[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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