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Underlining indicates amendments to bill.
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amendment.
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*hb0626*
HOUSE BILL 626
J1, C2 (3lr1178)
ENROLLED BILL
— Health and Government Operations and Ways and Means/Finance —
Introduced by Delegates Cullison, Allen, Bagnall, Bridges, Charkoudian, Fennell,
Fraser–Hidalgo, Lehman, R. Lewis, Lopez, Love, Patterson, Qi, Reznik,
Ruth, Shetty, Solomon, and Stein
Read and Examined by Proofreaders:
_______________________________________________
Proofreader.
_______________________________________________
Proofreader.
Sealed with the Great Seal and presented to the Governor, for his approval this
_______ day of _______________ at ________________________ o’clock, ________M.
______________________________________________
Speaker.
CHAPTER ______
AN ACT concerning 1
Animal Testing and Research – Human–Relevant Research Funding and Animal 2
Testing and Research Licensure Contributions 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 9
certain persons research facilities who engage in animal testing or research to pay a 10
certain contribution to the Secretary of Health before the person may use nonhuman 11
animals to conduct medical or product testing or research in the State; and generally 12
relating to the Human–Relevant Research Fund. 13 2 HOUSE BILL 626
BY repealing and reenacting, without amendments, 1
Article – Economic Development 2
Section 10–401(a) and (c) and 10–429(a) and (g) 3
Annotated Code of Maryland 4
(2018 Replacement Volume and 2022 Supplement) 5
BY adding to 6
Article – Economic Development 7
Section 10–4D–01 through 10–4D–06 to be under the new subtitle “Subtitle 4D. 8
Human–Relevant Research Fund and Program” 9
Annotated Code of Maryland 10
(2018 Replacement Volume and 2022 Supplement) 11
BY adding to 12
Article – Health – General 13
Section 24–2201 through 24–2205 24–2203 to be under the new subtitle “Subtitle 22. 14
Animal Testing and Research License Contribution” 15
Annotated Code of Maryland 16
(2019 Replacement Volume and 2022 Supplement) 17
BY repealing and reenacting, without amendments, 18
Article – State Finance and Procurement 19
Section 6–226(a)(1) and (2)(i) 20
Annotated Code of Maryland 21
(2021 Replacement Volume and 2022 Supplement) 22
BY repealing and reenacting, with amendments, 23
Article – State Finance and Procurement 24
Section 6–226(a)(2)(ii)170. and 171. 25
Annotated Code of Maryland 26
(2021 Replacement Volume and 2022 Supplement) 27
BY adding to 28
Article – State Finance and Procurement 29
Section 6–226(a)(2)(ii)172. 30
Annotated Code of Maryland 31
(2021 Replacement Volume and 2022 Supplement) 32
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 33
That the Laws of Maryland read as follows: 34
Article – Economic Development 35
10–401. 36
(a) In this subtitle the following words have the meanings indicated. 37 HOUSE BILL 626 3
(c) “Corporation” means the Maryland Technology Development Corporation. 1
10–429. 2
(a) In this part the following words have the meanings indicated. 3
(g) “Institutional review board” has the meaning stated in the federal regulations 4
on the protection of human subjects. 5
SUBTITLE 4D. HUMAN–RELEVANT RESEARCH FUND AND PROGRAM. 6
10–4D–01. 7
(A) IN THIS SUBTITLE THE FOLLOWING TERMS HAVE THE MEANINGS 8
INDICATED. 9
(B) “BOARD” MEANS THE HUMAN–RELEVANT RESEARCH REVIEW BOARD 10
ESTABLISHED UNDER § 10–4D–04 OF THIS SUBTITLE. 11
(C) “CORPORATION ” HAS THE MEANING STATED I N § 10–401 OF THIS TITLE. 12
(D) “FUND” MEANS THE HUMAN–RELEVANT RESEARCH FUND. 13
(E) “INSTITUTIONAL REVIEW BOARD” HAS THE MEANING STAT ED IN § 14
10–429 OF THIS TITLE. 15
10–4D–02. 16
(A) THERE IS A HUMAN–RELEVANT RESEARCH FUND. 17
(B) THE PURPOSE OF THE FUND IS TO PROMOTE STATE–FUNDED 18
RESEARCH INTENDED TO DEVELOP HUMAN –RELEVANT ALTERNATIVE S TO USING 19
NONHUMAN ANIMALS IN MEDICAL AND PRODUCT TESTING AND RESEARCH 20
THROUGH GRANTS AND L OANS TO PUBLIC AND P RIVATE ENTITIES IN T HE STATE. 21
(C) THE CORPORATION SHALL ADMI NISTER THE FUND. 22
(D) (1) THE FUND IS A SPECIAL , NONLAPSING FUND THAT IS NOT 23
SUBJECT TO § 7–302 OF THE STATE FINANCE AND PROCUREMENT ARTICLE. 24
(2) THE STATE TREASURER SHALL HOLD THE FUND SEPARATELY , 25
AND THE COMPTROLLER SHALL ACC OUNT FOR THE FUND. 26
(E) THE FUND CONSISTS OF : 27 4 HOUSE BILL 626
(1) REVENUE DISTRIBUTED TO THE FUND UNDER § 24–2203 § 1
24–2202 OF THE HEALTH – GENERAL ARTICLE; 2
(2) MONEY APPROPRIATED I N THE STATE BUDGET TO THE FUND; 3
(3) INTEREST EARNINGS OF THE FUND; AND 4
(4) ANY OTHER MONEY FROM ANY OTHER SOURCE ACCEPTE D FOR 5
THE BENEFIT OF THE FUND. 6
(F) MONEY IN THE FUND MAY BE USED ONLY TO: 7
(1) AWARD GRANTS AND LOA NS FOR STATE–FUNDED, 8
HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH IN ACCORDANCE 9
WITH THE RECOMMENDAT IONS OF THE BOARD; AND 10
(2) PAY THE COSTS NECESS ARY TO ADMINISTER TH E FUND. 11
(G) (1) THE STATE TREASURER SHALL INVES T THE MONEY IN THE FUND 12
IN THE SAME MANNER A S OTHER STATE MONEY MAY BE IN VESTED. 13
(2) ANY INTEREST EARNINGS OF THE FUND SHALL BE CREDITE D TO 14
THE FUND. 15
(H) (1) THE GOVERNOR MAY INCLUDE IN THE STATE BUDGET BILL EAC H 16
FISCAL YEAR AN APPRO PRIATION TO THE FUND. 17
(2) EXPENDITURES FROM THE FUND MAY BE MADE ONLY IN 18
ACCORDANCE WITH THE STATE BUDGET . 19
10–4D–03. 20
(A) SUBJECT TO THE PROVIS IONS OF THIS SUBTITLE, THE CORPORATION 21
SHALL ESTABLISH A GR ANT AND LOAN PROGRAM TO PROVIDE GRANTS AN D LOANS 22
FOR STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES 23
RESEARCH. 24
(B) A GRANT OR LOAN AWARDE D UNDER THIS SUBTITL E IS CONTINGENT ON 25
THE RECIPIENT: 26
(1) SUBMITTING TO THE BOARD APPROVAL FROM A N INSTITUTIONAL 27
REVIEW BOARD ; AND 28
HOUSE BILL 626 5
(2) ENTERING INTO A MEMO RANDUM OF UNDERSTAND ING WITH THE 1
CORPORATION THAT : 2
(I) (1) ESTABLISHES THE SCOP E OF THE STATE’S 3
OWNERSHIP OR OTHER F INANCIAL INTEREST IN THE COMMERCIALIZATION AN D 4
OTHER BENEFITS OF TH E RESULTS, PRODUCTS, INVENTIONS, AND DISCOVERIES 5
RESULTING FROM STATE–FUNDED, HUMAN–RELEVANT RESEARCH ; AND 6
(II) (2) TO THE EXTENT CONSIS TENT WITH FEDERAL AN D 7
STATE LAW , REFLECTS THE INTELLE CTUAL PROPERTY POLIC IES OF THE 8
CORPORATION . 9
(C) A RECIPIENT SHALL SUBM IT THE APPROVAL REQU IRED UNDER 10
SUBSECTION (B)(1) OF THIS SECTION WITH IN 6 MONTHS AFTER THE AWA RD OF THE 11
GRANT OR LOAN . 12
(D) THE CORPORATION MAY NOT D ISBURSE GRANT OR LOA N MONEY TO A 13
RECIPIENT UNTIL THE RECIPIENT MEETS THE REQUIREMENTS OF SUBS ECTION (B) 14
OF THIS SECTION. 15
10–4D–04. 16
(A) THE CORPORATION SHALL CON TRACT WITH AN INDEPE NDENT 17
SCIENTIFIC REVIEW BO ARD COMPOSED OF RECO GNIZED SCIENTIFIC EX PERTS IN 18
THE FIELD OF HUMAN –RELEVANT ANIMAL TEST ING ALTERNAT IVES TO ACT AS THE 19
HUMAN–RELEVANT RESEARCH REVIEW BOARD. 20
(B) THE BOARD SHALL: 21
(1) REVIEW, EVALUATE, RANK, AND RATE RESEARCH PR OPOSALS FOR 22
STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH: 23
(I) BASED ON THE PROCEDU RES AND GUIDELINES 24
ESTABLISHED BY THE CORPORATION ; AND 25
(II) IN A MANNER THAT GIV ES DUE CONSIDERATION TO THE 26
SCIENTIFIC, MEDICAL, AND ETHICAL IMPLICAT IONS OF THE RESEARCH ; AND 27
(2) BASED ON THE RANKING S AND RATINGS AWARDE D TO THE 28
RESEARCH PROPOSALS B Y THE BOARD, MAKE RECOMMENDATIONS TO TH E 29
CORPORATION FOR THE A WARD AND DISBURSEMEN T OF GRANTS AND LOAN S. 30
(C) A MEMBER OF THE BOARD: 31
6 HOUSE BILL 626
(1) IS NOT ELIGIBLE TO R ECEIVE A GRANT OR LO AN FOR 1
STATE–FUNDED, HUMAN–RELEVANT RESEARCH FR OM THE FUND; AND 2
(2) SHALL BE SUBJECT TO CONFLICT OF INTEREST S TANDARDS THAT 3
ARE AT LEAST AS STRI NGENT AS THE STANDAR DS ON CONFLICT OF IN TEREST 4
ADOPTED BY THE FEDER AL NATIONAL INSTITUTES OF HEALTH. 5
10–4D–05. 6
THE CORPORATION , IN CONSULTATION WITH THE BOARD, SHALL ADOPT 7
REGULATIONS TO ESTAB LISH PROCEDURES FOR AWARDIN G AND MAKING THE 8
DISBURSEMENT OF A GR ANT OR LOAN. 9
10–4D–06. 10
(A) ON OR BEFORE JANUARY 1 EACH YEAR, THE CORPORATION AND THE 11
BOARD SHALL REPORT TO THE GOVERNOR AND , IN ACCORDANCE WITH § 2–1257 OF 12
THE STATE GOVERNMENT ARTICLE, THE GENERAL ASSEMBLY ON THE PROGR ESS 13
OF THE HUMAN –RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH 14
CONDUCTED WITH MONEY FROM GRANTS OR LOANS AWARDED UNDER THIS 15
SUBTITLE. 16
(B) THE REPORT SHALL IDEN TIFY: 17
(1) EACH RECIPIENT OF MO NEY FROM THE FUND; 18
(2) THE AMOUNT OF MONEY AWAR DED TO EACH RECIPIEN T; AND 19
(3) A DESCRIPTION OF THE TYPE OF STATE–FUNDED, 20
HUMAN–RELEVANT RESEARCH PE RFORMED BY THE RECIP IENT AND THE ANIMAL 21
TESTS THE RESEARCH I S INTENDED TO REPLAC E. 22
Article – Health – General 23
SUBTITLE 22. ANIMAL TESTING AND RESEARCH LICENSE CONTRIBUTION . 24
24–2201. 25
(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS 26
INDICATED. 27
(B) “LICENSE” MEANS A LICENSE TO C ONDUCT MEDICAL OR PR ODUCT 28
TESTING OR RESEARCH USING ANIMALS . 29
HOUSE BILL 626 7
(C) “LICENSEE” MEANS A PERSON WHO HOLDS A LICENSE ISSUED UNDER 1
THIS SUBTITLE, “ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 7023” 2
MEANS THE FORM REQUI RED TO BE SUBMITTED TO THE FEDERAL DEPARTMENT OF 3
AGRICULTURE UNDER 7 U.S.C. § 2143 AND 9 C.F.R. § 2.36. 4
24–2202. 5
(A) ON OR AFTER BEFORE JANUARY 1, 15 EACH YEAR, BEGINNING IN 2024, 6
A PERSON EACH RESEARCH FACILI TY THAT IS LOCATED I N THE STATE AND IS 7
REQUIRED TO SUBMIT A N ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 8
7023 SHALL BE LICENSED BY THE SECRETARY BEFORE THE PERSON MAY USE 9
NONHUMAN ANIMALS TO CONDUCT MEDICAL OR PRODUCT T ESTING OR RESEARCH 10
IN THE STATE. 11
24–2203. 12
(A) (1) AN APPLICANT FOR A LI CENSE SHALL SUBMIT A N APPLICATION 13
TO THE SECRETARY ON THE FORM THAT THE SECRETARY REQUIRES . 14
(2) AN INITIAL APPLICATIO N SHALL REQUI RE AN APPLICANT TO 15
INCLUDE: 16
(I) THE NUMBER OF ANIMALS THAT WILL BE USED TO CONDUCT 17
THE MEDICAL OR PRODU CT TESTING OR RESEAR CH; 18
(II) A LIST OF THE SPECIE S OF ANIMALS THAT WI LL BE USED TO 19
CONDUCT THE MEDICAL OR PRODUCT TESTING O R RESEARCH; AND 20
(III) ANY OTHER INFORMATION REQUIRED BY THE SECRETARY. 21
(B) (1) THE ANNUAL LICENSE FE E IS PAY TO THE DEPARTMENT A 22
CONTRIBUTION IN THE AMOUNT OF: 23
(I) (1) $5,000 FOR UP TO 500 100 ANIMALS; 24
(II) (2) $10,000 FOR MORE THAN 500 100 BUT NOT MORE 25
THAN 1,000 500 ANIMALS; 26
(III) (3) $25,000 $55,000 FOR MORE THAN 1,000 500 BUT NOT 27
MORE THAN 5,000 ANIMALS; 28
(IV) $35,000 FOR MORE THAN 5,000 BUT NOT MORE THAN 10,000 29
ANIMALS; AND 30
8 HOUSE BILL 626
(V) (4) $50,000 $75,000 FOR MORE THAN 10,000 5,000 1
ANIMALS. 2
(2) THE ANNUAL LICENSE FEE M AY BE PAID IN QUARTE RLY 3
INSTALLMENTS . 4
(B) THE AMOUNT OF THE CON TRIBUTION TO BE PAID UNDER SUBSECTION 5
(A) OF THIS SECTION SHAL L BE BASED ON THE TO TAL NUMBER OF ANIMAL S 6
REPORTED IN COLUMN F ON THE MOST RECENTLY SUBMITTED ANIMAL AND PLANT 7
HEALTH INSPECTION SERVICE FORM 7023. 8
(C) THE SECRETARY SHALL : 9
(1) DISTRIBUTE THE AMOUNT OF LICENSING FEES NE CESSARY TO 10
ADMINISTER THE LICEN SING PROGRAM TO AN A DMINISTRATIVE COST A CCOUNT; 11
AND 12
(2) DISTRIBUTE DISTRIBUTE THE REMAINING FEES FUNDS PAID 13
UNDER SUBSECTION (A) OF THIS SECTION TO THE HUMAN–RELEVANT RESEARCH 14
FUND ESTABLISHED UNDE R § 10–4D–02 OF THE ECONOMIC DEVELOPMENT 15
ARTICLE AFTER MAKING THE DIS TRIBUTION REQUIRED U NDER ITEM (1) OF THIS 16
SUBSECTION. 17
24–2204. 18
(A) (1) THE SECRETARY SHALL ISSUE A LICENS E TO AN APPLICANT WH O 19
SUBMITS THE INFORMAT ION REQUIRED UNDER § 24–2203(A) OF THIS SUBTITLE AND 20
ON PAYMENT OF : 21
(I) THE TOTAL ANNUAL LICE NSE FEE; OR 22
(II) THE FIRST QUARTERLY I NSTALLMENT OF THE TO TAL 23
ANNUAL LICENSE FEE . 24
(2) THE TERM OF A LICENSE IS 1 YEAR. 25
(B) THE SECRETARY MAY DENY A LICENSE TO AN APPLIC ANT OR MAY 26
SUSPEND OR REVOKE A LICENSE IF THE APPLI CANT OR LICENSEE : 27
(1) FRAUDULENTLY OR DECEP TIVELY MAKES A STATE MENT ON AN 28
APPLICATION FOR A LI CENSE; 29
(2) FAILS TO MAKE A QUARTERLY INSTALLM ENT PAYMENT OF THE 30
ANNUAL LICENSE FEE ; OR 31 HOUSE BILL 626 9
(3) COMMITS FREQUENT OR N UMEROUS VIOLATIONS O F THIS 1
SUBTITLE OR THE REGU LATIONS ADOPTED UNDE R THIS SUBTITLE. 2
(C) EACH LICENSEE SHALL : 3
(1) MAINTAIN A RECORD OF ALL ANIMALS USED AND DISPOSED OF TO 4
CONDUCT MEDICAL OR P RODUCT TESTING OR RE SEARCH, INCLUDING THE NUMBER 5
AND TYPES OF ANIMALS USED; AND 6
(2) SUBMIT TO THE SECRETARY A QUARTERLY REPORT INCLUDING 7
THE INFORMATION REQU IRED UNDER ITEM (1) OF THIS SUBSECTION . 8
(D) ON OR BEFORE JANUARY 1 EACH YEAR, BEGINNING IN 2024, THE 9
SECRETARY SHALL REPOR T TO THE GENERAL ASSEMBLY, IN ACCORDANCE WITH § 10
2–1257 OF THE STATE GOVERNMENT ARTICLE, THE AGGREGATE NUMBER OF EACH 11
SPECIES OF ANIMAL US ED IN MEDICAL OR PRO DUCT TESTING OR RESE ARCH BY 12
LICENSEES IN THE STATE. 13
24–2205. 14
(A) (1) A PERSON MAY NOT USE N ONHUMAN ANIMALS TO C ONDUCT 15
MEDICAL OR PRODUCT T ESTING OR RESEARCH I N THE STATE UNLESS LICENSED BY 16
THE SECRETARY. 17
(2) A PERSON MAY NOT AID O R ABET THE UNAUTHORI ZED USE OF 18
NONHUMAN ANIMALS TO CONDUCT MEDICAL OR P RODUCT TESTING OR RE SEARCH 19
IN THE STATE. 20
(B) A PERSON IN VIOLATION OF SUBSECTION (A) OF THIS SECTION IS 21
GUILTY OF A FELONY A ND ON CONVICTION IS SUBJECT TO: 22
(1) FOR A FIRST OFFENSE , A FINE NOT EXCEEDING $5,000; OR 23
(2) FOR EACH SU BSEQUENT OFFENSE , A FINE NOT EXCEEDING 24
$20,000. 25
24–2203. 26
A RESEARCH FACILITY TH AT FAILS TO PAY THE CONTRIBUTION REQUIRE D 27
UNDER § 24–2202(A) OF THIS SUBTITLE MAY BE SUBJECT TO A CIVI L PENALTY OF 28
NOT MORE THAN $1,000 PER DAY. 29
Article – State Finance and Procurement 30 10 HOUSE BILL 626
6–226. 1
(a) (1) Except as otherwise specifically provided by law or by regulation of the 2
Treasurer, the Treasurer shall credit to the General Fund any interest on or other income 3
from State money that the Treasurer invests. 4
(2) (i) Notwithstanding any other provision of law, and unless 5
inconsistent with a federal law, grant agreement, or other federal requirement or with the 6
terms of a gift or settlement agreement, net interest on all State money allocated by the 7
State Treasurer under this section to special funds or accounts, and otherwise entitled to 8
receive interest earnings, as accounted for by the Comptroller, shall accrue to the General 9
Fund of the State. 10
(ii) The provisions of subparagraph (i) of this paragraph do not apply 11
to the following funds: 12
170. the Cannabis Public Health Fund; [and] 13
171. the Community Reinvestment and Repair Fund; AND 14
172. THE HUMAN–RELEVANT RESEARCH FUND. 15
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 16
1, 2023. 17
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
Speaker of the House of Delegates.
________________________________________________________________________________
President of the Senate.