UNITED STATES DEPARTMENT OF AGRICULTURE … · A summary of all the exceptknr is attachad to thh annual report. ... Northern grasshopper mouse Deer mouse ... result in an ode;

ANNUAL REPORT OF RESEARCH FACILITY ( TYPE OR PRINT )

Th~s report IS required by law (7 USC 2143). Failure lo report according to the regulat~ons can See attached form for -

Interagency Report Control No. result ~n an order to cease and desist and to be subject to penalties as provided for in Section 21! add~tional informat~on

Uniformed Services Univ. Of The Health Sciences 4301 Jones Bridge Rd. Bethesda, MD 20814

UNITED STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE

I Telephone: (301 ) -295-1 909

I

3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) 1

1. CERTIFICATE NUMBER: 51 -F-OOO 1 CUSTOMER NUMBER: 432

FACILITY LOCATIONS ( Sites ) - See Atached L~sting

REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets i f necessarv or use APHIS Form 7023A 1 I

FORM APPROVED OMB NO. 0579-0036

Animals Covered By The Animal

Welfare Regulations

B. Number of an~mal bemg bred. cond~tioned, or held for use in teaching, testlng. expenments, research, or surgery but not ye used for such purposes.

Number of animals upon which teaching. research. experiments, or tests were conducted involving no pain, distress, or use o pain-relieving drugs.

D. Number of animals upon which experiments. teaching. research. surgery. or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments. research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments. surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this report

TOTAL NUMBER OF ANIMALS

( COLUMNS C + D + E )

4. Dogs

1 ASSURANCE STATEMENTS I

5. Cats

6. Guinea Pigs

7. Hamsters

8. Rabbits

9. Non-human Primates

10. Sheep

1 1. Pigs

12. Other Farm Animals

Goats

13. Other Animals

Sand Rats

Gerbi l s

F e r r e t s

1) Professionally acceptable standards governing the care. treatment. and use of animals, including appropriate use of anestetic. analgesic, and Banquilizing drugs. prior lo, during. and following actual resf teaching, testing, surgery. or experimentation were followed by this research facility.

2) Each principal ~nvestigator has considered alternatives to painful procedures.

132

3) This facil~ty is adhering to the standards and regulations under the Act. and it has required that exceptions to the standards and regulations be spec~fied and explained by the principal investigator and ap lnst~tut~onal Anlrnal Care and Use Committee (IACUC). A summary of al l such exceptions i s attached t o this annual report. In addition to identifying the IACUC-approved exceptions. this summary In( br~ef explanat~on of the exceptions. as well as the specles and number of animals affected.

4) The attending velennarian for lhis research facility has appropriate authority to ensure Ihe provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use

14

14

498

35

75

11

38

14

14

498

35

75

11

38

CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL ( Chief Executive Officer or Legally Responsible Institutional Official )

NAME & TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL ( Type or Print)

DATE SIGNED

APHIS FO (OCT 88). which 1s obsolete.)

( AUG 91 )

C ,' This report is required by law (7 USC 2143). Failure to report according to the regulations can See reverse side for Interagency Report Control No rewlt in an order to cease and desist and to be subject to penalties as provided for in Section 2150. additional information. 01 80-WA-AN


1 sheets ~f necessary.) I FACILITY LOCAfK)NS(Mes)

US ARMY CENTER FOR HEALTH PROMOTIONS 8 PREV. ABERDEEN PROV GRND. MD 21010

ANNUAL REPORT OF RESEARCH FACILITY (WPE OR PRINT)

REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY (Attach add#bW sheds l necessary or use APHIS FORM 7023A )

1. REGISTRATION NO. CUSTOMER NO. 5 1 -F-0005 436

I 2. HEADQUARTERS RESEARCH FACILITY (Name and Addmss, as registered with USDA,

include Z@ Code) U.S. ARMY CENTER FOR HEALTH PROMOTIONS MEDICALITOXICOLOGY DIVISION 5158 BLACKHAWK RD. MCHB ABERDEEN PROV GRND, MD 21010


Welfare Regulations


1 3. REPORTING FACILITY (List all locations where animals were housed or used in actual research. testing, teaching, or experimentation, or held for these purposes. Attach additional

B. Number of animals being bred, conditioned, or held for use in teaching, testing, experiments. research, or surgery but not yet used for such purposes.

4. Dogs I 5. Cats

6. Guinea Pigs

7. Hamsters

8. Rabbits I

9. Non-Human Primates

10. Sheep

1 1. Pigs

12. Other Farm Animals I

13. Other Animals

Golden mouse I

Kangaroo mouse I ~ y g m y mouse I ASSURANCE STATEMENTS

C. Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain- relieving drugs.

D. Number of animals upon which sxpsriments. teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic,analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. (An explanation of the pmcedures producing pain or dislmss m these animals and the reasons such drugs were not used must be attached to this report)

F.

TOTAL NO. OF ANIMALS

(Cob. C + D + E)

--

1) Professionally acceptable standards governing the care, treatment, and use of animals, indudlng appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by this research faality.

2) Each principal investigator has considered alternatives to painful procedures.

3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the Institutional Animal Care and Use Committee (IACUC). A summary of all the exceptknr is attachad to thh annual report. In . addition to identifying the IACUC-approved exceptions, this summary includes a brief explanation of the exceptions, as well as the species and number of animals affected.

4) The attending veterinarian for this research facility has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use.

CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL (Chief Executive Officer or Legally Responsible Institutional official)

I cetii that the above is true, correct, and complete (7 U.S.C. Section 2143) SIGNATURE OF C.E.O. OR INSTITUTIONAL OFFICIAL NAME & TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL (Type or Print) DATE SIGNED

I I I APHIS FORM 7023 (Replaces VS FORM 18-23 ( ~ c t 88), which is obsolete PART 1 - HEADQUARTERS

(AUG 91)

This report is required by law (7 USC 2143). Failure to report according to the regulations can . .res::lt in an order to cease and desist and to be subject to penalties as provided for in Section 2150. See reverse side for additional informetion.

Interagency Report Control No 01 80-DOA-AN

FORM APPROVED OMB NO. 05794036


CONTINUATION SHEET FOR ANNUAL REPORT OF RESEARCH FACILITY

(TYPE OR PRINT)

- aspects of animal care and use.

CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL

1. REGISTRATION NO. CUSTOMER NO. 5 1 -F-0005 436 .

2. HEADQUARTERS RESEARCH FACILITY (Name and Address, as registered with USDA, includeZ@ Code)

U.S. ARMY CENTER FOR HEALTH PROMOTIONS MEDICAL/TOXICOLOGY DIVISION 5158 BLACKHAWK RD. MCHB ABERDEEN PROV GRND, MD 21010

(Chief Executive Officer or Legally Responsible Institutional official) I cet i i that the above is true, correct, and complete (7 U.S.C. Section 2143)

SIGNATURE OF C.E.O. OR INSTITUTIONAL OFFICIAL NAME & TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL (Type or Plint) DATE SIGNED

REPORT OF ANIMALS USED BY

A.


Welfare Regulations

Fulvous hawest mouse

W hite-footed mouse

Northern grasshopper mouse

Deer mouse

Hispid cotton rat

Marsh rice rat

Meadow vole

ASSURANCE STATEMENTS

1) Piofessionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be speciRed and explained by the principal investigator and approved by the Institutional Animal Care and Use Committee (IACUC). A sumnwy of all the exceptions h attached to this annual report In addition to identifying the IACUC-approved exceptions, this summary includes a brief explanation of the exceptions, as well as the species and number of animals affected.

4) The attending veterinarian for this research facility has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other

OR UNDER CONTROL OF

B. Number of animals being bred, conditioned, or held for use in teaching, testing. experiments, research, or surgery but not yet used for such purposes.

I

I I I APHIS FORM 7023A (~epl-s VS FORM 18-23 (oct 88), which is obsolete PART 1 - HEADQUARTERS

(AUG 91)

RESEARCH FACILITY

C. Number of animals upon which teaching, research, experiments. or tests were conducted involving no pain, distress, or use of pain- relieving drugs.

7

84

2

53

1

28

(Attach add#bnal sheds irnecessary

D. Number of animals upon which experiments. teaching, research. surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

33

- -- -

or use this form.)

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic,analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. (An explanation of the procedures producing pain or distress in these animals and the reasons such dnrgs were not used must be attached to this report)

- - -- - - - - - - - - -

F.


(Cols. C + D + E)

7

84

2

33

53

1

28

This reDort is required by law (7 USC 2143). Failure to report according to the regulations can O C T ~ 4 2 O b L & e d f m f m additional information. result in an ode; to cease and desist and to be subiect to.oenalties as ~rovided f i r in Section 21!

Interagency ~eport Control @) 0.:



I . REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tes

I 1. CERTIFICATE NUMBER: 51 +-0008

CUSTOMER NUMBER: 438

FORM APPROVED OM8 NO. 0579-0036

National Cancer Institute Frederick Cancer Research Building 429 P.O. Box B Frederick, MD 21702

pp -

ling, or experimentation, or held for these purposes. Attach additional sheets if necessary ) I

Anlmals Covered By The Animal

Welfare Regulations

4. Dogs - --

5. Cats -

6. Guinea Pigs - 7. Hamsters

8. Rabbits


10. Sheep

11. Pigs


13. Other Animals

F.

NUMBER OF


FACILITY LOCATIONS ( Sites ) - See Atached Listing

I ) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to. during, and following actual res€ teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions h attached to this annual report In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.


REPORT OF ANIMALS

fl


CERTiFlCATlON BY HEADQUARTERS RESEARCH FAClLlTY OFFICIAL ( Chief Executive Officer or Legally Responsible Institutional Official )

CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessaw or use APHIS Form 7023A \ USED BY OR UNDER

8. Number of animal being bred, conditiopd, or held for use in teaching, testing, experiments. research, or surgery but not yo used for such PUrpoS-

NAME 8 TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL ( Type or Print)

b ?

which is obsolete.)

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl

C. Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain. distress, or use o pain-relieving drugs.

mm 0 --

D. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

This report Is rrquked by law (7 USC 2143). FJlm La Rpar( .ecording to We ngukllona a n result In an order to curr and d d s l and to be subjea b peMIUes 88 provlded for In Section 21!


ANNUAL REPORT OF RESEARCH FACILITY ( TVPE OR PRINT )

I n w e n e y R.port Canlrd No.: 7 1. C~RNFICATE NUMBER: 51 -~-0025 I FORM APPROVED

OM8 NO. a5790038 CUSTOMER NUMBER 12780 I

Center For Drug Evaluation And Research / White Oak Animal Program 7519 Standish Place, Room 148 Rockville, Md 20855 Telephone:301-827-4172

1 REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEAR - -

6. Number al a n l d s bang brd, eondluoned. a held for use in teaching, tostlng. exparimwb, -, 01 wr~srybutnotye used for wch P'Jrporas.

---

C. Numbud Pnimrls upon which wchhg, research. -or tesb mvs conducted lnvdving no psln, d~stresa, or use a , p a M 4 . g drugs.

4. Dogs I I 5. Cats

6. Guinea Pigs

2H FACILITY I Attach addltlonrl sheets If neceuuv or u.0 APHIS Form 7023A I

D. N u n b w d a l ~ s u p a r VVhkhexPedmmtr, I - -w,rareuch, sufgay, o r b r t s w e ,

-1mrdvlnO Ice#npenylna pain or distress to the 8nlnmls an forwhlch epproprllle ~ a t h d c , arulgsdc, or bsnq-w dwP- used.

E. Numkt d rnknrSl upon which teaching, axpedmmts,

0. Rabbits

0. Nonhuman Primate8 - --

10. Sheep

\ 11.pig8

, 12. Other Farm Animals

13. Other Animals

I ASSURANCE STATEMENTS



-aL7c, See attached form for Interagency Report Control No.: additional information.

* This report Isrfl,quired by law (7 USC 2143). Failure to report according to the regulations can result in an order to cease and destst and to be s u b i to oenalties as orovided for in Section 21!


1. CERTIFICATE NUMBER: 5 1 -~-0026 FORM APPROVED I OMB NO. O!Vg-OO% CUSTOMER NUMBER: 12782 I

Center For Veterinary Medicine 7500 Standish Place Rockville, MD 20855 PEG 0 12004 ANNUAL REPORT OF RESEARCH FACILITY

( TYPE OR PRINT )

Telephone: (301) -827-41 72

3. REPORTING FACILITY ( List all locations where animals were housed or used in achral research, tes 1, or experimentation, or held for these purposes. Attach additional sheets if necessary )


REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach addltlonal sheets if necessaw or UM, APHIS Form 7023A 1 L

B. Number of animal being bred, conditioned. or held for use in teaching, testing. experiments. research, or surgery but not y~ used for such purposes.

c. Numberof animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.

D. Number of animals upon which experiments, teaching, research. surgery, or tests were conducted invdving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reas such drugs were not used must be attached to this report


Animab Covered By The Anlmal

Welfare Regulations ( COLUMNS C + D + E )

4. Dogs

5. Cats

6. Guinea Pigs I 7. Hamsters

8. Rabbits -----t--- 10. Sheep


13. Other Animals I

1) Prof8ssionally acceptable standards governing the care. treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual resc teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A s u m a y of all such exceptlorn is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary in< brief explanation of the exceptions, as well as the species and number of animals affected.



DATE SIGNED

I / ~ O / Q Y

hich is obsolete.) (

Facility Location: Certificate # 5 1 -F-0026

US FDA Center for Veterinav Medicine Office of Research 8401 Muirkirk Road Laurel, MD 20708

This mpwl Is required by law (7 USC 2143). Failura to repad according lo the rsgulalions can ~mladledformlor h,lerBgency RcportCon(rd No.: V result In M order b cease Md deslst and to be subject b paultles as prwlded lor in Scctkn 21! ~ U a u l Wmtlm.

UNITED STATES DEPARTMENT OF AGRICULTURE 1. CER~~F~CATE NU-ER: 5 1 - F - 0 0 2 7 FORMAPPROMO ANIMAL AND PLANT HEALTH INSPECTION SERVICE OMB NO. 05780036

CUSTOMER NUWER: 1 2 7 8 3


Center for Devices and Radiologica: Health 7519 Standish Place, Room 148 Rockville, MD 20855 Telephone: 301-827-4172

This report is required by law (7 USC 2143). Failure to report according to the regulations can See reverse side for resutt In an order to cease and desist and to be subject to penalties as provided for in Section 2150. additional information.


UNITED STATES DEPARTMENT OF AGRICULTURE 1. REGISTRATION NO. CUSTOMER NO. ANIMAL AND PLANT HEALTH INSPECTION SERVICE 51 -R-0003 79 FORM APPROVED

OMB NO. 0579-0036 I

ANNUAL REPORT OF RESEARCH FACILITY 2. HEADQUARTERS RESEARCH FACILITY (Name and Address, as rqstered wnh USDA,

include Zip Code)

(TYPE OR PRINT) BlORELlANCE CORPORATION 14920 BROSCHART ROAD ROCKVILLE, MD 20850

I

3. REPORTING FACILITY (List all locations where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes. Attach additional sheets if necessary.)

FACILITY LoCAllONS(sites)

BIORELIANCE CORPORATION ROCKVILLE, MD 20850

I

REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY (Attach addidionel sheets if necessary or use APHIS FORM 7023A )


Welfare Regulations

4. Dogs I

B. Number of animals being bred, conditioned, or held for use in teaching, testing, experiments. research, or surgery but not yet used for such purposes.

5. Cats

6. Guinea Pigs I 7. Hamsters

8. Rabbits I 9. Non-Human Primates

10. Sheep

1 1. Pigs


13. Other Animals


C. Number of D. Number of animals upon animals upon which experiments, which teaching, teaching, research, research. surgery, or tests were experiments, or conducted involving tests were accompanying pain or conducted distress to the enlmals involving no and for which appropriate pain, distress, or anesthetic, analgesic, or use of pain- tranquilizing drugs were relieving drugs. used.

E. Number of animals upon which teaching, F. experiments, research, surgery or tests were conducted involving accompanying pain or distress TOTAL NO. to the animals and for which the use of appropriate OF ANIMALS anesthetic,analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or (Cols. C + interpretation of the teaching, research, D + E) experiments, surgery, or tests. (An explanation of the pmcedures pmducing pain or distress in these animals and the reasons such drugs were not used must be attached to this repod)

1) Professionally aueptable standards governing the care. treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during. and following actual research, teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the Institutional Animal Care and Use Committee (IACUC). A swnmary of all the exceptions Is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary includes a brief explanation of the exceptions, as well as the species and number of animals affected.



I c e t i i that the above is true, correct. and complete (7 U.S.C. Section 2143) SIGNATURE OF C.E.O. OR INSTITUTIONAL OFFICIAL NAME & TITLE OF C.E.O. OR INSTlTUTlONAL OFFICIAL (Type or Print) DATE SIGNED

11/12/2004

APHIS FORM 7023 (Replaces VS FORM 18-23 (Oct 88), which is obsolete PART 1 - HEADQUARTERS (AUG 91)

, This report is req!rired by law47 USC 2143). Failure to report according to the regulations can result in an order t , cease and desist and to be subject to penalties as provided for in Section 21!

UNIT9ED STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE-


See attached form for additional information.

Interagency Report C@/

I I

1. CERTIF~CATE NUMBER: 5 1 -~-0004 FORM APPROVED OM8 NO. 0579-0036

CUSTOMER NUMBER: 80

I I

3. REPORTING FACILITY ( List all locations *ere animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) I

Virion Systems Inc 9610 Medical Center Drive Suite 100 Rockville, MD 20850

Telephone: (301) -309-1 844


I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessarv or use APHIS Form 7023A 1 I B. Number of animal

being bred. conditioned, or

Animak Covered held for use in By The Animal teaching, testing,

Welfare Regulatlonr experiments, research, or surgery but not ye used for such PUT'-. I

4. Dogs I m

5. Cats I

7. Hamsters

8. Rabbits


10. Sheep

11. Pigs


13. Other Animals

C. Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use u pain-relieving drugs.

D. Number of animals upon which experiments, teaching, research. surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquiliring drugs were used.


1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reas such drugs were not used must be attached to this reporl

I

I

teaching, testing, surgery, or experimentation were followed by this research facility.

F.

NUMBER OF



3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and aP Institutional Animal Care and Use Committee (IACUC). A s u m of all such exceptions k attached to this annual report. In addition to identifying the IACUCapproved exceptions, this summary in< brief explanation of the exceptions, as well as the species and number of animals affected.


CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL fficer or Legally Responsible Institutional Official )

( AUG 91 )

DATE SIGNED

*

APHIS FORM 7023 (Replaces VS FORM 18-23 (OCT 88), which is obsdete.)

NAME 8 TITLE OF C.E.O. OR INSTITUTIONAL OFFlClAL ( Type or Print /

Listine of Actual Facility Sites for Virion svstems. Inc,

1. Research Facility: Virion systems, Inc. * 9610 Medical Center Drive Suite 100 Rockville, Maryland 20850 (301) 309-1844

2. BreedingIHolding Facility: Virion systems, Inc.* 9620 Medical Center Drive Suite 102 Rockville, Maryland 20850 (301) 294-8061

* Animals are housed in the vivariums of both facilities.

. Noted Exce~tIons to the Redations and Stmdards

1. Rodents experiencing difficulty obtaining feed suspended in a wire bar lid or masticating biscuits are provided feedlfines or moistened feed on the floor of the cage. * *

2.Waste that is, or may be perceived to be, contaminated by biohazards is disposed of using Medical Pathological Waste boxes, which remain, uncovered until sealed for incineration.*' **

* The materials in these boxes are items such as exam/surgical gloves, disposable

drapes /toweling, gauze squares, closed tubes, large sharps containers, etc. Carcasses are kept in a carcass freezer until the disposal company arrives for pick-up. Then the Medical Pathological Waste bags and transport boxes are sealed. (The boxes are lined with biohazard bags).

** Both of the above mentioned items that deviate from the Animal Welfare Regulations and Standards have been discussed and approved by the entire IACUC Committee. At every meeting the two exceptions are discussed to see if it is necessary to continue having these items as exceptions to the regulations.

ease-for the Excepbons. b

1. Cotton rats being wild rodents feed differently than regular laboratory rodents. They also have a different body shape. These two items sometimes constitute a need to have rodent chow or another appropriate diet easily available to them. For example, heavily pregnant cotton rats sometimes have a difficult time sitting up on their haunches to get food when they are full term. Also cotton rats have a tendency to chip or break their incisors when attempting to escape. Therefore they often will not be able to obtain food through the bars of a wire bar lid and will not be able to chew standard rodent chow, so they are given a soft, balanced rodent diet until their incisors grow out. At what time the pregnant female delivers and/or the incisors have grown back, the animal is returned to being fed from a wire bar lid.

2. The MPW transport box is prepared in advance and lined with 2 biohazard bags. Any contaminated item or perceived contaminated item is placed into the box to await pick up. Sharps are in a contained, sealed secondary safety container. Any oozing, leaking, or odiferous items must be contained and placed in a secondary container prior to placing them in the MPW box (tissues, carcasses). These items are frozen and placed in the box just prior to being removed for incineration. The reasoning behind this is to reduce the number of places where biohazard items or those perceived as such are kept prior to pick up. The boxes are vividly marked as to what they contain and are kept in an out of the way area.

--------- ------ ------------- IACUC Chairperson

(b)(6), (b)(7)c

%is re~ort is required by law (7 USC 2143). Failure to report according to the regulations can DEC ~ 7 2 0 0 1 ,",,g,*,:z~. result in an order to cease and desist and to be subject to penalties as provided for in Sedion 21! .

-



Johns Hopkins University, The 459 S Ross Building 720 Rutland Avenue ~altimore, MD 21205

I Telephone: (41 0) -502-0421

1. CERTlFlCATE NUMBER: 51 -R-0006

CUSTOMER NUMBER: 81

I

REPORTING FACtLlM ( List ail locations where animals were housed or used in actual research, testing, or experimentation, or hdd for these purposes. Attach additional sheets if necessary )


- ---


r

I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY Attach additional shear if necessaw or use APHIS Form 7023A 1 I

Anknrlr Covered By The Animal

Welfam Regulations

B. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research. or surgery but not yc used for such purposes.

4. Dogs 0

5. Cats I 2a 6. Guinea Pigs

n 7. Hamsters 0

8. Rabbits 0

9. Non-hurnan Primates 2 2 9 10. Sheep 0

11. Pigs 0


13-&inrhilla 0

13. Other Animals


C. Number of animals upon which teaching, regearch. experiments, or tests were conducted involving no pain, distress, or use v pain-relieving drugs.

b. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted invdving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests wen conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretaUon of the teaching, research, expedments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these anlmals and the reasc such drugs m not used must be attached to this reporl



1) Profdonally -table standards governing the care, treatment, and use of animals, induding appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to. during, and following actual rest teaching, tesbng, surgety, or experimentation were followed by this research facility.

2) Eech principal investigator has considered alternatives to painful procedures.

3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be s p d e d and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summay of all such excoptiom h athched to thts armurl repoft. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the spedes and number of animals affected.

4) The attending veterinarian for this research fadlity has appropriate authority to enswe the provision d adequate veterinary care and to oversee the adequacy of other aspects of animal care and use.

CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL ( Chief Executive Officer or Legally Responsible InstiMional Official )

DATE SIGNED

1s -2- vy

e.)

NAME & TITLE OF C.E.O. OR INSlllWTIOE(AL OFFICIAL ( Type or W ) '

Johns Hopkins University Research Registration No. : 5 1-R-006 FY >04 USDA Annual Report

IACUC approved exceptions to AWA regulations:

A. Not cleaning or sanitizing at required frequencies. 1. Two cats are used for studies involving human allergy to cats. These animals are housed in a small room resembling an apartment to replicate conditions in a normal human household. The room has a rug, a bed with sheets, litter pans, food and water containers and portable cages. The cats deposit hair, dander, and other allergens on the sheets. Humans are exposed to these allergens by either entering the housing room, or by exposure to air from the room. At the request of the investigator, and approved by the IACUC the following room husbandry procedures are followed:

a. The room floor is mopped with clean water only b. The sheets are laundered only when changed by the investigator c. The rug is not vacuumed or shaken except by the investigators when they collect material for experimental challenges.

2. A number of baboon cages are machine sanitized at 3-5 week intervals rather than the required two-week interval. These are cages in which baboons have been fitted with chronically indwelling intravenous or intragastric catheters, which are protected by a tether and harness system. The back of the cage contains an instrument panel with levers and lights that the baboon uses to produce food pellets and/or drug delivery. To sanitize the cages, the animals must be chemically restrained (ketamine hydrochloride), and the system must be dismantled. The baboon must be chemically restrained on ketamine until the cage wash is complete and the system reassembled (about 30 min). (This time is used to perform a physical examination of the baboon, shave and scrub the catheter

exit site, clip nails, clean teeth, obtain a body weight, etc). For some studies, the administration of a drug like ketamine and the interruption of daily experimental assessment would introduce a potentially confounding variable if an arbitrary two-week (or shorter) interval were chosen. At the request of the investigator, the IACUC approved a maximum interval of up to 5 weeks between machine sanitization. All other routine husbandry procedures, including the cleaning of cage pans, are done on schedule. In addition some cleaning of the cage bars can be accomplished as needed when the baboon is in the cage to maintain the environment as clean as possible.

B. Providing space outside of that specified by the standards. 1. We occasionally house two juvenile monkeys in cages that contain a total of 6 square feet of floor space. These cages are 60 inches high however, so they contain a total of 30 cubic feet. The veterinary medical officer felt that with the installation of additional perches these cages could be approved by the IACUC for holding two juvenile animals. As necessary and when additional perches are installed animals will be pair housed in these cages.

2. As part of a vaccine study, monkeys will be pair housed in a 4 sq ft Horsfall isolator for up to 21 days to prevent exposure of personnel to infectious agents. Monkeys will be returned to normal after confirmation that they are no longer shedding the infectious agents.

3. As part of imaging studies, dogs will be housed in a 9.2 sq ft, 35.5 inch high cage for up to 10 days to contain radionuclides used in the study. This housing is required to assure personnel safety

and prevent environmental contamination.

C. Exemption from the institution's environmental enrichment program and use of alternative oxr rams - during study.

1. The investigator requested and obtained an exemption from the IACUC from the requirement for social housing and/or environmental enrichment as described in the institution's Primate Environmental Enrichment Program. Prior to behavioral training, or viral infection we routinely house compatible animals together in pairs, triples or groups, depending on their age and sex. In addition, the standard cage enrichment and novel food enrichments are made available. However, if there is a behavioral component to the study, animals must be individually housed for training on to the tasks using computerized response boards (food pellet reward), or non-computerized manual dexterity devices (raisin puzzle feeder). During this time other enrichment devices may not be used. It is important to consider, however, that the animal's use of the computerized board or manual device certainly provides enrichment. The investigators will try to pair house animals during the weekends if it does not interfere with the training. During infections animals may or may not be pair housed. Animals will be singly housed if necessary to complete the study goals.

2. As part of a study of control of appetite, satiety and gastric motility non human primates will be singly housed, however, they will be provided with toys, remain within visual and olfactory contact with other monkeys, and will interact with humans.

D . Exemption form normal environmental temperature requirements. 1. As part of a study of effects of different drugs on the brain, squirrel monkeys will be maintained in an environmental chamber at 33 OC [9 1.4 OF] for 12 hours.

' I l ~ c lol~ns Hopkins University 705 N. Wyman Park Center 3400 N. Charles Street Baltimore, MD 2 12 1 8-2692

FY 2004 USDA Annual Report

3. Facility locations

Site 001 : Colleges of Arts and Sciences and Engineering Site 003: Bloomberg School of Public Health Site 0 14: Research Farm Site 01 5: Bayview Medical Center Site 01 7: Medical Institutions Site 023: IACUC Records


This report is required by law (7 USC 2143). Failure to report according to the regulations can result in an order to cease and desist and to be subject to penalties as provided for in Section 21!

b

UNITFD STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE

Insect Control & Research Inc. I

1. CERTIFICATE NUMBER: 51 -R-0008

CUSTOMER NUMBER: 82


FORM APPROVED OM8 NO. 05794036

1330 Dillon Heights Avenue Baltimore, MD 21228

I Telephone: (41 0) -747-4500

3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tes I

I, or experimentation, or held for these purposes. Attach additional sheets if necessary )


B. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not ye used for such purpo=.

C. Number of animals upon which teaching, research. experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.

0. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted invdving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl




4. Dogs

5. Cats I 6. Guinea Pigs I 7. Hamsters I 8. Rabbits I 9. Non-human Primates

10. Sheep I 11. Pigs I 12. Other Farm Animals + 13. Other Animals

( ASSURANCE STATEMENTS

1) Rofessionally acceptable standards governing the care, treatment, and use of animals, induding appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual rest teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptlorn is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary inc brief explanation of the exceptions, as well as the species and number of animals affected.



( AUG 91 )

DATE SIGNED

9/21/04

e.)

This report is required by law (7 USC 2143). Failure to report according to the regulations can OCT 1 52004 See attached form for result in an order to cease and desist and to be subject to penalties as provided for in Section 21! additional informetion.

L UNITED STATES DEPARTMENT OF AGRICULTURE

I ANIMAL AND PLANT HEALTH INSPECTION SERVICE


3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tes

Interagency Report Control w 1. CERTIFICATE NUMBER: 51 -R-0009 FORM APPROVED V

OM6 NO. 0579-0036 CUSTOMER NUMBER: 83

Medirnmune Inc 35 W. Watkins Mill Road Gaithersburg, MD 20878

Telephone: (301 ) -41 7-0770

I, or experimentation, or held for these purposes. Attach additional sheets if necessary) I

Animah Covered By The Animal

Welfare Regulations

B. Number of animal being bred. conditioned, or held for use in teaching, testing, experiments. research, or surgery but not yc used for such purposes.


REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessarv or use APHIS Form 7023A ) I

4. Dogs

C. Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.

D. Number of animals upon which experiments. teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of anlmals upon which teaching, experiments, F. research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res OF

or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures ( COLUMNS producing pain or distress in these animals and the reasc C + D + E ) such drugs were not used must be attached to this reporl

6. Guinea Pigs I I 7. Hamsters 7 r 8. Rabbits

I rn

9. Nan-human Primates I 10. Sheep

11. Pigs I I

12. Other Farm Animals 1

I

13. Other Animals

- -

1 ASSURANCE STATEMENTS

1) Pr0f~ssi0nall~ acceptable standards govemlng the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual rest teachng, testing, surgery, or experirnentatlon were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to thb annual report. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.

4) The attending veterinarian for this research facility has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use. A


SIGNATURE OF C. TE SIGNED

3. Reporting Facility As of June 29,2004:

One MedImmune Way Gaithersburg, MD 20878

Telephone: 30 1-398-0000

ANNUAL REPORT OF RESEARCH FACILITY ( n p E OR PRIM )

Sinai Hospital Of Baltimore, Inc. Hoflberger #42 2401 W. Belvedere Avenue Baltimore, MD 21215

9. Nan-human Rm\aw

10. Sheep

11. PQS

12. Other Farm Anlmalr

Telephone: (4 10) 401-5544

JSED BY OR UNOER CONTROL OF RESEARCH FACUM ( Anach rddltlond sheets If m c n w or uw APHIS Fonn 7QSA 1 1 I

F.

TOTAL NUMBER OF ANUALS


This report is required by law (7 USC 2143). Failure to report according to the regulations can CT 1 5 m S e e attached form for additional information.

I I 1. CERTIFICATE NUMBER: 51 -~-0012

CUSTOMER NUMBER: 86 I FORM APPROVED OM6 NO. 0579-003

result in an order to cease and desist and to be subject to penalties as provided for in Section 21!



3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tes

Towson University 8000 York Rd Towson, MD 21252

Telephone: (41 0) -704-2236

I, or experimentation, or held for these purposes. Attach additional sheets if necessary ) 3 FACILITY LOCATIONS ( Sites ) - See Atached Listing

Animals Covered By Tho Animal

Welfare Regulations

4. Dogs

B. Number of animal being bred. conditioned, or held for use in teaching, testing, experiments, resetarch, or surgery but not yt: used for such purposes.

C. Numberof animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.

5. Cats N/A 6. Guinea Pigs N/A

7. Hamsters N/A

8. Rabbits N/ A 9. Nyhuman Primates 1 :; 10. Sheep

11. Pigs I N/A 12. Other Farm Animals I N/A

I A & ~ E STATEMENTS

D. Number of animals upon which experiments. teaching, research. surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, F. research, surgery or tests wetre conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz NUMBER

drugs would have adversely affected the procedures, res OF

or interpretation of the teaching, remarch. experiments, surgery, or tests. ( An explanation of the procedures ( COLUMNS producing pain or dislress in these animals and the re- C + D + E ) such drugs were not used must be attached to this reporl

I I 1) hofessionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual rest .



3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and exolained by the ~ r inc i~a l investigator and ap institutional Animal Cire and Use Committee (IACUC). A summary of all such exciptiom is attached to this annual report, In addition to identifying the l ~ d ~ C - a ~ ~ r a v e d &&tions, thisiummary in( brief explanation of the exceptions, as well as the species end number of animals affected.


CERTIFICATION BY HEADQUARTERS RESEARCH FAClLrrY OFFICIAL ( Chief Executive Officer or Legally Responsible Institutional Official )

NAME TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL (Type or Print)

DATE SIGNED

APHIS FORM 7023 (Replaces VS FORM 18-23 (OCT 88), which is obsolete.)

( AUG 91 )

Customer ID and Site Address:

ID: 86 Smith Hall Towson University 8000 York Road Towson, MD 21204

Telephone: (4 10) 704-306 1

I Cwmrnune Sciences. Inc. ANNUAL REPORT OF RESEARCH FACILITY 8075 Greenmead Drive

( TYPE OR PRINT ) College Park, MD 20740 JEC 0120D+

This qOi, i s r q ~ t e d DY iaw(7 USC 21431 Failwe torepcd accadlng bthereguiation~ cen See MMed form f a interagency Rwon mwol w.. resuii in an order to cease and desist and io be subW b psrutua aswmed for in Secllon 21: addillmi id-Urn.

I I Telephone: (301) -445-4220

UNITED STATES DEPARTMENT O F AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE

P I

3. REPORTINQ FACILITY (US all 1ocaUMaMmra snlmsls were houaad a used in asUa1 raswm. Imling. a arpmmniatim, a W d l w mesm pu-. MaCn addliianal sheers ilnrc-ry )

FACILITY LOCATiONS ( Silm 1 - Sas A w e d ushng

1. CERTIFICATE NUWER: 51-R-0013 I FORM APPROVED OM8 NO. 05796036

CWTMIER NUMBER: 76

REPORT OF ANIMALS USED BY OR UNDER CONTROL O F RESEARCH FACILITY I A l t l c h addnhmal sheets if m s u r v or uu APHIS Form 7023A I

B. Numb* d animal Wng bred. Umdittmed. w hWd for Use in leachmg, ienllng. e-mnts reseerch, w NgenlbVlnMW uaad for ourtl wD==%

C. Nvmhvd animals uw vhl* leaching, WeaICh, alpaimants, or lest. m mndUchld invdvlng no pain. m l l g s . a o pain-robing h g n .

E. Nm4wdsnoMls upm u h i 6 leaching, ameornsnls. r t ~ a m . suw a tmb wm mnducted invoivrng accapanrq win a diswss to fha animals and for uh the uls ofappmpnate ansrthaic, analgssic, w tranqu,iiz drugs w i d hew a d m y m a d the procedures, res a innpstaarn dm. teacniw, -d, exp.nmenb. surgav. at-. I m ewianaurn d the pmcsdunrs pradudng p3n w d i m in t h w animain and the ressr wen hupl w~ n~ u m 4 met M anached io this repan

13 Other An~mals

-- - i-

F.

'OTAL NUMBER OF AN'mLS

( COLUMNS c + D + E )

6. Guinea Pigs

7 Hamsters

8. Rabbits -

9. Non-hurnan Primates

3) mis facihty is adhdns to me standards andrepulaths vndsr 1-e m, and it h.a rsqdw that sxoaptim to fha siwderde and regdsbon?r be $&Red and explained by the pnntipai 8nwstigatar and np inslutionai Anlmai Care and Use Cornminee IIACUC). A s- drll such ~ r ~ e p l l o r m is atUshed I@ mh annual wm h addition UI i hu l t iwg ma I.GeG~pproved sxceplms. mi$ summary in< bnd expianalion Mthe exceptianr, as well e the rwla and n v m otanims an&)ed.

4) The anendlng vetemanan ior lhls m s a r d ~ fadlih has apvmp~steaulhadhto mwn h. pmnm d ldeqw ls Wmnary m and to DMIM. h. ad+quacydDlher aspects d anma1 care and use

CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL I ~ ~~ ~-

( C h M Exmmw ORcer or Legaliy Responribls l n s m u t l o ~ l mdel )

NlME 6 TITLE OF C.E.O. OR INSTITUTIOIUL OFFlClAL ( T w w Rnt) DATE SIGNEC

n f t t i s ~ o n u 7023 (nviacea vs FOW 18-23 (OCT 88). is obedefe.) IAUG91 I

9

--

1 7 -

- --

77.

Column E Explanation

This form is intended as an aid to completing the Column E explanation. It is not an official form and its use is voluntary. Names, addresses, protocols, veterinary care programs, and the like, are not required as part of an explanation. A Column E explanation must be written so as to be understood by lay persons as well as scientists

1. Registration Number: 51 -R-001 3

2. Number 3 7 of animals used in this study.

3. Species (common name) -4 t of animals used in the study.

4. Explain the procedure producing pain andlor distress.

Rabbits were injected intravenously with varying doses o f recombinant human Tumor Necrosis Factor alpha (rhTNF) or rhTNF bound to 25 nm colloidal gold particles (rhTNF-cAu). rhTNF- cAu i s being developed as a new cancer treatment, and based on extensive murine studies the new drug is both safer and more effective at reducing tumors than rhTNF alone. As part o f our efforts to bring this new drug entity into a first-in-man clinical trial, the FDA requires that we conduct a toxicology study in a second, non-rodent species. Based on our pre-1ND meeting with the FDA panel, i t was agreed that rabbits could be the species of choice for such a toxicology study. I t i s well-known in the literature that intravenous administration o f native rhTNF at specific doses can cause fever, malaise, hypotension, gastrointestinal distress, including a cessation in eating, organ failure and death. Conversely, the colloidal gold nanoparticles are safe and have been used clinically for over 30 years. Rabbits were injected with doses o f rhTNF-cAu that were known to cause fever, malaise and gastrointestinal distress, but were not fatal.

5. Provide scientific justification why pain andlor distress could not be relieved. State methods or means used to determine that pain andlor distress relief would interfere with test results. (For Federally mandated testing, see Item 6 below)

Scientifically, the study was designed to determine toxic effects o f rhTNF-cAu, so anesthesia or other palliative measures could not be taken. Each rabbit was monitored closely throughout the 8-hour maximum acute toxic period, and clear, defined measures o f clinical distress were established prior to treatment. Additionally, all animals were observed each day following treatment until normal eating, drinking and activity were re-established. If, during the acute toxicity period, a treated rabbit exhibited significant adverse effects over two consecutive 60- minute observation periods, then the animal was to be euthanized. No animals met these criteria and all treated animals resumed normal behavior within a maximum of 3 days post-treatment.

6. What, if any, federal regulations require this procedure? Cite the agency, the code of Federal Regulations (CFR) title number and the specific section number (e.g., APHIS, 9 CFR 113.102):

Agency CFR

Interagency Report Control fl See attached form for additional information.

This report is [equired by law (7 USC 2143). Failure to report according to the regulations can rewlt in an orcv to cease and desist and to be subject to penalties as provided for in Section 21!


- I 1. CERTIFICATE NUMBER: 51 -R-0016 FORM APPROVED OMB NO. 0579-0036

CUSTOMER NUMBER: 88

Henry M Jackson Foundation AdvancementIMilitary Medicine 1401 Rockville Pike, Suite 600 Rockville, MD 20850


Telephone: (301 ) -424-0800

b

3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tesl I , or experimentation, or held for these purposes. Attach additional sheets if necessary ) 1 AWf#€z mu5 &$ewA/L [#TE;4 PO&? /w ~ N M o A ' A ~ , f L 3 #/+=

I

FACILITY LOCATIONS ( Stes ) - See Atached Listing @?B/E~ &PXC/&& 8'3 W 0, L&-U,ILT, MD t, 7 9 3

I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets If necessarv or use APHIS Form 7023A 1

B. Number of animal being bred. conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yc used for such purposes.

C. Number of animals upon which teaching, research. experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.


E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wt the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research. experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl



Wetfare Regulations ( COLUMNS C + D + E )

4. Dogs

5. Cats

6. Guinea Pigs -

7. Hamsters - -

8. Rabbits -


10. Sheep -- --

11. Pigs


13. Other Animals

1 ASSURANCE STATEMENTS I

1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic. analgesic, and tranquilizing drugs, prior to, during, and following actual resc teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to thls annual report. In addition to identifying the IACUC-approved exceptions, this summary in< brief explanation of the exceptions, as well as the species and number of animals affected.


CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL ef Executive Officer or Legally Responsible Institutional Official )

DATE SIGNED

This report is required by law (7 USC 2143). Failure to report according to the regulations can See reverse side for Interagency Report Control No result in an order to cease and desist and to be subject to penalties as provided for in Section 2150. additional information. 01 80-DOA-AN


I MSTF BLDG, UMAB BALTIMORE, MD 21 201

) 3. REPORTING FACILITY (List all locations where animals were housed or used in actual research, testing. teaching, or experimentation, or held for these purposes. Attach additional

ANNUAL REPORT OF RESEARCH FACILITY (TYPE OR PRINT)

] sheets if necessary.) J FACILITY LOCATIONS(sit8s)

VETERINARY RESOURCES BALTIMORE, MD 21201

1. REGISTRATION NO. CUSTOMER NO. 51 -R-0018 89

1

2. HEAWUARTERS RESEARCH FACILITY (Name and Address, as registered with USDA, include Z@ Code)

UNIVERSITY OF MARYLAND @ BALTIMORE 10 S. PINE ST. RM G-100

1 REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY (Attach additional sheets if necessary or use APHIS FORM 7 0 2 3 !



Welfare Regulations

8. Number of animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.

4. Dogs

5. Cats

6. Guinea Pigs

7. Hamsters I --

8. Rabbits I 9. Non-Human Primates 1 29

10. Sheep

11. Pigs


13. Other Animals

Ferrets


I 1 D. Number of animals upon

which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic,analgesic. or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. (An explanation of the pmcedures pmduchg pain or distress in these animals and the reasons such drugs were not used must be attached to this report)

F.


(Cols. C + D + E)


1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during. and following actual research, teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to h e standards and regulations be specified and explained by the principal investigator and approved by the Institutional Animal Care and Use Committee (IACUC). A summaty of all the exceptions h attached to this annual report. In addition to identifyng the IACUC-approved exceptions, this summary includes a brief explanation of the exceptions, as well as the species and number of animals affected.


CERTIFICATION BY HEADQUARTERS RESEARCH FAClLlM OFFICIAL (Chief Executive Officer or Legally Responsible Institutional official)

I certify that the above is true, correct. and complete (7 U.S.C. Section 2143) . SIGNATURE OF C.E.O. OR INSTITUTIONAL OFFICIAL NAME & TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL (Type or PM) DATE SIGNED

APHIS FORM 7023 (Replaces VS FORM 18-23 (Od 88), which b obsolete

(AUG 91) PART 1 - HEADQUARTERS

APHIS Form 7023 Additional Reported Sites

The following additional sites have been reported by the facility. The reported sites have not been verified by APHIS and have been provided by the facility solely for completeness of the APHIS Form 7023 Annual Reporting submission.

Registration Number: 51-R-0018 Customer Number: 89 Facility: UNIVERSITY OF MARYLAND @ BALTIMORE

10 S. PINE ST. RM G-100 MSTF BLDG, UMAB BALTIMORE, MD 21201 -- --

Site A Bressler Research Building Site A 685 West Baltimore Street Site A Baltimore, Maryland 21201 Site B Health Sciences Facility-1 Site B 655 West Baltimore Street Site B Baltimore, Maryland 21201 Site C Maryland Psychiatric Research Center Site C Maple and Locust Streets Site C Baltimore, Maryland 21228 Site D Holland Laboratory Site D 15601 Crabbs Branch Way Site D Rockville, Maryland 20855

School Of Health Professions C C B C - Essex Campus 7201 Rossville Blvd Baltimore, MD 21237

This report is required by law ( I USC 2143) Failure to report according to the regulations can 0 E C 1 3 200 1 attached form for Interagency Report Contr No.: result in an order to cease and desist and to be subject to penalties as provided for in Section 21! additional information.

I - 3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary )

1 UNITED STATES DEPARTMENT OF AGRICULTURE


1. CERTIFICATE NUWER: 51 -R-0020

I I Telephone: (41 0) -522-1 628

-


Y

REPORT OF ANIMALS USED BY OR UNDER

-T-

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

INTROL OF RESEARCH FACILITY I Attach additional sheets If necessaw or use APHIS Form 7023A 1

B. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not ye used for such purp-.

CUSTOMER NUMBER: 90

C. Numberof animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.


E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res

D. Number of animals upon which experiments, teaching, research. surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.


Welfare Regulations


or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures ( COLUMNS

C + D + E ) producing pain or distress in these animals and the reas such drugs were not used must be attached to this report

4. Dogs

5. Cats

6. Guinea Pigs

7. Hamsters

8. Rabbits


10. S.*p

11. Pigs


13. Other Animals

I ASSURANCE STATEMENTS 1 1) Professionally acceptable standards governing the care. treatment, and use of animals. including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual resc



3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to this annual report In addition to identifying the IACUCapproved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.


BY HEADQUARTERS RESEARCH FACILITY OFFICIAL ficer or Legally Responsible Institutional Official )

This report is required by law (7 USC 2143). Failure to report according to the regulations can result in an order to cease and desist and to be subiect to ~enalties as provided for in Section 21!


Interagency eport Control No.: )" - -


1. CERTIFICATE NUMBER: 5 1 -R-002 1 I FORM APPROVED OMB NO. 0579-0036


American Red Cross Jerome H. Holland Laboratory 15601 Crabbs Branch Way Rockville, MD 20855


Telephone: (30 1 ) -738-0634

3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tes I, or experimentation, or held for these purposes. Attach additional sheets if necessary ) 1 -


I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach addltlonal sheets if necessarv or use APHIS Form 70234 1

8. Number of animal being bred. conditioned, or held f a use in teaching, testing. experiments, research, or surgery but not ye used for such purposes.

C. Numberof animals upon which teaching,

' research, experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.

D. Number of animals upon which experiments, teaching, research. surgery, or tests were conducted invdving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affeded the procedures, res or interpretation of the teaching. research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this repor(




4. Dogs

5. Cats I 6. Guinea Pigs I


10. Sheep I


13. Other Animals 0 I


1) Professionally acceptable standards governing the care, treatment, and use of animals. including appropriate use of anestetic, analgesic. and tranquilizing drugs, prior to, during, and following actual r m teaching, testing, surgery, or experimentation were followed by this research facility.

2) Each principal investigator has considered alternatives to painful pmedures.

3) This facility is adhering to the standards and regulations under the Act. and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to thk annual repon In addition to identifying the IACUC-approved exceptions, this summary inr brief explanation of the exceptions, as well as the species and number of animals affected.


CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFlClAL ( Chief Executive Officer or Legally Responsible InstMona1 Official )

TE SIGNED

. )

This report is requirsd by law (7 USC 2143). Failure to report according to the regulations can result i - an order to cease and desist and to be subiect to ~enalties as ~rovided for in Section 21!


- Interagency Report Control No.:

UNITED STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE I 1. CERTIFICATE NUMBER: 5 1 -&0025 1 FORM APPROVED

OMB NO. 0579-0036

1 CUSTOMER NUMBER: 91 I


University Of Maryland College Park Graduate Studies & Research College Park Campus 6V0r College Park, MD 20742

I I Telephone: (301 ) -405-4921

I

3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) 1 - -


I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FAClLlTY I Attach additional sheets if necessaw or use APHIS Form 7023A 1 I

Animah Covered By The Animal

Wetfan Regulations

B. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yc used for such PUrpoW.

4. Dogs 0

5. Cats n

6. Guinea Pigs I n

7. Hamsters I n

8. Rabbits 0

9. Non-human Primates 0

10. Sheep 0

11. Pigs 0

12. Other Farm Animals 0

Goats 0 13. Other Animals I

f e r r e t s 0

fruit bats 0

g. Numberof animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use u pain-relieving drugs.

Number of animals upon which experiments, teaching, research, surgery, or tests were conducted invdving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted invdving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic. analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasr such drugs were not used must be attached to this reporl



1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual rese teaching, testing. surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions Is attached to thh annual report. In addition to identifying the IACUC-approved exceptions, this summary inc brief explanation of the exceptions. as well as the species and number of animals affected.



NAME & TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL ( Type or Print) DATE SIGNER

hich is obsolete.)


1. CERTIFICATE NUMBER: 5 1 -&0029 CUSTOMER NUMBER: 476



Novascreen Biosciences Corporation 7170 Standard Drive Hanover, MD 21 076

Telephone: (41 0) -71 2-441 1

I I REPORTING FACILITY ( List all locations where animals were housed or used in actual research. testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) I


1 REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets If necessaw or use APHIS Form 7023A 1 I


Welfare Regulations

4. Dogs

B. Number of animal being bred. conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yc used for such purposes.

5. Cats I 6. Guinea Pigs I 7. Hamsters I

9. -Nowhuman Primates

11. Pigs

12. Other Farm Animals I

13. Other Animals I

ASSURANCE STATEMENTS s

C. Number of animals upon which teaching. research. experiments, or tests were conducted involving no pain, distress, or use o pain-relieving drugs.


E. Number of animals upon which teaching, experiments, research, surgery or tests.were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquilit drugs would have adversely affected the pracedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this repod

TOTAL NUMBER I OF ANIMALS


1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to. during, and following actual resc teaching, testing, surgery, w experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary inc brief explanation of the exceptions, as well as the species and number of animals affected.



is obsolete )

This report is required by law (7 USC 2143). Failure to report according to the regulations can result in an order to cease and desist and to be s u b i to Denalties as ~rovided for in Section 21!


Interagency Report Control No.:

UNITED STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE I 1. CERTIFICATE NUMBER: 5 1 -~-003 1

CUSTOMER NUMBER: 532 I FORM APPROVED OMB NO. 0579-0036


Washington Biotechnology, Inc. Po Box 21 1 Simpsonville, MD 21 150

Telephone: (41 0) -633-7449 NOV 3 02002

I 3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) I


Welfare Regulations

6. Number of animal being bred, conditioned, or held for use in teaching. testing. experiments, research, or surgery but not yc used for such purposes.

4. Dogs

5. Cats

6. Guinea Pigs

7. Hamsters

8. Rabbits


10. Sheep

1 I. Pigs


13. Other Animals


C. Numberof animals upon which teaching, research. experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.

D. Number of animals upon which experiments, teaching, research, surgery. or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessaw or use APHIS Form 7023A 1 1 E. Number of animals upon which teaching, experiments, F.

research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz NUMBER

drugs would have adversely affected the procedures, res OF AN'MALS

or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures ( COLUMNS producing pain or distress in these animals and the reasc C + D + E ) such drugs were not used must be attached to this report

1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual rew teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap lnstitutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary in(

. brief explanation of the exceptions, as well as the species and number of animals affected.



FICIAL ( Type or Print) 1 DATE SIGNED

obsolete.)

( AUG 91 )

I I Biocon, Inc. ANNUAL REPORT OF RESEARCH FACILITY 15801 Crabbs Branch Way

( TVPE OR P R I M ) Rockvilie. MD 20855

I Telephone: (301) -762-3202

REPORT OF A N W L S USED BY OR UNDER

FAClUrY LOCATIONS (SI*. 1 - S . e ~ m d m c LIam

NTROL OF RESEARCH FACILITY I A M 8ddlUonal sh..t. It n-rv a we APHIS Form 7OP* I

Column E Explanation

This form is intended as an aid to completing the Column E explanation. It is not an official fonn and its use is voluntary. Names, addresses, protocols, veterinary care Programs, and the like, are not required as part of an explanation. A Column E explanation must be written so as to be understood by lay persons as well as scientisb.

2. Number 1 8 5 of animals used in this study.

3. species (common name) G u n e a X ~ s of animals used in the study.

4. Explain the procedure producing pain andlor distress.

5. Provide scientific justification why pain andlor distress could not be relieved. State methods or means used to determine that pain andlor distress relief would interfere with test results. (For Federally mandated testing, see Item 6 below)

6. What, if any, federal regulations require this procedure? Cite the agency, the code of Federal Regulations (CFR) title number and the specific section number (e.g.. APHIS, 9 CFR 113.102):

Agency CFR

Interagency Report Control w- 0.. This report is required by law (7 USC 2143). Failure lo report accordina to the regulations can LJ ' C 0 6 2001 See attached form for rc13dt ~n an or&) to ceaie and desist and 1-0 be subject to'~enalties as kovided for in Section 21! additional information.

UNITED STATES DEPARTMENT OF AGRICULTURE I ANIMAL AND PLANT HEALTH INSPECTION SERVICE

1. CERTIFICATE NUMBER: 5 1 -R-0034 CUSTOMER NUMBER: 505


University Of Maryland Dental School 666 W. Baltimore St. Baltimore, MD 21 201


3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) 1

Telephone: (41 0) -706-7461


6. Number of animals being bred, conditioned, or held for use in teaching, testlng, experiments, research, or surgery but not ye used for such purposes.

C. Number of D. Number of animals upon animals upon I whichenperimsnts.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgeslc, or tranquiliz drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals a the reasons such drugs were not used must be attached this report ).

which teaching, research, experiments, or tests were conducted involving no pain, distress, or use or pain-relieving drugs.

teaching, research, surgery, or lasts were conducted involving accompanying pain of distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

Anlmals Covered By The Animal

Welfare Requhtlonr



4. Dogs

5. Cats

8. Guinea Pig8

7. Hamsten

8. Rabbits


10. -Sheep

1 1. Pig8


13. Other Animals


1) Profeuiwl ly acceptable standard8 m i n g tha care, treatmenl, Md use of Mimels, including appropriate u w of anestetic, anelgeric, and tranquilizing drugl, prior lo, during, end following actual rel t teaching, tuting, wrrgwy, or experimwrtation were followlsd by lhii research facilii.

2) Each principal investigator has conridered altsmotiiea to painful procedures.

3) Thir facility is .dh.ring to the stsnderdr Md rqulations under the Ad, and it has required that exoeptions to tha standards and regulations be 8pecifled Md explained by the poincipsl inves,rtiqstor and ap lnstitutiond Animal Care and Use Committea (IACUC). A summary of a11 such exceptions Is attached to thls annual report. In addition to identifying the IACUC-approved exceptm, this summary im brid explanation of the exceptmu, as well as the species and number of animals affected.

4) The attending vetorimrim for this resew& facility has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal w e and use

CERTiFlCATiON BY HEADQUARTERS RESEARCH FACILITY OFFICIAL ( Chief Executive Officer or Legally Responsible Institutional Oflicial )

TE SIGNED

, whlch a obsolete )

i ,

Thls repon is required by law (7 USC 2143). Faliun to report acmding to the regulations can N 0 v 0 1 200) See attachedm for result in an order to cease and desist and to be subject to penalties as provlded for in Section 21! additional informetion.

b

-

interagency Reporl Control w l UNITED STATES DEPARTMENT OF AGRICULTURE

ANIMAL AND PLANT HEALTH INSPECTION SERVICE 1. CERTIFICATE NUMBER: 51 -R-0036

CUSTOMER NUMBER: 93

FORM APPROVED OM8 NO. 0579-0036 I

Bioqual lnc 9600 Medical Center Drive Rockville, MD 20850


Telephone: (301 ) -251 -0633

3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tes 1. or experimentation, or held for these purp&es. Attach additional sheets if necessary ) 1 -


I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FAClLrrY I Attach additional sheets If necessarv or use APHIS Form 7023A )

B. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not ye used for such purposes.

C. Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain. distress, or use o pain-relieving drugs.

0. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distressto the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, expertments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments,




surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this repod

4. Dogs

5. Cats

6. Guinea Pigs

7. Hamsters

8. Rabbits


10. Sheep

1 1. Pigs


13. Other Animals

L I ASSURANCE STATEMENTS

1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual rese teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions Is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary inc brief explanation of the exceptions, as well as the species and number of animals affected.



NAME 8 TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL ( Type or Print) DATE SIGNED ,

10/26/04 CT 88). which is obsolete.)

This report is required by law (7 USC 2143). Failure to report according to the regulations J" " 2004 See attachedformfor F

Interagency Report Control No.:

1 ANNUAL REPORT OF RESEARCH FACILITY

I ( TYPE OR PRINT )

result in an order to cease and desist and to be subject to penalties as provided for in Section 21! additional information.

I Cambrex Bio Science Walkersville Inc 8830 Biggs Ford Rd - M01 Walkersville, MD 21 793

UNITED STATES DEPARTMENT OF AGRICULTURE '


I Telephone: (301 ) -898-7025

3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) I

1. CERTIFICATE NUMBER: 5 1 -R-0038 CUSTOMER NUMBER: 94

Animals Covered By The Anlmal

Welfare Regulations


' 6. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not ye used for such purposes.

C. Numberof animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use o pain-relieving drugs.


5. Cats

6. Guinea Pigs

7. Hamsters 0 8. Rabbits

9. Nowhuman Primates

I 0. Sheep 0 11. Pigs 0

I

12. Other Farm Animals N/A

Goats 8 13. Other Animals

N/A Burros 2


Number of animals upon which experiments. teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted invdving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl


( COLUMNS . C + D + E )

P I 1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual resc-

teaching, testing, surgery, or experimentation were fdlowed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.

4) The attending veterinarian for this research facility has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy d other aspects of animal care and use.


FFICIAL

2

(Replaces VS FORM 18-23 (OCT 88), which is obsolete.) ( AUG 91 )

NAME & TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL ( Type or Print)

DATE SIGNED

-VLL V ;3LUU+ This report is requ~red by law (7 USC 2143). Failure to report according to the regulations can See reverse side for Interagency Report Control No result in an order to cease and desist and to be subject to penalties as provided for in Section 2150. additional information. 01 80-DOA-AN

REISTERSTOWN, MD 21 136 (41 0) 356-6780

) 3. REPORTING FACILITY (List all locations where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes. Attach additional


J sheets if necessary.) I FACILITY LOCATIONS(sitesJ



1 J 2. HEADQUARTERS RESEARCH FACILITY (Name and Address, as registered with USDA,

mdude zip Code) THOMAS D. MORRIS, INC 4001 MILLENDER MILL ROAD

See Attached Listing

1. REGISTRATION NO. CUSTOMER NO. 51 -R-0048 745

REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY (Attach additional sheets if necessafy or use APHIS FORM 7023A )


Welfare Regulations

6. Number of animals being bred. conditioned, or held for use in teaching, testing. experiments, research, or surgery but not yet used for such purposes.

4. Dogs 0 5. Cats I 0 6. Guinea Pigs

7. Hamsters

8. Rabbits

9. Non-Human Primates i)

10. Sheep

11. Pigs

G & Q ? ~ 0


13. Other Animals 0 ASSURANCE STATEMENTS

C. Number of animals upon which teaching. research, experiments, or tests were conducted involving no pain, distress, or use of pain- relieving drugs.

D. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic,analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. (An explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used must be attached to this remrtI


(Cols. C + D + E)

1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during. and following actual research, teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the Institutional Animal Care and Use Cornnittee (IACUC). A summary of all the exceptlons Is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary includes a brief explanation of the exceptions, as well as the species and number of animals affected.



I certify that the above is true, correct, and complete (7 U.S.C. Section 2143) CIAL

DATE SIGNED

F o 11-3;?ooY 8-23 (Oct 88). whkh is obsolete EADQUARTERS

(AUG 91)

Th~s report is required by law (7 USC 2143). Failure to report according to the regulations can result In an order to cease and desist and to be subject to penalties as provided for in Section 21:



I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach addltlonal sheets If necessarv or use APHIS Form 7023A 1


Welfare Regulations

- 4. Dogs -- 5. Cats

6 Gumea Pigs --

7 Hamsters

9 Non-human Primates

10 Sheep

1 1. Pigs

12 Other Farm Animals

: 3. She; Animals

( ASSURANCE STATEMENTS

B. Number of animal being bred, conditioned, or held for use in teachmg, testing, experiments. research, or surgery but not ye used for such purposes.

C. Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain. distress, or use a pain-relieving drugs.

0. Number of an~mals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of anlmals upon wh~ch teachmg, expenments, research, surgery or tests were conducted mvolvlng accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranqulllz drugs would have adversely affected the procedures, res or Interpretation of the teaching, research, experiments, surgery, or tests. ( An explanat~on of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl

-

See attached form for addttional informat~on

1. CERTIFICATE NUMBER: 5 143-0050

CUSTOMER NUMBER: 51 3 OMB NO 0579-3036

Biomedical Research Institute 121 1 1 Parklawn Drive Rockville, MD 20852

OCT 2 22001

Telephone: (301 ) -881 -3300

3 REPORTING FACILITY ( L~st all locations where animals were housed or used In actual research, testmg, or expenmentatton, or held for these purposes Attach add~t~onal sheets 11 necessary )

FACILITY LOCATIONS ( Sites ) - See Atached L~st~ng

m r-'-'-- TOTAL NUMBER

OF ANIMALS


I - +-- -

I 1

7 4 - - - - -

I - + - -- - - - - - --

' 454 - - I I -- - I

1 I-

I

-- I

- I

1 - -- - - - -

I I

-- -- I I - -- - - -- I -- --

-- - -- - -

I I 1 ) Profess~onally acceptable standards govemmg the care, treatment, and use of an~mals, ~ncludmg appropnate use of anestetlc, analges~c, and tranqu~llzrng drugs, pnor to, dunng and following actual r e s ~

teaching, testmg, surgery, or expenmentation were followed by th~s research facility

2) Each pnnc~pal investigator has cons~dered altematlves to painful procedures

3) Thls fac~ltty IS adhermg to the standards and regulations under the Act. and ~t has required that exceptlons to the standards and regulations be specified and explained by the ?rincrpal lnvestlgator a m dp lnst~tut~onal An~mal Care and Use Committee (IACUC) A summary of all such exceptlons is attached to this annual report. In add~t~on to ~dent~fymg the IACUC-approved e~ceotlons, t t x SJiTiPldr+

bnef explanat~on of the exceptions as well as the Specles and number of anlmals affected

41 The anendmg veterlnanan for th~s research facil~ty has appropnate authonty to ensure the provlslon of adequate vetennary care and to oversee the adequacy of other aspects of snlmal c t r e and use

CERTlFlCATlON BY HEADQUARTERS RESEARCH FACILITY OFFICIAL ( Ch~ef Executive Officer or Legally Responsible Institutional Official )

NAME 8 TITLE OF C E 0 OR lNSTlTUTlONAL OFFICIAL ( Type or Pnnt ) DATE SIGNED

10/20/0~

See attached form for Interagency Report C additional information.

This report is required by law (7 USC 2143). Failure to report according to the regulations can result in an order tc -ease and desist and to be subject to penalties as provided for in Section 21! -


1. CERTIFICATE NUMBER: 5 1 -~-0051 I FORM APPROVED OMB NO. 0579-0036

CUSTOMER NUMBER: 96

Spring Valley Laboratories Inc. 1500 Fannie Dorsey Rd Sykesville, MD 21 784 2 6200(


Telephone: (41 0) -795-2222

4 13. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary )


1 REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessaw or use APHIS Form 7023A

B. Number of animal being bred. c~nilitior~ad, or held for use in teaching, testing. experiments, research, or surgery but not ye used for such purposes.

0. Number of animals upon which experiments, teaching. research, surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

C. Numberof animals upon vihki; tewhing. research, experiments, or tests were conducted involving no pain, distress, or use u pain-relieving drugs.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wn the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this report




-

4. Dogs I 5. Cats

6. Guinea Pigs I

7. Hamsters

8. Rabbits


10. Sheep 3 1 I. Pigs I 12. Other Farm Animals I

13. Other Animals -=--I-- 1 ASSURANCE STATEMENTS

1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual resc teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act. and it has required that exceptions to the standards and regulations be specified and explained by the principal invstigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to this annual repoh In addition to identifying the IACUGapproved exceptions, this summary inc brief explanation of the exceptions, as well as the species and number of animals affected.



( AUG 91 )

( Type or Print) DATE SIGNED

APHIS 23 (OCT 88). which is obsolete.)

This report Is required by law (7 USC 2143). Failure to report according to the regulations can result in an order to mise and desist and to be subbed to penalties as provided for in Section 21!



3. REPORTING FACIUTY ( Ust ail locations where animals were housed or used in actual research, tes

See attached form for Interagency Report Control No.: additional Information.

1. CERTIFICATE NUMBER: 51 -R-0055 FORM APPROVED I OMB NO. OVWO36 I CUSTOMER NUMBER: 740 I I

Sitek Corporation Sitek Research Laborato"es NO Y 2 6 2@1 15235 Shady Grove Road Suite 303 Rockville, MD 20850

I I, or experimentation, or held for these purposes. Attach additional sheets i f necessary ) I

Anknalr Covered By The Animal

Welfare Regulattons

8. Number d animal being bred. conditioned, or held for use in teaching, testing, experiments, research, or surgery but not ye used for such purposes.

C. Numberof animals upon which teaching, research, experiments. or tests were conducted invdving no pain, distress, or use a pain-relieving drugs.

FACILITY LOCATIONS ( Stes ) - See Atached Listing

REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY Attach additional stwets if necessarv or use APHIS Form 7023A 1 i I

I

4. Dogs

6. Guinea Pigs

7. Hamsters

10. Sheep

1 1. Pigs I 12. Other Farm Animals I

13. Other Animals


I D. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or

1 tranquilidng drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the anlmals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these anlmals and the reasc such drugs were not used must be attached to this repofl

1 F.



1) Raf85sionelly acceptable standards g o m i n g the care, tregtment. and we of animals. including amupdate use of anestetic, analgesic, and tranquilidng drugs, prior to, during, and fdlowlng ecbel rest teaching, testing, surgery, or experimentation were followed by this research fadlity.

2) Each principal investigator has considered alternatives to painful procedures. '

3) This facility is adhering to the standards and regulations under the Act. and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A surmwy of all such oxcrptions k attachad to thb annual report. In addltion to i-ng the IACUC-approved exceptions, thls summary inc brief explanation of the exceptions, as well as the species and number of animals affected.

4) attending veterinarian for this research fadlity has appropriate authority to ensm the provision of adequate veterinary care and to oversee the adequecy of other aspects of animal care and use.

CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFflClAL ( Chief Executive Officer or Legally Responsible Institutional Official )

ype or M) DATE SIGNED

4'

obsolete.) (AUG91 )

I 3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) 1

I

his rc ~ort is required by law (7 USC 2143). Failure to report according to the regulations can 0 E C C 2 20kt attached form for Interagency Report Control N%, c, reslrh in an orde: to cease and desist and to be subject to penalties as provided for in Section 21! additional information. -T


Welfare Regulations

B. Number of animal being bred, conditioned, or held for use in teaching, testing. experiments. research, or surgery but not ye used for such purposes.



2. Numberof animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use o pain-relieving drugs.



4. Dogs


I

5. Cats

Osiris Therapeutics, Inc. 2001 Aliceanna Street Baltimore, MD 21231

Telephone: (41 0) -522-5005

6. Guinea Pigs I I

7. Hamsters -


Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this report



I I I - o - 8. Rabbits I --

10. Sheep -.-...-

11. Pigs -- 12. Other Farm Animals

13. Other Animals a I ASSURANCE STATEMENTS

1) Professionally acceptable standards governing the care, treatment. and use of animals, induding appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual resf teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to h e standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.



1 NAME 8 TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL ( Type or hint )

DATE SIGNED

/ / 'z9-*f ' A h is obsolete.)

( AUG 91 )

4 This report is requlrad by law (7 USC 2143). Failure lo report according to the regulations cen result in an order lo cease and desist and to be sublect lo penallies as prov~ded lor in Section 2150.

S.e remru rid. lor D @ l l W v W y - 8 bUll8DW SVV.

additional information. 01 80-DOA-AN - * UNITED STATES DEPARTMENT OF AGRICULTURE 1. REOlSTRATlON NO.

ANIMAL AND PLANT HEALTM INSPECTION SERVICE I FORM APPROVED OMB NO. 0579-003(1

( include Zip Code)


Weltare Regulalions

------------------ 12. &OR 13. 0 t h ~

(Lst by species)

an~mab bang bred, conditioned, or held lor usa in teaching, lesting, experiments. research, or surgery but not yet used lor such P u r v .

CONTINUATION SHEET FOR ANNUAL REPORT Osiris Therapeutics f Inc OF RESEARCH FACILITY 2001 Aliceanna Street

( TYPE OR PRINT) Baltimore, MD 21231

REPORT OF ANIMALS USED BV OR UNDER CONTROL OF RESEARCH FACILITY (Mach 8di(fitiand sheets 11 necessary or use this lorm.)

A [R Number ol C

- - - -

- - - - 4 - 4

-

- - - - - -

7 L

-, - - - - m

- - * I ASSURANCE STATEMENTS

: Number ot 0. Number of animals upon E. Number ol animals upon which leaching. experiments, resetarch, surgery or tests were

f animals upon which exper~menls. whtch leaching* leaching. research, conducted involving accompanytng pain or distress research, surgery, oc lesls were to the animals and for which the use of appropriale TOTAL NO. erperiments, or c d u c t d invding anesthelic, analgesic, or lranquilizing drugs would OF AN~MALS tests were accompanytng pain OI

have adversely affected the procedures, results, or conducted distress to the animals inlerprelalion of the leaching. research, involv~ng no lor whtch appropriole experimenls. surgery, or tests. (An explanation d (coil. c + Pam, distress, or analges,c, or the procedwer producing pain or distress in there 0 + E) use ol pain- tranqui)iz,,,g drugs were animal8 end the reaaons such drug* were n d used relieving drugs. used. musf be &ached to thlr report).

1). Prolessionally acceplirM standards governmg the cale. treatmenl, and use of animak, includmg approriate use of a~lesthetw, analgesic, and tra.~quilizing tirt~gs, prwr to, clur~r~g. and lollowing actudl research, tciachmg. Iesling, suryery, or experlmentatlon were lollowecl by th~s research Iac~lity

2). Each principal ~nvestigator has coi~sidered alternatives to paii~tul procedures

3). This lacility a adhering to the standards and regulat~ms uder the Act. dnd 11 has required that excepllons lo the standards and regulations be specified and explamed by the principal invest~gator and approvecl by lhe I ~ ~ s t ~ t u t i o n ~ l Anr~nal Care and Use Commlltee (IACUC). A summary of all such exceptions Is atlachod lo lhis annual report In addition lo ~denlifying the IACUC-approved exceptmns, lhts summary includes a brlel erplanat~on ot the exceptions, as well as the speaes and nu~rlber ot animals affected

4). The attending veterinar~an lor th~s research lacllily has appoyrlate aulhorlly to ensure Ihe provision of adequate veterinary care and lo oversee the adequacy 01 other aspects of an~mal care and use. -- -

CERTIFICATION BY HEADQUAHTES HEBEAHCH FACILITY OFFICIAL (Chief Executive Officer or Legally Responsible lnvtitutional Off~cial)

I cert~ly that the above IS true, correcl, and complete (7 U S C Sect~on 2143)

S DATE SIGNED

) ( - z ? - o ~

APHIS FORM 7023A (AUG 91 ) PART 1 - H E A D Q U ~ R S

'TMS rspolt is requiwd by ir (7 usc 2143). ~aiture to report according to the nwiat ionsDE C O 9 2aD) S e e a m c h d f o r m ~ Interagency Report ~ontrol NO.:

can additional infwnretlon I I


ANNUAL REPORT OF RESEARCH FAClLlN ( TYPE OR PRINT )

1. CERTIFICATE NUMBER 51 -R-0059 FORM APPROVED OMB NO. 0579-0038


( Advanced Bioscience Labs., Inc.

I 5510 Nicholson Lane Kensington, MD 20895

I 3. REPORTING FACILITY ( Ust all locatlons where animals were housed or used in actual research, testlng, or experimentation. or held for these purposes. Attach additional sheets ff necessary )

FAClLrPl LOCATIONS ( Sit- ) - See Atached Usting

REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach addltlanal sheets If neceuarv or use APHIS Form 7023A 1 I I I

8. Number of animels being bred, condltlond. or held for use in teachlng, testlng, experiments, research, or surgery but not ye

I C. Number af I anlmebupon

which teaching, 1 research, I expdments,or

tests were conducted invdving no pain, distress, or use of pain-

Number of animals upon which experiments, teachlng, resserch, surgsry, w tests ware conducted invdving accompanying pain or dlstress to the animals and for which appropriate anesthetic, a

E. Number of animals upon whlch teaching, experiments, mearch, surgery or tests were conducted invdving acconpanylng pain or distress to the animal8 and for which the use of appropriate anesthetic, analgaale, or tranquilizing dmga would have advarsely affected the pmcedurus, results, or interpretation of the teaching, research. experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress In these anlmals and the reasons such drugs were not used mt be attached to



rdleving drugs.

4. Dogs

5. Cats

6. Guinea Pigs I n 1 I I

7. Hamsters

8. Rabbi 25 25 g. Non-human Primate 192 392 3 1 423 10. Sheep

11. Pigs


13. Other Animals

I MSURANCE STATEMENTS 1 1) p e w b acaptrbk stmdmh g o ~ m h g cer~, Wmbnd, and w a d enkruk, lndudino approgrlata we of aneabtk analgrri~ and trtmwilbing drugr, prior to, during, and following

3) R d r f a d l Y r i r a d t w l n g t o t h s ~ a n d r s g u l . t i m u n d w t h e A 4 a n d I t I w r ~ i n d t h a ~ m t o ~ M u d r o n d ~ . b k n r b s ~ e d B n d ~ ~ b y t h e p r i n c i p . l inwrtigator and a p p m d by tho In- Animal Care and Uw CommHtee (IACUC). A swnmpry of all such exceptlorn is attached to thb annual mpoh In eddition to i d e m the I A C U ~ ~ a ~ . ~ s u m n w y i n d ~ a M d a c p l r w t k n d t h . ~ n W r r t h . ~ a n d n u m k r d m i m d s e f h c t # l

4) The attending votdrwrim for this wew-ch facility haa approprlata aulhaity to emum th. pmvirion of admamta vetorim m and ta overme the adequw of 0 t h ~ o f m h d

CERTlFlCATlON BY HEADQUARTERS RESEARCH FAClLrrY OFFICIAL ( Chief Exearthre Officer or Legally Responsible I-al OMdal )

& OF C.E.O. ( DATE SIGNED J

. ( AUG 91 )

This repo-! is required by law (7 USC 2143). Failure to report according to the regulations can result in an order to cease and desist and to be subjed to penalties as provided for in Section 2150.

See reverse side for additional information.


P" UNITED STATES DEPARTMENT OF AGRICULTURE


I KENSINGTON, MD 20895 I


I

3. REPORTING FACILITY (List all locations where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes. Attach additional ?

sheets if necessary.)

FACILITY LOCATK)NS(s#es)

ABL BIOCONTAINMENT FACILITY ROCKVILLE, MD 20850

1. REGISTRATION NO. CUSTOMER NO. 51 -RM>59 1636

I 2. HEADQUARTERS RESEARCH FACILITY (Name and Address, as registered with USDA,

include Z& Code) ADVANCED BlOSClENCE LABS.. INC. 551 0 NICHOLSON LANE


Welfare Regulations

FORM APPROVED OMB NO. 05794036

B. Number of animals being bred. conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.


4. Dogs 1 1 5. Cats

6. Guinea Pigs

7. Hamsters I I 8. Rabbits

9. Non-Human Primates 192 392

10. Sheep

1 I. Pigs I I


13. Other Animals


D. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompenying pain or dlstress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for whlch the use of appropriate anesthetic.analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. (An explanation of the pmcedums producing pak, or distress in these animals and the masons such dfugs were not used must be attached to this report)

F.


(Cob. C + D + E)

--

I) Professionally acceptable standards governing the care, treatment, and use of animals, induding appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during. and following actual research, teaching, testing, surgery, or experimentation were followed by this research facility.


3) This fac~lity is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the Institutional Animal Care and Use Committee (IACUC). A Summary of all the exceptlorn k attached to thb annual report. In addition to identifylng the IACUC-approved exceptions, this summary includes a brief explanation of the exceptions, as well as the species and number of animals affected.


I I

APHIS FORM 7023 (Replaces VS FORM 18-23 (Oct 88). whkh k obsolete PART 1 - HEADQUARTERS (AUG 91)


I cetii that the above is true, correct, and complete (7 U.S.C. Section 2143) SIGNATURE OF C.E.O. OR INSTITUTIONAL OFFICIAL NAME & TITLE OF C.E.O. OR INSTITUTIONAL OFFICIAL (Type or Print) DATE SIGNED

3 0 zoo4 !he att8chedfortn for additional information.

This report is required by law (7 USC 2143). Failure to report according to the regulations can NOV result in an order 10 Cease and desist and to be subject to penalties as provided for in Section 21!





Umbi Animal Core Facility Mbcrf 1st FI., South 725 W. Lombard St. Baltimore, MD 21201


Telephone: (41 0) -706-2754

--

5. REPORTING FACILI< ( Lbst all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) I


1 REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY ( Attach additional sheets if necessarv or use APHIS Form 7023A 1

Number of animal C. Number of animals upon which teaching, research, experiments. or tests were conducted involving no pain, distress, or use a pain-relieving drugs.

--

0. Number of animals upon F.



E. Number of animals upon whlch teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the enimels end for wh

being bred. conditioned, or held for use in teaching, testing, experiments, research, or surgery but not ye used for such purposes.

which experiments, teaching, research,


Welfare Regulations

surgery, or tests were conducted involving

the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery. or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl

accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

4. Dogs

5. Cats

6. Guinea Pigs

7: Hamsters

8. Rabbits

9. - Non-human Primates

10. Sheep

11. Pigs

12. Other Fann Animals - 13. Other Animals

1) Professionally acceptable standards governing the care. treatment. and use of animals. including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to. during, and following actual rest teaching, testing, surgery, or experimentation were followed by this reseerch faciliiy.


3) This facility is adhering to the standards and regulations under the Acl, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to thb annual report. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.


CERllFlCATlON BY HEADQUARTERS RESEARCH FAClLiTY OFF lClAL ( Chief Executive Officer or Legally Responsible Institutional Oftidal )

SIGNATURE OF C.E.O. OR INSTITUTIONAL OFFICIAL DATE SIGNED

/ , / Z ~

NOV 2 92001 See attached form for Interagency Report Co $%? This report is required by law (7 USC 2143). Failure to report according to the regulations can

result in an order to cease and desist and to be subiect to ~enalties as ~rovided for in Section 21! additional information.

I 3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary )

-- -


1. CERTIFICATE NUMBER: 5 1 -~-006 1 I FORM APPROVED OMB NO. 0579-0036


Human Genome Sciences Inc 9410 Key West Avenue Rockville, MD 20850


Telephone: (301) -251 -6023


6. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments. research, or surgery but not ye used for such purposes.

C. Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use u pain-relieving drugs.

0. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl

F.




Welfare Regulations

4. Dogs

5. Cats

6. Guinea Pigs

7. Hamsters

4. Rabbits


10. Sheep

1 1. Pigs


13. Other Animals

-- - - - -

1) Professionally acceptable standards governing the care, treatment. and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual r e teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap lnstitutlonal Animal Care and Use Committee (IACUC). A summary of all such exceptlons Is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.



DATE SIGNED APHIS

( A

F This report is required by law (7 USC 2143). Failure to reoort accordina to the reaulations can 2004 See attachedform for Interagency Report dwQJ


- - result in an order to cease and desist and t'o be subpct t~'~enalt ies as bovided f& in Section 21! additional information.

Mid-Atlantic States Veterinary Clinic 801 5 Corporate Drive Suite A Baltimore, MD 21236


I Telephone: (41 0) -931-3332

rn I 3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary ) i


CUSTOMER NUMBER: 84


Welfare Regulations


B. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not ye used for such purposes.

4. Dogs

5. Cats

6. Guinea Pigs

7. Hamsters

8. Rabbits


10. Sheep

1 1. Pigs

12. Other Farm Animals m 13. Other Animals I

ASSURANCE STATEMENTS s


C. Number of animals upon which teaching. research. experiments, or tests were conducted involving no pain, distress, or use cr pain-relieving drugs.


E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of epproprlate anesthetic, ailalgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments. surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl



1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic. and tranquilizing drugs, prior to, during, and following actual resc teaching, testing, surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap lnstitutional Animal Care and Use Committee (IACUC). A summary of all such exceptions b attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.



( AUG 91 )

hich is obsolete.)

DATE SIGNED

11*22*04

APHIS Form 7023 Site List

The following sites have been reported by the facility.

-

Registration Number: 51 - R - 0072

Customer Number: 84

Facility: Howard County Fairgrounds 21 1 0 Fairgrounds Road West Friendship, MD 21 794

Maryland Veterinary Medical Association 801 5 Corporate Drive, Suite A Baltimore, MD 21236 phone (41 0) 931 -3332 fax (41 0) 931-2060

Interagency Report Control %p' N : This report is required by law (i' USC 2143). Failure to report according to the regulations a n W 0 V 1 6 2004 See attached form for result in an order to cease and desist and to be subject to penalties as provided for in Section 21!


additional information.




Avalon 20358 Seneca Meadows Parkway Germantown, MD 20876


Telephone: (301 ) -556-9829

13. REPORTING F A C I L N ( Llst all locations where animals were housed or used in actual research, testing, or experimentation. or held for these purposes. Attach additional sheets if necessary ) I FACILITY LOCATIONS ( Sites ) - See Atached Listing

1 REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach addltlonal sheets if necessarv or use APHIS Form 7023A 1 I

B. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yc used for such purposes.

C. Numberof animals upon which teaching, research. experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.


Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments,

F.




Welfare Regulations surgery, or tests. ( An explanahn of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl

4. Dogs

5. Cats

6. Guinea Pigs

7. Hamsters

8. Rabbits


10. Sheep

11. Pigs -


--

13. Other Animals


1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual resc teaching, testing, surgery. or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to this annual report. In addition to identifylng the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.


TlON BY HEADQUARTERS RESEARCH FACILITY OFFICIAL ecutive Officer or Legally Responsible Institutional mcial )

DATE SIGNED

APHIS ~ s obsolete.)

This report is required by law (7 USC 2143). Failure to report according to the regulations can result in an order to cease and desist and to be subiect to oenalties as orovided for in Section 21!

No ' See amched form for additional information.

Interagency Report Control 76" UNITED STATES DEPARTMENT OF AGRICULTURE

ANIMAL AND PLANT HEALTH INSPECTION SERVICE I 1. CERTIFICATE NUMBER: 51 -R-0075

CUSTOMER NUMBER: 13764 I FORM APPROVED OMB NO. 0579-0036


Biosynexus l ncorporated 9298 Gaither Road Gaithersburg, MD 20877

#. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary )


1 REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessarv or use APHIS Form 7023A 1 I


Welfare Regulations

4. Dogs

B. Number of animal being bred. conditioned, or held for use in teaching, testing, experiments, research. or surgery but not ye used for such purposes.

5. Cats

6- Guinea Pigs

7. Hamsters

6. Rabbits


10. Sheep

11. Pigs

12. Other Farm Animals 0 13. Other Animals I


C. Number of animals upon which teaching. research, experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.


E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquilit

f drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl



1 ) Professionally acceptable standards governing the care, treatment. and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual rest teaching. testing. surgery, or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions b attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary int brief explanation of the exceptions, as well as the species and number of animals affected.


CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL

( Chief Executive Officer or Legally Responsible Institutional Official )

~ DATE SIGNED

t t /23 I c ~ APHIS FORM 7 OCT 88), which is obsolete.)

I AUG 91 1

Interagency Report Contr q?f This report is required by law (7 USC 2143). Failure to report according to the regulations can result in an order to cease and desist and to be subject to ~enalties as ~rovided for in Section 21!


- - -





NOV I 2 2004 ANNUAL REPORT OF RESEARCH FACILITY

( TYPE OR PRINT )

Otsuka Maryland Medicinal Laboratories Llc

9900 Medical Center Drive Rockville, MD 20850

Telephone: (30 1 ) -424-9055

I. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tes I, or experimentation, or held for these purposes. Attach additional sheets if necessary )


I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessarv or use APHIS Form 7023A \ 1 - -

E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquillz drugs would have adversely affected the procedures, res or interpretation of the teachng, research, experiments. surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl

B. Number of animal being bred. conditioned, or held for use in teaching, testing, experiments, research. or surgery but not ye used for such purposes.

Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use o pain-relieving drugs.

D. Number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate anesthetic. analgesic, or tranquilizing drugs were used.




4. Dogs

5. Cats

6. Guinea Pigs

7. !-iarnsters

8. Rabbits


10. Sheep

1 1. Pigs


13. Other Animals

I 1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual rest



3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptions is attached to this annual report. In addition to identifying the IACUGapproved exceptions. this summary in( brief explanation of the exceptions. as well as the species and number of animals affected.


CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL 1 ( Chief Executive Officer or Legally Responsible Institutional Official )

SIGN 1 DATE SIGNED

- -

APHIS T 88). which is obsolete.) ( AUG 91 )

NOV This report is required by law (7 USC 2143). Failure to report according to the regulations can See attached form for Interagency Report ~ontrol W' N result in an order to cease and desist and to be subiect to oenalties as orovided for in Section 21! additional information. I

. I 3. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, testing, or experimentation, or held for these purposes. Attach additional sheets if necessary )


I



Welfare Regulations

8. Number of animal being bred, conditioned, or held for use in teaching, testing. experiments, research, or surgery but not ye used for such purposes.

1. CERTIFICATE,NUMBER: 51 -R-0077


C. Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.



Taconic Anmed 7676 Standish Place Rockville, MD 20855

Telephone: (301 ) -762-0366

5. Cats

6. Guinea Pigs

7. Hamsters I 0

9. Nonhuman Primates 0 10. Sheep 0 1 1. Pigs 0 12. Other Farm Animals 0

13. Other Animals 0 I ASSURANCE STATEMENTS

D. Number of animals upon which experiments, teaching, research. surgery, or tests were conducted involving accompanying pain or distress to the animals an for which appropriate\ anesthetic, analgesic, or tranquilizing drugs were used.

E. Number of animals upon which teaching, experiments, research, surgery w tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments. surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this reporl

F.



1) Professionally acceptable standards governing the care. treatment. and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and foilawing actual rest teaching, testing, surgery, or experimentation were followed by this research facility.

REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessarv or urn APHIS Form 7023A 1 I

- -

- -

- -

- - - - - -

- -


-

-

-

-

-

3) This facility is adhering to the standards and regulations under the Act, and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use C~tnmittee (IACUC). A summary of all such exceptions is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.

- -

-

- -

-


CERTIFICATION BY HEADQUARTERS RESEARCH FACILITY OFFICIAL ( Chief Executive Officer or Legally Responsible lnstiional Official )

4

DATE SIGNED

1 0/28/C

This report is required by law (7 USC 2143). Failure to report according to the regulations can result in an order to cease and desist and to be subject to penalties as provided for in Section 21!



I. REPORTING FACILITY ( List all locations where animals were housed or used in actual research, tes


w Interagency Report Control 0..

1. CERTIFICATE NUMBER: 5 1 -R-0080 FORM APPROVED OMB NO. 0579-0036

CUSTOMER NUMBER: 261 09 I Functional Genetics Inc 121 1 1 Parklawn Drive Suite 202 Rockville, MD 20852

#

Telephone: (740) -698-0001

-- -- -

I, or experimenition, or held for these purposes. Attach additional sheets if necessary ) 1


I REPORT OF ANIMALS USED BY OR UNDER CONTROL OF RESEARCH FACILITY I Attach additional sheets if necessarv or use APHIS Form 7023A 1 I

Animals Covered By 1 he Animal

Welfare Regulations

6. Number of animal being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not ye used for such purposes.

4. Dogs

5. Cats I 6. Guinea Pigs I 7. Hamsters I

9. Non-human Primates -

10. Sheep I 1 1. Pigs

12. Other F a n Animals

13. Other Animals 0 I ASSURANCE STATEMENTS

3. Number of animals upon which teaching, research. experiments, or tests were conducted involving no pain, distress, or use a pain-relieving drugs.


E. Number of animals upon which teaching, experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for wh the use of appropriate anesthetic, analgesic, or tranquiliz drugs would have adversely affected the procedures, res or interpretation of the teaching, research, experiments, surgery, or tests. ( An explanation of the procedures producing pain or distress in these animals and the reasc such drugs were not used must be attached to this repod



1) Professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anestetic, analgesic, and tranquilizing drugs, prior to, during, and following actual resc teaching, testing, surgery. or experimentation were followed by this research facility.


3) This facility is adhering to the standards and regulations under the Act. and it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and ap Institutional Animal Care and Use Committee (IACUC). A summary of all such exceptlons is attached to this annual report. In addition to identifying the IACUC-approved exceptions, this summary in( brief explanation of the exceptions, as well as the species and number of animals affected.



/ ( Type or Print) DATE SIGNED

A P H I ~ O R M 7d23 (Replaces VS FORM 18-23 (OCT 88). which is obsolete.) ( AUG 91 )

Thts report IS requtred by law (7 USC 2143) Fa~lure l o report according l o Ihe regulal~ons calr resull In an order l o cease and deslsl and to be subject to pefrall~es as prov~ded lor 111 Sectton 2150

See reverse side lor Interagency Report Colt1 rol No

additional inlormal~on. 01 80-DOA-AN

i

UNITED STATES DEPARTMENT OF AGRICULTURE 1. REGISTRATION NO. ANIMAL AND PLANT HEALTH INSPECTION SERVICE I FORM APPROVED

OMB NO 0579-0036


I rnclude Zip Code)

Dept. of Veterans Affairs Headquarters 810 Vermont Avenue, N.W. Washington, DC 20420

I

3. REPORTING FACILITY (L~st all locations where an~mals were housed or used In actual research, lesrlrrg, leaching. or expertmel~tation, or held lor these purposes. Attach additional sheets il rrecessary.)

1 I FACILITY LOCATIONS (S~tesl

1 512 VAMHCS - 10 N. Greene Street I Baltimore, MD 21201 I

A 1 B. Number o l


Wellare Regulalions

animals being bred. conditioned, or held for use In leaching, testing. experiments, research, or surgery but not yet used lor such purposes.

4. Dogs

5. C a t s I

6. Guinea Pigs I 7. Hams te r s 0

10. Sheep

8. Rabb i ts

12. O the r Farm An~mals

0

13. Other Animals


1) Proless~or~ally acceptable standards governing Ihe care, trealmenl, and use ol animals. ~ncluding approrlate use o l anesthetic, analgesic, and t ranqu i l i~~og drugs, prlor to, durtrrg. and iollowirrg actual research. leachtng, lesling, suryery, or exper~rnerrlalior~ were lnllowed by Ihls research lacility

I

RESEARCH FACILITY (ARach aciiditror~al sheets r l necessary or use APHIS FORM 70234)

2 ) Each prtrrc~pal mvesllyator has constdered alterrraltveb lo patrrlul procedures

3) ~ h ; s lacillty is adhering to the standards and regulaliocts under the Act. and 11 has required lhal enceptlons lo the slandards and regulations be specttied and explained by the pr~nc:tpal invesl~galor and approved by the Insl i tu l io~~al Atwrtal Care and Use Corntnrltee (IACUC) A summary of all such exceptions is a t tached t o this annual report. 111 add i l ~o t~ l o tdenlily~rrg Ihe IACUC-approved excepttans, thts summary includes a brlei ex plan at tor^ o l the exceplio~rs. as well as the species and number 01 ~ni l r ta ls atlecled.

F.

TOTAL NO. OF A N ~ M A L ~

(COIS. c + D + E)

4) The altendlng veterlnarlatl for l h ~ s research tacrlily has approprute author~ly lo ensure the provtstolr ol adequate veterinary care and lo oversee Ihe adequacy o l other aspecls of al~ttnal care a ~ t d use.

E. Number ol animals upon which leaching, experlmenrs, research, surgery or tests were conducled involving accompanying pain or distress to the animals and lor which the use of appropriate anesthetrc, analgesic, or tranquilizing drugs would have adversely affected !he procedures, results, or lnterprelatlon of the leaching, research. experiments, surgery. or tests. (An explanation 01 the procedures produciw pain or distress in these animals and the reasons such drugs were not used must be attached to thrs report).

C Number o l an~rnals upon wh'ch teachtng, research. expertmenls, or tests were conducted involvtng no pain, distress, or use o l palm relieving drugs.

D. ol upor, wh~ch experifnenls. teaching, research, surgery, or tests were conducted ~nvolving accompatrytng pain or distress l o he arr~mals and for which appropriate anesthellc, allalgeslc, or

drugs were used

(AUG 91)

L

CEK'I'IFICA'I'ION BY 1IEAI)QUAK'l'KS RESEAKC11 FACII.II'Y OFFICIAI, (Chief Executive Officer or Legally Itesponsible Institutional Ofticial)

I cerllly I ha1 I he above is I r

PART 1 - HEADQUARTERS

SIGNATURE OF C.E.O. OR INSTITUTIONAL OFFICIAL

DATE SIGNED

4 b

APHIS FORM 7023 (Replaces VS FORM 18-23 (OCT 88), w h h IS / / '

Documents

UNITED STATES DEPARTMENT OF AGRICULTURE … · A summary of all the exceptknr is attachad to thh annual report. ... Northern grasshopper mouse Deer mouse ... result in an ode;