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1 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | ACORP_Appendix3_59.docx | Sun Aug 26 17:51:28 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | ACORP_Appendix3_59.docx | Thu Nov 8 21:25:48 2018 UTC |
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1 | Official D ate of App roval► | |
2 | ||
3 | ACORP Appe ndix 3 | |
4 | Biosafety | |
5 | Version 4 | |
6 | ||
7 | See ACORP App. 3 Ins tructions, for more detailed e xplanation s of the i nformation requested . | |
8 | ||
9 | Summary of All Mater ials Admin istered to Animals o n this Pro tocol. Co mplete the table bel ow for all materials to be adm inistered to any ani mal on thi s protocol , indicati ng the nat ure of the material by marking EVERY box that appl ies, and i ndicating the BSL nu mber for a ny infecti ous agents : | |
10 | ||
11 | Material | |
12 | (Identify the specif ic | |
13 | agent, de vice, stra in, constr uct, isoto pe, etc.) | |
14 | ||
15 | ||
16 | Source | |
17 | (Identify the vendor or collea gue, or sp ecify whic h animals on this pr otocol wil l serve as donors) | |
18 | Nature of Material | |
19 | ||
20 | ||
21 | Toxic Agen t (Item 4) | |
22 | Infectious Agent (I tem 5) -- | |
23 | Enter the CDC Biosaf ety Level | |
24 | (BSL 1, 2, 3, or 4) | |
25 | Biological Agent (It em 6) | |
26 | Radioactiv e Agent (I tem 7) | |
27 | ||
28 | Contains R ecombinant Nucleic A cid (Item 8) | |
29 | Routine P re- or Pos t-Procedur al Drug | |
30 | Euthanasia agent | |
31 | ||
32 | ||
33 | ( ) | |
34 | ( )BSL_ | |
35 | ( ) | |
36 | ( ) | |
37 | ( ) | |
38 | ( ) | |
39 | ( ) | |
40 | ||
41 | ||
42 | ( ) | |
43 | ( )BSL_ | |
44 | ( ) | |
45 | ( ) | |
46 | ( ) | |
47 | ( ) | |
48 | ( ) | |
49 | ||
50 | ||
51 | ( ) | |
52 | ( )BSL_ | |
53 | ( ) | |
54 | ( ) | |
55 | ( ) | |
56 | ( ) | |
57 | ( ) | |
58 | ||
59 | ||
60 | ( ) | |
61 | ( )BSL_ | |
62 | ( ) | |
63 | ( ) | |
64 | ( ) | |
65 | ( ) | |
66 | ( ) | |
67 | ||
68 | ||
69 | ( ) | |
70 | ( )BSL_ | |
71 | ( ) | |
72 | ( ) | |
73 | ( ) | |
74 | ( ) | |
75 | ( ) | |
76 | ||
77 | ||
78 | ( ) | |
79 | ( )BSL_ | |
80 | ( ) | |
81 | ( ) | |
82 | ( ) | |
83 | ( ) | |
84 | ( ) | |
85 | ||
86 | ||
87 |
|
|
88 | ||
89 | Material* (Identify the specif ic agent, device, st rain, cons truct, iso tope, etc. ) | |
90 | Dose (e.g. , mg/kg, C FU, PFU, n umber of c ells, mCi) | |
91 | and Volum e (ml) | |
92 | Diluent* o r Vehicle* | |
93 | Route of a dmin | |
94 | Frequency or duratio n of admin | |
95 | Reason for Administr ation and Expected E ffects | |
96 | Location o f Further Details i n this ACO RP (specif y “Main Bo dy” or “Ap p #”, and identify the Item) | |
97 | Administra tion Under Anesthesi a, sedati on, or tra nquilizati on (Y/N) | |
98 | ||
99 | ||
100 | ||
101 | ||
102 | ||
103 | ||
104 | ||
105 | ||
106 | ||
107 | ||
108 | ||
109 | ||
110 | ||
111 | ||
112 | ||
113 | ||
114 | ||
115 | ||
116 | ||
117 | ||
118 | ||
119 | ||
120 | ||
121 | ||
122 | ||
123 | ||
124 | ||
125 | ||
126 | ||
127 | ||
128 | ||
129 | ||
130 | ||
131 | ||
132 | ||
133 | ||
134 | ||
135 | ||
136 | ||
137 | ||
138 | ||
139 | ||
140 | ||
141 | ||
142 | ||
143 | ||
144 | ||
145 | ||
146 | ||
147 | *Each mate rial, dilu ent, or ve hicle that is listed as FDA ap proved or is labeled “USP” is pharmaceut ical grade . Check o n-line for formulati ons that a re FDA app roved for administra tion to hu mans (http ://www.fda .gov/Drugs /Informati onOnDrugs/ ucm129662. htm) or an imals (htt p://www.fd a.gov/Anim alVeterina ry/Product s/Approved AnimalDrug Products/U CM042847). Designate with a * each mater ial and ea ch diluent or vehicl e to be us ed that is not pharm aceutical grade. For each of t hese, expl ain here w hy the use of a non- pharmaceut ical grade formulati on is nece ssary, and describe how it wil l be ensur ed that th e material is suitab le for use . (See ACO RP App. 3 Instructio ns, for sp ecifics ab out the le vel of det ail requir ed.) | |
148 | ► | |
149 | ||
150 | Anesthesia , Sedation , or Tranq uilization . Complet e 3.a. and 3.b. belo w: | |
151 | ||
152 | For each m aterial wi th “Y” ent ered in th e last col umn of the table in Item 2 abo ve, descri be the ane sthesia, s edation, o r tranquil ization to be used, identifyin g the anes thetic, se dative, or chemical tranquiliz er, and de tailing th e dose, vo lume, and route of a dministrat ion (Make sure that these agen ts are als o included in Item 1 of this appendix, as materia ls to be a dministere d): | |
153 | ► | |
154 | ||
155 | For each m aterial wi th “N” ent ered in th e last col umn of the table in Item 2 ab ove, expla in why no anesthesia , sedation , or tranq uilization is necess ary, or ca n be provi ded, and d escribe an y alternat e methods of restrai nt that wi ll be used . | |
156 | ► | |
157 | ||
158 | Toxic Agen ts. Compl ete the ta ble below for each o f the mate rials list ed as a “t oxic agent ” in the t able in It em 1 above , checking the all o f the prop erties tha t apply (s ee ACORP A pp. 3 Inst ructions, for detail s). | |
159 | ||
160 | Name of To xic Agent | |
161 | a. Mutagen | |
162 | b. Carcino gen | |
163 | c. Teratog en | |
164 | d. Select Agent? | |
165 | e. Other – specify t oxic prope rties | |
166 | ||
167 | ||
168 | ||
169 | ||
170 | Not a Sele ct Agent | |
171 | Select Age nt Used in | |
172 | Sub-thresh old Quanti ties | |
173 | Select Age nt that Re quires Reg istration/ Approval | |
174 | ||
175 | ||
176 | ( ) | |
177 | ( ) | |
178 | ( ) | |
179 | ( ) | |
180 | ( ) | |
181 | ( )* | |
182 | ( )► | |
183 | ||
184 | ( ) | |
185 | ( ) | |
186 | ( ) | |
187 | ( ) | |
188 | ( ) | |
189 | ( )* | |
190 | ( )► | |
191 | ||
192 | ( ) | |
193 | ( ) | |
194 | ( ) | |
195 | ( ) | |
196 | ( ) | |
197 | ( )* | |
198 | ( )► | |
199 | ||
200 | ( ) | |
201 | ( ) | |
202 | ( ) | |
203 | ( ) | |
204 | ( ) | |
205 | ( )* | |
206 | ( )► | |
207 | ||
208 | ( ) | |
209 | ( ) | |
210 | ( ) | |
211 | ( ) | |
212 | ( ) | |
213 | ( )* | |
214 | ( )► | |
215 | ||
216 | ( ) | |
217 | ( ) | |
218 | ( ) | |
219 | ( ) | |
220 | ( ) | |
221 | ( )* | |
222 | ( )► | |
223 | ||
224 | *For each “select ag ent” that requires r egistratio n/approval (copy the lines bel ow for eac h agent): | |
225 | ||
226 | Name of ag ent ► | |
227 | ||
228 | Registered with CDC or USDA ► | |
229 | Registrati on Number ► | |
230 | Registrati on Date ► | |
231 | Expiration Date of R egistratio n ► | |
232 | ||
233 | Name of of ficial who granted a pproval on behalf of VACO► | |
234 | Date of ap proval► | |
235 | ||
236 | Infectious Agents. Complete t he table b elow for e ach of the materials listed as an “infec tious agen t” in the table in I tem 1 abov e (see ACO RP App. 3 Instructio ns, for de tails). | |
237 | ||
238 | Name and B SL Number of Infecti ous Agent | |
239 | a. ABSL Nu mber* | |
240 | b. Drug Se nsitivity Panel Avai lable? (De scribe) | |
241 | c. Select Agent? | |
242 | ||
243 | ||
244 | ||
245 | Not a Sele ct Agent | |
246 | Select Age nt used in Sub-thres hold quant ities | |
247 | Select Age nt that Re quires Reg istration/ Approval | |
248 | ||
249 | ||
250 | (Yes/No) | |
251 | ( ) | |
252 | ( ) | |
253 | ( )** | |
254 | ||
255 | ||
256 | (Yes/No) | |
257 | ( ) | |
258 | ( ) | |
259 | ( )** | |
260 | ||
261 | ||
262 | (Yes/No) | |
263 | ( ) | |
264 | ( ) | |
265 | ( )** | |
266 | ||
267 | ||
268 | (Yes/No) | |
269 | ( ) | |
270 | ( ) | |
271 | ( )** | |
272 | ||
273 | ||
274 | (Yes/No) | |
275 | ( ) | |
276 | ( ) | |
277 | ( )** | |
278 | ||
279 | ||
280 | (Yes/No) | |
281 | ( ) | |
282 | ( ) | |
283 | ( )** | |
284 | ||
285 | *Complete the follow ing for ea ch agent f or which t he ABSL Nu mber given is less t han the BS L Number s hown (copy the lines below for each agen t): | |
286 | ||
287 | Name of ag ent ► | |
288 | Justificat ion for ap plying ABS L measures that are less prote ctive than those rec ommended ► | |
289 | ||
290 | **For each “select a gent” that requires registrati on/approva l (copy th e lines be low for ea ch agent): | |
291 | ||
292 | Name of ag ent ► | |
293 | ||
294 | Registered with CDC or USDA ► | |
295 | Registrati on Number ► | |
296 | Registrati on Date ► | |
297 | Expiration Date of R egistratio n ► | |
298 | ||
299 | Name of of ficial who granted a pproval on behalf of VACO► | |
300 | Date of ap proval► | |
301 | ||
302 | Biological Agents. Complete t he table b elow for e ach of the materials listed as a “biolog ical agent ” in the t able in It em 1 above (see ACOR P App. 3 I nstruction s, for det ails). | |
303 | ||
304 | Name of Bi ological A gent | |
305 | Screening for Infect ious Agent s | |
306 | ||
307 | ||
308 | ||
309 | ||
310 | ||
311 | ||
312 | ||
313 | ||
314 | ||
315 | ||
316 | ||
317 | ||
318 | ||
319 | Radioactiv e Agents. Complete the table below for each of th e agents l isted as a “radioact ive agent” in the ta ble in Ite m 1 above (see ACORP App. 3 In structions , for deta ils). | |
320 | ||
321 | Name of Ra dioactive Agent (spe cify the i sotope) | |
322 | Authorized Individua l | |
323 | Approving Committee or Officia l | |
324 | ||
325 | ||
326 | ||
327 | ||
328 | ||
329 | ||
330 | ||
331 | ||
332 | ||
333 | ||
334 | ||
335 | ||
336 | ||
337 | ||
338 | ||
339 | ||
340 | Agents Con taining Re combinant Nucleic Ac id. For e ach of the materials checked i n the tabl e in Item 1, above, as “contai ns recombi nant nucle ic acid”, indicate w hich of th e conditio ns applies (see ACOR P App. 3 I nstruction s, for det ails). | |
341 | ||
342 | Name of Ag ent | |
343 | that Conta ins Recomb inant Nucl eic Acid | |
344 | Subject to the NIH G uidelines for Resear ch Involvi ng Recombi nant DNA M olecules | |
345 | Exempt | |
346 | ||
347 | ( ) | |
348 | ( ) | |
349 | ||
350 | ( ) | |
351 | ( ) | |
352 | ||
353 | ( ) | |
354 | ( ) | |
355 | ||
356 | ( ) | |
357 | ( ) | |
358 | ||
359 | ( ) | |
360 | ( ) | |
361 | ||
362 | ( ) | |
363 | ( ) | |
364 | ||
365 | ||
366 | Potential for Pain o r Distress . Complet e the tabl e below fo r each of the agents listed in Item 1, a bove, that is expect ed to have potential ly painful or distre ssing effe cts on the animals ( see ACORP App. 3 Ins tructions, for detai ls). | |
367 | ||
368 | Name of Ag ent | |
369 | Nature of Potential Pain/Distr ess | |
370 | Measures t o Alleviat e Pain/Dis tress | |
371 | ||
372 | ||
373 | ||
374 | ||
375 | ||
376 | ||
377 | ||
378 | ||
379 | ||
380 | ||
381 | ||
382 | ||
383 | ||
384 | ||
385 | ||
386 | ||
387 | ||
388 | Protection of Animal Facility Staff from Hazardous Materials . Complet e Items 10 .a and 10. b, below, for each o f the agen ts listed in the tab le in Item 1, above, as “toxic ”, “infect ious”, “bi ological”, “radioact ive”, or “ contains r ecombinant nucleic a cid” (deta iled in It ems 4 – 8) . This it em specifi cally addr esses memb ers of the animal fa cility sta ff; protec tion of th e research staff fro m each of these agen ts must be addressed in Item G of the ma in body of the ACORP . See ACO RP App.3 I nstruction s, for det ails. | |
389 | ||
390 | Complete t he table b elow. | |
391 | ||
392 | Name of Ha zardous Ag ent | |
393 | Approving Committee or Officia l | |
394 | Institutio n | |
395 | (VA or aff iliate) | |
396 | Names of A nimal Faci lity Staff Members a t Risk | |
397 | ||
398 | ||
399 | ||
400 | ||
401 | ||
402 | ||
403 | ||
404 | ||
405 | ||
406 | ||
407 | ||
408 | ||
409 | ||
410 | ||
411 | ||
412 | ||
413 | ||
414 | ||
415 | ||
416 | ||
417 | ||
418 | ||
419 | ||
420 | ||
421 | Detail how the indiv iduals lis ted in the table abo ve (Item 1 0.a.) have been (or will be) i nformed of the possi ble risks of exposur e, and hav e been (or will be) trained to avoid exp osure to t hese agent s. | |
422 | ► | |
423 | ||
424 | Signatures . Provide the appli cable sign atures on the signat ure pages (Item Z.3) of the ma in body of this ACOR P. |
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