NY State Senate Bill 2021-S2119

Archive: Last Bill Status Via A228 - Signed by Governor

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Dec 21, 2021	approval memo.65 signed chap.675
Dec 09, 2021	delivered to governor
Mar 30, 2021	returned to assembly passed senate 3rd reading cal.577 substituted for s2119
Mar 30, 2021	substituted by a228
Mar 18, 2021	advanced to third reading
Mar 17, 2021	2nd report cal.
Mar 16, 2021	1st report cal.577
Jan 19, 2021	referred to health

Votes

- Mar 30, 2021 - Floor Vote
  A228
  
  63
  
  Aye
  
  0
  
  Nay
  
  0
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Floor Vote: Mar 30, 2021
      
      aye (63)
      
      Addabbo Jr.
      
      Akshar
      
      Bailey
      
      Benjamin
      
      Biaggi
      
      Borrello
      
      Boyle
      
      Breslin
      
      Brisport
      
      Brooks
      
      Brouk
      
      Comrie
      
      Cooney
      
      Felder
      
      Gallivan
      
      Gaughran
      
      Gianaris
      
      Gounardes
      
      Griffo
      
      Harckham
      
      Helming
      
      Hinchey
      
      Hoylman-Sigal
      
      Jackson
      
      Jordan
      
      Kaminsky
      
      Kaplan
      
      Kavanagh
      
      Kennedy
      
      Krueger
      
      Lanza
      
      Liu
      
      Mannion
      
      Martucci
      
      Mattera
      
      May
      
      Mayer
      
      Myrie
      
      O'Mara
      
      Oberacker
      
      Ortt
      
      Palumbo
      
      Parker
      
      Persaud
      
      Ramos
      
      Rath III
      
      Reichlin-Melnick
      
      Ritchie
      
      Rivera
      
      Ryan
      
      Salazar
      
      Sanders Jr.
      
      Savino
      
      Sepúlveda
      
      Serino
      
      Serrano
      
      Skoufis
      
      Stavisky
      
      Stec
      
      Stewart-Cousins
      
      Tedisco
      
      Thomas
      
      Weik
  Mar 16, 2021 - Health Committee Vote
  S2119
  
  15
  
  Aye
  
  0
  
  Nay
  
  0
  
  Aye with Reservations
  
  0
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Health Committee Vote: Mar 16, 2021
      
      aye (15)
      
      Benjamin
      
      Biaggi
      
      Boyle
      
      Brouk
      
      Gallivan
      
      Hoylman-Sigal
      
      Kaminsky
      
      May
      
      Oberacker
      
      Rath III
      
      Rivera
      
      Ryan
      
      Salazar
      
      Stec
      
      Thomas

co-Sponsors

View additional co-sponsors

2021-S2119 (ACTIVE) - Details

See Assembly Version of this Bill:: A228
Law Section:: Public Health Law
Laws Affected:: Amd §571, add §575-a, Pub Health L
Versions Introduced in 2019-2020 Legislative Session:: S7811, A9915

2021-S2119 (ACTIVE) - Summary

Relates to source plasma donation centers.

2021-S2119 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S2119

SPONSOR: RIVERA
 
TITLE OF BILL:

An act to amend the public health law, in relation to source plasma
donation centers

 
PURPOSE:

To authorize collection of source plasma at source plasma donation
centers that comply with federal law.

 
SUMMARY OF PROVISIONS:

Section one of the bill amends Public Health Law § 571 to create defi-
nitions of "source plasma donation center," "source plasma," and "plas-
mapheresis."  Section two creates a new Public Health Law § 575-a
authorizing source plasma donation centers to collect source plasma
using plasmapheresis, including employing individuals to perform total
protein tests, if the center and the individual comply with federal law

and regulations.

Section two also authorizes the commissioner of health to make reason-
able additional regulations governing source plasma donation centers.

Section three is the effective date.

 
JUSTIFICATION:

Source plasma collection through donation is the first step in manufac-
turing plasma protein therapies to treat diseases, including creation of
clotting factor products for individuals with bleeding disorders, auto-
immune disorders, and other conditions. It is a completely separate
process from blood collection for donation purposes. Source plasma is
not used for transfusion; it is used to manufacture therapeutic products
and is collected at separate centers.

This bill would authorize plasma donation centers to operate in New York
State, as long as they meet federal standards. Plasma donation centers
are regulated extensively by the FDA and most states allow plasma
donation centers to operate under these federal standards (CFR title 21,
part 640, sub-part G.) Federal rules govern donor screening, blood
collection processes (such as containers), blood sample handling (such
as storage and pooling), and other processes.  The bill also allows the
Department of Health to make additional regulations.

New York's regulatory requirements for source plasma collection are
substantially and unnecessarily more restrictive than the requirements
in Federal law. Consequently, there are fewer than 10 source plasma
donation centers operating in New York out of over 800 across the coun-
try.

 
LEGISLATIVE HISTORY:

2019-2020: S7811/A9915 Gottfried

 
FISCAL IMPLICATIONS:

None to the state.

 
EFFECTIVE DATE:
180 days from enactment

2021-S2119 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2119
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             January 19, 2021
                                ___________
 
 Introduced  by  Sens.  RIVERA,  ADDABBO, GALLIVAN, HOYLMAN, MAYER, ORTT,
   SKOUFIS -- read twice and ordered printed,  and  when  printed  to  be
   committed to the Committee on Health
 
 AN  ACT  to  amend  the  public health law, in relation to source plasma
   donation centers

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  Section 571 of the public health law is amended by adding
 two new subdivisions 2-a and 2-b to read as follows:
   2-A. "SOURCE PLASMA DONATION CENTER" MEANS  A  FACILITY  WHERE  SOURCE
 PLASMA  IS  COLLECTED BY PLASMAPHERESIS. "SOURCE PLASMA" MEANS THE FLUID
 PORTION OF HUMAN BLOOD  COLLECTED  BY  PLASMAPHERESIS  AND  INTENDED  AS
 SOURCE  MATERIAL  FOR  PLASMA PROTEIN THERAPIES. "SOURCE PLASMA DONATION
 CENTER" SHALL NOT INCLUDE SINGLE  DONOR  PLASMA  PRODUCTS  INTENDED  FOR
 INTRAVENOUS USE.
   2-B.  "PLASMAPHERESIS"  MEANS  A  PROCEDURE  IN WHICH, DURING A SINGLE
 VISIT TO THE FACILITY, BLOOD IS REMOVED FROM AN INDIVIDUAL,  THE  SOURCE
 PLASMA  SEPARATED  FROM  THE FORMED ELEMENTS, AND AT LEAST THE RED BLOOD
 CELLS ARE RETURNED TO THE DONOR.
   § 2. The public health law is amended by adding a new section 575-a to
 read as follows:
   § 575-A. SOURCE PLASMA DONATION CENTERS. 1. A SOURCE  PLASMA  DONATION
 CENTER  MAY COLLECT SOURCE PLASMA THROUGH PLASMAPHERESIS, AND MAY EMPLOY
 A PERSON TO PERFORM TOTAL PROTEIN TESTS USING DIGITAL REFRACTOMETERS, IF
 THE SOURCE PLASMA DONATION CENTER AND SUCH PERSON COMPLY  WITH  ALL  THE
 REQUIREMENTS  OF FEDERAL LAW AND REGULATIONS GOVERNING THE COLLECTION OF
 SOURCE PLASMA, INCLUDING, BUT  NOT  LIMITED  TO,  LAWS  GOVERNING  STAFF
 SUPERVISION, TRAINING, AND DUTIES, INCLUDING REQUIREMENTS FOR PERFORMING
 TOTAL  PROTEIN  TESTS  USING  DIGITAL  REFRACTOMETERS IN A SOURCE PLASMA
 DONATION CENTER.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00571-01-1

 S. 2119                             2
 
   2. THE COMMISSIONER MAY MAKE REASONABLE ADDITIONAL REGULATIONS GOVERN-
 ING SOURCE PLASMA DONATION CENTERS, INCLUDING REQUIREMENTS FOR REGISTRA-
 TION AS A SOURCE PLASMA DONATION CENTER  AND  PAYMENT  OF  A  REASONABLE
 REGISTRATION  FEE.  RULES  AND  REGULATIONS  APPLICABLE TO SOURCE PLASMA
 DONATION CENTERS SHALL BE CONSISTENT WITH THIS SECTION.
   § 3. This act shall take effect on the one hundred eightieth day after
 it  shall have become a law. Effective immediately, the addition, amend-
 ment and/or repeal of any rule or regulation necessary for the implemen-
 tation of this act on its effective date are authorized to be  made  and
 completed on or before such effective date.

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Senate Bill S2119

Sponsored By

Archive: Last Bill Status Via A228 - Signed by Governor

Mar 30, 2021 - Floor Vote

Floor Vote: Mar 30, 2021

Mar 16, 2021 - Health Committee Vote

Health Committee Vote: Mar 16, 2021

co-Sponsors

2021-S2119 (ACTIVE) - Details

2021-S2119 (ACTIVE) - Summary

2021-S2119 (ACTIVE) - Sponsor Memo

2021-S2119 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S2119

Share this bill

Sponsored By

Archive: Last Bill Status Via A228 - Signed by Governor

co-Sponsors

2021-S2119 (ACTIVE) - Details

2021-S2119 (ACTIVE) - Summary

2021-S2119 (ACTIVE) - Sponsor Memo

2021-S2119 (ACTIVE) - Bill Text download pdf

Comments