[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 28 Engrossed in House (EH)]
<DOC>
115th CONGRESS
1st Session
H. R. 28
_______________________________________________________________________
AN ACT
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 Department of Veterans Affairs, and for other purposes.
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 ``Biological Implant Tracking and
Veteran Safety Act of 2017''.
SEC. 2. IDENTIFICATION AND TRACKING OF BIOLOGICAL IMPLANTS USED IN
DEPARTMENT OF VETERANS 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:
``Sec. 7330C. Identification and tracking of biological implants
``(a) Standard Identification System for Biological Implants.--(1)
The Secretary shall adopt the unique device identification system
developed for medical devices by the Food and Drug Administration under
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 biological implants intended for use in medical
procedures conducted in medical facilities of the Department.
``(2) In adopting or implementing a standard identification 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 Administration 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 biological implants described in
subsection (a) from human donor or animal source to implantation.
``(2) The tracking system implemented under paragraph (1) shall be
compatible with the identification system adopted or implemented under
subsection (a).
``(3) The Secretary shall implement inventory controls compatible
with the tracking system implemented under paragraph (1) so that all
patients who have received, 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 by appropriate medical personnel of the
Department of the risks and benefits, the Secretary determines such
notification is appropriate.
``(c) Consistency With Food and Drug Administration 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 section 351 or 361 of the Public Health Service Act (42 U.S.C.
262 and 264) (including any regulations issued under such provisions),
the provision of the Federal Food, Drug, and Cosmetic Act or Public
Health Service Act (including any regulations issued under such
provisions) shall apply.
``(d) Biological Implant Defined.--In this section, the term
`biological implant' means any human cell, tissue, or cellular or
tissue-based product or animal product--
``(1) under the meaning given the term `human cells,
tissues, or cellular or tissue-based products' 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 (21 U.S.C. 321(h)).''.
(b) Clerical Amendment.--The table of sections at the beginning of
such chapter is amended by inserting after the item relating to section
7330B the following new item:
``7330C. Identification and tracking of biological implants.''.
(c) Implementation Deadlines.--
(1) Standard identification system.--The Secretary of
Veterans Affairs shall adopt or implement the standard
identification system for biological implants required by
subsection (a) of section 7330C of title 38, United States
Code, as added by subsection (a), with respect to biological
implants described in--
(A) subsection (d)(1) of such section, by not later
than the date that is 180 days after the date of the
enactment of this Act; and
(B) subsection (d)(2) of such section, in
compliance with the compliance dates established by the
Food and Drug Administration under section 519(f) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360i(f)).
(2) Tracking system.--The Secretary of Veterans Affairs
shall implement the biological implant tracking system required
by section 7330C(b) of title 38, United States Code, as added
by subsection (a), by not later than the date that is 180 days
after the date of the enactment of this Act.
(d) Reporting Requirement.--
(1) In general.--If the biological implant tracking system
required by section 7330C(b) of title 38, United States Code,
as added by subsection (a), 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 submit to the Committee on
Veterans' Affairs of the Senate and the Committee on Veterans'
Affairs of the House of Representatives a report explaining why
the system is not operational for each month until such time as
the system is operational.
(2) Elements.--Each report submitted under paragraph (1)
shall include a description of the following:
(A) Each impediment to the implementation of the
system described in such paragraph.
(B) Steps being taken to remediate each such
impediment.
(C) Target dates for a solution to each such
impediment.
SEC. 3. PROCUREMENT OF BIOLOGICAL IMPLANTS USED IN DEPARTMENT OF
VETERANS AFFAIRS MEDICAL FACILITIES.
(a) Procurement.--
(1) In general.--Subchapter II of chapter 81 of title 38,
United States Code, is amended by adding at the end the
following new section:
``Sec. 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 identification system
adopted or implemented by the Secretary under section 7330C(a)
of this title and has safeguards to ensure that a distinct
identifier has been in place at each step of distribution of
each biological 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 Regulations, 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.
``(C) The vendor ensures that donor eligibility
determinations and such other records as the Secretary may
require accompany each biological implant at all times,
regardless of the country of origin of the donor of the
biological material.
``(D) The vendor agrees to cooperate with all biological
implant recalls conducted on the initiative of the vendor, on
the initiative of the original product manufacturer used by the
vendor, by the request of the Food and Drug Administration, or
by a statutory order of the Food and Drug Administration.
``(E) 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 sections 1271.3 and
1271.350 of title 21, Code of Federal Regulations, or any
successor regulation, or any warning letter from the Food and
Drug Administration issued to the vendor or a tissue processor
or tissue distribution intermediary used by the vendor by not
later than 60 days after the vendor receives such report or
warning letter.
``(F) The vendor agrees to retain all records associated
with the procurement of a biological implant by the Department
for at least 10 years after the date of the procurement of the
biological implant.
``(G) The vendor provides assurances that the biological
implants provided by the vendor are acquired only from tissue
processors that maintain active accreditation with the American
Association of Tissue Banks or a similar national accreditation
specific to biological implants.
``(2) The Secretary may procure biological implants of nonhuman
origin only from vendors that meet the following conditions:
``(A) The vendor uses the standard identification system
adopted or implemented by the Secretary under section 7330C(a)
of this title.
``(B) The vendor is registered as an establishment as
required by the Food and Drug Administration under sections
807.20 and 807.40 of title 21, Code of Federal Regulations, or
any successor regulation (or is not required to register
pursuant to section 807.65(a) of such title, 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 (or
is not required to register).
``(C) The vendor agrees to cooperate with all biological
implant recalls conducted on the initiative of the vendor, on
the initiative of the original product manufacturer used by the
vendor, by the request of the Food and Drug Administration, or
by a statutory order of the Food and Drug Administration.
``(D) The vendor agrees to notify the Secretary of any
adverse event report it provides to the Food and Drug
Administration as required under part 803 of title 21, Code of
Federal Regulations, or any successor regulation, or any
warning letter from the Food and Drug Administration issued to
the vendor or the original product manufacturer used by the
vendor by not later than 60 days after the vendor receives such
report or warning letter.
``(E) The vendor agrees to retain all records associated
with the procurement of a biological implant by the Department
for at least 10 years after the date of the procurement of the
biological implant.
``(3)(A) The Secretary shall procure biological implants under the
Federal Supply Schedules of the General Services Administration unless
such implants are not available under such Schedules.
``(B) With respect to biological implants listed on the Federal
Supply Schedules, the Secretary shall accommodate reasonable vendor
requests to undertake outreach efforts to educate medical professionals
of the Department about the use and efficacy of such biological
implants.
``(C) In the case of biological implants that are unavailable 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, including
through the use of a national contract.
``(4) In procuring biological implants under this section, the
Secretary shall permit a vendor to use any of the accredited entities
identified by the Food and Drug Administration as an issuing agency
pursuant to section 830.100 of title 21, Code of Federal Regulations,
or any successor regulation.
``(5) Section 8123 of this title shall not apply to the procurement
of biological implants.
``(b) Penalties.--In addition to any applicable penalty 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 appointment
as a contracting officer or to serve as the representative of an
ordering officer, contracting officer, or purchase card holder.
``(c) Definitions.--In this section:
``(1) The term `biological implant' has the meaning given
that term in section 7330C(d) of this title.
``(2) The term `distinct 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 facilitate
effective tracking, using the distinct identification
code, from the donor to the recipient and from the
recipient to the donor; and
``(C) satisfies the requirements of section
1271.290(c) of title 21, Code of Federal Regulations,
or any successor regulation.
``(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 entity
processing human tissue for use in biological implants,
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 sections at the
beginning of chapter 81 is amended by inserting after the item
relating to section 8128 the following new item:
``8129. Procurement of biological implants.''.
(b) Effective Date.--Section 8129 of title 38, United States Code,
as added by subsection (a), shall take effect on the date that is 180
days after the date on which the tracking system required under section
7330C(b) of such title, as added by section 2(a), is implemented.
(c) Special Rule for Cryopreserved Products.--During the three-year
period beginning on the effective date of section 8129 of title 38,
United States Code, as added by subsection (a), biological implants
produced and labeled before that effective date may be procured by the
Department of Veterans Affairs without relabeling under the standard
identification system adopted or implemented under section 7330C of
such title, as added by section 2(a).
SEC. 4. FUNDING.
No additional funds are authorized to carry out the requirements of
this Act and the amendments made by this Act. Such requirements shall
be carried out using amounts otherwise authorized.
Passed the House of Representatives January 3, 2017.
Attest:
Clerk.
115th CONGRESS
1st Session
H. R. 28
_______________________________________________________________________
AN ACT
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 Department of Veterans Affairs, and for other purposes.