EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
*hb0626*
HOUSE BILL 626
J1, C2 3lr1178
CF SB 560
By: Delegates Cullison, Allen, Bagnall, Bridges, Charkoudian, Fennell,
Fraser–Hidalgo, Lehman, R. Lewis, Lopez, Love, Patterson, Qi, Reznik,
Ruth, Shetty, Solomon, and Stein
Introduced and read first time: February 3, 2023
Assigned to: Health and Government Operations and Ways and Means
Committee Report: Favorable with amendments
House action: Adopted
Read second time: March 7, 2023
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 who engage in animal testing or research to pay a certain 10
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
BY repealing and reenacting, without amendments, 14
Article – Economic Development 15
Section 10–401(a) and (c) and 10–429(a) and (g) 16
Annotated Code of Maryland 17
(2018 Replacement Volume and 2022 Supplement) 18
BY adding to 19
Article – Economic Development 20 2 HOUSE BILL 626
Section 10–4D–01 through 10–4D–06 to be under the new subtitle “Subtitle 4D. 1
Human–Relevant Research Fund and Program” 2
Annotated Code of Maryland 3
(2018 Replacement Volume and 2022 Supplement) 4
BY adding to 5
Article – Health – General 6
Section 24–2201 through 24–2205 24–2203 to be under the new subtitle “Subtitle 22. 7
Animal Testing and Research License Contribution” 8
Annotated Code of Maryland 9
(2019 Replacement Volume and 2022 Supplement) 10
BY repealing and reenacting, without amendments, 11
Article – State Finance and Procurement 12
Section 6–226(a)(1) and (2)(i) 13
Annotated Code of Maryland 14
(2021 Replacement Volume and 2022 Supplement) 15
BY repealing and reenacting, with amendments, 16
Article – State Finance and Procurement 17
Section 6–226(a)(2)(ii)170. and 171. 18
Annotated Code of Maryland 19
(2021 Replacement Volume and 2022 Supplement) 20
BY adding to 21
Article – State Finance and Procurement 22
Section 6–226(a)(2)(ii)172. 23
Annotated Code of Maryland 24
(2021 Replacement Volume and 2022 Supplement) 25
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 26
That the Laws of Maryland read as follows: 27
Article – Economic Development 28
10–401. 29
(a) In this subtitle the following words have the meanings indicated. 30
(c) “Corporation” means the Maryland Technology Development Corporation. 31
10–429. 32
(a) In this part the following words have the meanings indicated. 33
(g) “Institutional review board” has the meaning stated in the federal regulations 34
on the protection of human subjects. 35 HOUSE BILL 626 3
SUBTITLE 4D. HUMAN–RELEVANT RESEARCH FUND AND PROGRAM. 1
10–4D–01. 2
(A) IN THIS SUBTITLE THE FOLLOWING TERMS HAVE THE MEANINGS 3
INDICATED. 4
(B) “BOARD” MEANS THE HUMAN–RELEVANT RESEARCH REVIEW BOARD 5
ESTABLISHED UNDER § 10–4D–04 OF THIS SUBTITLE. 6
(C) “CORPORATION ” HAS THE MEANING STAT ED IN § 10–401 OF THIS TITLE. 7
(D) “FUND” MEANS THE HUMAN–RELEVANT RESEARCH FUND. 8
(E) “INSTITUTIONAL REVIEW BOARD” HAS THE MEANING STAT ED IN § 9
10–429 OF THIS TITLE. 10
10–4D–02. 11
(A) THERE IS A HUMAN–RELEVANT RESEARCH FUND. 12
(B) THE PURPOSE OF THE FUND IS TO PROMOTE STATE–FUNDED 13
RESEARCH INTENDED TO DEVELOP HUMAN –RELEVANT ALTERNATIVE S TO USING 14
NONHUMAN ANIMALS IN MEDICAL AND PRODUCT TESTING AND RESEARCH 15
THROUGH GRANTS AND L OANS TO PUBLIC AND P RIVATE ENTITIES IN T HE STATE. 16
(C) THE CORPORATION SHALL ADM INISTER THE FUND. 17
(D) (1) THE FUND IS A SPECIAL , NONLAPSING FUND THAT IS NOT 18
SUBJECT TO § 7–302 OF THE STATE FINANCE AND PROCUREMENT ARTICLE. 19
(2) THE STATE TREASURER SHALL HOLD THE FUND SEPARATELY , 20
AND THE COMPTROLLER SHALL ACC OUNT FOR THE FUND. 21
(E) THE FUND CONSISTS OF: 22
(1) REVENUE DISTRIBUTED TO THE FUND UNDER § 24–2203 § 23
24–2202 OF THE HEALTH – GENERAL ARTICLE; 24
(2) MONEY APPROPRIATED I N THE STATE BUDGET TO THE FUND; 25
(3) INTEREST EARNINGS OF THE FUND; AND 26
4 HOUSE BILL 626
(4) ANY OTHER MONEY FROM ANY OTHER SOURCE ACCEPTED FOR 1
THE BENEFIT OF THE FUND. 2
(F) MONEY IN THE FUND MAY BE USED ONLY TO: 3
(1) AWARD GRANTS AND LOA NS FOR STATE–FUNDED, 4
HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH IN ACCORDANCE 5
WITH THE RECOMMENDAT IONS OF THE BOARD; AND 6
(2) PAY THE COSTS NECESSARY TO A DMINISTER THE FUND. 7
(G) (1) THE STATE TREASURER SHALL INVES T THE MONEY IN THE FUND 8
IN THE SAME MANNER A S OTHER STATE MONEY MAY BE IN VESTED. 9
(2) ANY INTEREST EARNINGS OF THE FUND SHALL BE CREDITE D TO 10
THE FUND. 11
(H) (1) THE GOVERNOR MAY INCLUDE IN THE STATE BUDGET BILL EAC H 12
FISCAL YEAR AN APPRO PRIATION TO THE FUND. 13
(2) EXPENDITURES FROM THE FUND MAY BE MADE ONLY IN 14
ACCORDANCE WITH THE STATE BUDGET . 15
10–4D–03. 16
(A) SUBJECT TO THE PROVIS IONS OF THIS SUBTITL E, THE CORPORATION 17
SHALL ESTABLISH A GRANT AN D LOAN PROGRAM TO PR OVIDE GRANTS AND LOA NS 18
FOR STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES 19
RESEARCH. 20
(B) A GRANT OR LOAN AWARDE D UNDER THIS SUBTITL E IS CONTINGENT ON 21
THE RECIPIENT: 22
(1) SUBMITTING TO THE BOARD APPROVAL FROM AN INSTITUTIONA L 23
REVIEW BOARD ; AND 24
(2) ENTERING INTO A MEMO RANDUM OF UNDERSTAND ING WITH THE 25
CORPORATION THAT : 26
(I) (1) ESTABLISHES THE SCOP E OF THE STATE’S 27
OWNERSHIP OR OTHER F INANCIAL INTEREST IN THE COMMERCIALIZATIO N AND 28
OTHER BENEFITS OF TH E RESULTS, PRODUCTS, INVENTIONS, AND DISCOVERIES 29
RESULTING FROM STATE–FUNDED, HUMAN–RELEVANT RESEARCH ; AND 30
HOUSE BILL 626 5
(II) (2) TO THE EXTENT CONSIS TENT WITH FEDERAL AN D 1
STATE LAW , REFLECTS THE INTELLE CTUAL PROPERTY POLIC IES OF THE 2
CORPORATION . 3
(C) A RECIPIENT SHALL SUBMIT THE APP ROVAL REQUIRED UNDER 4
SUBSECTION (B)(1) OF THIS SECTION WITH IN 6 MONTHS AFTER THE AWA RD OF THE 5
GRANT OR LOAN . 6
(D) THE CORPORATION MAY NOT D ISBURSE GRANT OR LOA N MONEY TO A 7
RECIPIENT UNTIL THE RECIPIENT MEETS THE REQUIREMENTS OF SUBS ECTION (B) 8
OF THIS SECTION. 9
10–4D–04. 10
(A) THE CORPORATION SHALL CON TRACT WITH AN INDEPE NDENT 11
SCIENTIFIC REVIEW BO ARD COMPOSED OF RECO GNIZED SCIENTIFIC EX PERTS IN 12
THE FIELD OF HUMAN –RELEVANT ANIMAL TEST ING ALTERNATIVES TO ACT AS THE 13
HUMAN–RELEVANT RESEARCH REVIEW BOARD. 14
(B) THE BOARD SHALL: 15
(1) REVIEW, EVALUATE, RANK, AND RATE RESEARCH PR OPOSALS FOR 16
STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH: 17
(I) BASED ON THE PROCEDU RES AND GUIDELINES 18
ESTABLISHED BY THE CORPORATION ; AND 19
(II) IN A MANNER THAT GIV ES DUE CONSIDERATION TO THE 20
SCIENTIFIC, MEDICAL, AND ETHICAL IMPLICAT IONS OF THE RESEARCH ; AND 21
(2) BASED ON THE RANKING S AND RATINGS AWARDE D TO THE 22
RESEARCH PROPOSALS B Y THE BOARD, MAKE RECOMMENDATIONS TO THE 23
CORPORATION FOR THE A WARD AND DISBURSEMEN T OF GRANTS AND LOAN S. 24
(C) A MEMBER OF THE BOARD: 25
(1) IS NOT ELIGIBLE TO R ECEIVE A GRANT OR LO AN FOR 26
STATE–FUNDED, HUMAN–RELEVANT RESEARCH FR OM THE FUND; AND 27
(2) SHALL BE SUBJECT TO CONFLICT OF INTEREST STANDARDS THAT 28
ARE AT LEAST AS STRINGENT AS THE STANDARDS ON CON FLICT OF INTEREST 29
ADOPTED BY THE FEDER AL NATIONAL INSTITUTES OF HEALTH. 30
10–4D–05. 31 6 HOUSE BILL 626
THE CORPORATION , IN CONSULTATION WITH THE BOARD, SHALL ADOPT 1
REGULATIONS TO ESTAB LISH PROCEDURES 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 PROGR ESS 7
OF THE HUM AN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH 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 MO NEY FROM THE FUND; 12
(2) THE AMOUNT OF MONEY AWARDED TO EACH RECI PIENT; AND 13
(3) A DESCRIPTION OF THE TYPE OF STATE–FUNDED, 14
HUMAN–RELEVANT RESEARCH PE RFORMED BY THE RECIP IENT AND THE ANIMAL 15
TESTS THE RESEARCH I S INTENDED TO REPLAC E. 16
Article – Health – General 17
SUBTITLE 22. ANIMAL TESTING AND RESEARCH LICENSE CONTRIBUTION . 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, “ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 7023” 25
MEANS THE FORM REQUI RED TO BE SUBMITTED TO THE FEDERAL DEPARTMENT OF 26
AGRICULTURE UNDER 7 U.S.C. § 2143 AND 9 C.F.R. § 2.36. 27
24–2202. 28
(A) ON OR AFTER BEFORE JANUARY 1, 15 EACH YEAR, BEGINNING IN 2024, 29
A PERSON EACH RESEARCH FACILI TY THAT IS LOCATED I N THE STATE AND IS 30 HOUSE BILL 626 7
REQUIRED TO SUBMIT A N ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 1
7023 SHALL BE LICENSED BY THE SECRETARY BEFORE THE PERSON MAY USE 2
NONHUMAN ANIMALS TO CONDUCT MEDICAL OR PRODUCT TESTING OR RESEARCH 3
IN THE STATE. 4
24–2203. 5
(A) (1) AN APPLICANT FOR A LI CENSE SHALL SUBMIT A N APPLICATION 6
TO THE SECRETARY ON THE FORM THAT THE SECRETARY REQUIRES . 7
(2) AN INITIAL APPLICATIO N SHALL REQUIRE AN A PPLICANT TO 8
INCLUDE: 9
(I) THE NUMBER OF ANIMALS THAT WILL BE USED TO CONDUCT 10
THE MEDICAL OR PRODU CT TESTING OR RESEAR CH; 11
(II) A LIST OF THE SPECIE S OF ANIMALS THAT WI LL BE USED TO 12
CONDUCT THE MEDICAL OR PRODUCT TESTING O R RESEARCH; AND 13
(III) ANY OTHER INFORMATION REQUIRED BY THE SECRETARY. 14
(B) (1) THE ANNUAL LICENSE FE E IS PAY TO THE DEPARTMENT A 15
CONTRIBUTION IN THE AMOUNT OF: 16
(I) (1) $5,000 FOR UP TO 500 100 ANIMALS; 17
(II) (2) $10,000 FOR MORE THAN 500 100 BUT NOT MORE 18
THAN 1,000 500 ANIMALS; 19
(III) (3) $25,000 $55,000 FOR MORE THAN 1,000 500 BUT NOT 20
MORE THAN 5,000 ANIMALS; 21
(IV) $35,000 FOR MORE THAN 5,000 BUT NOT MORE THAN 10,000 22
ANIMALS; AND 23
(V) (4) $50,000 $75,000 FOR MORE THAN 10,000 5,000 24
ANIMALS. 25
(2) THE ANNUAL LICENSE FE E MAY BE PAID IN QUA RTERLY 26
INSTALLMENTS . 27
(B) THE AMOUNT OF THE CON TRIBUTION TO BE PAID UNDER SUBSECTION 28
(A) OF THIS SECTION SHAL L BE BASED ON THE TO TAL NUMBER OF ANIMAL S 29 8 HOUSE BILL 626
REPORTED IN COLUMN F ON THE MOST RECENTLY SUBMITTED ANIMAL AND PLANT 1
HEALTH INSPECTION SERVICE FORM 7023. 2
(C) THE SECRETARY SHALL : 3
(1) DISTRIBUTE THE AMOUNT OF LICENSING FEES NE CESSARY TO 4
ADMINISTER THE LICEN SING PROGRAM TO AN A DMINISTRATIVE COST A CCOUNT; 5
AND 6
(2) DISTRIBUTE DISTRIBUTE THE REMAINING FEES FUNDS PAID 7
UNDER SUBSECTION (A) OF THIS SECTION TO THE HUMAN–RELEVANT RESEARCH 8
FUND ESTABLISHED UNDE R § 10–4D–02 OF THE ECONOMIC DEVELOPMENT 9
ARTICLE AFTER MAKING THE DIS TRIBUTION REQUIRED U NDER ITEM (1) OF THIS 10
SUBSECTION. 11
24–2204. 12
(A) (1) THE SECRETARY SHALL ISSUE A LICENSE TO AN APPL ICANT WHO 13
SUBMITS THE INFORMATION REQU IRED UNDER § 24–2203(A) OF THIS SUBTITLE AND 14
ON PAYMENT OF : 15
(I) THE TOTAL ANNUAL LICE NSE FEE; OR 16
(II) THE FIRST QUARTERLY I NSTALLMENT OF THE TO TAL 17
ANNUAL LICENSE FEE . 18
(2) THE TERM OF A LICENSE IS 1 YEAR. 19
(B) THE SECRETARY MAY DENY A LICENSE T O AN APPLICANT OR MA Y 20
SUSPEND OR REVOKE A LICENSE IF THE APPLI CANT OR LICENSEE : 21
(1) FRAUDULENTLY OR DECEP TIVELY MAKES A STATE MENT ON AN 22
APPLICATION FOR A LI CENSE; 23
(2) FAILS TO MAKE A QUART ERLY INSTALLMENT PAY MENT OF THE 24
ANNUAL LICENSE FEE; OR 25
(3) COMMITS FREQUENT OR N UMEROUS VIOLATIONS O F THIS 26
SUBTITLE OR THE REGU LATIONS ADOPTED UNDE R THIS SUBTITLE. 27
(C) EACH LICENSEE SHALL : 28
HOUSE BILL 626 9
(1) MAINTAIN A RECORD OF ALL ANIMALS USED AND DISPOSED OF TO 1
CONDUCT MEDICAL OR P RODUCT TESTING OR RESEARCH, INCLUDING THE NUMBER 2
AND TYPES OF ANIMALS USED; AND 3
(2) SUBMIT TO THE SECRETARY A QUARTERLY REPORT INCLUDING 4
THE INFORMATION REQU IRED UNDER ITEM (1) OF THIS SUBSECTION . 5
(D) ON OR BEFORE JANUARY 1 EACH YEAR, BEGINNING IN 2024, THE 6
SECRETARY SHALL REPORT TO THE GENERAL ASSEMBLY, IN ACCORDANCE WITH § 7
2–1257 OF THE STATE GOVERNMENT ARTICLE, THE AGGREGATE NUMBER OF EACH 8
SPECIES OF ANIMAL US ED IN MEDICAL OR PRO DUCT TESTING OR RESE ARCH BY 9
LICENSEES IN THE STATE. 10
24–2205. 11
(A) (1) A PERSON MAY NOT USE NONHUMAN ANIMALS TO CONDUCT 12
MEDICAL OR PRODUCT T ESTING OR RESEARCH I N THE STATE UNLESS LICENSED BY 13
THE SECRETARY. 14
(2) A PERSON MAY NOT AID O R ABET THE UNAUTHORI ZED USE OF 15
NONHUMAN ANIMALS TO CONDUCT MEDICAL OR P RODUCT TESTING OR RE SEARCH 16
IN THE STATE. 17
(B) A PERSON IN VIOLATION OF SUBSECTION (A) OF THIS SECTION IS 18
GUILTY OF A FELONY A ND ON CONVICTION IS SUBJECT TO: 19
(1) FOR A FIRST OFFENSE , A FINE NOT EXCEEDING $5,000; OR 20
(2) FOR EACH SUBSEQUENT O FFENSE, A FINE NOT EXCEEDING 21
$20,000. 22
24–2203. 23
A RESEARCH FACILITY TH AT FAILS TO PAY THE CONTRIBUTION REQUIRE D 24
UNDER § 24–2202(A) OF THIS SUBTITLE MAY BE SUBJECT TO A CIVI L PENALTY OF 25
NOT MORE THAN $1,000 PER DAY. 26
Article – State Finance and Procurement 27
6–226. 28
(a) (1) Except as otherwise specifically provided by law or by regulation of the 29
Treasurer, the Treasurer shall credit to the General Fund any interest on or other income 30
from State money that the Treasurer invests. 31
10 HOUSE BILL 626
(2) (i) Notwithstanding any other provision of law, and unless 1
inconsistent with a federal law, grant agreement, or other federal requirement or with the 2
terms of a gift or settlement agreement, net interest on all State money allocated by the 3
State Treasurer under this section to special funds or accounts, and otherwise entitled to 4
receive interest earnings, as accounted for by the Comptroller, shall accrue to the General 5
Fund of the State. 6
(ii) The provisions of subparagraph (i) of this paragraph do not apply 7
to the following funds: 8
170. the Cannabis Public Health Fund; [and] 9
171. the Community Reinvestment and Repair Fund; AND 10
172. THE HUMAN–RELEVANT RESEARCH FUND. 11
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 12
1, 2023. 13
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
Speaker of the House of Delegates.
________________________________________________________________________________
President of the Senate.