[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5318 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 5318

   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

                             July 31, 2014

   Mr. Gosar (for himself and Mr. Franks of Arizona) 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 2014'' or as the ``LATTS Act of 2014''.

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 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--
                            (i) labeled with 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) unique donor identifier, tissue type, 
                        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) labeled ``not for transplantation''; 
                        and
                    (C) each package of the human tissue specimen is 
                wrapped and packaged in such a manner that--
                            (i) mitigates potential contamination and 
                        cross contamination;
                            (ii) mitigates potential safety hazards;
                            (iii) 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 specimen that 
                                is the subject of the application is 
                                legally donated, properly screened for 
                                communicable disease agents, properly 
                                labeled, transported, stored and used 
                                according to the donor's donation 
                                authorization; and
                                    (II) the facility in which the 
                                human tissue specimen is donated, 
                                recovered, processed, packed, or held 
                                meets standards designed to assure that 
                                the human tissue specimen does not pose 
                                a communicable disease risk to the 
                                general public and/or unknown 
                                communicable disease risk to; and
                            (ii) 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) 
                        of this section.
            (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 biological product so as to falsify the 
label or mark.
    (c) Inspection of Establishment for Propagation and Preparation.--
            (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 establishment for the propagation or 
        recovery and preparation of any human tissue specimen.
            (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 
        establishment for the propagation or recovery and preparation 
        of any human tissue specimen.
            (3) Rule of construction.--Nothing in this subsection or 
        Act limits any existing authority of the Attorney General, any 
        State Attorney General or local law enforcement to enter and 
        inspect any establishment for the propagation or recovery and 
        preparation of any human tissue.
    (d) Recall of Specimen Presenting Imminent Hazard; Violations.--
            (1) Recall.--Upon a determination that a human tissue 
        specimen or collection of specimens 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.
            (2) Violations.--Any violation of 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 year beginning 1 
        year 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) 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 $500, or both. Section 3571 of title 18, United States Code 
shall not apply to an offense under this subsection.
    (f) Construction With Other Laws.--Nothing contained in this Act 
shall be construed as in any way affecting, modifying, repealing, or 
superseding under any existing provisions under current Federal law.
    (g) Human Tissue Specimen Defined.--In this section, the term 
``non-transplant tissue specimen'' means legally donated anatomical 
segments, cells, collection of cells, bodily fluids, or the complete 
body that are recovered for medical research and education. The term 
does not include anything that would qualify as a biological product 
under the Public Health Service Act.
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