I 
114TH CONGRESS 
1ST SESSION H. R. 1016 
To amend title 38, United States Code, to direct the Secretary of Veterans 
Affairs to adopt and implement a standard identification protocol for 
use in the tracking and procurement of biological implants by the Depart-
ment of Veterans Affairs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 20, 2015 
Mr. ROE of Tennessee introduced the following bill; which was referred to the 
Committee on Veterans’ Affairs 
A BILL 
To amend title 38, United States Code, to direct the Sec-
retary of Veterans Affairs to adopt and implement a 
standard identification protocol for use in the tracking 
and procurement of biological implants by the Depart-
ment of Veterans Affairs, and for other purposes. 
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 ‘‘Biological Implant 
Tracking and Veteran Safety Act of 2015’’. 
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SEC. 2. IDENTIFICATION AND TRACKING OF BIOLOGICAL 
IMPLANTS USED IN DEPARTMENT OF VET-
ERANS AFFAIRS MEDICAL FACILITIES. 
(a) IN GENERAL.—Subchapter II of chapter 73 of 
title 38, United States Code, is amended by adding at the 
end the following new section: 
‘‘§ 7330B. Identification and tracking of biological im-
plants 
‘‘(a) STANDARD IDENTIFICATION SYSTEM FOR BIO-
LOGICAL IMPLANTS.—(1) The Secretary shall adopt the 
unique device identification system developed for medical 
devices by the Food and Drug Administration pursuant 
to section 519(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360i(f)), or implement a comparable 
standard identification system, for use in identifying bio-
logical implants intended for use in medical procedures 
conducted in medical facilities of the Department. 
‘‘(2) In adopting or implementing a standard identi-
fication system for biological implants under paragraph 
(1), the Secretary shall permit a vendor to use any of the 
accredited entities identified by the Food and Drug Ad-
ministration as an issuing agency pursuant to section 
830.100 of title 21, Code of Federal Regulations, or any 
successor regulation. 
‘‘(b) BIOLOGICAL IMPLANT TRACKING SYSTEM.—(1) 
The Secretary shall implement a system for tracking the 
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biological implants referred to in subsection (a) from 
human donor or animal source to implantation. Such sys-
tem shall be compatible with the identification system 
adopted or implemented under subsection (a). 
‘‘(2) The Secretary shall implement inventory con-
trols compatible with the tracking system implemented 
under paragraph (1) so that all patients who have re-
ceived, in a medical facility of the Department, a biological 
implant subject to a recall can be notified of the recall, 
if based on the evaluation of appropriate medical per-
sonnel of the Department of the risks and benefits, the 
Secretary determines such notification is appropriate. 
‘‘(c) CONSISTENCY WITH FOOD AND DRUG ADMINIS-
TRATION REGULATIONS.—To the extent that a conflict 
arises between this section and a provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
or sections 351 or 361 of the Public Health Service Act 
(42 U.S.C. 262) (including any regulations issued under 
such Acts), the provision the Federal Food, Drug, and 
Cosmetic Act or Public Health Service Act (including any 
regulations issued under such Acts) shall apply. 
‘‘(d) DEFINITION OF BIOLOGICAL IMPLANT.—In this 
section, the term ‘biological implant’ means any animal 
or human cell, tissue, or cellular or tissue-based product— 
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‘‘(1) under the meaning given the term ‘human 
cells’ in section 1271.3 of title 21, Code of Federal 
Regulations, or any successor regulation; or 
‘‘(2) that is regulated as a device under section 
201(h) of the Federal Food, Drug, and Cosmetic 
Act.’’. 
(b) CLERICAL AMENDMENT.—The table of sections 
at the beginning of such chapter is amended by adding 
at the end of the items relating to such subchapter the 
following new item: 
‘‘7330B. Identification and tracking of biological implants.’’. 
(c) IMPLEMENTATION DEADLINES.— 
(1) STANDARD IDENTIFICATION SYSTEM.— 
(A) IN GENERAL.—With respect to biologi-
cal implants described in paragraph (1) of sub-
section (d) of section 7330B of title 38, United 
States Code, as added by subsection (a), the 
Secretary of Veterans Affairs shall adopt or im-
plement a standard identification system for bi-
ological implants, as required by subsection (a) 
of such section, by not later than the date that 
is 180 days after the date of the enactment of 
this Act. 
(B) IMPLANTS REGULATED AS DEVICES.— 
With respect to biological implants described in 
paragraph (2) of subsection (d) of such section, 
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the Secretary of Veterans Affairs shall adopt or 
implement such standard identification system 
in compliance with the compliance dates estab-
lished by the Food and Drug Administration 
pursuant to section 519(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360i(f)). 
(2) TRACKING SYSTEM.—The Secretary of Vet-
erans Affairs shall implement the biological implant 
tracking system required by subsection (b) of section 
7330B, as added by subsection (a), by not later than 
the date that is 180 days after the date of the enact-
ment of this Act. 
(d) REPORTING REQUIREMENT.—If the biological 
implant tracking system required by subsection (b) of such 
section is not operational by the date that is 180 days 
after the date of the enactment of this Act, the Secretary 
of Veterans Affairs shall provide to the Committees on 
Veterans’ Affairs of the Senate and House of Representa-
tives a written explanation for each month until such time 
as the system is operational. Each such explanation shall 
describe each impediment to the implementation of the 
system, steps being taken to remediate each such impedi-
ment, and target dates for a solution to each such impedi-
ment. 
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SEC. 3. PROCUREMENT OF BIOLOGICAL IMPLANTS USED IN 
DEPARTMENT OF VETERANS AFFAIRS MED-
ICAL FACILITIES. 
(a) PROCUREMENT.— 
(1) IN GENERAL.—Subchapter II of chapter 81 
of such title is amended by adding at the end the 
following new section: 
‘‘§ 8129. Procurement of biological implants 
‘‘(a) IN GENERAL.—(1) The Secretary may procure 
biological implants of human origin only from vendors that 
meet the following conditions: 
‘‘(A) The vendor uses the standard identifica-
tion system adopted or implemented by the Sec-
retary under section 7330B(a) of this title and has 
safeguards to ensure that a production identifier has 
been in place at each step of distribution of each bio-
logical implant from its donor. 
‘‘(B) The vendor is registered as required by 
the Food and Drug Administration under subpart B 
of part 1271 of title 21, Code of Federal Regula-
tions, or any successor regulation, and in the case of 
a vendor that uses a tissue distribution intermediary 
or a tissue processor, the vendor provides assurances 
that the tissue distribution intermediary or tissue 
processor is registered as required by the Food and 
Drug Administration. 
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‘‘(C) The vendor ensures that donor eligibility 
determinations and such other records as the Sec-
retary may require accompany each biological im-
plant at all times, regardless of the country of origin 
of the donor of the biological material. 
‘‘(D) The vendor consents to periodic inspec-
tions and audits by the Secretary regarding the ac-
curacy of records and the handling of products. 
‘‘(E) The vendor agrees to cooperate with all bi-
ological implant recalls conducted on the vendor’s 
own initiative, on the initiative of the original prod-
uct manufacturer used by the vendor, by the request 
of the Food and Drug Administration, or by a statu-
tory order of the Food and Drug Administration. 
‘‘(F) The vendor agrees to notify the Secretary 
of any adverse event or reaction report it provides 
to the Food and Drug Administration, as required 
by section 1271.3 of title 21, Code of Federal Regu-
lations, or any successor regulation, or of any warn-
ing letter from the Food and Drug Administration 
issued to the vendor or a tissue processor or tissue 
distribution intermediary it uses by not later than 
60 days after the vendor receives such report or 
warning letter. 
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‘‘(G) The vendor agrees to retain all records as-
sociated with the procurement of a biological implant 
by the Department for at least five years after the 
date of the procurement of the biological implant. 
‘‘(H) The vendor provides assurances that the 
biological implants provided by the vendor are ac-
quired only from tissue processors that maintain ac-
tive accreditation with the American Association of 
Tissue Banks or a similar national accreditation spe-
cific to biological implants. 
‘‘(2) The Secretary may procure biological implants 
of non-human origin only from vendors that meet the fol-
lowing conditions: 
‘‘(A) The vendor uses the standard identifica-
tion system adopted or implemented by the Sec-
retary under section 7330B(a) of this title. 
‘‘(B) The vendor is registered as required by 
the Food and Drug Administration under section 
807.3(c) of title 21, Code of Federal Regulations, or 
any successor regulation, and in the case of a vendor 
that is not the original product manufacturer of 
such implants the vendor provides assurances that 
the original product manufacturer is registered as 
required by the Food and Drug Administration. 
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‘‘(C) The vendor consents to periodic inspec-
tions and audits by the Secretary regarding the ac-
curacy of records and the handling of products. 
‘‘(D) The vendor agrees to cooperate with all 
biological implant recalls conducted on the vendor’s 
own initiative, on the initiative of the original prod-
uct manufacturer used by the vendor, by the request 
of the Food and Drug Administration, or by a statu-
tory order of the Food and Drug Administration. 
‘‘(E) The vendor agrees to notify the Secretary 
of any adverse event report it provides to the Food 
and Drug Administration as required in 21 C.F.R. 
part 803 or any warning letter from the Food and 
Drug Administration issued to the vendor or the 
original product manufacturer it uses by not later 
than 60 days after the vendor receives such report 
or warning letter. 
‘‘(F) The vendor agrees to retain all records as-
sociated with the procurement of a biological implant 
by the Department for at least five years after the 
date of the procurement of the biological implant. 
‘‘(3) The Secretary shall procure biological implants 
under the Federal Supply Schedules of the General Serv-
ices Administration, unless such implants are not available 
under such Schedules. For biological implants listed on 
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the Federal Supply Schedules, the Secretary shall accom-
modate reasonable vendor requests to undertake outreach 
efforts to educate medical professionals of the Department 
about the use and efficacy of such biological implants. 
‘‘(4) Section 8123 of this title shall not apply to the 
procurement of biological implants. 
‘‘(5) In the case of biological implants that are un-
available for procurement under the Federal Supply 
Schedules, the Secretary shall procure such implants using 
competitive procedures in accordance with applicable law 
and the Federal Acquisition Regulation. 
‘‘(b) PENALTIES.—In addition to any applicable pen-
alty under any other provision of law, any procurement 
employee of the Department who is found responsible for 
a biological implant procurement transaction with intent 
to avoid or with reckless disregard of the requirements of 
this section shall be ineligible to hold a certificate of ap-
pointment as a contracting officer or to serve as the rep-
resentative of an ordering officer, contracting officer, or 
purchase card holder. 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) The term ‘biological implant’ shall have 
the meaning given such term in section 7330B(d) of 
this title. 
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‘‘(2) The term ‘production identifier’ means a 
distinct identification code that— 
‘‘(A) relates a biological implant to the 
human donor of the implant and to all records 
pertaining to the implant; 
‘‘(B) includes information designed to fa-
cilitate effective tracking, using the distinct 
identification code, from the donor to the recipi-
ent and from the recipient to the donor; and 
‘‘(C) satisfies the requirements of sub-
section (c) of section 1271.290 of title 21, Code 
of Federal Regulations, or any successor regula-
tion. 
‘‘(3) The term ‘tissue distribution intermediary’ 
means an agency that acquires and stores human 
tissue for further distribution and performs no other 
tissue banking functions. 
‘‘(4) The term ‘tissue processor’ means an enti-
ty processing human tissue for use in biological im-
plants including activities performed on tissue other 
than donor screening, donor testing, tissue recovery 
and collection functions, storage, or distribution.’’. 
(2) CLERICAL AMENDMENT.—The table of sec-
tions at the beginning of such chapter is amended 
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