BILL NUMBER: AB 2750 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 7, 2016
AMENDED IN ASSEMBLY MARCH 17, 2016
INTRODUCED BY Assembly Member Gomez
FEBRUARY 19, 2016
An act to amend Section 68130.5 of the Education Code,
relating to postsecondary education. An act to amend
Section 1635.1 of the Health and Safety Code, relating to tissue
banks.
LEGISLATIVE COUNSEL'S DIGEST
AB 2750, as amended, Gomez. Postsecondary education:
exemption from nonresident tuition. Tissue banks.
Existing federal law governs the processing, storage, and use of
human tissue and human cell, tissue, or cellular- or tissue-based
products (HCT/P), as specified, and imposes certain regulatory duties
relating to HCT/P upon the federal Food and Drug Administration
(FDA).
Existing state law requires the State Department of Public Health
to license and regulate tissue banks, which process, store, or
distribute human tissue for transplantation into human beings.
Existing law generally requires every tissue bank operating in this
state to have a current and valid tissue bank license issued or
renewed by the department, but exempts certain activities from that
requirement, including the storage of HCT/P by a licensed physician
or podiatrist, as specified, if the products were obtained from a
California-licensed tissue bank, stored in strict accordance with
manufacturer instructions, and used solely for the express purpose of
direct implantation into or application on the practitioner's own
patient, among other criteria.
This bill would create an additional exemption from the tissue
bank licensing requirement for the storage of HCT/P by a person if
that person is a hospital or outpatient setting and the HCT/P meets
specified requirements, including, among other things, that the HCT/P
was obtained from a tissue bank licensed by the state, is stored in
the original unopened enclosure for one finished unit of
transplantable tissue and in strict accordance with the package
insert and any other manufacturer instructions and guidelines, and is
intended for the express purpose of implantation into or application
on a patient.
(1) Existing law exempts a student, other than a nonimmigrant
alien, as defined, from paying nonresident tuition at the California
State University and the California Community Colleges if the student
meets certain requirements. These requirements include either high
school attendance in California for 3 or more years or the attainment
of credits earned in California from a California high school
equivalent to 3 or more years of full-time high school coursework and
a total of 3 or more years of attendance in California elementary or
secondary schools, or a combination of those schools.
This bill would delete the requirement of a total of 3 or more
years of attendance in California elementary or secondary schools, or
a combination of those schools, as referenced above. The bill would
also add the requirement that a student be born after January 1,
1980.
The bill would request the Regents of the University of California
to enact exemptions from requirements to pay nonresident tuition for
its students that are equivalent to those applicable to students of
the California Community Colleges and the California State University
pursuant to this bill.
Because the bill would impose new duties on community college
districts with respect to determining eligibility for exemptions from
paying nonresident tuition, the bill would constitute a
state-mandated local program.
(2) The California Constitution requires the state to reimburse
local agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that, if the Commission on State Mandates
determines that the bill contains costs mandated by the state,
reimbursement for those costs shall be made pursuant to these
statutory provisions.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes no .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1635.1 of the Health
and Safety Code is amended to read:
1635.1. (a) Except as provided in subdivision (b), every tissue
bank operating in California on or after July 1, 1992, shall have a
current and valid tissue bank license issued or renewed by the
department pursuant to Section 1639.2 or 1639.3.
(b) This chapter does not apply to any of the following:
(1) The collection, processing, storage, or distribution of human
whole blood or its derivatives by blood banks licensed pursuant to
Chapter 4 (commencing with Section 1600) or any person exempt from
licensure under that chapter.
(2) The collection, processing, storage, or distribution of tissue
for autopsy, biopsy, training, education, or for other medical or
scientific research or investigation, when transplantation of the
tissue is not intended or reasonably foreseeable.
(3) The collection of tissue by an individual physician and
surgeon from his or her patient or the implantation of tissue by an
individual physician and surgeon into his or her patient. This
exemption shall not be interpreted to apply to any processing or
storage of the tissue, except for the processing and storage of semen
by an individual physician and surgeon when the semen was collected
by that physician and surgeon from a semen donor or obtained by that
physician and surgeon from a tissue bank licensed under this chapter.
(4) The collection, processing, storage, or distribution of fetal
tissue or tissue derived from a human embryo or fetus.
(5) The collection, processing, storage, or distribution by an
organ procurement organization (OPO), as defined in Section
485.302 486.302 of Title 42 of the Code of
Federal Regulations, if the OPO, at the time of collection,
processing, storage, and distribution of the organ, has been
designated by the Secretary of Health and Human Services as an
OPO, pursuant to Section 485.305 of Title 42 of the Code of
Federal Regulations, OPO and meets the
requirements of Sections 485.304 486.304
and 485.306 486.306 of Title 42
of the Code of Federal Regulations, as applicable.
(6) The storage of prepackaged, freeze-dried bone by a general
acute care hospital.
(7) The storage of freeze-dried bone and dermis by any licensed
dentist practicing in a lawful practice setting, if the freeze-dried
bone and dermis has have been obtained
from a licensed tissue bank, is are
stored in strict accordance with a kit's package insert and any other
manufacturer instructions and guidelines, and is
are used for the express purpose of implantation into a
patient.
(8) The storage of a human cell, tissue, or cellular- or
tissue-based product, product (HCT/P),
as defined by the federal Food and Drug Administration,
Administration (FDA), that is either a medical
device approved pursuant to Section 510 or 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. Secs. Sec.
360 and 360e) et seq.) or that is
a biologic product approved under Section 351 of the federal Public
Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or
podiatrist acting within the scope and authority of his or her
license and practicing in a lawful practice setting. The medical
device or biologic product must have been obtained from a
California licensed C alifornia-licensed
tissue bank, been stored in strict accordance with the device's
or product's package insert and any other manufacturer instructions,
and used solely for the express purpose of direct implantation into
or application on the practitioner's own patient. In order to be
eligible for the exemption in this paragraph, the entity or
organization where the physician or podiatrist who is eligible for
the exemption is practicing shall notify the department, in writing,
that the practitioner is licensed and meets the requirements of this
paragraph. The notification shall include all of the following:
(A) A list of all practitioners to whom the notice applies.
(B) Acknowledgment that each listed practitioner uses the medical
device or biologic product in the scope and authority of his or her
license and practice for the purposes of direct patient care as
described in this paragraph.
(C) A statement that each listed practitioner agrees to strictly
abide by the directions for storage in the device's or product's
package insert and any other manufacturer instructions and
guidelines.
(D) Acknowledgment by each practitioner that the medical device or
biologic product shall not be resold or distributed.
(9) The storage of an HCT/P by a person if both of the following
apply:
(A) The person, as defined in Section 1635, is a hospital, or an
outpatient setting regulated by the Medical Board of California
pursuant to Chapter 1.3 (commencing with Section 1248), including an
ambulatory surgical center.
(B) The HCT/P meets all of the following:
(i) The HCT/P was obtained from a tissue bank licensed by the
state.
(ii) The HCT/P is stored in the original unopened enclosure for
one finished unit of transplantable tissue and is stored in strict
accordance with the package insert and any other manufacturer
instructions and guidelines.
(iii) The HCT/P is intended for the express purpose of
implantation into or application on a patient.
(iv) The HCT/P is not intended for further distribution.
(v) The HCT/P is regulated by the FDA pursuant to Part 1270 and
Part 1271 of Title 21 of the Code of Federal Regulations.
SECTION 1. Section 68130.5 of the Education
Code is amended to read:
68130.5. Notwithstanding any other law:
(a) A student, other than a nonimmigrant alien within the meaning
of paragraph (15) of subsection (a) of Section 1101 of Title 8 of the
United States Code, who meets all of the following requirements
shall be exempt from paying nonresident tuition at the California
State University and the California Community Colleges:
(1) Satisfaction of either of the following:
(A) High school attendance in California for three or more years.
(B) Attainment of credits earned in California from a California
high school equivalent to three or more years of full-time high
school coursework.
(2) Graduation from a California high school or attainment of the
equivalent thereof.
(3) Registration as an entering student at, or current enrollment
at, an accredited institution of higher education in California not
earlier than the fall semester or quarter of the 2001-02 academic
year.
(4) Was born after January 1, 1980.
(5) In the case of a person without lawful immigration status, the
filing of an affidavit with the institution of higher education
stating that the student has filed an application to legalize his or
her immigration status, or will file an application as soon as he or
she is eligible to do so.
(b) A student exempt from nonresident tuition under this section
may be reported by a community college district as a full-time
equivalent student for apportionment purposes.
(c) The Board of Governors of the California Community Colleges
and the Trustees of the California State University shall prescribe
rules and regulations for the implementation of this section.
(d) Student information obtained in the implementation of this
section is confidential.
SEC. 2. The Regents of the University of
California are requested to enact exemptions from requirements to pay
nonresident tuition for its students that are equivalent to those
applicable to students of the California Community Colleges and the
California State University pursuant to Section 68130.5 of the
Education Code, as amended pursuant to this act.
SEC. 3. If the Commission on State Mandates
determines that this act contains costs mandated by the state,
reimbursement to local agencies and school districts for those costs
shall be made pursuant to Part 7 (commencing with Section 17500) of
Division 4 of Title 2 of the Government Code.