Amended in Assembly April 7, 2016

Amended in Assembly March 17, 2016

California Legislature—2015–16 Regular Session

Assembly Bill No. 2750

Introduced by Assembly Member Gomez

February 19, 2016

begin delete An act to amend Section 68130.5 of the Education Code, relating to postsecondary education. end delete begin insert An act to amend Section 1635.1 of the Health and Safety Code, relating to tissue banks. end insert

LEGISLATIVE COUNSEL’S DIGEST

AB 2750, as amended, Gomez. begin delete Postsecondary education: exemption from nonresident tuition. end delete begin insert Tissue banks. end insert

begin insert

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).

end insert begin insert

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.

end insert begin insert

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.

end insert begin delete

(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.

end delete begin delete

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.

end delete begin delete

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.

end delete begin delete

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.

end delete begin delete

(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.

end delete begin delete

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.

end delete

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program:  begin delete yes end delete begin insert no end insert .

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 1635.1 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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
begin delete 485.302 end delete begin insert 486.302 end insert 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 begin delete OPO, pursuant to Section
485.305 of Title 42 of the Code of Federal Regulations, end delete begin insert OPO end insert and
meets the requirements of Sections begin delete 485.304 end delete begin insert 486.304 end insert and begin delete 485.306 end delete
begin insert 486.306 end insert 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 begin delete has end delete begin insert have end insert been obtained from a licensed tissue
bank, begin delete is end delete begin insert are end insert stored in strict accordance with a kit’s package insert
and any other manufacturer instructions and guidelines, and begin delete is end delete begin insert are end insert
used for the express purpose of implantation into a patient.

(8) The storage of a human cell, tissue, or cellular- or
tissue-based begin delete product, end delete begin insert product (HCT/P), end insert as defined by the federal
Food and Drug begin delete Administration, end delete begin insert Administration (FDA), end insert 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. begin delete Secs. end delete
begin insert Sec. end insert 360 begin delete and 360e) end delete begin insert et seq.) end insert 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 begin delete California licensed end delete
begin insert California-licensed end insert 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.

begin insert

(9) The storage of an HCT/P by a person if both of the following
apply:

end insert begin insert

(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.

end insert begin insert

(B) The HCT/P meets all of the following:

end insert begin insert

(i) The HCT/P was obtained from a tissue bank licensed by the
state.

end insert begin insert

(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.

end insert begin insert

(iii) The HCT/P is intended for the express purpose of
implantation into or application on a patient.

end insert begin insert

(iv) The HCT/P is not intended for further distribution.

end insert begin insert

(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.

end insert

begin delete

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.

end delete