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A bill for an act1.1
relating to pediatric medical devices; creating a pediatric medical device1.2
innovation program; appropriating money; proposing coding for new law in1.3
Minnesota Statutes, chapter 116J.1.4
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:1.5
Section 1. [116J.8735] PEDIATRIC MEDICAL DEVICE INNOVATION1.6
PROGRAM.1.7
Subdivision 1. Definitions. (a) For the purposes of this section, the following terms1.8
have the meanings given.1.9
(b) "Board" means the advisory board established under subdivision 2.1.10
(c) "Commissioner" means the commissioner of health.1.11
(d) "Pediatric medical device" means a medical device intended for human use, as1.12
defined under section 510 of the federal Food, Drug, and Cosmetic Act, designed to be1.13
used for a pediatric population and requiring approval under section 515A of the federal1.14
Food, Drug, and Cosmetic Act for a pediatric indication.1.15
(e) "Qualified business" means a for profit or nonprofit entity that is engaged in the1.16
development of a pediatric medical device and intends to pursue federal Food and Drug1.17
Administration approval.1.18
(f) "Qualified expenditures" means the aggregate amount of the costs paid or1.19
incurred by a qualified business for expenses necessary for and directly related to the1.20
conduct of a qualifying pediatric medical device innovation project in this state, but1.21
excluding any of the following costs:1.22
(1) those funded in whole or in part with moneys or investments that received a1.23
credit under section 116J.8737 or 116J.8736; or1.24
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(2) of the type defined under section 48D(b)(3) of the Internal Revenue Code.2.1
(g) "Qualifying pediatric medical device innovation project" or "project" means2.2
a project that is recommended by the board and approved by the commissioner under2.3
subdivision 3 as qualifying for a grant under this section.2.4
Subd. 2. Pediatric medical device advisory board. (a) The commissioner shall2.5
establish an 11 member pediatric medical device advisory board comprised of:2.6
(1) one representative chosen by the governor;2.7
(2) one representative chosen by the University of Minnesota;2.8
(3) nine representatives from the state's pediatric medical technology industry,2.9
chosen by private sector stakeholders and which represent each of the following sectors:2.10
(i) research and development;2.11
(ii) device design and manufacturing;2.12
(iii) investors;2.13
(iv) regulators;2.14
(v) preclinical and clinical research;2.15
(vi) legal;2.16
(vii) nonprofits;2.17
(viii) governmental affairs; and2.18
(ix) pediatric medical practitioners.2.19
(b) The membership terms, removal of members, and filling of vacancies are as2.20
provided under section 15.059. Members shall not be compensated.2.21
(c) The advisory board expires June 30, 2017.2.22
Subd. 3. Program established; application process. (a) The commissioner, in2.23
consultation with the board, shall establish a pediatric medical device innovation program2.24
to provide grants under this section for projects carried on in this state, that are designed to2.25
create, develop, test and produce pediatric devices to diagnose, treat, or prevent diseases2.26
or conditions by:2.27
(1) conducting preclinical activities, clinical trials, and clinical studies, or carrying2.28
out research protocols, for the purpose of securing approval of a pediatric medical device2.29
by the federal Food and Drug Administration;2.30
(2) developing a product, process, or technology to further the delivery or2.31
administration of a pediatric medical device; or2.32
(3) conducting commercialization activities for pediatric medical devices.2.33
(b) The commissioner shall establish a process for the application for and award2.34
of grants under this section. The commissioner must specify the time, manner, form,2.35
and amount of application fee, if any, for the applications and the information to be2.36
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provided with the applications. The commissioner shall approve only projects that have3.1
been recommended by the board.3.2
Subd. 4. Board review. The commissioner shall submit all applications for pediatric3.3
medical device innovation project grants to the board for review. The board must review3.4
each application and make recommendations to the commissioner for approval or denial,3.5
including a recommendation as to the amount of the grant for a recommended project,3.6
based on the extent to which the proposed project:3.7
(1) shows reasonable potential to result in new therapies, to treat areas of unmet3.8
medical need, to prevent, detect, or treat chronic or acute diseases and conditions, or to3.9
reduce the cost of health care; and3.10
(2) is likely to create and sustain (directly or indirectly) high-quality, high-paying3.11
jobs in the state and to advance the state's competitiveness in the fields of life, biological,3.12
and medical sciences.3.13
Subd. 5. Annual report. By February 1 of each year, a recipient of a grant under3.14
this section in a prior year must file a report with the commissioner. Reports must be made3.15
in the form and contain the information required by the commissioner. The commissioner3.16
shall require the annual report to include information indicating the extent to which the3.17
project furthers the selection criteria under subdivision 4.3.18
Sec. 2. PEDIATRIC MEDICAL DEVICE PROGRAM APPROPRIATION.3.19
$10,000,000 in fiscal year 2016 is appropriated from the general fund to the3.20
commissioner of health for the pediatric medical device grant program under section3.21
116J.8735. This is a onetime appropriation and is available until June 30, 2017.3.22
Sec. 2. 3