I 

116TH CONGRESS 

1ST SESSION H. R. 547 

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 

JANUARY 15, 2019 

Mr. DAVID P. 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 2019’’. 


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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 ‘‘§ 7330D. Identification and tracking of biological im8 plants 

9 ‘‘(a) STANDARD IDENTIFICATION SYSTEM FOR BIO10 LOGICAL IMPLANTS.—(1) The Secretary shall adopt the 

11 unique device identification system developed for medical 

12 devices by the Food and Drug Administration under sec13 tion 519(f) of the Federal Food, Drug, and Cosmetic Act 

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

15 identification system, for use in identifying biological im16 plants intended for use in medical procedures conducted 

17 in medical facilities of the Department. 

18 ‘‘(2) In adopting or implementing a standard identi19 fication system for biological implants under paragraph 

20 (1), the Secretary shall permit a vendor to use any of the 

21 accredited entities identified by the Food and Drug Ad22 ministration as an issuing agency pursuant to section 

23 830.100 of title 21, Code of Federal Regulations, or any 

24 successor regulation. 

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

26 The Secretary shall implement a system for tracking the 


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1 biological implants described in subsection (a) from 

2 human donor or animal source to implantation. 

3 ‘‘(2) The tracking system implemented under para4 graph (1) shall be compatible with the identification sys5 tem adopted or implemented under subsection (a). 

6 ‘‘(3) The Secretary shall implement inventory con7 trols compatible with the tracking system implemented 

8 under paragraph (1) so that all patients who have re9 ceived, in a medical facility of the Department, a biological 

10 implant subject to a recall can be notified of the recall 

11 if, based on the evaluation by appropriate medical per12 sonnel of the Department of the risks and benefits, the 

13 Secretary determines such notification is appropriate. 

14 ‘‘(c) CONSISTENCY WITH FOOD AND DRUG ADMINIS15 TRATION REGULATIONS.—To the extent that a conflict 

16 arises between this section and a provision of the Federal 

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

18 or section 351 or 361 of the Public Health Service Act 

19 (42 U.S.C. 262 and 264) (including any regulations issued 

20 under such provisions), the provision of the Federal Food, 

21 Drug, and Cosmetic Act or Public Health Service Act (in22 cluding any regulations issued under such provisions) shall 

23 apply. 

24 ‘‘(d) BIOLOGICAL IMPLANT DEFINED.—In this sec25 tion, the term ‘biological implant’ means any human cell, 


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1 tissue, or cellular or tissue-based product or animal prod2 uct— 

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

4 cells, tissues, or cellular or tissue-based products’ in 

5 section 1271.3 of title 21, Code of Federal Regula6 tions, or any successor regulation; or 

7 ‘‘(2) that is regulated as a device under section 

8 201(h) of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 321(h)).’’. 

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

11 at the beginning of such chapter is amended by inserting 

12 after the item relating to section 7330C the following new 

13 item: 

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

14 (c) IMPLEMENTATION DEADLINES.— 

15 (1) STANDARD IDENTIFICATION SYSTEM.—The 

16 Secretary of Veterans Affairs shall adopt or imple17 ment the standard identification system for biologi18 cal implants required by subsection (a) of section 

19 7330C of title 38, United States Code, as added by 

20 subsection (a), with respect to biological implants 

21 described in— 

22 (A) subsection (d)(1) of such section, by 

23 not later than the date that is 180 days after 

24 the date of the enactment of this Act; and 


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1 (B) subsection (d)(2) of such section, in 

2 compliance with the compliance dates estab3 lished by the Food and Drug Administration 

4 under section 519(f) of the Federal Food, 

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

6 (2) TRACKING SYSTEM.—The Secretary of Vet7 erans Affairs shall implement the biological implant 

8 tracking system required by section 7330C(b) of title 

9 38, United States Code, as added by subsection (a), 

10 by not later than the date that is 180 days after the 

11 date of the enactment of this Act. 

12 (d) REPORTING REQUIREMENT.— 

13 (1) IN GENERAL.—If the biological implant 

14 tracking system required by section 7330C(b) of title 

15 38, United States Code, as added by subsection (a), 

16 is not operational by the date that is 180 days after 

17 the date of the enactment of this Act, the Secretary 

18 of Veterans Affairs shall submit to the Committee 

19 on Veterans’ Affairs of the Senate and the Com20 mittee on Veterans’ Affairs of the House of Rep21 resentatives a report explaining why the system is 

22 not operational for each month until such time as 

23 the system is operational. 


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1 (2) ELEMENTS.—Each report submitted under 

2 paragraph (1) shall include a description of the fol3 lowing: 

4 (A) Each impediment to the implementa5 tion of the system described in such paragraph. 

6 (B) Steps being taken to remediate each 

7 such impediment. 

8 (C) Target dates for a solution to each 

9 such impediment. 

10 SEC. 3. PROCUREMENT OF BIOLOGICAL IMPLANTS USED IN 

11 DEPARTMENT OF VETERANS AFFAIRS MED12 ICAL FACILITIES. 

13 (a) PROCUREMENT.— 

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

15 of title 38, United States Code, is amended by add16 ing at the end the following new section: 

17 ‘‘§ 8129. Procurement of biological implants 

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

19 biological implants of human origin only from vendors that 

20 meet the following conditions: 

21 ‘‘(A) The vendor uses the standard identifica22 tion system adopted or implemented by the Sec23 retary under section 7330C(a) of this title and has 

24 safeguards to ensure that a distinct identifier has 


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1 been in place at each step of distribution of each bio2 logical implant from its donor. 

3 ‘‘(B) The vendor is registered as required by 

4 the Food and Drug Administration under subpart B 

5 of part 1271 of title 21, Code of Federal Regula6 tions, or any successor regulation, and in the case of 

7 a vendor that uses a tissue distribution intermediary 

8 or a tissue processor, the vendor provides assurances 

9 that the tissue distribution intermediary or tissue 

10 processor is registered as required by the Food and 

11 Drug Administration. 

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

13 determinations and such other records as the Sec14 retary may require accompany each biological im15 plant at all times, regardless of the country of origin 

16 of the donor of the biological material. 

17 ‘‘(D) The vendor agrees to cooperate with all 

18 biological implant recalls conducted on the initiative 

19 of the vendor, on the initiative of the original prod20 uct manufacturer used by the vendor, by the request 

21 of the Food and Drug Administration, or by a statu22 tory order of the Food and Drug Administration. 

23 ‘‘(E) The vendor agrees to notify the Secretary 

24 of any adverse event or reaction report it provides 

25 to the Food and Drug Administration, as required 


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1 by sections 1271.3 and 1271.350 of title 21, Code 

2 of Federal Regulations, or any successor regulation, 

3 or any warning letter from the Food and Drug Ad4 ministration issued to the vendor or a tissue proc5 essor or tissue distribution intermediary used by the 

6 vendor by not later than 60 days after the vendor 

7 receives such report or warning letter. 

8 ‘‘(F) The vendor agrees to retain all records as9 sociated with the procurement of a biological implant 

10 by the Department for at least 10 years after the 

11 date of the procurement of the biological implant. 

12 ‘‘(G) The vendor provides assurances that the 

13 biological implants provided by the vendor are ac14 quired only from tissue processors that maintain ac15 tive accreditation with the American Association of 

16 Tissue Banks or a similar national accreditation spe17 cific to biological implants. 

18 ‘‘(2) The Secretary may procure biological implants 

19 of nonhuman origin only from vendors that meet the fol20 lowing conditions: 

21 ‘‘(A) The vendor uses the standard identifica22 tion system adopted or implemented by the Sec23 retary under section 7330C(a) of this title. 

24 ‘‘(B) The vendor is registered as an establish25 ment as required by the Food and Drug AdministraVerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547

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1 tion under sections 807.20 and 807.40 of title 21, 

2 Code of Federal Regulations, or any successor regu3 lation (or is not required to register pursuant to sec4 tion 807.65(a) of such title, or any successor regula5 tion), and in the case of a vendor that is not the 

6 original product manufacturer of such implants, the 

7 vendor provides assurances that the original product 

8 manufacturer is registered as required by the Food 

9 and Drug Administration (or is not required to reg10 ister). 

11 ‘‘(C) The vendor agrees to cooperate with all bi12 ological implant recalls conducted on the initiative of 

13 the vendor, on the initiative of the original product 

14 manufacturer used by the vendor, by the request of 

15 the Food and Drug Administration, or by a statu16 tory order of the Food and Drug Administration. 

17 ‘‘(D) The vendor agrees to notify the Secretary 

18 of any adverse event report it provides to the Food 

19 and Drug Administration as required under part 

20 803 of title 21, Code of Federal Regulations, or any 

21 successor regulation, or any warning letter from the 

22 Food and Drug Administration issued to the vendor 

23 or the original product manufacturer used by the 

24 vendor by not later than 60 days after the vendor 

25 receives such report or warning letter. 


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1 ‘‘(E) The vendor agrees to retain all records as2 sociated with the procurement of a biological implant 

3 by the Department for at least 10 years after the 

4 date of the procurement of the biological implant. 

5 ‘‘(3)(A) The Secretary shall procure biological im6 plants under the Federal Supply Schedules of the General 

7 Services Administration unless such implants are not 

8 available under such Schedules. 

9 ‘‘(B) With respect to biological implants listed on the 

10 Federal Supply Schedules, the Secretary shall accommo11 date reasonable vendor requests to undertake outreach ef12 forts to educate medical professionals of the Department 

13 about the use and efficacy of such biological implants. 

14 ‘‘(C) In the case of biological implants that are un15 available for procurement under the Federal Supply 

16 Schedules, the Secretary shall procure such implants using 

17 competitive procedures in accordance with applicable law 

18 and the Federal Acquisition Regulation, including through 

19 the use of a national contract. 

20 ‘‘(4) In procuring biological implants under this sec21 tion, the Secretary shall permit a vendor to use any of 

22 the accredited entities identified by the Food and Drug 

23 Administration as an issuing agency pursuant to section 

24 830.100 of title 21, Code of Federal Regulations, or any 

25 successor regulation. 


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1 ‘‘(5) Section 8123 of this title shall not apply to the 

2 procurement of biological implants. 

3 ‘‘(b) PENALTIES.—In addition to any applicable pen4 alty under any other provision of law, any procurement 

5 employee of the Department who is found responsible for 

6 a biological implant procurement transaction with intent 

7 to avoid or with reckless disregard of the requirements of 

8 this section shall be ineligible to hold a certificate of ap9 pointment as a contracting officer or to serve as the rep10 resentative of an ordering officer, contracting officer, or 

11 purchase card holder. 

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

13 ‘‘(1) The term ‘biological implant’ has the 

14 meaning given that term in section 7330C(d) of this 

15 title. 

16 ‘‘(2) The term ‘distinct identifier’ means a dis17 tinct identification code that— 

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

19 human donor of the implant and to all records 

20 pertaining to the implant; 

21 ‘‘(B) includes information designed to fa22 cilitate effective tracking, using the distinct 

23 identification code, from the donor to the recipi24 ent and from the recipient to the donor; and 


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1 ‘‘(C) satisfies the requirements of section 

2 1271.290(c) of title 21, Code of Federal Regu3 lations, or any successor regulation. 

4 ‘‘(3) The term ‘tissue distribution intermediary’ 

5 means an agency that acquires and stores human 

6 tissue for further distribution and performs no other 

7 tissue banking functions. 

8 ‘‘(4) The term ‘tissue processor’ means an enti9 ty processing human tissue for use in biological im10 plants, including activities performed on tissue other 

11 than donor screening, donor testing, tissue recovery 

12 and collection functions, storage, or distribution.’’. 

13 (2) CLERICAL AMENDMENT.—The table of sec14 tions at the beginning of chapter 81 is amended by 

15 inserting after the item relating to section 8128 the 

16 following new item: 

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

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

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

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

20 the tracking system required under section 7330C(b) of 

21 such title, as added by section 2(a), is implemented. 

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 Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547

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1 duced and labeled before that effective date may be pro2 cured by the Department of Veterans Affairs without re3 labeling under the standard identification system adopted 

4 or implemented under section 7330C of such title, as 

5 added by section 2(a). 

6 SEC. 4. FUNDING. 

7 No additional funds are authorized to carry out the 

8 requirements of this Act and the amendments made by 

9 this Act. Such requirements shall be carried out using 

10 amounts otherwise authorized. 

Æ 


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