[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2334 Introduced in Senate (IS)]

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114th CONGRESS
  1st Session
                                S. 2334

   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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 30, 2015

  Mr. Cassidy introduced the following bill; which was read twice and 
             referred to the Committee on Veterans' Affairs

_______________________________________________________________________

                                 A BILL


 
   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 2015''.

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. 7330B. 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 sections 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 
7330A the following new item:

``7330B. 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 7330B 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 7330B(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 7330B(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 written explanation 
        on why the system is not operational for each month until such 
        time as the system is operational.
            (2) Elements.--Each explanation 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 such title 
        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 7330B(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 non-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 7330B(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.
    ``(4) 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 
        such term in section 7330B(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 such chapter 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 
7330B(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 7330B of 
such title, as added by section 2(a).
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