[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2022 Introduced in House (IH)]
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115th CONGRESS
1st Session
H. R. 2022
To ensure certain safety measures are utilized in the interest of
public health security with respect to labeling and transporting human
tissue specimen or collection of specimens into interstate commerce.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 6, 2017
Mr. Gosar introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To ensure certain safety measures are utilized in the interest of
public health security with respect to labeling and transporting human
tissue specimen or collection of specimens into interstate commerce.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Label and Transport Tissues Safely
Act of 2017'' or as the ``LATTS Act of 2017''.
SEC. 2. IN GENERAL.
(a) Non-Transplant Tissue Bank License.--
(1) Prohibition.--No person may introduce or deliver for
introduction into interstate commerce any human tissue specimen
for medical research or education unless--
(A) a non-transplant tissue bank license is in
effect for the entity introducing the human tissue
specimen into interstate commerce;
(B) each package of the human tissue specimen is
labeled with--
(i) the proper name of the human tissue
specimen contained in the package;
(ii) the name, address, and applicable
license number of the source tissue bank of the
human tissue specimen;
(iii) a unique donor identifier, the tissue
type, the cause of death, serological test
results, and any known infectious disease
agents;
(iv) a statement about the mandatory use of
personal protective equipment and universal
precautions when handling human tissue; and
(v) the statement ``not for
transplantation''; and
(C) each package of the human tissue specimen is
wrapped and packaged in a manner that--
(i) mitigates potential contamination and
cross contamination;
(ii) mitigates potential safety hazards;
(iii) is sealed to prevent leakage; and
(iv) ensures the integrity of the tissue.
(2) Procedures established.--
(A) In general.--The Secretary of Health and Human
Services shall establish, by rule, requirements for the
approval, suspension, and revocation of non-transplant
tissue bank licenses.
(B) Approval.--The Secretary shall approve a non-
transplant tissue bank license application--
(i) on the basis of a demonstration that--
(I) the human tissue specimens of
the applicant are legally donated,
properly screened for communicable
disease agents, properly labeled,
transported, and stored, and used
according to the donor's donation
authorization;
(II) each facility in which the
human tissue specimens of the applicant
are donated, recovered, processed,
packed, or held meets standards
designed to ensure that the human
tissue specimens do not pose a
communicable disease risk to the
general public; and
(III) the applicant creates,
compiles, and maintains a complete
record on each donor from which it
recovers a human body or human tissue
specimen for educational or research
purposes, which record shall include,
at a minimum--
(aa) documentation
demonstrating that the donor or
the agent making the donation
on the donor's behalf has
knowingly consented to the
anatomical donation for
educational or research
purposes;
(bb) documentation showing
that the donor or the agent
making the donation on the
donor's behalf has been
informed as to whether the body
or human tissue specimens shall
be returned to a relative or
personal representative or
whether the applicant shall
arrange and carry out the
disposition of the human body
or human tissue specimens;
(cc) documentation of the
identity and address of each
entity which has been in
possession of the human body or
human tissue specimen before
the applicant took possession,
such as a funeral home,
coroner, hospital, organ
procurement organization, or
tissue bank; and
(dd) documentation on the
use and disposition of each
human body or human tissue
specimen, including the name
and address of each person or
entity that receives the human
body or human tissue specimen
directly from the applicant;
and
(ii) only if the applicant (or other
appropriate person) consents to the inspection
of the facility that is the subject of the
application, in accordance with subsection (c).
(3) Requirements for exemption.--The Secretary shall
prescribe requirements under which a human tissue specimen
shall be exempt from the requirements of paragraph (1).
(b) Falsely Labeling or Marking Package or Container; Altering
Label or Mark.--No person shall falsely label or mark any package or
container of any human tissue specimen or alter any label or mark on
the package or container of the human tissue specimen so as to falsify
the label or mark.
(c) Inspection of Facilities.--
(1) In general.--Any officer, agent, or employee of the
Department of Health and Human Services, authorized by the
Secretary for the purpose, may during all reasonable hours
enter and inspect any facility that is subject to a non-
transplant tissue bank license under this section.
(2) Inspection by nationally recognized accrediting
bodies.--Any authorized agent of a nationally recognized
accrediting body authorized by the Secretary for the purpose,
may during all reasonable hours enter and inspect any such
facility.
(3) Rule of construction.--Nothing in this Act limits any
existing authority of the Attorney General, any State Attorney
General, or local law enforcement to enter and inspect any such
facility.
(d) Recall of Specimen Presenting Imminent Hazard; Violations.--
(1) Recall.--Upon a determination that a human tissue
specimen or collection of specimens of a tissue bank licensed
under this section presents an imminent or substantial hazard
to the public health, the Secretary shall issue an order
immediately ordering the recall of such batch, lot, or other
quantity of such product. An order under this paragraph shall
be issued in accordance with section 554 of title 5, United
State Code.
(2) Violations.--Any violation of a recall order under
paragraph (1) shall subject the violator to a civil penalty of
up to $10,000 per day of violation. The amount of a civil
penalty under this paragraph shall, effective December 1 of
each calendar year beginning 1 year or more after the effective
date of this paragraph, be increased by the percent change in
the Consumer Price Index for the base quarter of such year over
the Consumer Price Index for the base quarter of the preceding
year, adjusted to the nearest \1/10\ of 1 percent. For purposes
of this paragraph, the term ``base quarter'', as used with
respect to a year, means the calendar quarter ending on
September 30 of such year, and the price index for a base
quarter is the arithmetical mean of such index for the 3 months
comprising such quarter.
(e) Prohibitions of Sales and Purchases of Human Tissue Specimen.--
It shall be unlawful for any person to knowingly sell, acquire,
receive, or otherwise transfer any human tissue specimen for valuable
consideration if the transfer affects interstate commerce.
(f) Penalties for Offenses.--Whoever violates any of the provisions
of this section shall be imprisoned not more than 1 year, or fined not
more than $10,000, or both. Section 3571 of title 18, United States
Code, shall not apply to an offense under this section.
(g) Construction With Other Laws.--Nothing in this Act (other than
subsection (f)) shall be construed as in any way affecting, modifying,
repealing, or superseding any other provision of Federal law.
(h) Definitions.--For the purposes of this section:
(1) Unless the context indicates otherwise, the term
``agent'' means the person who is expressly authorized to make
an anatomical donation on the donor's behalf under State law.
(2) The term ``donor'' means a person whose body or whose
human tissue specimen is the subject of an anatomical donation.
(3) The term ``human tissue specimen''--
(A) means legally donated anatomical segments,
cells, or body fluids (including a complete body) that
are recovered for medical research or education; and
(B) does not include a biological product (as
defined in section 351 of the Public Health Services
Act (42 U.S.C. 262)).
(4) The term ``valuable consideration'' means something of
value, but does not include the reasonable payments associated
with the removal, transportation, processing, preservation,
quality control, storage, and lawful disposition of human
tissue specimens.
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