley,MD, December 1969

Pick, Robert 0., COL Postgraduate Course in Clinical Pharma-cology, Drug Development, and Mequlation, Tufts UniversityCenter for the Study of Drug Development, moston, NA,February-March 1989

Pick, Robert 0., COL Introduction t. the Regulatory Pr oess,University of Wisoonsin, Iadisow, W1, June 1989

49

Priebe, Rebecca A. Installation and A&Ministration of 3ConNetwork, Rockville, ND, January 1989

Priebe, Rebecca A. 3Com Plus Coinnication, Rockville, ND,January 1989

Priebe, Rebecca A. How to Recover Damaged Data Files and Disks,Baltimore, ND, September 1989

Montgomery, Jaxw, D., MAJ dBase III Plus, Fort Detrick,Frederick, April 1989

Rice, Robert N, LTC dBase III Plus, Fort Detrick, Frederick,ND, February 1989.

Rice, Robert N., LTC Fundamentals of Syb.tems AcquisitionManagement Course, D=C, Fort Belvoir, VA, March 1989.

Rice, Robert N., LTC Contract Management for Program ManagersCourse, DSXC, Fort Delvoir, 7A, Xarch 1989.

Rice, Robert N., LTC Good Clinical Practices, Chicago, IL,September 1989.

Rice, Robert N., LTC Practical Considerations in PreparingInvestigational New Drug and New Drug Applications, EastBrunswick, W, October 1989.

Routzahn, Ricky dBase III Plus, Fort Detrick, Frederick, NDMarch 1989

Routzahn, Ricky badqet Istizating Techniques, Fort Detrick,Frederick, ND, April 1969

Routzahn, Ricky AdvanCed Lotus 1-2-3, Fort Detrick, Frederick,. D. June 1969

Poutzahn, Ricky•j qet axecution, Fort Detrick, Frederick, NDJuly 1969

Roy, Michael J. dBase II Plus, Fort Detrick, Frederick, ND,February 1969

Roy, Michael J. eulatotry COWliance, Pftrieto, NJ, April 1989

Roy, Michael J. Project -anqemet in Pharmaceutical Industry,Zast Brunswick, M, May 1969

Roy, Michael J. oAelerated Pleadin, Fort Detzaick, Frederick,MDO, June 1909

50

Salter, Cecil S., LTC Research and Development OrientationCourse, ALMC, Fort Lee, VA, August 1989

Salter, Cecil S., LTC Evaluating Contractors Proposals,Fairfax, VA, November 1989

Schiefer, Bernard, A., COL Trivervice Medical Entomology PostGraduate Professional Short Course, Jacksonville, FL,February 1989

Schieferstein, George J. Postgraduate Course in Clinical Pharma-cology, Drug Development, and Regulation, Tufts UniversityCenter for the Study of Drug Development, Boston, MA,February-March 1989

Schieferstein, George J. Introduction to the Regulatory Process,University of Wisconsin, Madison, WI, June 19a9

Schieferstein, George J. Gordon Conference on Mechanisms ofToxicity, Meriden, NH, July 1989

Schieferstein, George J. Research and Development OrientationCourse, ALMC, Fort Lee, VA, August 1989

Schieferstein, George J. 1989 Medical Defense BioscienceReview, Columbia, MD, August 1989

Schieferstein, George J. Evaluating Contractors Proposals,Fairfax, VA, November 1989

Sheffer, Linda J. Budget Estimating Techniques, Fort Detrick,MD, April 1989

Sheffer, Linda J. Principles of Economics, FCC, Frederick, MD,January-May 1989

Sheffer, Linda J. Budget Execution, Fort Detrick, Frederick, MD,July 1969

Sheffer, Linda J. Enqlish Composition, FCC, Frederick, MD,Auqust-0ecomber 1969

Splitstoeer, Jeffrey C., CPT Nemory Development & EffectiveListening, Fort Detrick, Frederick, MD, March 1969

Splitatoser, Jeffrey C., CPT Advanced dBase III Plus, FortDetrick, FrederiCk, IND, June 1969

Splitstoaer, Jeffrey C., CPT Program Management, The AmericanGraduate University, Alexandria, VA, October 1969.

51

Splitatoser, Jeffrey C., CPT Contract Management for ProgramManagers Course, DSMC, Fort Belvoir, VA, December 1989

Stickel, Linda K. The Secretarial Seminar, Frederick, MD,November 1989

Twist, Anne P. Effective Briefing Techniques, Fort Detrick,Frederick, ND, August 1989

Twist, Anne P. International Symposium on Military OperationsResearch, Shrivenham, England, September 1989

Twist, Anne P. Army Streamlined Acquisition Program, Reston,VA, November 1989

Vrouls, Joan P., MAJ Part 11, Program Management Course, DSMC,Fort Belv3ir, VA, May 1989

Williams, Linda N., CPT Lotus 1-2-3 3S/DOS-Intro, Fort Detrick,MD, February 1989

Zajac, Andrew J., CPT Management Project, University ofMaryland, College Park, MD, January-May 1989

Zaj ac, Andrew J., CPT Production Management and Automation,University of Maryland, College Park, MD, January-May 1989

52

DISTINGUISHED VISITORS

Representatives from Duphar, The Netherlands. Discussions on thestatus of their efforts on the morphine autoinjector, multi-chambered autoinjector, and sustained release pyridostigmine,17 January 1989.

Major Dani Cohen, Israeli Defense Forces, Israel. Discussion ofShigella studies in progress, 10 February 1989.

Representatives from Duphar, The Netherlands. Discussions on thestatus of their efforts on the morphine autoinjector, multi-chambered autoinjector, and sustained release pyridostignine,29-30 March 1989.

Mr. Ab Polak, Duphar, The Netherlands. Discussions on the conductof a clinical study for the nerve agent anticonvulsant, 27 April1989.

Dr. Benjamin Bramer and Dr. Jansen van Galen, Duphar, TheNetherlands. Discussion on CANA development, 8 June 1989.

Lieutenant Colonel W.D. Crossman, Chief Pharmacist, Department ofDefense, Australia. To discuss the development status ofproducts in support of defense against chemical agents. Hispurpose was to obtain background information as the new chairmanof the Nuclear, Biological and Chemical Quadripartrite WorkingGroup, 12 June 1989.

Lieutenant Colonel Manfred Green, Israeli Defence Forces, Israeli.Joint Israeli Defence Forces-U.S. Army Testing, and discussion ofHepatitis protozol and progress on grant, 28 June 1989.

Dr. Benjamin Brauer, Duphar, The Netherlands. Delivery ofInvestigational New Drug Application (IND) for the nerve agentanticonvulsant to the Government, 3 July 1989.

Major Yona Zaide, Israeli Defence Forces, Israel. Discussion ofarbovirus serological studies to be undertaken during her 6-weekstay at USAXRIID, 26 Beptwaber 1989.

Mr. Hans Werner, Dr. Benjamin Brauer, Dr. Jansen van Galen, andMr. Ab Polak, Duphar, The Netherlands. Discussions on the nerveagent anticonvulsant, the morphine autoinjector, and themultichambered autoinjector, 12 October 1989.

Dr. Julio Naistoqui, Instituto Nacional de 2studios VirosisHemorrtaqicas, Perqamino, Argentina. Field Testing of ArgentineHemorrhagic Fever Vaccine, 12 October 1989.

53

Major Geoffrey Ritson, Kedinec, Ltd., United xingdom. Discussionon progress of morphine autoinjector, 16 October 1989.

Dr. Jansen van Galen, Duphar, The Netherlands. Discussions on thenerve agent anticonvulsant projects interactions with the Foodand Drug Administration, and the multichambered autoinjector,30-31 October 1989.

Dr. Yun-Su Chung and Dr. Ki Woon Hwang, Agency for DefenseDevelopment, Republic of Korea. Discussions of applications ofreactive and sorptive polymeric resins to skin decontauination,6 November 1989.D ,*fjaii.l raýer, .-.ha-, Thu A t-erlands. Delivery of IND

amendment for the nerve agent anticonvulsant, 11 December 1989.

54

DISTRI •WU LIST

Commander CommadoerU.S. Army Medical Research Letterman Army Institute

and Development Command of ResearchATTN: SGRD-ZB Bldg 1110Fort Detrick Presidio of Sap, Francisco,Frederick, MD 21701-5012 CA 94129-6800

Commander CommanderU.S. Army Medical Research U.S. Army Medical Research

and Development Command Institute of Chemical DefenseATTN: SGRD-RNI-S Bldg 93100, Idgewood AreaFort Detrick Aberdeen Proving Ground, MDFrederick, MD 21701-5012 21010-5425

Commander CommanderU.S. Army Medical Research U.S. Army Institute oZ Dental

and Development Command ResearchATTN: SGRD-PLA Bldg 40Fort Detrick Washington, DC 20307-5300Frederick, MD 21701-5012

Commander CommanderU.S. Army Medical Research U.S. Army Aeromedical Research

and Development Command LaboratoryATTN: SGRD-PLB Bldg 8708Fort Detrick Fort Rucker, AL 36362-5292Frederick, MD 21701-5012

Commander CommanderU.S. Army Medical Research U.S. Army Institute of Surgical

and Development Command ResearchATTN: SGRD-PLC Bldg 2653Fort Detrick Fort Sam Houston, TX 78234-6200Frederick, MD 21701-5012

Commander CommanderU.S. Army Medical Research U.S. Army Medical Research

and Development Command Acquisition ActivityATTN: SGRD-PLE Bldg 820Fort Detrick Fort DetrickFrederick, MD 21701-5012 Frederick, MD 21701-5014

Commander CommanderU.S. Army Medical Research U.S. Army Biomedical Research

Institute of Infectious and Development LaboratoryDiseases Bldg 568

Bldg 1425 Fort DetrickFort Detrick Frederick, MD 21701-5010Frederick, MD 21701-5011

55

Commander CommanderU.S. Amy Research Institute U.S. Army Training and Doctrine

of Environmental Medicine CommandBldg 42 ATTN: ATCDNatick, MA 01760-5007 Fort Monroe, VA 23651

Director CommanderWalter Reed Army Institute U.S. Army Forces Command

of Research ATTN: APLG-FKEDldg 40 Fort McPherson, GA 30330-6000Washington, DC 20307-5100

HQDA (DASG-HCL-P) Commanding General5109 Leesburg Pike Marine Corps Research,Falls Church, VA 22041-3258 Development, and Acquisition

CommandATTN: Code SSC/GPWashington, DC 20380-0001

HQDA (DASG-HCD-D) Chief of Staff5109 Leesburg Pike U.S. Central CommandFalls Church, VA 22041-3256 VacDill AFB, FL 33608

Commandant Chief of StaffAcademy of Health Sciences, 8th United States Army

U.S. Army U.S. Forces KoreaATTN: HSHA-CDS APO San Francisco 96301-0009Fort Sam Houston, TX

78234-6100

Commandant CommanderAcademy of Health Sciences, U.S. Army Laboratory Command

U.S. Army AflN: AMDZL-CDATTN: HSHA-TTC Adelphi, ND 20783-1145Fort Sam Houston, TX

78234-6100

Commandant CoamanderAcademy of Health Sciences, 10th Mountain Division

U.S. Army ATTN: Division SurgeonATTN: ESHA-UBD Fort Drum, New York 13602-5000Fort Sam Houston, TX

78234-6100

Commander CommanderU.S. Army Medical Materiel let Special Operations Command

Aqency ATTNI: Am-CATTN: 5MMA-VA Fort BDqq, NC 28307Fort DetrickFrederick, MD 21701-5001

54

Commander CommanderU.S. Army Human Engineering U.S. Army John F. Kennedy

Laboratory Special Waz fare CenterAberdeen Proving Ground, ND ATTN: ATSU`-CG

21005 Fort Bragg, NC 28307

Commander CommanderU.S. Army Troop Suppozt 9th Infantry Division

Command ATTN: AFVO-CGATTN: AMXSO-tL Fort Levix, VA 98433-5000St. Louis, NO 63120-1787

Commander -ComanderU.S. Army Materiel Command 44th Medical Brigade)LT1'N: AMCDE Fort Bragg, NC 28307-50005001 Eisenhower AvenueAlexandria, VA 22333

Commander CommanderU.S. Army Natick Research and 18th Medical Command

Development Command ATTN: EANC-CDATTN: STRNC-Z APO San Francisco 96101-008oNatick, MA 01760

Commander CommanderU.S. Army Research office 7th Medical CommandP.O. Box 12211 APO Nev York 09102Research Triangle Park, NC

27709-2211

Commander Commanding officerU.S. Army Health Services Naval Medical Research andCommand Development Command

ATTN: HSHA National Naval Medical CenterFort San Houston, TX 78234 Bethesda, ND 20014

Staff Director HO USAF/SGPTDefense Medical Standardization Bolling Air Force BaseBoard Washington, DC 20332-61888

Fort Detrick, Frederick, ND.21701-5013

Commander no USA?/SGHR6th Infantry Division (Light) Bolling Air Force BaseFort Richardson, AX 99505 Washington, Dc 20332-61588

Commnder NO ASC/XT=U.S. Army Environmental Andrew. All, MD 20334-5000

Hygiene AgencyAberdeen Proving Groun, ND

21010-5422

57

HQ HSD/CC-XA Department of the NavyBrooks APB, TX 78235-5000 Naval Sea Systems Command

ATTN: Code 55X25/Nr. Pat* JungWashington, DC 20362-5101

Defense Technical InformationCenter

ATTN: DTIC-DDAAlexandria, VA 22314-6145

HQ EUCOMOffice of the Command SurgeonATTN: Chief Operations/Logistics

DivisionAPO New York 09128

58

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