PWS Appendices.pdf

Appendix 1: Historical and Estimated Workload

Historical and Estimated Workload

Studies at NCTR are funded by different sources and are designed for various purposes.

These studies are designed to provide sufficient data to form the basis for regulatory decisions.

Standard NTP studies include 14-day toxicity studies (range-finding studies), 13-week toxicity studies (subchronic studies), and 2-year bioassays (carcinogenicity studies). All three study types are performed at NCTR, often with additions to any aspect of the study, including but not limited to, the standard number of test groups. Center for Tobacco Products funds studies to provide information to guide regulatory decision making. Typical studies include single inhalation exposure, 5-day inhalation exposures, 14-day inhalation exposure and 28-day inhalation exposure. Additional studies are also performed as required based on the data needed for regulatory decisions. In the past, these studies have included mechanistic studies involving collection of blood and urine, pharmacokinetic studies, teratology and reproductive studies, developmental studies, neurotoxicology studies, neurobehavioral studies, multi-generational studies, phototoxicology studies, perinatal toxicology studies, and methods development studies.

The test materials have varied from individual test chemicals added to the food (dosed feed), water (dosed water), or daily gavage, to unique materials including nanomaterials. It is the US Government’s responsibility to select the material and provide the certification that the material meets the specification of the Protocol. It is the Contractor’s responsibility to deliver the test material to the test animals per Standard Operating Procedure (SOP) established to fulfill the specifications in the Protocol.

The workload for animal care and technical procedures will be dependent upon the level of funding available to NCTR researchers for research protocols. Between June 2018 and Aug 2021, the number of protocols supported per month ranged from 13 to 27. During any given month, animal care, technical procedures, formulations, and veterinary care services were performed for an average of 20 different studies. Recent historical workloads are provided below.

Animal Census

Table 1 shows annual animal census data and monthly averages from June 2018 to Aug 2021 for rodents, zebrafish, and non-human primates (NHP). The key information is the average monthly census of animals in the facility.

More detailed censuses of animals by species are shown in Tables 2 – 5 for 2018, 2019, 2020, and 2021, respectively. The data are taken from the weekly animal census reports provided by the Contractor to the Government, and the data presented are the closest report to the first day of each month. This data is intended to provide an understanding of the animal census.

Discrepancies between Tables 1-5 may occur and are due to different methods for compiling the data.

Overtime and Holidays Worked

Due to the nature of the animal husbandry and the daily (seven days a week) requirements of some protocols, considerable overtime has historically been required for this contract. The overtime used for the Animal Care, Technical Procedures, Formulations and Veterinary Care Services contract between June 2018 and Aug 2021 is shown in Table 6.

Technical Procedures Performed

Technical procedures required from June 2018 and Aug 2021 are summarized in Table 7.

Graphs that show the technical procedures required each month during this period are provided in Figures 1 - 14. Please note that the workload in specific areas ebbs and flows such that during the same period of time, one area may experience a heavy workload while another (or others) experiences a lower workload. The contractor is expected to cross-train personnel to ensure maximum efficiency in utilization.

The number of behavior assessments for rats, mice, and NHP is shown in Figure 1. The number of blood collections from rats, mice, and NHP are shown in Figure 2.

The number of oral gavages for mice, rats, and NHP, is shown in Figure 3.

The numbers of intramuscular, intraperitoneal (IP), intravenous (IV), and subcutaneous (SQ) injections in mice and rats are shown in Figures 4, 5, 6, and 7, respectively. Intravenous (IV) injections in NHP are not shown graphically. A total of 34 IV injections were administered to NHP intermittently between June 2018 and Aug 2021 with a maximum of 7 per month in May and August 2019. SQ injections in NHP are not shown graphically as there was a total of 74 with 20 each in February and March 2021, 13 in April 2021, and 21 in Aug 2021.

The numbers of rodents receiving ear clipping for and tattooing for identification are shown in Figures 8, and 9, respectively.

The numbers of vaginal swabs, pregnancy checks, tuberculosis tests, and anesthesia monitoring performed on NHP from June 2018 and Aug 2021 are shown in Figures 12, 13, 14, and 15, respectively.

Diet Distribution

The volume of animal diet received and distributed to animals at NCTR from 2018 to 2021 is shown in Table 8.

Overall Comment on Workload.

The workload is highly dependent upon the availability of funding to the researchers at NCTR.

The data that has been provided is intended to inform the potential contractor of the workload that has occurred over the past 3 years and indicate that at times the workload can shift from one study requirement (e.g., gavage) to a different study requirement (e.g., behavioral assessments). However, there are consistent requirements for all studies (e.g., tail tattoo, wellness checks, weekly or bi-weekly cage changes, feeding, and water checks) that are required on a fairly constant basis.

Table 1. Annual Animal Census from January 2018 to August 2021.

2018 2019 2020 2021a Rodents

Total 11865 18813 24308 12944 Monthly Average 989 1568 2026 1618

Zebrafish Total 3494 2602 9381 4839 Monthly Average 291 217 782 605

Non-human Primatesb,c Total 189 150 115 89 Monthly Average 179 132 105 77 a Only data for Jan - Aug of 2021 included.

b NHP include Rhesus Macaques and squirrel monkeys until Dec 2018.

c NHP: Rhesus Macaques only beginning Dec 2018.

Table 2. Monthly Animal Census for 2018

Jan Feb Mar April May Jun Jul Aug Sep Oct Nov Dec Average Rat 567 493 427 364 458 684 539 471 404 436 570 614 502 Mice 767 705 465 300 278 296 418 593 604 566 490 356 487 Zebrafish 397 352 352 250 216 216 235 289 298 297 297 295 291 Squirrel Monkey 26 26 26 26 26 26 26 26 26 26 26 0 24 Rhesus Monkey 163 159 159 158 158 158 158 155 154 152 152 150 156 All Species 1920 1735 1429 1098 1136 1380 1376 1534 1486 1477 1535 1415 1460

Table 3. Monthly Animal Census for 2019

Rat 677 777 886 971 1015 910 937 1008 1120 1024 1019 995 945 Mice 352 363 359 428 518 640 796 844 753 824 825 772 623 Zebrafish 293 293 293 196 196 196 192 192 190 188 188 185 217 Rhesus Monkey 150 147 145 140 132 130 128 127 125 121 118 116 132 All Species 1472 1580 1683 1735 1861 1876 2053 2171 2188 2157 2150 2068 1916

Table 4. Monthly Animal Census for 2020

Rat 1053 1096 1202 1104 1153 1203 1325 1557 1607 1524 1446 1436 1309 Mice 683 617 633 561 555 561 634 857 922 917 823 839 717 Zebrafish 184 323 334 331 869 1088 1087 1057 1027 1027 1027 1027 782 Rhesus Monkey 115 115 115 115 115 114 107 98 94 90 89 89 105 All Species 2035 2151 2284 2111 2692 2966 3153 3569 3650 3558 3385 3391 2912

Table 5. Monthly Animal Census for 2021

Rat 1395 1155 1096 1108 1044 1164 1157 987 - - - - 1138 Mice 781 698 579 469 322 297 307 385 - - - - 480 Zebrafish 771 677 672 566 540 539 537 537 - - - - 605 Rhesus Monkey 89 89 86 76 73 69 67 66 - - - - 77 All Species 3036 2619 2433 2219 1979 2069 2068 1975 2300

Table 6. Overtime Worked May 2018 to March 2021

Overtime Worked May 2018 thru July 2021 2018a 2019 2020 2021h

Rodent Areas Overtime Hoursb 2.1 14.2 35.1 19.1 Overtime hours (Mgmt)c,d 41 117 158.1 102.5 Worked Holiday hourse 467 566 660 414.8 Sunday Premium hoursf 1126.8 1782.3 2525.9 1464.7 Night Premium hoursg - 10.5 10.5 -

2018a 2019 2020 2021 NHP Areas

Overtime Hoursb 20.6 118.3 60.4 37.6 Overtime hours (Mgmt)c,d 5 34.9 121.3 50.5 Worked Holiday hourse 503.3 585 624 338.2 Sunday Premium hoursf 879.6 1262 1443.9 744 Night Premium hoursg 2.5 333 - -a Only 8 months of 2018 are reported (May-December 2018).

b Overtime hours are hours in excess of 40 in a week, 8 in a day, or when the employee did not have at least 12 hours off prior to the beginning of the shift.

c Management included Supervisors, Technical Specialist, Cage Processing Foremen, Equipment Specialist, and QC/Safety Specialist. The Project Director, Administrator, Clinical Veterinarian, IQA, and Program Managers were exempt from receiving overtime pay rates d The clinical veterinarian was removed from the contract in February 2019.

e Worked Holidays are compensated at 2 times the regular pay rate due to an agreement with the union. Management not eligible for overtime are not included in this agreement.

f Sunday Premium hours are compensated at 1.25 times the regular pay rate due to an agreement with the union. Management not eligible for overtime are not included in this agreement.

g Night Premium hours occur between 5 pm and 5 am and are compensated with an additional $0.50 per hour due to an agreement with the union. Management not eligible for overtime are not included in this agreement.

h Only 3 months of 2021 are reported (January - March 2021).

Table 7. Total Technical Procedures Performed between June 2018 and August 2021.

Technique Mice Rats NHP Behavioral Assessments 1546 63535 57484 Blood Collection 993 6373 498 Gavage (oral dose) 1449 70157 20382 IM Injections 132 130 1355 IP Injections 59 537 0 IV Injections 1679 1405 34 Subcutaneous Injections 1410 2663 74 Breeding/Date Mating 402 374 0 Tattoo 857 6842 112 Ear Clip Identification 775 1221 - Developmental Landmarks 1058 12672 0 Vaginal Lavages 0 201 45112 NHP Pregnancy Checks - - 80 NHP anesthesia monitoring - - 187 NHP TB Testing - - 807

Techniques performed only rarely are not included in this list.

Figure 1. Behavior assessments performed per month from June 2018 to August 2021 on mice, rats, and NHP.

Figure 2. Blood collections performed per month from June 2018 to August 2021 on mice, rats, and NHP.

Figure 3. Gavages performed per month from June 2018 to August 2021 on mice, rats, and NHP.

Figure 4. Intramuscular injections performed per month on mice, rats, and NHP from June 2018 to August 2021.

Figure 5. Intraperitoneal injections performed per month on mice and rats from June 2018 to August 2021.

Figure 6. Intravenous injections performed per month on mice and rats from June 2018 to August 2021.

Figure 7. Subcutaneous injections performed per month on mice and rats from June 2018

Figure 8. Ear Clip Identifications performed per month on mice and rats from June 2018

Figure 9. Tattoo Identifications performed per month on mice, rats, rat pups, and NHP from June 2018 to August 2021.

Figure 12. Vaginal swabs performed on NHP from June 2018 to August 2021.

Figure 13. Pregnancy detection performed on NHP from June 2018 to August 2021.

Figure 14. Tuberculosis testing performed on nonhuman primates from June 2018 to

Figure 15. Anesthesia monitoring performed on nonhuman primates from June 2018 to

Table 7. Diet Received and Distributed to Animals

Received Distributed to Animal Areas

NTP 2000 Standard Rodent Diet 5,183 kg/year 462 kg/month

NIH07 Standard Breeding Rodent Diet 1,785 kg/year 165 kg/month

Special Experimental Rodent Diet 162 kg/year 6 kg/month

Non-human Primate Diet 5,987 kg/year 665 kg/month

Appendix 2: Government Furnished Property

PAGE ONE 5A 62 53 TOTALS

ACS Rat Water Bottles 0 519 519

Acs Station 50 0 20 70

Acs Bottle lids 0 200 200

Regular Rat Water Bottles 965 0 965

ACS Mouse Cages 350 0 511 861

ACS Rat Cages 931 0 669 1600

REG RAT CAGES 349 349

BPA RAT CAGES 229 150 379

GREEN LINE IVC RAT CAGES 255 255

BLUE LINE IVC RAT CAGES 0 129 129

METABOLISM CAGES (RAT) 39 0 58 97

REG MOUSE CAGES 11 32 243 286

BPA MOUSE CAGES 184 0 184

GREEN LINE IVC MOUSE CAGES 0 105 105

BLUE LINE IVC MOUSE CAGES 0 340 340

METABOLISM CAGES (MOUSE) 41 0 41

5 SHELF RACK 49 1 40 90

6 SHELF RACK 11 0 16 27

Acs Mouse Lids 424 0 472 896

Acs Rat Lids 959 0 459 1418

METABOLISM RACK 0 1 1

REG RAT LIDS 836 150 399 1385

REG MOUSE LIDS 109 32 147 288

BLUE LINE IVC RAT LIDS 0 391 391

BLUE LINE IVC MOUSE LIDS 0 553 553

ACS Mouse bonnets 518 0 239 757

GREEN LINE IVC RAT LIDS 300 300

ACS Rat Bonnets 931 0 424 1355

ACS Rat Feeders 1000 0 510 1510

GREEN LINE IVC MOUSE LIDS 0 105 105

ACS mouse feeders 350 0 117 467

REG RAT BONNETS 457 148 451 1056

BPA RAT BONNETS 528 150 0 678

REG MOUSE BONNETS 32 1167 1199

BPA MOUSE BONNETS 81 0 81

GREENLINE IVC RAT BONNETS 255 255

GREENLINE IVC MOUSE BONNETS 0 105 105

BLUE LINE IVC RAT BONNETS 0 215 215

BLUE LINE IVC MOUSE BONNETS 0 171 171

GREEN STOPPERS 0 300 300

BLACK STOPPERS 0

DOUBLE STOPPERS 0 923 923

SILICONE STOPPERS (BPA) 450 0 450

RAT TOYS 292 280 394 966

Tobaco Rat Cages 0 540 540

PAGE TWO 5A 62 53 TOTALS

MOUSE TOYS 411 0 159 570

PHOTOTOX RACKS 29 0 29

PHOTOTOX PANS 1600 0 1600

PHOTOTOX DOORS 2100 0 2100

GREEN LINE IVC RAT RACK 3 3

BLUE LINE IVC RAT RACK 0 4 4

GREEN LINE DOUBLE IVC RAT RACK 2 2

BLUE LINE DOUBLE IVC RAT RACK 1 1

NTP RAT TOYS (BLUE) 0 160 160

mop bucket/silver tin 7 7

GREEN LINE IVC MOUSE RACK 0 2 2

BLUE LINE IVC MOUSE RACK 1 2 3

GREEN LINE DOUBLE IVC MOUSE RACK 0 1 1

BLUE LINE DOUBLE IVC MOUSE RACK 1 1

MONITORS 20 4 17 41

COMPUTER KEYBOARD 11 4 26 41

COMPUTER MOUSE 21 4 18 43

HP H1536 TERMINAL BOXES 4 2 13 19

BALANCE 32 2 19 53

CLOCKS 27 0 22 49

PIV BADGE READER 8 0 20 28

SCANNER 8 2 19 29

REG FEED BINS 13 3 20 36

STAINLESS STEEL FEED BINS 19 0 19

STAINLESS STEEL CABINETS 7 6 13

DOSE STIR PLATES 48 0 48

MOP BUCKETS/yellow 12 4 26 42

MOP HANDLES 19 4 16 39

BROOMS 16 4 31 51

DUSTPAN W/BROOM 18 4 31 36

PHONES 16 2 27 45

TERMINAL CARTS 10 6 19 35

SMALL FLAT CART 10 2 18 30

LONG FLAT CART 10 0 30 40

PAGE THREE 5A 62 53 TOTALS

BROWN STORAGE CABINET 9 3 16 28

metal trash can with lid 4 0 5 9

GREY STORAGE CABINET 6 2 4 12

TRASH CANS 20 4 41 65

PPE STATION 4 2 5 11

WATER RACKS 70 12 39 121

WATER CARTS 14 8 102 124

REG WATER BOTTLES 70 0 350 420

GLASS WATER BOTTLES 93 0 250 343

IVC BOTTLES (SHORT 300ml) 150 47 197

IVC BOTTLES (TALL 350ml) 530 463 993

IVC BOTTLES (SHORT FAT 400ml) 0 428 428

IVC LONG SIPPER TUBES 530 463 993

IVC SHORT SIPPER TUBES 400 150 30 580

EUTHANEX BOX 1 1

EUTHANEX LARGE LID 1 3 4

EUTHANEX SMALL LID 1 3 4

NYLA BONES 280 153 433

Wire Basket lids 310 5 315

SMALL WIRE BASKET 4 3 7

REGULAR WIRE BASKET 5 2 28 35

URINE FLAPS & SPOUTS FOR METAB 0 50 50

METAL FRAME FOR METABOLISM 0 50 50

METABOLISM ICE BIN (STYROFOAM) 0 24 24

DIVIDED MOUSE CAGES 0 290 290

DIVIDERS 0 296 296

HAMSTER BOWLS 0 136 136

HAMSTER BLOCKS 0 60 60

SPRING WATER RACK LID 0 22 22

Spades(mouse) 19 0 10 29

Spades (Rat) 20 0 20

WATER RACK SPADE 14 0 51 65

SPRAYER JUG 0 0 1 1

SOAP DISPENSERS 6 1 2 9

RAT FEEDERS 480 0 480

Shower Curtains 10 0 2 12

Footstool 2 1 3 floormat 2 0 2

Five gal. plastic drum with metal lid 2 2 euthanizer 1 1 plastic tan cart 1 1

Sink 3 3

2 shelf tables 3 13 16 Scale 4 1 1 6

Buffer 1 1

Floor machine 1 1

Lighting Panel 2 0 2

Metal cage Card holders 50 200 250

Plastic cage card holders 150 200 350 plastic wrap holder 1 1 1 3

Table 0 35 35

4 Drawer Chest 0 1 1

PAGE FOUR 5A 62 53 TOTALS

wet pallet 2 1 3

Plastic Pallets 2 2 7 11

30 GALLON DRUM (PIG FOR SOAP) 2 1 3 6

PALLET JACK 1 0 1 2

YELLOW CHEMICAL CABINET 1 0 1 2

WATER COVERS 7 70 77

BONNET DRYING RACKS (3 SHELF) 0 9 9

PRINTER/COPIER 2 1 5 8

MOP HEADS 5 4 15 24

LAB COATS 25 3 46 74

TATTOO KITS 4 1 3 8

SHOP VAC 2 1 2 5

SHOP FAN 1 1 2 4

BLUE WASH TRAYS 23 0 36 59

BLUE HOPPERS 3 0 3 6

RAT THERMA CAGE WARMER 3 0 1 4

CO2 TANK 1 1 2 4

BLEED STATION 2 1 5 8

30 GALLON METAL CANS 0 6 6

FILTER DRYING CART 1 0 4 5

RAT RESTRAINER 1 15 16

MOUSE RESTRAINER 2 3 5

STEAM KETTLE 1 0 1

WATER HOSE 2 0 1 3

ULINE ENTRY DOOR STICKY PADS 2 1 3

DESKS 3 1 4 8

MANAGEMENT LAPTOPS 3 1 2 6

MANAGEMENT DESKTOPS 1 1 2 4

FILE CABINETS 4 3 9 16

LIMEAWAY (4/CS) 2jugs 78gal 78gal/2jug

Optirat Gen II Racks 18 0 18

Optirat Gen II Racks Cages 882 0 882

LARGE WHITE RAT CAGE COVERS 8 5 5 18

HEPA FILTERS ( NOT IN USE) 1 32 33

PAGE FIVE 5A 62 53 Totals

NIH FEED 7 1 2.2 10.2

DIET GEL RECOVERY 1.5 12cups 0.75 13 3/4 cups

HYDROGEL 12cups 0.75 12cps+.75

5K96 FEED 0 1 1

ALPHA DRY BEDDING 16 3 15 34

ALPHA DRY PLUS BEDDING 0 12 12

SANI-CHIP BEDDING 16 0 5 21

TD.97184 PURIFIED DIET 0

TD 08485 1 0 1

TD 88137 1 0 1

HIGH FAT DIET 0 0.5 0.5

RODENT TREATS 0.00 2 2

EQUIPMENT

Ace ANIMAL TRANSFER STATION 1

ANIMAL TRANSFER STATION (cc) 2 2

GREENLINE IVC TOWER 2 2

GREENLINE IVC TOWER 0 0

GREENLINE IVC TOWER 0 0

GREENLINE IVC TOWER 0 0

BLUE LINE IVC TOWER 0 0

GREENLINE IVC TOWER (BROKEN) 0 0

BLUE LINE IVC TOWER (BROKEN) 0 0

BLUE LINE TOWER 0 0

BLUE LINE TOWER 0 0

BLUE LINE TOWER 0 0

BLUE LINE TOWER 0 0

GREENLINE TOWER 4 4

2 2

Nuaire CAGE CHANGE STATION 0 0

TRANSFER STATION IN 5A 0

LOCKS

ITEM Total INDIVIDUAL TOY LIST Total

Play Cages 6 Manzanita Wood 150

Quads (NHP) 21 Z 2 toy 35

BIPLEX 39 DUMB BELL 257

ULTRA SOUND MACHINE 3 JINGLE BALL 55

CABINETS 6 KONG /Blue 50

Carter Cages 65 KONG DENTAL CHEW/small 39

CATCH POLES 33 BONES 203

Old Chambers 2 CHILL BALL 0

Adult Chambers 13 TIRE 0

COLLARS 397 TRIANGLE 101

COMPUTER CARTS 5 MIRROR 204

COMPUTERS FORAGE BOARD 5

COMPUTERS FOOD BALL/forage ball 26

COMPUTERS CONE 30

COMPUTERS PURPLE BALL 1

COMPUTERS SILVER BALL/stainless/mirrow 90

COMPUTERS HAVA BALL 25

MONITORS 21 PUZZLE/bell hanging 52

MOUSE 17 JACKS 0

ID SCANNER 3 HOLEE MOLEE 0

KEY BOARDS 19 DENTAL CHEW 24

LAPTOP 5 TURF ROLLER/astro tube 47

DESKS 1 RINGS 0

FOX TAILS NOBBLY WOBBLY 0

DOSE CARTS 5 TINY TRIANGLE 1

STAINLESS STEEL CARTS 10 FINGER PUZZLE 30

SURGICAL TABLES 2 TOYS 747

SQUIRREL 4 PLEX 0 KONG DENTAL CHEW 24

METAL CARTS 4 Crumble disk feeder 26

MALE CAGES 0 Primate busy box 41

PRIMATE CHAIRS 38 super saucer/frisbee 46

FEED HOPPER 0 Z-Toy 105

TABLES 2 Shake a treat 41

FLAT BEDS 4 tap a treat 25

LOCKS 441 challenger balls 34

ITEM Total Primate 2 tubes 44

WATER BOTTLE CARTS 1 PVC biscuit tubes 11

WATER BOTTLES 5 Snack ball 17

STOPPERS 7 Cap feeders 14

SIPPER TUBES 7 Fleece flat hanging board 13

WAND 1 Puzzle forage board 6

SCRUB BRUSH 13 feeder food balls (2p) 19

SQUEEGEE 3 balls 40

STORAGE RACKS 8 4 tier PVC biscuit feeder 1

SLEEVES 20

STOOLS 13

WHEELS

DUST PANS 5

TRASH BAG RACK 5

TRASH CANS 17

BROOMS 8

MOPS 11

MOP BUCKET 8

SHOWER CURTAINS 7

PPE STATION 1

SAFETY GLASSES 37

UNIFORMS(SCRUBS) 128

SOCKS 54

LAB COATS 56

COOLER 0

REFRIGERATOR 4

Monkey chairs 28

Freezer 5

BPA Mouse Cages 32

Regular Rat Cages 29

Rat Bonnets 19 Face Shield 22

Disposoble Face Shield 43 Vacumm 2 Metal Racks 14

ITEM Total

DESKS 3

MANAGEMENT LAPTOPS 3

MANAGEMENT DESKTOPS 0

FILE CABINETS 8

PRINTERS 2

MONITOR,KEYBOARD,MOUSE 17

TRASH CANS 5

CLOCK 5

PHONE 9

CHAIRS 10

COAT RACK 2

SHREDDER 1

SCANNERS 1

Firehose 45 bingo ball 87

Shall 6 a treat jr. 41

Grenade 118 lucky clover 25

Nyla bone dental chew 20 denal star 97

Best ball 97

Texas t-bone 49

Bionic ball 35

Nylabone power chewer 25

Bionic Bone 37 playstrong trident 39

Dura chew 74 bionic stuffer 22 dental dinosaur 21 zig zag 25 120 turf board 33 springs stainless steel 49

BUILDING 50 - 3RD FLOOR TOTAL

4 SHELF RACKS 4

HANGING RACK & PARTS 1

Building 62 174 Totals

Footstool 1 wire shelf 1 terminal cart 6

Alpha Dri Plus 1 sweegie mop 2 water cart 2 trash can 2 chair 6 mop bucket 1 broom 2 dust pan with brush 2 clock 12 mop bucket 3 wet vac 1 shower curtain 1 black file cabinet 1 200 cage klenz 0.25 wire basket 2 rat cage 2 rat bonnet 0 short flat carts 5 Nuaire Bio Safety Cabinet 4 IVC mouse lids 175 cage cart holders 100 cage cart filters 100 Ivc blue line bonnet 180 technoplast hood 1 water racks 2 IVC mouse bonnet 180 IVC mouse cage 180 water bottle 24

PAGE 1 Total Total

HEPA FILTERS IVC (CS) 3 BLUELINE IVC RAT CAGES 177

PRE FILTERS IVC- 14 5 SHELF RACKS 14

TECH BOARDS 24X24 15 6 SHELF RACK 6

BLUE TECHBOARDS 0 TERMINAL CARTS 8

PHOTOTOX PADS 19,900 WATER CARTS 25

MOUSE FEEDER BOXES PHOTOX RACKS 74

RAT FEEDER BOXES 0 NHP CAGES (Bi-Plex) 17

WHITE JUG PLASTIC LIDS 200 7 SHELF RACKS 0

METABOLISM FRAMES 22 3 SHELF RACKS 2

WIRE BASKETS 80 BPA RAT BONNETS 4523

MOUSE FEEDERS 18 FEED BINS 0

MOUSE BONNETS 1996 METABOLISM CAGES 72

RAT BONNETS 3915 TRASH CANS 19

REGULAR WATER BOTTLES 10820 MOP BUCKETS 14

WATER RACKS 754 MOP SQUEEZERS 28

SMALL DOSE WATER RACKS 52 METABOLISM ICE CHESTS 0

BPA WATER BOTTLES 1176 GLASS WATER BOTTLES 0

CLEAR WATER BOTTLES 13450 BLUELINE IVC RAT BONNETS 373

NON AUTOCLAVABLE BOTTLES 4200 BLUELINE IVC MOUSE BONNETS 549

AMBER WATER BOTTLES (NEW) 240 BLUELINE DOUBLE MOUSE IVC RACK 2

METAL CAGE CARD HOLDERS 8000 BLUELINE IVC RAT RACKS 7

BLUE TRAYS 229 REGULAR RAT LIDS(BROKEN) 0

AMBER WATER BOTTLES 4491 REGULAR MOUSE LIDS(BROKEN) 0

PHOTOTOX PANS 800 PHOTOTOX CAGES 37

HANGING RATS BREEDER PANS 330 BLUELINE IVC RAT LIDS 165

BPA MOUSE BONNETS 882 GREENLINE IVC MOUSE LIDS 215

HOG SCALES 2 IVC SIPPER TUBES (LONG) 800

REGULAR RAT LIDS 7791 FOOTBATHS 24

REGULAR RATS CAGES 6664 STEP STOOLS 12

REGULAR MOUSE CAGES 7233 5 GALLON WHITE JUGS 5

RAT CAGES AMBER 4617 SHORT PLASTIC WATER BOTTLES 2295

MOUSE CAGES AMBER 2766 IVC WATER RACKS 225

NHP Play Cages 0 NHP Bylex cages 4

IVC WATER RACKS WITH LIDS 8CASES ROLL PAPER TOWELS (CS-6rolls) 19

MOUSE LIDS (LONG NOT IN USE) 0 SMALL WATER BOTTLES 240

REGULAR MOUSE LIDS 2000 MOUSE FEEDERS 80

MOUSE CAGE DIVIDERS 12,500 PALLET JACK 1

PRIMATE SPRING LIDS 15 Cage Klenz 100 8

3 1/2 SIPPER TUBES 1000 CAGE KLENZ 200 (30GAL) 2

3 IN SIPPER TUBES (BB) 200 NPD (EA) 0

3 IN SIPPER TUBE/STOPPER 3000 15 GALLON PLASTIC JUGS 5

X-TRA LONG SIPPER TUBE 2000 STEEL DOSE BOTTLE CONTAINERS 75

REGULAR SIPPER TUBE (ONLY) 5000 STEEL TRASH CAN BASE HOLDERS 7

BLACK STOPPERS 500 CLARK SHOP VACCUMS 3

WATER RACK SPADES 0 RODENT BOWLS 155

WATER RACK SPRING LID REG 18 SMALL FEED JARS W/LIDS 0

BPA STOPPERS SILICONE 4350 SMALL V FEEDERS 46

400 ML IVC BOTTLES 109 LG V FEEDERS 30

BLUELINE IVC CARD HOLDERS 170 SILICON STOPPERS (ONLY) 1284

GREENLINE IVC RAT CAGES 154 WHITE MOP HEADS (USED) 0

GREENLINE RAT BONNETS 119 RAT FEEDERS 4055

GREENLNE RAT LIDS 42 MOUSE FEEDERS 9496

250 ML SHORT IVC BOTTLES 24 HANGING RAT RACK BOTTLES & HOLDERS 479

300 ML TALL IVC BOTTLES 148 STEEL CONTAINERS FOR DOSE FEED 400

ERGONOMIC MATS 32 METAL WATER CONTAINER LIDS 40

STAINLESS STEEL FEED BOXES(water) 40 METAL FEED JUGS 82(2)

VINEGAR 1 GALLON WHITE 0 FLOOR BUFFERS MINUTE MAN 1

BUCKEYE BLUE ALL PURPOSE (CS) 0 FLOOR BUFFER MATADOR 1

BUCKEYE BLUE MULTI ACID CLEANER 0 RUBBERMAID SHOP VACUUM 1

ACETIC ACID 2.5L 0 BAR SOAP 2

DEGREASER GAL 0 HAND SOAP 1case

QUATRICIDE TB 0 FOLDED PAPER TOWEL(CS) 11

POWER DRIVE GOLF CART BATTERY 1 MR. CLEAN c/S 2

COMET CLEANER (container ea) 30 BLEACH (gal jug) 0

GOOF OFF SPRAY 2 AUTOMATIC ROLLER MOP 4

OFF INSECT SPRAY 0 BROOM HANDLE W/BROOM 10

TOILET TISSUE (CS-96 ROLLS) 14 PLASTIC SHELVES 0

WET VACUUM 2 SONIC INSECT CONTROL 4

FORCEP HOLDER 20 FLASHLIGHTS 5

RAT FORCEPS 8 SOAP DISPENSER 18

PIG HARNESS 14 LIGHT STICKS (50/CS) 1

DISTILLED WATER 0 ELECTRICAL CABLE ASSEMBLY 2

HAZARD WASTE CONTAINERS 44 9 FT EXPENSION CORDS 10

TRASH BAGS (30GAL) 80 AIR ONE FAN 1

TAN SORAGE CABINETS 6 STEARIS CLEANING SPRAY 0

GRAY STORAGE CABINET 1 VICTOR MOUSE TRAPS 14

BLUE MOP HEADS (12/CS) 4 100 FT EXTENSION CORD BLUE 1

SPONGES 13 SHOP VAC PRO 1

TECH WIPES (BX) 7 PAPER TOWEL DISPENSER 1

LPH (GAL) 0 PH KITS (INCOMPLETE) 4

WATER CART COVERS 5LG 60 GALLON TRASH BAGS CLEAR 2

PRIMATE WATER BOTTLES(50/CS) 2 SHRINK WRAP (4/CS) 20

PRIMATE SIPPY TUBES 100 ULINE CAN LINER (BLUE/ 13 gal) 11

DUSTPAN/BROOM SET 0 BUFFERS PADS (5/CS) 4box

SMALL CAN LINERS (20/PK) 0 MICROWAVE 0

White mop heads 3 SMALL REFRIGERATOR 0

WESTWARD 6000PSI GREASE GUN 5 WHEELCHAIRS 0

SUAVE SHAMPOO 1case PALLETS 4

CHEMICAL PALLETS 3

13 IN WALL CLOCKS 0 7 STEP LADDER 2

MOP HANDLES 28 5 STEP LADDER 4

BALANCE CALIBRATION KITS 26 2 STEP LADDER 1

KEVLAR 9IN ARM GLOVES 9 SOAP TRANSFER PUMPS 3

INDUSTRIAL EXTENSION CORD 10 GOLF CARTS 5

GREASE FOR GREASE GUN 3case FORKLIFTS 5

EYE WASH STATION 1

PAGE 4 Total

SMALL FLAT CART 23

LONG FLAT CART 11

ULINE ENTRY DOOR STICKY PADS 0

PPE STATION RACKS 1

ROLL-O-MATIC 36

CAGE KLENZ 100 (30GAL) 0

LARGE WHITE RAT CAGE COVERS 1bx

1 TEMP THERMOLABELS 0

3 TEMP THERMOLABELS 0

PLASTIC WHITE SPRAY BOTTLES 2bx

PLASTIC SPRAY BOTTLE NOZZLES 50

SOS PADS (BX) 4

TOILET BRUSHES 9

STAINLESS STEEL WIPES (CS) 12

MOUTHWASH (CS) 0

Red Sipper caps 1000

Green Plastic Stopper 250

Water Bottle Carts 16

Slip Sheet for forklift 1

EQUIPMENT

NUAIRE DUMP STATION

BIOLOGICAL SAFETY CABINET

TECHNICPLASTTRANSFER STATION 3

BLUE LINE IVC BLOWER 8

NUAIRE BIOLOGICAL SAFETY CABINET 0

Nuaire Cage Changing

Allentown Transfer Station

MIXERS:

Silverson

Lightnin

Leeson

Eurostar Power Control

Sor Vall Omni 2

Nuairee Dump Station 1

Ace Animal Transfer Station 1

DIET PREPARATION INVENTORY

SCALES: GLASS BEAKER:

OHAUS RANGER 3 PYREX (20 ml) 1 OHAUS EXPLORER 5 PYREX (50 ml) 5 OHAUS CHAMP 3 PYREX (100 ml) 15 OHAUS PRO EXPLORER 1 PYREX ( 150 ml) 2 AND SCALE 1 PYREX ( 250 ml) 4 METTLER TOLEDO 2 PYREX ( 600 ml) 1

KIMAX ( 30 ml) 2

STIRRERS : KIMAX ( 50 ml) 4

CIMARAC 1 KIMAX ( 100 ml) 1 THERMO ELECTRON 5 KIMAX ( 150 ml) 1 CORING (MUTI) 3 KIMAX ( 250 ml) 5 THEMOLYNE 45700 CELLGRO 1 KIMAX ( 300 ml) 3 VARIO MAG 2 KIMAX ( 400 ml) 1 VNR 4 KIMAX ( 600 ml) 3 MAGNETIC MOTION 11 FISHERBRAND ( 1000 ml) 56 THERMO SCIENTIFIC 9 PYREX ( 2000 ml) 28 HEIDOLPH 1 FISHERBRAND ( 4000 ml) 23 CORING 9 PYREX ( 4000 ml) 2 BELL-STIR 1 KIMAX ( 4000 ml) 3

PUMPS : AMBER WATER BOTTLE :

GAST 1 AMBER WATER BOTTLES 397

MASTER FLEX 2 60 ml JAR 288

100 ml JAR 60 200 ml JAR 134

MIXERS: 500 ml JAR 14 SILVERSON 3 1000 ml JAR 28

LIGHTNIN 6 PYREX (1000 ML) ORANGE CAPS 3

LEESON 1 PYREX (2000 ML) ORANGE CAPS 5

EUROSTAR POWER CONTROL 1

SOR VALL OMNI 1

BLENDERS : FRIDGE:

PATTERSON KELLEY V (.5 cubit) 1 THERMOS SCIENTIFIC REFRIGERA 1 PATTERSON KELLEY V (5 cubit) 1 THERMOS SCIENTIFIC FREEZERS 1 PATTERSON KELLEY V (1 cubit) 1 FRIGIDARE FREEZER 1 PATTERSON KELLEY V 2.5 cubit) 2 DEEP FREEZER 1

Vissan refriderator 1 GE Rifridgerator 1 UL refridgerator 1

GLASS FLASK: PLASTIC CONTAINERS:

PYREX VOLUMETRIC (10 ml ) 2 VOLUMETRIC (1000 ml ) 2 PYREX VOLUMETRIC (25 ml ) 1 VOLUMETRIC (2000 ml ) 1 PYREX VOLUMETRIC ( 50 ml) 3 0 PYREX VOLUMETRIC ( 100 ml) 2 0 PYREX VOLUMETRIC ( 250 ml) 2 0 KIMAX VOLUMETRIC ( 10 ml) 1 KIMAX VOLUMETRIC ( 25 ml) 1

KIMAX VOLUMETRIC ( 100 ml) 2 GLASS CARBOY:

KIMAX VOLUMETRIC ( 250 ml ) 2 CORNING ( 1 liter) 1 CAHATAS VOLUMETRIC ( 50 ml) 1 PYREX (1 liter) 1 CAHATAS (50ml) 1 PYREX (2 liter) 2 PYREX (50 ml) 3 PYREX (5 liter) 3 CAHATAS (100 ml) 2 PYREX ( 9 liter) 20 PYREX ( 100 ml) 1 PYREX ( 12 liter) 12 PYREX ( 200ml) 1 KIMAX ( 5 liter) 1 PYREX ( 250 ml) 1 KIMAX ( 9 liter) 1 PYREX ( 500 ml) 12

SGB ( 250 ml) 1 MISCELLANEOUS:

KIMAX (50 ml) 2 BLACK PALLETS 7 KIMAX (100 ml) 1 STAINLESS STEEL BUCKET 1 KIMAX ( 125 ml) 1 DOLLEYS 2 KIMAX ( 200 ml) 3 0

KIMAX (250ml) 9 KIMAX (500 ml) 11 FLOOR JACK 2 PYREX ( 1000 ml) 9 SHOP VACCUM 2 PYREX ( 2000 ml) 7 TOYOTA FORKLIFT 1 PYREX ( 4000 ml) 11 HYSTER FORKTRUCK 0 PYREX ( 6000 ml) 3 GOLF CARTS 1 KIMAX (2000 ml) 5 DESK 1 KIMAX (4000 ml) 4 PHONES 1 KIMAX ( 6000 ml) 4 LAB TOP COMPUTER 1 VOLUMETRIC ( 100ml) 1 PRINTER 1 VOLUMETRIC ( 250ml) 1 SMALL FLAT CART 7 RED PYREX ( 100 ml) 4 LARGER FLAT CART 8 RED KIMAX ( 100 ml) 1 Hotplate 1

RED KIMAX ( 250 ml) 2 BEDDING ROUND (2000 ml) 4 SANI- CHIPS BEDDING (bgs) 250 KIMAX VOLUMETRCI (1000 ml) 1 ALPHA DRY BEDDING (bgs) 0 KIMAX VOLUMETRIC ( 2000 ml) 1 ALPHA DRY PLUS (bgs) 80 KIMAX ( 1000 ml) 6 KIMAX ERLENMEYER (2000ml) 4

GLASS FUNNEL 11

LAB. EQUIPMENT AND SUPPLIES PACKAGE SUPPLIES :

STERIGARD HOOD 1 METAL RAT FEED CASES 0

LAB LINE INCUBATOR 1 METAL MOUSE FEED CASES 0

HEAVY DUTY KITCHEN AID MIXER 3 METAL WATER BOTTLE CASES 90

MORTAL PESTAL LARGE BOWL 1 WIRE BASKET 0

MORTAL PESTAL MED BOWL 3 METAL FEEDER PACKAGE CASE 0

GOLD SERIES DISHWASHER 1 GUINEA PIG CASES 0

8210 BRANSON SONICATOR 1 METAL SIX PACK TRAYS 0

2510 BRANSON SONICATOR 1 METAL BASKET 0

VORTEX GENIE 2 WATER BOTTLE CARTS 0

SMALL WATER BOTTLES 0

STERIS AUTOCLAVE 1

RAT FEEDERS 24750

MOUSE FEEDERS 13000

SONICS VIBRA CELL 1 FUNNEL 7

BARNSTEAD ACS MEGA-PURE SYS 1 SCOOP 7

GLASS WATER BOTTLE 0

STERIS LAB GLASSWARE WASHER 1 CLEAR PLASTIC WATER BOTTLE 0

SFM BALL MILLER 1 CLEAR STOPPER 0

CMA Dish Machine 1 GREEN STOPPER 0

FEED: METAL STOPPER 0

0 GRAY BIN 8

0 STORAGE BIN 4

Primate Diet Gel 3 RED SIPPERS CAPS 0

0 GREEN PLASTIC STOPPER 0

163 STORAGE CABINET 1

0 FLAMMABLE CABINET 1

16 STAINLESS STEEL TABLE 13

STAINLESS STEEL SMALL TABLE 2

3 STAINLESS STEEL MED TABLE 1

0 STAINLESS STEEL carts 8

VEGGIE BITE (cs) 0 0

TD.97184 PURIFIED DIET METAL SAFETY GUARDS 1

0 MIXING STAINLESS STEEL CAN 13

D 1251i 3 Open source diet 3 cs 3 STAINLESS STEEL CANS 36 SUNFLOWER SEEDS (3kg) 17 bag 0

Zeigler-Rodent Irr 0 Alfalfa Diet 0

HALO ORANGES 24 LBS

TD 88137 1 cs (exp) TD 08485 2 cs (exp)

HYDRO GEL (cs) DIET GEL (cs) MORSEL TREATS (2choc/2grp)

NIH- 41 IR RODENT DIET (33 lb) NIH- 41 IR MEAL (33 lb)

SQUIRREL MONKEY DIET

MONKEY CHOW (25lb) RODENT TREATS (cs)

BANANA PELLETS

Nip Rodent Zeiglaer Blue 6 Nip Rodent Zeigler Yellow 3 Peanuts 0 Popcorn 2 bags Popcorn poppers 3

NTP 2000 186

NIH-07 43

D12451+ (box) 3

Feeders 0 IVC Blue line mouse cages 0 Blue line Bonnets 0 Metal cages 0

ITEM # SERIAL NUMBER ITEM

2 FISH RACKS SYSTEM 2 TAN CABINET

FISH TANKS & LIDS 297 TERMINAL CART

1 YSI MONITORING 1 FDA 4005239 PHONE

1 MILLIPORE FILTERING SYSTEM 0 F9SN22546C PLASTIC ROLL CART

BREEDER TANKS 11 PLASTIC 5 SHELF STORAGE RACK

SWEETWATER FISH PUMP 3 S/N 909 4 SHELF WIRE RACK

S/N 315 PLASTIC TRASH CAN

S/N 1009 BALANCE

IWAKI AQUARIUM PUMPS 2 S/N 803121231 INCUBATOR (surplused)

S/N 1504091521 LAMPS

S/N 803121231 PLASTIC CONTAINER SHORT

UV STERILIZERS 2 S/N 80159712 PLASTIC CONTAINER LONG W/LIDS

S/N 411205301 METAL TABLE

MILLIPORE PRETREATMENT FILTERS 0 FISH FOOD

MILLIPORE TS 2 FILTER 0 TROPICAL FLAKES 5LBS/CS

AQUARIUM HEATERS 8 RACEWAY PLUS PELLETS (LBS)

4 INCH FISH NETS (12/CS) 3cs AP100 LARVAL FEED (CAN)

SODIUM BICARBONATE 2bgs BRINE SHRIMP (CAN)

SEA SALT 2.5cs FISHER BTAND PIPETTE

REEF CARBON (BUCKET) 2

50 MICRON FILTERS 30

100 MICRON FILTERS 26

UV LAMPS 2

UV QUARTZ SLEEVES 2

SUMP FILTERS (30/PK) 4pk

BLACK FISH NETS (4 IN) 10

BLUE FISH NETS (4 IN) 0

BLUE NETS (8 IN) 10

# SERIAL NUMBER

1.5

1.75

1.5

DESKS 9

MANAGEMENT LAPTOPS 5

MANAGEMENT DESKTOPS 4

FILE CABINETS 18

PRINTERS 5

SCANNER /COPIER/PRINTER 2

MONITOR,KEYBOARD,MOUSE 12

LAMINATING MACHINE 2

TRASH CANS 6

CLOCK 4

PHONE 7

CHAIRS 30

COAT RACK 1

FAX MACHINE 1

TABLE 14

BOOKCASE 4

PAPER CUTTER 1

VIZIO TELEVISION 1

OLD TYPEWRITER 0

FOUR SHELF RACKS 5

KEYBOARDS 10

Appendix 3: Facility Floor Plans

February 28, 2019

March 6, 2019

March 6, 2019

Appendix 4: Quality Assurance Surveillance Plan (QASP)

Appendix 4 - Quality Assurance Surveillance Plan

Performance Objective

Performance Standard

Acceptable Quality Level

(AQL)

Assessment Method

Incentive

Remedy

Maintain high percentage of AALAS-certified technicians.

PWS 4.1.9

Technical workforce will be maintained at ≥ 85%

AALAS-

certified.

95% compliance.

workforce includes foremen, technicians, assistant technicians, and production aides.

COR review of monthly AALAS Certification Report.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years or future awards.

Government will provide notification of noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until acceptable at no additional cost to the Government.

Ensure keys &/or PIV cards are not lost or used by unauthorized persons.

PWS 4.1.5

Report loss or misuse of keys &/or cards to COR within 24 hours. No incidences of keys or cards being used by unauthorized persons.

100 % compliance.

NCTR’s Office of Research Compliance and Risk Management will notify COR of any requests for replacement keys or cards.

Investigation of reports of key or card misuse.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Ensure that accurate, up-to-date SOPs are written for areas, operations, and procedures within the Contractor’s responsibility.

PWS 4.1.6

SOPs are established as set forth in

GLP

regulations (21 CFR; Part 58; §58.81) before implementatio n of procedures.

100%

COR

inspections and review of Government QA reports and Contractor QC reports.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years notification of noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance. Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Perform procedures as described in SOPs.

PWS 4.1.6

No SOP deviations that negatively impact study integrity or animal welfare.

SOP deviations that may have a negative impact on study integrity or animal welfare are unacceptable. A small number of SOP deviations (≤ 5 per month) determined to have no negative impact on study integrity are tolerable.

and review of Government QA reports and Contractor QC reports.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance. Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Compliance with Occupational Safety and Health Plan

PWS 4.1.11

Compliance with requirements for PPE, hazardous materials handling, training, waste disposal, etc.

Noncompliance which causes or has the potential to cause a detrimental effect on the health and/or safety of an individual or animal is unacceptable.

Government quality assurance activities;

review of Contractor reports; COR surveillance.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance. Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Medical Examinations of employees prior to working in animal care facilities and annually thereafter.

PWS 4.1.12

No Contractor employee is allowed to work in animal care facilities prior to completion of medical exam. Annual exams are completed as scheduled.

95% compliance.

review of NCTR Health Unit records.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Exemplary data management.

PWS 4.1.13

All records & reports are accurate, up-to-date, and complete.

Data input & documentatio n of work is timely, accurate, and FDA Quality Policies compliant.

Records and reports which are incomplete, inaccurate, illegible, noncompliant with FDA Quality Policies are not acceptable (infrequent minor errors notwithstanding) assurance activities;

review of Contractor documents & reports; COR surveillance.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Accurate Inventory Control.

PWS 4.1.16

Accurate inventory of stored and in-use government furnished supplies, materials, & equipment is maintained.

100 % accuracy of items of ≥ $5000 In value.

95% accuracy of items < $5000.

inspections of facilities/equip ment and review of inventory reports.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Equipment Maintenance Support.

PWS 4.1.17

Equipment is maintained in working condition.

Maintenance/rep air of equipment or submission of WOs/RMRs to have equipment maintained/repai red are affected in a timely manner to ensure equipment is maintained in working inspections of equipment;

review of WOs/RMRs.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Employee Training

PWS 4.1.10

Each employee is certified competent to perform assigned tasks.

>95% observations and review of training records & reports.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Internal Quality Assurance

PWS 4.1.8

Perform audits as per FDA Quality Policies compliance review of audit reports; COR surveillance.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Quality Control

PWS 4.1.7

Documents and facilities are reviewed/ins pected as per the Quality Control Plan.

review of QC reports; COR surveillance.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Facilities & Equipment Sanitation

PWS 4.2.1.2,

4.2.1.3.4, 4.2.1.3.5, 4.2.1.3.12, 4.2.2.1

Facilities and equipment are cleaned in accordance with SOPs and facilities are maintained in a clutter-free inspections;

review of Contractor’s inspection reports.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Assure availability of fresh diet, water, & bedding at all times.

PWS 4.1.22,

4.1.26, 4.2.1, 4.2.1.1, 4.2.1.3.1, 4.2.1.3.2, 4.2.1.3.3, 4.2.1.3.12, 4.2.2.2

Fresh diet, water, and bedding as specified in SOPs or protocols is available to animals at all times; diet, water, and bedding are changed on schedule as per SOP or protocol or more often as necessary to meet performance objective.

reports of noncompliance

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Make daily observations of all animals & promptly report abnormalities

PWS 4.2.1,

4.2.1.3.6, 4.2.1.3.11

Observations of all animals are performed as per SOP &/or protocol.

Any animal showing illness &/or abnormal behavior is promptly reported to Veterinary Services.

and review of room reports.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Maintain a comprehensive environmental and health monitoring program.

PWS 4.1.26,

4.2.1.3.8

Collection of samples for environmental monitoring and collection of biological samples and use of sentinel animals for health monitoring are performed as per SOPs.

95% compliance and review of reports.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

procedures certification.

PWS 4.4

Each technical procedure is performed by a skilled individual who has been certified by the contractor to consistently and accurately perform the procedure.

observations and review of training documentation

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until performance.

PWS 4.4

Protocol performed are consistently accurate and successful by individual.

99% compliance;

however, infrequent, minor errors that do not adversely affect the integrity of the study will be waived.

Review of documentation of errors;

investigation of customer complaints.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance. Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Support large animal preventative medicine program.

PWS 4.3.1.2,

4.3.1.3

Schedules annual physical exams, twice yearly TB testing (NHP only), and parasite screens annually.

Ensures medical records are updated.

Government/

IACUC

inspections

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance. Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Maintain the environmental enrichment program as per SOPs established for all NCTR laboratory animals.

PWS 4.2.1,

4.2.1.1, 4.2.1.3.7

Environmental enrichment devices as prescribed by SOP or protocol will be provided to designated

NCTR

laboratory animals.

Status of environmental enrichment program for NHPs is reported to annually.

(infrequent, minor deviations notwithstanding) review of IACUC records

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability.

If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Maintenance of veterinary medical records

PWS 4.2.1.3.6,

4.3.1.2

Veterinary medical records are accurate and up-to-date.

99% Compliance, minor errors that do not impact the health and welfare of the animals will be tolerated.

Government inspections.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Medications and supplies used in the large animal area are not expired.

PWS 4.3.1.6

Drugs, supplies, materials, etc.

used for veterinary care and for potential B-virus exposures are maintained in a non-expired and “ready-to-use”

Government inspections.

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until

Objective

Performance Standard

Acceptable Quality Level

(AQL)

Submit deliverables as scheduled

All deliverables will be submitted as scheduled unless COR grants exception after receiving request for extension in writing from Contractor.

monitoring

Past performance report card noting standards met or failed.

Positive reports may lead to exercising contract option years.

Negative reports may negatively affect exercising option years noncompliance and Contractor will reconcile immediately or present a plan, within 24 hours of notification, to reconcile noncompliance.

Government will review plan and determine its acceptability. If not acceptable, revised plans will be submitted until cost to the Government