Colorado 2025 Regular Session

Colorado House Bill HB1270 Compare Versions

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11 First Regular Session
22 Seventy-fifth General Assembly
33 STATE OF COLORADO
4-REREVISED
5-This Version Includes All Amendments
6-Adopted in the Second House
4+REVISED
5+This Version Includes All Amendments Adopted
6+on Second Reading in the Second House
77 LLS NO. 25-0747.01 Brita Darling x2241
88 HOUSE BILL 25-1270
99 House Committees Senate Committees
1010 Health & Human Services Health & Human Services
1111 A BILL FOR AN ACT
1212 C
1313 ONCERNING GRANTING ELIGIBLE PATIENTS THE RIGHT TO TRY101
1414 INDIVIDUALIZED INVESTIGATIONAL MEDICAL TREATMENTS .102
1515 Bill Summary
1616 (Note: This summary applies to this bill as introduced and does
1717 not reflect any amendments that may be subsequently adopted. If this bill
1818 passes third reading in the house of introduction, a bill summary that
1919 applies to the reengrossed version of this bill will be available at
2020 http://leg.colorado.gov
2121 .)
2222 The bill allows, but does not require, an eligible patient to request
2323 from a manufacturer the manufacturer's individualized investigational
2424 drug, biological product, or device, which is a drug, biological product,
2525 or device that is unique and produced exclusively for use by an individual
2626 patient based on the patient's own genetic profile. The manufacturer must
2727 be operating within an institution that operates under federal rules for the
2828 SENATE
29-3rd Reading Unamended
30-April 14, 2025
31-SENATE
3229 2nd Reading Unamended
3330 April 11, 2025
3431 HOUSE
3532 3rd Reading Unamended
3633 March 14, 2025
3734 HOUSE
3835 2nd Reading Unamended
3936 March 13, 2025
4037 HOUSE SPONSORSHIP
4138 Pugliese and Gilchrist, Bacon, Barron, Bird, Boesenecker, Bradley, Caldwell, Camacho,
4239 Clifford, Duran, English, Espenoza, Feret, Froelich, Garcia, Garcia Sander, Gonzalez R.,
4340 Hamrick, Jackson, Johnson, Keltie, Lieder, Lindsay, Marshall, Martinez, McCluskie,
4441 McCormick, Rutinel, Stewart K., Story, Taggart, Titone, Weinberg, Winter T.
4542 SENATE SPONSORSHIP
46-Kirkmeyer and Daugherty, Amabile, Bright, Catlin, Cutter, Frizell, Hinrichsen, Jodeh,
47-Kipp, Michaelson Jenet, Pelton B., Roberts, Simpson, Wallace
43+Kirkmeyer and Daugherty,
4844 Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
4945 Capital letters or bold & italic numbers indicate new material to be added to existing law.
5046 Dashes through the words or numbers indicate deletions from existing law. protection of human subjects. An eligible patient is an individual who
5147 has:
5248 ! A life-threatening or severely debilitating illness, as
5349 attested to by the patient's treating physician;
5450 ! Considered all other treatment options currently approved
5551 by the United States food and drug administration;
5652 ! Received a recommendation from the patient's treating
5753 physician;
5854 ! Given written, informed consent for the use of the
5955 individualized investigational drug, biological product, or
6056 device; and
6157 ! Documentation from the treating physician that the
6258 individual meets the definition of "eligible patient".
6359 The bill authorizes, but does not require, a manufacturer to make
6460 the individualized investigational drug, biological product, or device
6561 available to an eligible patient at no charge, but the manufacturer may
6662 require payment to cover the cost.
6763 If any harm is caused to the eligible patient resulting from the use
6864 of the individualized investigational drug, biological product, or device,
6965 a private right of action cannot be brought against the manufacturer or
7066 against any other individual or entity involved in the care of the eligible
7167 patient with regard to the eligible patient's use of the individualized
7268 investigational drug, biological product, or device, so long as the
7369 manufacturer, individual, or entity complied with the law and exercised
7470 reasonable care.
7571 The bill prohibits any action against a health-care provider's
7672 license based on the health-care provider's recommendations regarding
7773 the use of the individualized investigational drug, biological product, or
7874 device.
7975 Nothing in the bill affects a health-care insurer's obligation under
8076 current law relating to coverage for an insured's participation in a clinical
8177 trial.
8278 Be it enacted by the General Assembly of the State of Colorado:1
8379 SECTION 1. In Colorado Revised Statutes, 25-45-102, amend2
8480 (1) introductory portion and (2) as follows:3
8581 25-45-102. Legislative declaration. (1) F
8682 OR PURPOSES OF THIS4
8783 PART 1, the general assembly finds and declares that:5
8884 (2) It is the intent of the general assembly
8985 FOR THIS PART 1 to6
9086 allow for terminally ill patients to use potentially life-saving7
9187 1270-2- investigational drugs, biological products, and devices.1
9288 SECTION 2. In Colorado Revised Statutes, 25-45-103, amend2
9389 the introductory portion as follows:3
9490 25-45-103. Definitions. As used in this article PART 1, unless the4
9591 context otherwise requires:5
9692 SECTION 3. In Colorado Revised Statutes, 25-45-104, amend6
9793 (1) and (3)(a) as follows:7
9894 25-45-104. Drug manufacturers - availability of investigational8
9995 drugs, biological products, or devices - costs - insurance coverage.9
10096 (1) A manufacturer of an investigational drug, biological product, or10
10197 device may make available the manufacturer's investigational drug,11
10298 biological product, or device to eligible patients pursuant to this article12
10399 PART 1. This article PART 1 does not require that a manufacturer make13
104100 available an investigational drug, biological product, or device to an14
105101 eligible patient.15
106102 (3) (a) Nothing in this article PART 1 expands the coverage16
107103 provided in sections SECTION 10-16-104 (20) or 10-16-104.6. C.R.S.17
108104 SECTION 4. In Colorado Revised Statutes, amend 25-45-107 as18
109105 follows:19
110106 25-45-107. No cause of action created. This article PART 1 does20
111107 not create a private cause of action against a manufacturer of an21
112108 investigational drug, biological product, or device, or against any other22
113109 person or entity involved in the care of an eligible patient using the23
114110 investigational drug, biological product, or device, for any harm done to24
115111 the eligible patient resulting from the investigational drug, biological25
116112 product, or device, so long as the manufacturer or other person or entity26
117113 is complying in good faith with the terms of this article PART 1, unless27
118114 1270
119115 -3- there was a failure to exercise reasonable care.1
120116 SECTION 5. In Colorado Revised Statutes, add part 2 to article2
121117 45 of title 25 as follows:3
122118 PART 24
123119 INDIVIDUALIZED TREATMENTS5
124120 25-45-201. Legislative declaration. (1) F
125121 OR PURPOSES OF THIS6
126122 PART 2, THE GENERAL ASSEMBLY FINDS AND DETERMINES THAT :7
127123 (a) S
128124 OME PUBLIC AND PRIVATE ENTITIES OPERATING UNDER8
129125 FEDERAL STANDARDS FOR THE PROTECTION OF HUMAN SUBJECTS IN9
130126 RESEARCH DEVELOP INDIVIDUALIZED INVESTIGATIONAL DRUGS ,10
131127 BIOLOGICAL PRODUCTS, AND DEVICES THAT ARE UNIQUE AND PRODUCED11
132128 EXCLUSIVELY FOR USE BY AN INDIVIDUAL PATIENT BASED ON THE12
133129 PATIENT'S GENETIC PROFILE, INCLUDING INDIVIDUAL GENE THERAPY ,13
134130 ANTISENSE OLIGONUCLEOTIDES , AND INDIVIDUALIZED NEOANTIGEN14
135131 VACCINES; AND15
136132 (b) A
137133 PATIENT WHO HAS A LIFE-THREATENING OR SEVERELY16
138134 DEBILITATING ILLNESS MAY BENEFIT FROM THESE INDIVIDUALIZED17
139135 TREATMENTS.18
140136 (2) T
141137 HEREFORE, THE GENERAL ASSEMBLY DECLARES THAT , IN19
142138 ACCORDANCE WITH THE RECOMMENDATION OF THE PATIENT 'S TREATING20
143139 PHYSICIAN AND WITH THE SAFEGUARDS DESCRIBED IN THIS PART 2, A21
144140 PATIENT SHOULD HAVE THE RIGHT TO TRY AN INDIVIDUALIZED22
145141 INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE, AND THE23
146142 TREATING PHYSICIAN AND MANUFACTURER THAT PROVIDES THE24
147143 INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR25
148144 DEVICE, ACTING IN ACCORDANCE WITH THIS PART 2, SHOULD BE26
149145 PROTECTED FROM ADVERSE CONSEQUENCES RESULTING FROM THE27
150146 1270
151147 -4- PATIENT'S DECISION TO TRY THE INDIVIDUALIZED INVESTIGATIONAL DRUG ,1
152148 BIOLOGICAL PRODUCT, OR DEVICE.2
153149 25-45-202. Definitions. A
154150 S USED IN THIS PART 2, UNLESS THE3
155151 CONTEXT OTHERWISE REQUIRES :4
156152 (1) "E
157153 LIGIBLE FACILITY" MEANS AN INSTITUTION OPERATING5
158154 UNDER THE FEDERALWIDE ASSURANCE FOR THE PROTECTION OF HUMAN6
159155 SUBJECTS IN ACCORDANCE WITH 45 CFR 46 AND 42 U.S.C. SEC. 289a.7
160156 (2) "E
161157 LIGIBLE PATIENT" MEANS AN INDIVIDUAL WHO HAS:8
162158 (a) A
163159 LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESS , AS9
164160 ATTESTED TO BY THE PATIENT'S TREATING PHYSICIAN;10
165161 (b) I
166162 N CONSULTATION WITH THE TREATING PHYSICIAN ,11
167163 CONSIDERED ALL OTHER TREATMENT OPTIONS CURRENTLY APPROVED BY12
168164 THE UNITED STATES FOOD AND DRUG ADMINISTRATION ;13
169165 (c) R
170166 ECEIVED A RECOMMENDATION FROM THE TREATING14
171167 PHYSICIAN FOR USE OF AN INDIVIDUALIZED INVESTIGATIONAL DRUG ,15
172168 BIOLOGICAL PRODUCT , OR DEVICE FOR TREATMENT OF THE16
173169 LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESS ;17
174170 (d) G
175171 IVEN WRITTEN, INFORMED CONSENT FOR THE USE OF THE18
176172 INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR19
177173 DEVICE, OR, IF THE PATIENT IS A MINOR OR LACKS THE MENTAL CAPACITY20
178174 TO PROVIDE INFORMED CONSENT , A PARENT OR LEGAL GUARDIAN HAS21
179175 GIVEN WRITTEN, INFORMED CONSENT ON THE PATIENT 'S BEHALF; AND22
180176 (e) D
181177 OCUMENTATION FROM THE TREATING PHYSICIAN THAT THE23
182178 PATIENT MEETS THE REQUIREMENTS OF THIS SUBSECTION (2), INCLUDING24
183179 ATTESTATION FROM THE TREATING PHYSICIAN THAT THE TREATING25
184180 PHYSICIAN WAS CONSULTED IN THE CREATION OF THE WRITTEN , INFORMED26
185181 CONSENT GIVEN UNDER THIS PART 2.27
186182 1270
187183 -5- (3) "INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL1
188184 PRODUCT, OR DEVICE" MEANS A DRUG, BIOLOGICAL PRODUCT, OR DEVICE2
189185 THAT IS UNIQUE AND PRODUCED EXCLUSIVELY FOR USE BY AN ELIGIBLE3
190186 PATIENT, BASED ON THE PATIENT'S OWN GENETIC PROFILE, INCLUDING4
191187 INDIVIDUALIZED GENE THERAPY , ANTISENSE OLIGONUCLEOTIDES , AND5
192188 INDIVIDUALIZED NEOANTIGEN VACCINES .6
193189 (4) "I
194190 NSTITUTION" HAS THE MEANING SET FORTH IN 45 CFR 46.1027
195191 (f).8
196192 (5) "L
197193 IFE-THREATENING OR SEVERELY DEBILITATING ILLNESS " HAS9
198194 THE MEANING SET FORTH IN 21 CFR 312.81.10
199195 (6) "M
200196 INOR" MEANS AN INDIVIDUAL WHO IS UNDER EIGHTEEN11
201197 YEARS OF AGE.12
202198 (7) "W
203199 RITTEN, INFORMED CONSENT " MEANS A WRITTEN13
204200 DOCUMENT SIGNED BY AN ELIGIBLE PATIENT ; BY A PARENT OR LEGAL14
205201 GUARDIAN, IF THE PATIENT IS A MINOR ; OR BY A DESIGNATED15
206202 HEALTH-CARE AGENT PURSUANT TO A HEALTH -CARE POWER OF16
207203 ATTORNEY, IF THE PATIENT IS INCAPACITATED, THAT, AT A MINIMUM:17
208204 (a) E
209205 XPLAINS THE CURRENTLY APPROVED PRODUCTS AND18
210206 TREATMENTS FOR THE LIFE-THREATENING OR SEVERELY DEBILITATING19
211207 ILLNESS FROM WHICH THE ELIGIBLE PATIENT SUFFERS ;20
212208 (b) A
213209 TTESTS THAT THE ELIGIBLE PATIENT CONCURS WITH THE21
214210 TREATING PHYSICIAN'S BELIEF THAT ALL CURRENTLY APPROVED22
215211 TREATMENTS ARE UNLIKELY TO PROLONG THE PATIENT 'S LIFE;23
216212 (c) C
217213 LEARLY IDENTIFIES THE SPECIFIC INDIVIDUALIZED24
218214 INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE PROPOSED FOR25
219215 TREATMENT OF THE ELIGIBLE PATIENT'S LIFE-THREATENING OR SEVERELY26
220216 DEBILITATING ILLNESS;27
221217 1270
222218 -6- (d) DESCRIBES THE POTENTIAL BEST AND WORST OUTCOMES1
223219 RESULTING FROM USE OF THE INDIVIDUALIZED INVESTIGATIONAL DRUG ,2
224220 BIOLOGICAL PRODUCT, OR DEVICE, WITH A REALISTIC DESCRIPTION OF THE3
225221 MOST LIKELY OUTCOME , INCLUDING THE POSSIBILITY THAT NEW ,4
226222 UNANTICIPATED, DIFFERENT, OR WORSE SYMPTOMS MIGHT RESULT AND5
227223 THAT DEATH COULD BE HASTENED BY THE PROPOSED TREATMENT , BASED6
228224 ON THE PHYSICIAN'S KNOWLEDGE OF THE PROPOSED TREATMENT IN7
229225 CONJUNCTION WITH AN AWARENESS OF THE ELIGIBLE PATIENT 'S8
230226 CONDITION;9
231227 (e) M
232228 AKES CLEAR THAT THE PATIENT'S ELIGIBILITY FOR HOSPICE10
233229 CARE MAY BE WITHDRAWN IF THE ELIGIBLE PATIENT BEGINS TREATMENT11
234230 OF THE LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESS WITH AN12
235231 INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR13
236232 DEVICE AND THAT HOSPICE CARE MAY BE REINSTATED IF SUCH TREATMENT14
237233 ENDS AND THE PATIENT AGAIN MEETS HOSPICE CARE ELIGIBILITY15
238234 REQUIREMENTS;16
239235 (f) M
240236 AKES CLEAR THAT IN-HOME HEALTH CARE MAY BE DENIED IF17
241237 TREATMENT BEGINS;18
242238 (g) M
243239 AKES CLEAR THAT THE ELIGIBLE PATIENT 'S HEALTH19
244240 INSURANCE PROVIDER OR HEALTH -CARE PROVIDER IS NOT OBLIGATED TO20
245241 PAY FOR ANY CARE OR TREATMENTS CONSEQUENT TO THE USE OF THE21
246242 INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR22
247243 DEVICE UNLESS SPECIFICALLY REQUIRED BY LAW OR CONTRACT ;23
248244 (h) S
249245 TATES THAT THE PATIENT UNDERSTANDS THAT THEY ARE24
250246 LIABLE FOR ALL EXPENSES CONSEQUENT TO THE USE OF THE25
251247 INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR26
252248 DEVICE, AND THAT THIS LIABILITY EXTENDS TO THE PATIENT 'S ESTATE,27
253249 1270
254250 -7- UNLESS A CONTRACT BETWEEN THE PATIENT AND THE MANUFACTURER OF1
255251 THE INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR2
256252 DEVICE STATES OTHERWISE; AND3
257253 (i) S
258254 TATES THAT THE ELIGIBLE PATIENT , OR, FOR AN ELIGIBLE4
259255 PATIENT WHO IS A MINOR OR WHO LACKS CAPACITY TO PROVIDE INFORMED5
260256 CONSENT, THE PARENT OR LEGAL GUARDIAN , CONSENTS TO THE USE OF6
261257 THE INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR7
262258 DEVICE FOR TREATMENT OF THE LIFE -THREATENING OR SEVERELY8
263259 DEBILITATING ILLNESS.9
264260 25-45-203. Drug manufacturers - authorized access to and use10
265261 of individualized investigational drugs, biological products, or devices11
266262 - costs. (1) A
267263 MANUFACTURER OPERATING WITHIN AN ELIGIBLE FACILITY12
268264 AND IN ACCORDANCE WITH APPLICABLE FEDERAL LAW MAY MAKE13
269265 AVAILABLE TO AN ELIGIBLE PATIENT , AND AN ELIGIBLE PATIENT MAY14
270266 REQUEST, THE MANUFACTURER 'S INDIVIDUALIZED INVESTIGATIONAL15
271267 DRUG, BIOLOGICAL PRODUCT, OR DEVICE FROM THE ELIGIBLE FACILITY OR16
272268 MANUFACTURER OPERATING WITHIN THE ELIGIBLE FACILITY .17
273269 (2) A
274270 MANUFACTURER OF AN INDIVIDUALIZED INVESTIGATIONAL18
275271 DRUG, BIOLOGICAL PRODUCT, OR DEVICE MAY:19
276272 (a) P
277273 ROVIDE THE INDIVIDUALIZED INVESTIGATIONAL DRUG ,20
278274 BIOLOGICAL PRODUCT, OR DEVICE TO AN ELIGIBLE PATIENT WITHOUT21
279275 RECEIVING COMPENSATION; OR22
280276 (b) R
281277 EQUIRE AN ELIGIBLE PATIENT TO PAY THE COSTS OF, OR THE23
282278 COSTS ASSOCIATED WITH, THE MANUFACTURE OF THE INDIVI DUALIZED24
283279 INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE.25
284280 (3) N
285281 OTHING IN THIS PART 2 REQUIRES A MANUFACTURER OF AN26
286282 INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR27
287283 1270
288284 -8- DEVICE TO MAKE THE INDIVIDUALIZED INVESTIGATIONAL DRUG ,1
289285 BIOLOGICAL PRODUCT, OR DEVICE AVAILABLE TO AN ELIGIBLE PATIENT.2
290286 (4) I
291287 F A PATIENT DIES WHILE BEING TREATED WITH AN3
292288 INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR4
293289 DEVICE, THE PATIENT'S HEIRS ARE NOT LIABLE FOR OUTSTANDING DEBT5
294290 RELATED TO THE TREATMENT, INCLUDING COSTS ATTRIBUTED TO LACK OF6
295291 INSURANCE COVERAGE FOR THE TREATMENT .7
296292 25-45-204. Action against health-care provider's license or8
297293 medicare certification prohibited. N
298294 OTWITHSTANDING ANY OTHER LAW ,9
299295 A LICENSING BOARD SHALL NOT REVOKE , FAIL TO RENEW, SUSPEND, OR10
300296 TAKE OTHER ACTION AGAINST A HEALTH -CARE PROVIDER'S LICENSE11
301297 ISSUED PURSUANT TO TITLE 12 BASED SOLELY ON THE HEALTH -CARE12
302298 PROVIDER'S RECOMMENDATION TO AN ELIGIBLE PATIENT REGARDING13
303299 ACCESS TO OR TREATMENT WITH AN INDIVIDUALIZED INVESTIGATIONAL14
304300 DRUG, BIOLOGICAL PRODUCT , OR DEVICE, SO LONG AS THE15
305301 RECOMMENDATION IS CONSISTENT WITH MEDICAL STANDARDS OF CARE .16
306302 A
307303 CTION AGAINST A HEALTH-CARE PROVIDER'S MEDICARE CERTIFICATION17
308304 BASED SOLELY ON THE HEALTH -CARE PROVIDER'S RECOMMENDATION18
309305 THAT AN ELIGIBLE PATIENT HAVE ACCESS TO AN INDIVIDUALIZED19
310306 INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE IS PROHIBITED.20
311307 25-45-205. Access to individualized investigational drugs,21
312308 biological products, and devices - prohibition on state action. A
313309 N22
314310 OFFICIAL, EMPLOYEE, OR AGENT OF THIS STATE SHALL NOT BLOCK OR23
315311 ATTEMPT TO BLOCK AN ELIGIBLE PATIENT'S ACCESS TO AN INDIVIDUALIZED24
316312 INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. COUNSELING,25
317313 ADVICE, OR A RECOMMENDATION CONSISTENT WITH MEDICAL ST ANDARDS26
318314 OF CARE FROM A LICENSED HEALTH-CARE PROVIDER IS NOT A VIOLATION27
319315 1270
320316 -9- OF THIS SECTION.1
321317 25-45-206. No cause of action created. T
322318 HIS PART 2 DOES NOT2
323319 CREATE A PRIVATE RIGHT OF ACTION AGAINST A MANUFACTURER OF AN3
324320 INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR4
325321 DEVICE, OR AGAINST AN INDIVIDUAL OR ENTITY INVOLVED IN THE CARE OF5
326322 AN ELIGIBLE PATIENT USING AN INDIVIDUALIZED INVESTIGATIONAL DRUG ,6
327323 BIOLOGICAL PRODUCT, OR DEVICE, FOR ANY HARM CAUSED TO THE7
328324 ELIGIBLE PATIENT RESULTING FROM USE OF THE INDIVIDUALIZED8
329325 INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE, SO LONG AS9
330326 THE MANUFACTURER OR INDIVIDUAL OR ENTITY HAS MADE A GOOD FAITH10
331327 EFFORT TO COMPLY WITH THE PROVISIONS OF THIS PART 2 AND HAS11
332328 EXERCISED REASONABLE CARE IN ACTIONS TAKEN PURS UANT TO THIS PART12
333329 2.13
334330 25-45-207. Effect on health-care coverage. N
335331 OTHING IN THIS14
336332 PART 2 AFFECTS A HEALTH INSURANCE PROVIDER 'S OBLIGATION TO15
337333 PROVIDE COVERAGE FOR AN INSURED 'S PARTICIPATION IN A CLINICAL16
338334 TRIAL PURSUANT TO SECTION 10-16-104 (20).17
339335 SECTION 6. Safety clause. The general assembly finds,18
340336 determines, and declares that this act is necessary for the immediate19
341337 preservation of the public peace, health, or safety or for appropriations for20
342338 the support and maintenance of the departments of the state and state21
343339 institutions.22
344340 1270
345341 -10-