EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*sb0560*
SENATE BILL 560
J1, C2 3lr0607
CF HB 626
By: Senator Guzzone
Introduced and read first time: February 6, 2023
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
Animal Testing and Research – Human–Relevant Research Funding and Animal 2
Testing and Research Licensure 3
FOR the purpose of establishing the Human–Relevant Research Fund under the 4
administration of the Maryland Technology Development Corporation as a special, 5
nonlapsing fund; requiring that the interest earnings of the Fund be credited to the 6
Fund; requiring the Corporation to establish a grant and loan program to provide 7
grants and loans for State–funded, human–relevant animal testing alternatives 8
research; requiring a person, on or after a certain date, to be issued a license by the 9
Secretary of Health before the person may use nonhuman animals to conduct 10
medical or product testing or research in the State; and generally relating to the 11
Human–Relevant Research Fund. 12
BY repealing and reenacting, without amendments, 13
Article – Economic Development 14
Section 10–401(a) and (c) and 10–429(a) and (g) 15
Annotated Code of Maryland 16
(2018 Replacement Volume and 2022 Supplement) 17
BY adding to 18
Article – Economic Development 19
Section 10–4D–01 through 10–4D–06 to be under the new subtitle “Subtitle 4D. 20
Human–Relevant Research Fund and Program” 21
Annotated Code of Maryland 22
(2018 Replacement Volume and 2022 Supplement) 23
BY adding to 24
Article – Health – General 25
Section 24–2201 through 24–2205 to be under the new subtitle “Subtitle 22. Animal 26
Testing and Research License” 27
Annotated Code of Maryland 28 2 SENATE BILL 560
(2019 Replacement Volume and 2022 Supplement) 1
BY repealing and reenacting, without amendments, 2
Article – State Finance and Procurement 3
Section 6–226(a)(1) and (a)(2)(i) 4
Annotated Code of Maryland 5
(2021 Replacement Volume and 2022 Supplement) 6
BY repealing and reenacting, with amendments, 7
Article – State Finance and Procurement 8
Section 6–226(a)(2)(ii)170. and 171. 9
Annotated Code of Maryland 10
(2021 Replacement Volume and 2022 Supplement) 11
BY adding to 12
Article – State Finance and Procurement 13
Section 6–226(a)(2)(ii)172. 14
Annotated Code of Maryland 15
(2021 Replacement Volume and 2022 Supplement) 16
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 17
That the Laws of Maryland read as follows: 18
Article – Economic Development 19
10–401. 20
(a) In this subtitle the following words have the meanings indicated. 21
(c) “Corporation” means the Maryland Technology Development Corporation. 22
10–429. 23
(a) In this part the following words have the meanings indicated. 24
(g) “Institutional review board” has the meaning stated in the federal regulations 25
on the protection of human subjects. 26
SUBTITLE 4D. HUMAN–RELEVANT RESEARCH FUND AND PROGRAM. 27
10–4D–01. 28
(A) IN THIS SUBTITLE THE FOLLOWING TERMS HAVE THE MEANINGS 29
INDICATED. 30
SENATE BILL 560 3
(B) “BOARD” MEANS THE HUMAN–RELEVANT RESEARCH REVIEW BOARD 1
ESTABLISHED UNDER § 10–4D–04 OF THIS SUBTITLE. 2
(C) “CORPORATION ” HAS THE MEANING STATE D IN § 10–401 OF THIS TITLE. 3
(D) “FUND” MEANS THE HUMAN–RELEVANT RESEARCH FUND. 4
(E) “INSTITUTIONAL REVIEW BOARD” HAS THE MEANING STAT ED IN § 5
10–429 OF THIS TITLE. 6
10–4D–02. 7
(A) THERE IS A HUMAN–RELEVANT RESEARCH FUND. 8
(B) THE PURPOSE OF THE FUND IS TO PROMOTE STATE–FUNDED 9
RESEARCH INTENDED TO DEVELOP HUMAN–RELEVANT ALTERNATIVE S TO USING 10
NONHUMAN ANIMALS IN MEDICAL A ND PRODUCT TESTING A ND RESEARCH 11
THROUGH GRANTS AND L OANS TO PUBLIC AND P RIVATE ENTITIES IN T HE STATE. 12
(C) THE CORPORATION SHALL ADM INISTER THE FUND. 13
(D) (1) THE FUND IS A SPECIAL , NONLAPSING FUND THAT IS NOT 14
SUBJECT TO § 7–302 OF THE STATE FINANCE AND PROCUREMENT ARTICLE. 15
(2) THE STATE TREASURER SHALL HOLD THE FUND SEPARATELY , 16
AND THE COMPTROLLER SHALL AC COUNT FOR THE FUND. 17
(E) THE FUND CONSISTS OF : 18
(1) REVENUE DISTRIBUTED TO THE FUND UNDER § 24–2203 OF THE 19
HEALTH – GENERAL ARTICLE; 20
(2) MONEY APPROPRIATED I N THE STATE BUDGET TO THE FUND; 21
(3) INTEREST EARNINGS OF THE FUND; AND 22
(4) ANY OTHER MONEY FROM ANY OTHER SOURCE ACCEPTED FOR 23
THE BENEFIT OF THE FUND. 24
(F) MONEY IN THE FUND MAY BE USED ONLY TO: 25
4 SENATE BILL 560
(1) AWARD GRANTS AND LOANS FOR STATE–FUNDED, 1
HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH IN ACCORDANCE 2
WITH THE RECOMMENDAT IONS OF THE BOARD; AND 3
(2) PAY THE COSTS NECESSARY TO A DMINISTER THE FUND. 4
(G) (1) THE STATE TREASURER SHALL INVES T THE MONEY IN THE FUND 5
IN THE SAME MANNER A S OTHER STATE MONEY MAY BE INVESTE D. 6
(2) ANY INTEREST EARNINGS OF THE FUND SHALL BE CREDIT ED TO 7
THE FUND. 8
(H) (1) THE GOVERNOR MAY INCLUDE IN THE STATE BUDGET BILL EAC H 9
FISCAL YEAR AN APPRO PRIATION TO THE FUND. 10
(2) EXPENDITURES FROM THE FUND MAY BE MADE ONLY IN 11
ACCORDANCE WITH THE STATE BUDGET . 12
10–4D–03. 13
(A) SUBJECT TO THE PROVIS IONS OF THIS SUBTITL E, THE CORPORATION 14
SHALL ESTABLISH A GR ANT AND LOAN PROGRAM TO PROVIDE GRANTS AN D LOANS 15
FOR STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES 16
RESEARCH. 17
(B) A GRANT OR LOAN AWARDE D UNDER THIS SUBTITLE IS CONTINGENT ON 18
THE RECIPIENT: 19
(1) SUBMITTING TO THE BOARD APPROVAL FROM AN INS TITUTIONAL 20
REVIEW BOARD ; AND 21
(2) ENTERING INTO A MEMORANDUM OF UNDERSTANDING WITH T HE 22
CORPORATION THAT : 23
(I) ESTABLISHES THE SCOPE OF THE STATE’S OWNERSHIP OR 24
OTHER FINANCIAL INTE REST IN THE COMMERCIALIZA TION AND OTHER BENEF ITS 25
OF THE RESULTS , PRODUCTS, INVENTIONS, AND DISCOVERIES RESULTING FROM 26
STATE–FUNDED, HUMAN–RELEVANT RESEARCH ; AND 27
(II) TO THE EXTENT CO NSISTENT WITH FEDERA L AND STATE 28
LAW, REFLECTS THE INTELLE CTUAL PROPERTY POLIC IES OF THE CORPORATION . 29
SENATE BILL 560 5
(C) A RECIPIENT SHALL SUBM IT THE APPROVAL REQU IRED UNDER 1
SUBSECTION (B)(1) OF THIS SECTION WITH IN 6 MONTHS AFTER THE AWA RD OF THE 2
GRANT OR LOAN . 3
(D) THE CORPORATION MAY NOT D ISBURSE GRANT OR LOA N MONEY TO A 4
RECIPIENT UNTIL THE RECIPIENT MEETS THE REQUIREMENTS OF SUBSECTION (B) 5
OF THIS SECTION. 6
10–4D–04. 7
(A) THE CORPORATION SHALL CON TRACT WITH AN INDEPE NDENT 8
SCIENTIFIC REVIEW BO ARD COMPOSED OF RECO GNIZED SCIENTIFIC EX PERTS IN 9
THE FIELD OF HUMAN –RELEVANT ANIMAL TEST ING ALTERNATIVES TO ACT AS THE 10
HUMAN–RELEVANT RESEARCH REVIEW BOARD. 11
(B) THE BOARD SHALL: 12
(1) REVIEW, EVALUATE, RANK, AND RATE RESEARCH PR OPOSALS FOR 13
STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH: 14
(I) BASED ON THE PROCEDURES AN D GUIDELINES 15
ESTABLISHED BY THE CORPORATION ; AND 16
(II) IN A MANNER THAT GIVES DUE CONSIDERATION TO THE 17
SCIENTIFIC, MEDICAL, AND ETHICAL IMPLICAT IONS OF THE RESEARCH ; AND 18
(2) BASED ON THE RANKING S AND RATINGS AWARDE D TO THE 19
RESEARCH PROPOSALS B Y THE BOARD, MAKE RECOMMENDATIONS TO T HE 20
CORPORATION FOR THE AWARD AND DI SBURSEMENT OF GRANTS AND LOANS . 21
(C) A MEMBER OF THE BOARD: 22
(1) IS NOT ELIGIBLE TO RECE IVE A GRANT OR LOAN FOR 23
STATE–FUNDED, HUMAN–RELEVANT RESEARCH FR OM THE FUND; AND 24
(2) SHALL BE SUBJECT TO CONFLI CT OF INTEREST STAND ARDS THAT 25
ARE AT LEAST AS STRI NGENT AS THE STANDAR DS ON CONFLICT OF IN TEREST 26
ADOPTED BY THE FEDERAL NATIONAL INSTITUTES OF HEALTH. 27
10–4D–05. 28
6 SENATE BILL 560
THE CORPORATION , IN CONSULTATION WITH THE BOARD, SHALL ADOPT 1
REGULATIONS TO ESTABLISH PROCEDU RES FOR AWARDING AND MAKING THE 2
DISBURSEMENT OF A GR ANT OR LOAN. 3
10–4D–06. 4
(A) ON OR BEFORE JANUARY 1 EACH YEAR, THE CORPORATION AND THE 5
BOARD SHALL REPORT TO THE GOVERNOR AND , IN ACCORDANCE WITH § 2–1257 OF 6
THE STATE GOVERNMENT ARTICLE, THE GENERAL ASSEMBLY ON THE PROGRESS 7
OF THE HUMAN–RELEVANT ANIMAL TESTING ALTER NATIVES RESEARCH 8
CONDUCTED WITH MONEY FROM GRANTS OR LOANS AWARDED UNDER THIS 9
SUBTITLE. 10
(B) THE REPORT SHALL IDEN TIFY: 11
(1) EACH RECIPIENT OF MONEY F ROM THE FUND; 12
(2) THE AMOUNT OF MONEY AWAR DED TO EACH RECIPIEN T; AND 13
(3) A DESCRIPTION OF THE T YPE OF STATE–FUNDED, 14
HUMAN–RELEVANT RESEARCH PE RFORMED BY THE RECIP IENT AND THE ANIMAL 15
TESTS THE RESEARCH IS INTENDED TO REPLACE. 16
Article – Health – General 17
SUBTITLE 22. ANIMAL TESTING AND RESEARCH LICENSE. 18
24–2201. 19
(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS 20
INDICATED. 21
(B) “LICENSE” MEANS A LICENSE TO C ONDUCT MEDICAL OR PR ODUCT 22
TESTING OR RESEARCH USING ANIMALS . 23
(C) “LICENSEE” MEANS A PERSON WHO H OLDS A LICENSE ISSUE D UNDER 24
THIS SUBTITLE. 25
24–2202. 26
ON OR AFTER JANUARY 1, 2024, A PERSON SHALL BE LICENSED BY THE 27
SECRETARY BEFORE THE PERSON MAY USE NONHUMAN ANIMALS TO CONDUCT 28
MEDICAL OR PRODUCT TESTING OR RESEARCH IN THE STATE. 29 SENATE BILL 560 7
24–2203. 1
(A) (1) AN APPLICANT FOR A LICENSE SHALL SUBMIT AN APPLICATIO N 2
TO THE SECRETARY ON THE FORM THAT THE SECRETARY REQUIRES. 3
(2) AN INITIAL APPLICATION SHALL REQUIRE AN APP LICANT TO 4
INCLUDE: 5
(I) THE NUMBER OF ANIMALS THAT WILL BE USED TO CONDUCT 6
THE MEDICAL OR PRODUCT T ESTING OR RESEARCH; 7
(II) A LIST OF THE SPECIES OF ANIMALS THAT WILL BE USED TO 8
CONDUCT THE MEDICAL OR PRODUCT TESTING OR RESEARCH; AND 9
(III) ANY OTHER INFORMATION REQUIRED BY THE SECRETARY. 10
(B) (1) THE ANNUAL LICENSE FEE IS: 11
(I) $5,000 FOR UP TO 500 ANIMALS; 12
(II) $10,000 FOR MORE THAN 500 BUT NOT MORE THAN 1,000 13
ANIMALS; 14
(III) $25,000 FOR MORE THAN 1,000 BUT NOT MORE THAN 5,000 15
ANIMALS; 16
(IV) $35,000 FOR MORE THAN 5,000 BUT NOT MORE THAN 10,000 17
ANIMALS; AND 18
(V) $50,000 FOR MORE THAN 10,000 ANIMALS. 19
(2) THE ANNUAL LICENSE FE E MAY BE PAID IN QUA RTERLY 20
INSTALLMENTS . 21
(C) THE SECRETARY SHALL: 22
(1) DISTRIBUTE THE AMOUNT OF LICENSING FEES NECESSARY TO 23
ADMINISTER THE LICEN SING PROGRAM TO AN A DMINISTRATIVE COST A CCOUNT; 24
AND 25
(2) DISTRIBUTE THE REMAINING FEES TO THE HUMAN–RELEVANT 26
RESEARCH FUND ESTABLISHED UNDER § 10–4D–02 OF THE ECONOMIC 27 8 SENATE BILL 560
DEVELOPMENT ARTICLE AFTER MAKING THE DIS TRIBUTION REQUIRED UNDER 1
ITEM (1) OF THIS SUBSECTION . 2
24–2204. 3
(A) (1) THE SECRETARY SHALL ISSUE A LICENSE TO AN APPL ICANT WHO 4
SUBMITS THE INFORMAT ION REQUIRED UNDER § 24–2203(A) OF THIS SUBTITLE AND 5
ON PAYMENT OF : 6
(I) THE TOTAL ANNUAL LICE NSE FEE; OR 7
(II) THE FIRST QUARTERLY I NSTALLMENT OF THE TO TAL 8
ANNUAL LICENSE FEE . 9
(2) THE TERM OF A LICENSE IS 1 YEAR. 10
(B) THE SECRETARY MAY DENY A LICENSE TO AN APPL ICANT OR MAY 11
SUSPEND OR REVOKE A LICENSE IF THE APPLI CANT OR LICENSEE : 12
(1) FRAUDULENTLY OR DECEP TIVELY MAKES A STATE MENT ON AN 13
APPLICATION FOR A LI CENSE; 14
(2) FAILS TO MAKE A QUART ERLY INSTALLMENT PAY MENT OF THE 15
ANNUAL LICENSE FEE ; OR 16
(3) COMMITS FREQUENT OR N UMEROUS VIOLATIONS OF THIS 17
SUBTITLE OR THE REGU LATIONS ADOPTED UNDE R THIS SUBTITLE. 18
(C) EACH LICENSEE SHALL : 19
(1) MAINTAIN A RECORD OF ALL ANIMALS USED AND DISPOSED OF TO 20
CONDUCT MEDICAL OR P RODUCT TESTING OR RE SEARCH, INCLUDING THE NUMBER 21
AND TYPES OF ANIMALS USED; AND 22
(2) SUBMIT TO THE SECRETARY A QUARTERLY REPORT INCLUDING 23
THE INFORMATION REQU IRED UNDER ITEM (1) OF THIS SUBSECTION . 24
(D) ON OR BEFORE JANUARY 1 EACH YEAR, BEGINNING IN 2024, THE 25
SECRETARY SHALL REPORT TO THE GENERAL ASSEMBLY, IN ACCORDANCE WITH § 26
2–1257 OF THE STATE GOVERNMENT ARTICLE, THE AGGREGATE NUMBER OF EACH 27
SPECIES OF ANIMAL US ED IN MEDICAL OR PRODUC T TESTING OR RESEARC H BY 28
LICENSEES IN THE STATE. 29
SENATE BILL 560 9
24–2205. 1
(A) (1) A PERSON MAY NOT USE N ONHUMAN ANIMALS TO C ONDUCT 2
MEDICAL OR PRODUCT T ESTING OR RESEARCH IN THE STATE UNLESS LICENSED BY 3
THE SECRETARY. 4
(2) A PERSON MAY NOT AID O R ABET THE UNAUTHORI ZED USE OF 5
NONHUMAN ANIMALS TO CONDUCT MEDICAL OR P RODUCT TESTING OR RESEARCH 6
IN THE STATE. 7
(B) A PERSON IN VIOLATION OF SUBSECTION (A) OF THIS SECTI ON IS 8
GUILTY OF A FELONY A ND ON CONVICTION IS SUBJECT TO: 9
(1) FOR A FIRST OFFENSE , A FINE NOT EXCEEDING $5,000; OR 10
(2) FOR EACH SUBSEQUENT O FFENSE, A FINE NOT EXCEEDING 11
$20,000. 12
Article – State Finance and Procurement 13
6–226. 14
(a) (1) Except as otherwise specifically provided by law or by regulation of the 15
Treasurer, the Treasurer shall credit to the General Fund any interest on or other income 16
from State money that the Treasurer invests. 17
(2) (i) Notwithstanding any other provision of law, and unless 18
inconsistent with a federal law, grant agreement, or other federal requirement or with the 19
terms of a gift or settlement agreement, net interest on all State money allocated by the 20
State Treasurer under this section to special funds or accounts, and otherwise entitled to 21
receive interest earnings, as accounted for by the Comptroller, shall accrue to the General 22
Fund of the State. 23
(ii) The provisions of subparagraph (i) of this paragraph do not apply 24
to the following funds: 25
170. the Cannabis Public Health Fund; [and] 26
171. the Community Reinvestment and Repair Fund; AND 27
172. THE HUMAN–RELEVANT RESEARCH FUND. 28
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 29
1, 2023. 30