I 
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 Representa-
tives 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.— 
VerDate Sep 11 2014 
22:46 Apr 13, 2017
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2022.IH
H2022
asabaliauskas on DSK3SPTVN1PROD with BILLS
(1) PROHIBITION.—No person may introduce or 
deliver for introduction into interstate commerce any 
human tissue specimen for medical research or edu-
cation 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 tis-
sue 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 tis-
sue type, the cause of death, serological 
test results, and any known infectious dis-
ease 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 transplan-
tation’’; and 
VerDate Sep 11 2014 
22:46 Apr 13, 2017
Jkt 069200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2022.IH
H2022
asabaliauskas on DSK3SPTVN1PROD with BILLS
(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 li-
censes. 
(B) APPROVAL.—The Secretary shall ap-
prove a non-transplant tissue bank license ap-
plication— 
(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 ac-
VerDate Sep 11 2014 
22:46 Apr 13, 2017
Jkt 069200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2022.IH
H2022
asabaliauskas on DSK3SPTVN1PROD with BILLS
cording to the donor’s donation au-
thorization; 
(II) each facility in which the 
human tissue specimens of the appli-
cant are donated, recovered, proc-
essed, packed, or held meets stand-
ards designed to ensure that the 
human tissue specimens do not pose a 
communicable disease risk to the gen-
eral public; and 
(III) the applicant creates, com-
piles, and maintains a complete record 
on each donor from which it recovers 
a human body or human tissue speci-
men for educational or research pur-
poses, which record shall include, at a 
minimum— 
(aa) 
documentation 
dem-
onstrating that the donor or the 
agent making the donation on 
the donor’s behalf has knowingly 
consented to the anatomical do-
nation for educational or re-
search purposes; 
VerDate Sep 11 2014 
22:46 Apr 13, 2017
Jkt 069200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2022.IH
H2022
asabaliauskas on DSK3SPTVN1PROD with BILLS
(bb) documentation showing 
that the donor or the agent mak-
ing the donation on the donor’s 
behalf has been informed as to 
whether the body or human tis-
sue specimens shall be returned 
to a relative or personal rep-
resentative or whether the appli-
cant shall arrange and carry out 
the disposition of the human 
body or human tissue specimens; 
(cc) documentation of the 
identity and address of each enti-
ty which has been in possession 
of the human body or human tis-
sue specimen before the applicant 
took possession, such as a fu-
neral 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 en-
VerDate Sep 11 2014 
22:46 Apr 13, 2017
Jkt 069200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2022.IH
H2022
asabaliauskas on DSK3SPTVN1PROD with BILLS