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H.R. 2022 (115th): LATTS Act of 2017

The text of the bill below is as of Apr 6, 2017 (Introduced).


I

115th CONGRESS

1st Session

H. R. 2022

IN THE HOUSE OF REPRESENTATIVES

April 6, 2017

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.

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.

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.