2010 Maine Code
TITLE 5: ADMINISTRATIVE PROCEDURES AND SERVICES
Chapter 383: ECONOMIC AND COMMUNITY DEVELOPMENT
5 §13103. Maine Biomedical Research Program

Part 18-A: ECONOMIC AND COMMUNITY DEVELOPMENT

Subchapter 5-A: RESEARCH

§13103. Maine Biomedical Research Program

1. Definitions. As used in this section, unless the context otherwise indicates, the following terms have the following meanings.

A. "Biennium" means that period of time encompassed by the state budget fiscal biennium. [1999, c. 731, Pt. SSS, §1 (NEW).]

A-1. "Academic medical center" is a Maine-based nonprofit clinical, educational and research organization with a critical number of hospital beds, with multiple and independent residency and fellowship programs, with a significant number of residents and fellows and that is affiliated with but independent of a medical school. [2001, c. 196, §2 (NEW).]

A-2. "Affiliate" means a corporation, limited liability company or other entity that controls, is controlled by or is under common control with the applicant. A majority of the membership, stock ownership or other voting authority is conclusively presumed to establish control. [2005, c. 168, §1 (NEW).]

B. "Eligible institution" means a Maine-based private nonprofit biomedical research institution or academic medical center or medical school that, as of July 1, 2001:

(1) Performs competitive biomedical research in on-site, wetbench biomedical research laboratories in the State, as evidenced by publications in recognized peer review journals; and

(2) Receives or expends funds in the State from federal agencies or specified grant sources for the purpose of producing peer-reviewed biomedical research in on-site, wetbench biomedical research laboratories.

For purposes of this paragraph, "wetbench" has the meaning generally ascribed to that term by the biomedical research community and refers to laboratories that use solutions or cell extracts and biological reagents. [2001, c. 196, §3 (RPR).]

C. "Fund" means the Maine Biomedical Research Fund established in subsection 3. [1999, c. 731, Pt. SSS, §1 (NEW).]

D. "Program" means the Maine Biomedical Research Program established in subsection 2. [1999, c. 731, Pt. SSS, §1 (NEW).]

E. "Private nonprofit biomedical research institution" means a Maine-based institution that is a nonprofit organization described in 26 United States Code, Section 501(c)(3); with a primary purpose of biomedical research; with research laboratories on site; with scientific doctoral degrees who are principal investigators on biomedical research grants expended in the State through that institution and who have published a significant number of publications in Index Medicus journals in each of the past 3 years; and with a significant level of research activity funded by specified grant sources. [2001, c. 196, §4 (NEW).]

F. "Specified grant sources" means a federal agency, a nonprofit foundation, private company or corporation, a voluntary membership organization such as the American Cancer Society, or an out-of-state educational university, that, as of July 1, 2001, issues grants or contracts for the purpose of producing peer-reviewed biomedical research when the grantee retains complete editorial control over the content of the research performed. [2001, c. 196, §4 (NEW).]

G. "Medical school" means a state-based private nonprofit medical school that, as of July 1, 2001, is authorized to grant a doctorate degree in osteopathic or allopathic medicine and is accredited by the American Osteopathic Association or its successor or the Liaison Committee on Medical Education or its successor. [2001, c. 196, §4 (NEW).]

[ 2005, c. 168, §1 (AMD) .]

1-A. Eligibility and fulfillment of requirements based on prior activity of affiliate. Until July 1, 2009, any one or more of the requirements of this subchapter, including eligibility requirements under subsection 1, paragraph B, may be satisfied by an applicant created after July 1, 2001 if that requirement is satisfied by one or more affiliates of the applicant and if at least one affiliate of the applicant received funding from the fund prior to July 1, 2005. After July 1, 2009, an applicant that has established eligibility pursuant to this subsection must itself meet all other requirements of this subchapter.

[ 2005, c. 168, §2 (NEW) .]

2. Program established. The Maine Biomedical Research Program is established to promote economic development and jobs in the State primarily by making state investments in organizations with successful results in attracting biomedical research funds from specified grant sources. As a secondary purpose, the Maine Biomedical Research Program is intended to provide incentives for small eligible institutions to grow. The program shall disburse program funds from the Maine Biomedical Research Fund to eligible institutions pursuant to this section. The Maine Biomedical Research Board shall administer the program. The Maine Biomedical Research Board shall:

A. Develop and modify detailed program guidelines consistent with this section in consultation as needed with members of the biomedical community; [1999, c. 731, Pt. SSS, §1 (NEW).]

B. Review and if necessary verify applications for funds from eligible institutions; [1999, c. 731, Pt. SSS, §1 (NEW).]

C. Determine whether the institution is an eligible institution; [1999, c. 731, Pt. SSS, §1 (NEW).]

D. Verify that the proposed use of program funds is consistent with subsection 4; [1999, c. 731, Pt. SSS, §1 (NEW).]

E. Determine the allocation that each eligible institution will receive in a given biennium; [1999, c. 731, Pt. SSS, §1 (NEW).]

F. Advertise the availability of funds each biennium; and [1999, c. 731, Pt. SSS, §1 (NEW).]

G. Submit each biennium a report to the Governor, the joint standing committee of the Legislature having jurisdiction over appropriations and financial affairs and the joint standing committee of the Legislature having jurisdiction over business, research and economic development matters. The report must include detailed information on the status of the funds in the Maine Biomedical Research Fund and a listing and explanation of each specific source of funding from grant sources for biomedical research . [2009, c. 337, §6 (AMD).]

[ 2009, c. 337, §6 (AMD) .]

3. Fund established. The Maine Biomedical Research Fund is established as an Other Special Revenue fund for the purposes specified in this section. Funds appropriated for this purpose may be transferred on a one-time basis to the Other Special Revenue fund in fiscal year 2000-01. Any unexpended balance in the fund may not lapse, but must be carried forward for the benefit of the fund.

[ 1999, c. 731, Pt. SSS, §1 (NEW) .]

4. Use of funds. Program funds are to support biomedical research in this State, with priority given to research and research technologies with the potential to affect diseases and biomedical mechanisms. An eligible institution receiving program funds under this section may use those funds for any of the following purposes:

A. Project funding; [1999, c. 731, Pt. SSS, §1 (NEW).]

B. Facilities funding, including debt service; [1999, c. 731, Pt. SSS, §1 (NEW).]

C. Equipment used in research, including debt service; or [1999, c. 731, Pt. SSS, §1 (NEW).]

D. Ancillary support. [1999, c. 731, Pt. SSS, §1 (NEW).]

An eligible institution that receives funds under this section may charge overhead expenses consistent with federal research granting criteria. The institution may utilize up to 2% of the program funds it receives to evaluate the impact of the research it is conducting. An institution is not obligated to expend program funds during the period in which those funds are received, but may carry over funding for up to 5 years.

[ 2001, c. 196, §6 (AMD) .]

5. Application procedure. In order to receive program funds, an eligible institution must submit to the program:

A. A preliminary plan describing how the institution would utilize program funds and what research and economic benefits it anticipates as a result of this funding; [1999, c. 731, Pt. SSS, §1 (NEW).]

B. Citations of articles from peer review journals published within the previous 2 years that show the institution is engaged in competitive biomedical research; [1999, c. 731, Pt. SSS, §1 (NEW).]

C. Copies of the institution's Internal Revenue Service form 990, showing the amount of funding from outside sources; [1999, c. 731, Pt. SSS, §1 (NEW).]

D. A breakdown and explanation of all funding from specified grant sources for biomedical research, listing each specific source of funding and its use; and [2001, c. 196, §7 (AMD).]

E. A statement signed by the institution's chief executive officer asserting that all the submitted materials are accurate. [1999, c. 731, Pt. SSS, §1 (NEW).]

[ 2001, c. 196, §7 (AMD) .]

6. Allocation of funds to eligible institutions. The Maine Biomedical Research Board shall allocate funds from the fund to eligible institutions biannually, based on a formula to be developed by the board. The formula must be designed both to provide an ongoing incentive to leverage outside funding and to facilitate the growth of smaller institutions.

A. The formula must link the amount of the program funds to be received by an eligible institution to the total amount of funding that the institution has received or expended from specific grant sources during the previous 2 calendar years for the purpose of producing peer-reviewed biomedical research in on-site biomedical research laboratories in the State. An institution receiving more funding from federal agencies and specified grant sources must receive more program funds under the formula. [2001, c. 196, §8 (RPR).]

B. The formula must be weighted to provide smaller eligible institutions with an incentive to grow. [2001, c. 196, §8 (RPR).]

C. [2001, c. 196, §8 (RP).]

[ 2001, c. 196, §8 (RPR) .]

7. Final plan. Once funding decisions are made according to the formula established pursuant to subsection 6, each eligible institution shall revise its preliminary plan into a final plan that reflects the actual amount of funding allocated. A final plan must describe how the institution would utilize the allocated program funds and what research and economic benefits it anticipates as a result of this funding. An institution must submit a final plan to the department prior to disbursement of funding.

[ 1999, c. 731, Pt. SSS, §1 (NEW) .]

8. Accounting, evaluation and reporting requirements. Each institution receiving funding shall:

A. Maintain an accurate accounting of the use of all program funds as required by state procedures and program guidelines; [1999, c. 731, Pt. SSS, §1 (NEW).]

B. Undertake an ongoing process to evaluate the impact of the research undertaken with program funds. At a minimum, the evaluation process must be designed to provide the following:

(1) An assessment of the direct and indirect economic impact of the funded research; and

(2) An assessment of the contribution of the funded research to scientific advancement and the institution's competitive position; and [1999, c. 731, Pt. SSS, §1 (NEW).]

C. Each biennium, submit a report to the department. The report must include:

(1) An accounting of the use of all program funds received in the previous 2 years, prepared by a certified public accountant;

(2) A summary of the status of any ongoing research;

(3) A summary of the results of any completed research; and

(4) Evaluation data and assessment. [2003, c. 20, Pt. RR, §18 (AFF); 2003, c. 20, Pt. RR, §4 (AMD).]

[ 2003, c. 20, Pt. RR, §18 (AFF); 2003, c. 20, Pt. RR, §4 (AMD) .]

9. Rulemaking. The Maine Biomedical Research Board may adopt routine technical rules pursuant to Title 5, chapter 375, subchapter 2-A to implement this section.

[ 2003, c. 464, §3 (AMD) .]

SECTION HISTORY

1999, c. 731, §SSS1 (NEW). 2001, c. 196, §§2-8 (AMD). 2003, c. 20, §RR18 (AFF). 2003, c. 20, §RR4 (AMD). 2003, c. 50, §B1 (AMD). 2003, c. 50, §B2 (AFF). 2003, c. 464, §3 (AMD). 2005, c. 168, §§1,2 (AMD). 2009, c. 337, §6 (AMD).