I 

113TH CONGRESS 

2D SESSION H. R. 4374 

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 HOUSE OF REPRESENTATIVES 

APRIL 2, 2014 

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 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. 

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 ‘‘Biological Implant 

5 Tracking and Veteran Safety Act of 2014’’. 


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1 SEC. 2. IDENTIFICATION AND TRACKING OF BIOLOGICAL 

2 IMPLANTS USED IN DEPARTMENT OF VET3 ERANS AFFAIRS MEDICAL FACILITIES. 

4 (a) IN GENERAL.—Subchapter II of chapter 73 of 

5 title 38, United States Code, is amended by adding at the 

6 end the following new section: 

7 ‘‘§ 7330B. Identification and tracking of biological im8 plants 

9 ‘‘(a) STANDARD IDENTIFICATION SYSTEM FOR BIO10 LOGICAL IMPLANTS.—The Secretary shall adopt the 

11 unique device identification system developed for medical 

12 devices by the Food and Drug Administration pursuant 

13 to section 519(f) of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 360i(f)), or implement a comparable 

15 standard identification system, for use in identifying bio16 logical implants intended for use in medical procedures 

17 conducted in medical facilities of the Department. 

18 ‘‘(b) BIOLOGICAL IMPLANT TRACKING SYSTEM.—(1) 

19 The Secretary shall implement a system for tracking the 

20 biological implants referred to in subsection (a) from 

21 donor to implantation. Such system shall be compatible 

22 with the identification system adopted or implemented 

23 under subsection (a). 

24 ‘‘(2) The Secretary shall implement inventory con25 trols compatible with the tracking system implemented 

26 under paragraph (1) so that all patients who have reVerDate Mar 15 2010 19:03 Apr 04, 2014 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4374.IH H4374

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1 ceived, in a medical facility of the Department, a biological 

2 implant subject to a recall by the Food and Drug Adminis3 tration can be notified of the recall, if based on the evalua4 tion of appropriate medical personnel of the Department 

5 of the risks and benefits, the Secretary determines such 

6 notification is appropriate. 

7 ‘‘(c) CONSISTENCY WITH FOOD AND DRUG ADMINIS8 TRATION REGULATIONS.—To the extent that a conflict 

9 arises between this section and a provision of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 

11 or sections 351 or 361 of the Public Health Service Act 

12 (42 U.S.C. 262) (including any regulations issued under 

13 such Acts), the provision the Federal Food, Drug, and 

14 Cosmetic Act or Public Health Service Act (including any 

15 regulations issued under such Acts) shall apply. 

16 ‘‘(d) DEFINITION OF BIOLOGICAL IMPLANT.—In this 

17 section, the term ‘biological implant’ means any human 

18 cell, tissue, or cellular or tissue-based product— 

19 ‘‘(1) under the meaning given the term ‘human 

20 cells’ in section 1271.3 of title 21, Code of Federal 

21 Regulations, or any successor regulation; or 

22 ‘‘(2) that is regulated as a device under subpart 

23 A of part 801 of title 21, Code of Federal Regula24 tions, or any successor regulation.’’. 


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1 (b) CLERICAL AMENDMENT.—The table of sections 

2 at the beginning of such chapter is amended by adding 

3 at the end of the items relating to such subchapter the 

4 following new item: 

‘‘7330B. Identification and tracking of biological implants.’’. 

5 (c) IMPLEMENTATION DEADLINES.— 

6 (1) STANDARD IDENTIFICATION SYSTEM.— 

7 (A) IN GENERAL.—With respect to biologi8 cal implants described in paragraph (1) of sub9 section (d) of section 7330B of title 38, United 

10 States Code, as added by subsection (a), the 

11 Secretary of Veterans Affairs shall adopt or im12 plement a standard identification system for bi13 ological implants, as required by subsection (a) 

14 of such section, by not later than the date that 

15 is 180 days after the date of the enactment of 

16 this Act. 

17 (B) IMPLANTS REGULATED AS DEVICES.— 

18 With respect to biological implants described in 

19 paragraph (2) of subsection (d) of such section, 

20 the Secretary of Veterans Affairs shall adopt or 

21 implement such standard identification system 

22 in compliance with the compliance dates estab23 lished by the Food and Drug Administration 

24 pursuant to section 519(f) of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 360i(f)). 


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1 (2) TRACKING SYSTEM.—The Secretary of Vet2 erans Affairs shall implement the biological implant 

3 tracking system required by subsection (b) of section 

4 7330B, as added by subsection (a), by not later than 

5 the date that is 180 days after the date of the enact6 ment of this Act. 

7 (d) REPORTING REQUIREMENT.—If the biological 

8 implant tracking system required by subsection (b) of such 

9 section is not operational by the date that is 180 days 

10 after the date of the enactment of this Act, the Secretary 

11 of Veterans Affairs shall provide to the Committees on 

12 Veterans’ Affairs of the Senate and House of Representa13 tives a written explanation for each month until such time 

14 as the system is operational. Each such explanation shall 

15 describe each impediment to the implementation of the 

16 system, steps being taken to remediate each such impedi17 ment, and target dates for a solution to each such impedi18 ment. 

19 SEC. 3. PROCUREMENT OF BIOLOGICAL IMPLANTS USED IN 

20 DEPARTMENT OF VETERANS AFFAIRS MED21 ICAL FACILITIES. 

22 (a) PROCUREMENT.— 

23 (1) IN GENERAL.—Subchapter II of chapter 81 

24 of such title is amended by adding at the end the 

25 following new section: 


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1 ‘‘§ 8129. Procurement of biological implants 

2 ‘‘(a) IN GENERAL.—(1) The Secretary may procure 

3 biological implants only from vendors that meet the fol4 lowing conditions: 

5 ‘‘(A) The vendor uses the standard identifica6 tion system adopted or implemented by the Sec7 retary under section 7330B(a) of this title and has 

8 safeguards to ensure that a production identifier has 

9 been in place at each step of distribution of each bio10 logical implant from its donor. 

11 ‘‘(B) The vendor is registered with the Food 

12 and Drug Administration under subpart B of part 

13 1271 of title 21, Code of Federal Regulations, or 

14 any successor regulation, and in the case of a vendor 

15 that uses tissue distribution intermediaries, the ven16 dor uses only tissue distribution intermediaries that 

17 are appropriately registered with the Food and Drug 

18 Administration. 

19 ‘‘(C) The vendor ensures that donor eligibility 

20 determinations and such other records as the Sec21 retary may require accompany each biological im22 plant at all times, regardless of the country of origin 

23 of the donor of the biological material. 

24 ‘‘(D) The vendor consents to periodic inspec25 tions and audits by the Department of Veterans AfVerDate Mar 15 2010 19:03 Apr 04, 2014 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4374.IH H4374

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1 fairs regarding the accuracy of records and the han2 dling of products. 

3 ‘‘(E) The vendor agrees to cooperate with all bi4 ological implant recalls conducted on the vendor’s 

5 own initiative, by the request of the Food and Drug 

6 Administration, or by a statutory order of the Food 

7 and Drug Administration. 

8 ‘‘(F) The vendor agrees to provide to the Sec9 retary any adverse event report or warning letter of 

10 the Food and Drug Administration issued to the 

11 vendor by not later than 30 days after the vendor 

12 receives such report or warning letter. 

13 ‘‘(G) The vendor agrees to retain all records as14 sociated with the procurement of a biological implant 

15 by the Department for at least five years after the 

16 date of the procurement of the biological implant. 

17 ‘‘(H) The vendor maintains active accreditation 

18 with the American Association of Tissue Banks or a 

19 similar national accreditation specific to biological 

20 implants. 

21 ‘‘(2) The Secretary shall procure biological implants 

22 under the Federal Supply Schedules of the General Serv23 ices Administration, unless such implants are not available 

24 under such Schedules. For biological implants listed on 

25 the Federal Supply Schedules, the Secretary shall accomVerDate Mar 15 2010 19:03 Apr 04, 2014 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4374.IH H4374

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1 modate reasonable vendor requests to undertake outreach 

2 efforts to educate medical professionals of the Department 

3 about the use and efficacy of such biological implants. 

4 ‘‘(3) Section 8123 of this title shall not apply to the 

5 procurement of biological implants. 

6 ‘‘(4) In the case of biological implants that are un7 available for procurement under the Federal Supply 

8 Schedules, the Secretary shall procure such implants using 

9 competitive procedures in accordance with applicable law 

10 and the Federal Acquisition Regulation. 

11 ‘‘(b) PENALTIES.—In addition to any applicable pen12 alty under any other provision of law, any procurement 

13 employee of the Department who is found responsible for 

14 a biological implant procurement transaction with intent 

15 to avoid or with reckless disregard of the requirements of 

16 this section shall be ineligible to hold a certificate of ap17 pointment as a contracting officer or to serve as the rep18 resentative of an ordering officer, contracting officer, or 

19 purchase card holder. 

20 ‘‘(c) DEFINITIONS.—In this section: 

21 ‘‘(1) The term ‘biological implant’ shall have 

22 the meaning given such term in section 7330B(d) of 

23 this title. 

24 ‘‘(2) The term ‘production identifier’ means a 

25 distinct identification code that— 


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1 ‘‘(A) relates a biological implant to the 

2 donor of the implant and to all records per3 taining to the implant; 

4 ‘‘(B) includes information designed to fa5 cilitate effective tracking, using the distinct 

6 identification code, from the donor to the recipi7 ent and from the recipient to the donor; and 

8 ‘‘(C) satisfies the requirements of sub9 section (c) of section 1271.290 of title 21, Code 

10 of Federal Regulations, or any successor regula11 tion.’’. 

12 (2) CLERICAL AMENDMENT.—The table of sec13 tions at the beginning of such chapter is amended 

14 by adding at the end of the items relating to such 

15 subchapter the following new item: 

‘‘8129. Procurement of biological implants.’’. 

16 (b) EFFECTIVE DATE.—Section 8129 of title 38, 

17 United States Code, as added by subsection (a), shall take 

18 effect on the date that is 180 days after the date on which 

19 the tracking system required under subsection (b) of sec20 tion 7330B of such title, as added by section 2(a) is imple21 mented. 

22 (c) SPECIAL RULE FOR CRYOPRESERVED PROD23 UCTS.—During the three-year period beginning on the ef24 fective date of section 8129 of title 38, United States 

25 Code, as added by subsection (a), biological implants proVerDate Mar 15 2010 19:03 Apr 04, 2014 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4374.IH H4374

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1 duced and labeled before that date may be procured by 

2 the Department of Veterans Affairs without relabeling 

3 under the standard identification system adopted or imple4 mented under section 7330B of such title, as added by 

5 section 2(a). 

Æ 


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