I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Label and Transport 

5 Tissues Safely Act of 2014’’ or as the ‘‘LATTS Act of 

6 2014’’. 

7 SEC. 2. IN GENERAL. 

8 (a) NON-TRANSPLANT TISSUE BANK LICENSE.— 


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1 (1) PROHIBITION.—No person may introduce or 

2 deliver for introduction into interstate commerce any 

3 human tissue specimen for medical research or edu4 cation unless— 

5 (A) a tissue bank license is in effect for 

6 the entity introducing the human tissue speci7 men into interstate commerce; 

8 (B) each package of the human tissue 

9 specimen is— 

10 (i) labeled with the proper name of 

11 the human tissue specimen contained in 

12 the package; 

13 (ii) the name, address, and applicable 

14 license number of the source tissue bank of 

15 the human tissue specimen; 

16 (iii) unique donor identifier, tissue 

17 type, cause of death, serological test re18 sults and any known infectious disease 

19 agents; 

20 (iv) a statement about the mandatory 

21 use of personal protective equipment and 

22 universal precautions when handling 

23 human tissue; and 

24 (v) labeled ‘‘not for transplantation’’; 

25 and 


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1 (C) each package of the human tissue 

2 specimen is wrapped and packaged in such a 

3 manner that— 

4 (i) mitigates potential contamination 

5 and cross contamination; 

6 (ii) mitigates potential safety hazards; 

7 (iii) sealed to prevent leakage; and 

8 (iv) ensures the integrity of the tissue. 

9 (2) PROCEDURES ESTABLISHED.— 

10 (A) IN GENERAL.—The Secretary of 

11 Health and Human Services shall establish, by 

12 rule, requirements for the approval, suspension, 

13 and revocation of non-transplant tissue bank li14 censes. 

15 (B) APPROVAL.—The Secretary shall ap16 prove a non-transplant tissue bank license ap17 plication— 

18 (i) on the basis of a demonstration 

19 that— 

20 (I) the human tissue specimen 

21 that is the subject of the application 

22 is legally donated, properly screened 

23 for communicable disease agents, 

24 properly labeled, transported, stored 


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1 and used according to the donor’s do2 nation authorization; and 

3 (II) the facility in which the 

4 human tissue specimen is donated, re5 covered, processed, packed, or held 

6 meets standards designed to assure 

7 that the human tissue specimen does 

8 not pose a communicable disease risk 

9 to the general public and/or unknown 

10 communicable disease risk to; and 

11 (ii) if the applicant (or other appro12 priate person) consents to the inspection of 

13 the facility that is the subject of the appli14 cation, in accordance with subsection (c) of 

15 this section. 

16 (3) REQUIREMENTS FOR EXEMPTION.—The 

17 Secretary shall prescribe requirements under which 

18 a human tissue specimen shall be exempt from the 

19 requirements of paragraph (1). 

20 (b) FALSELY LABELING OR MARKING PACKAGE OR

21 CONTAINER; ALTERING LABEL OR MARK.—No person 

22 shall falsely label or mark any package or container of 

23 any human tissue specimen or alter any label or mark on 

24 the package or container of the biological product so as 

25 to falsify the label or mark. 


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1 (c) INSPECTION OF ESTABLISHMENT FOR PROPAGA2 TION AND PREPARATION.— 

3 (1) IN GENERAL.—Any officer, agent, or em4 ployee of the Department of Health and Human 

5 Services, authorized by the Secretary for the pur6 pose, may during all reasonable hours enter and in7 spect any establishment for the propagation or re8 covery and preparation of any human tissue speci9 men. 

10 (2) INSPECTION BY NATIONALLY RECOGNIZED

11 ACCREDITING BODIES.—Any authorized agent of a 

12 nationally recognized accrediting body authorized by 

13 the Secretary for the purpose, may during all rea14 sonable hours enter and inspect any establishment 

15 for the propagation or recovery and preparation of 

16 any human tissue specimen. 

17 (3) RULE OF CONSTRUCTION.—Nothing in this 

18 subsection or Act limits any existing authority of the 

19 Attorney General, any State Attorney General or 

20 local law enforcement to enter and inspect any es21 tablishment for the propagation or recovery and 

22 preparation of any human tissue. 

23 (d) RECALL OF SPECIMEN PRESENTING IMMINENT

24 HAZARD; VIOLATIONS.— 


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1 (1) RECALL.—Upon a determination that a 

2 human tissue specimen or collection of specimens li3 censed under this section presents an imminent or 

4 substantial hazard to the public health, the Sec5 retary shall issue an order immediately ordering the 

6 recall of such batch, lot, or other quantity of such 

7 product. An order under this paragraph shall be 

8 issued in accordance with section 554 of title 5. 

9 (2) VIOLATIONS.—Any violation of paragraph 

10 (1) shall subject the violator to a civil penalty of up 

11 to $10,000 per day of violation. The amount of a 

12 civil penalty under this paragraph shall, effective 

13 December 1 of each year beginning 1 year after the 

14 effective date of this paragraph, be increased by the 

15 percent change in the Consumer Price Index for the 

16 base quarter of such year over the Consumer Price 

17 Index for the base quarter of the preceding year, adjusted to the nearest 1 18 ⁄10 of 1 percent. For purposes 

19 of this paragraph, the term ‘‘base quarter’’, as used 

20 with respect to a year, means the calendar quarter 

21 ending on September 30 of such year and the price 

22 index for a base quarter is the arithmetical mean of 

23 such index for the 3 months comprising such quar24 ter. 


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1 (e) PENALTIES FOR OFFENSES.—Whoever violates 

2 any of the provisions of this section shall be imprisoned 

3 not more than 1 year, or fined not more than $500, or 

4 both. Section 3571 of title 18, United States Code shall 

5 not apply to an offense under this subsection. 

6 (f) CONSTRUCTION WITH OTHER LAWS.—Nothing 

7 contained in this Act shall be construed as in any way 

8 affecting, modifying, repealing, or superseding under any 

9 existing provisions under current Federal law. 

10 (g) HUMAN TISSUE SPECIMEN DEFINED.—In this 

11 section, the term ‘‘non-transplant tissue specimen’’ means 

12 legally donated anatomical segments, cells, collection of 

13 cells, bodily fluids, or the complete body that are recovered 

14 for medical research and education. The term does not in15 clude anything that would qualify as a biological product 

16 under the Public Health Service Act. 

Æ 


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