II 

115TH CONGRESS 

1ST SESSION S. 23 

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 

JANUARY 4, 2017 

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. 

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 2017’’. 


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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.—(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 sections 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 7330A the following new 

13 item: 

‘‘7330B. 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 7330B 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 7330B(b) of 

9 title 38, United States Code, as added by subsection 

10 (a), by not later than the date that is 180 days after 

11 the 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 7330B(b) of 

15 title 38, United States Code, as added by subsection 

16 (a), is not operational by the date that is 180 days 

17 after the date of the enactment of this Act, the Sec18 retary of Veterans Affairs shall submit to the Com19 mittee on Veterans’ Affairs of the Senate and the 

20 Committee on Veterans’ Affairs of the House of 

21 Representatives a written explanation on why the 

22 system is not operational for each month until such 

23 time as the system is operational. 


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1 (2) ELEMENTS.—Each explanation submitted 

2 under paragraph (1) shall include a description of 

3 the following: 

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 such title is amended by adding at the end the 

16 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 7330B(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 non-human 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 7330B(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 00:38 Jan 11, 2017 Jkt 069200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S23.IS S23

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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. 

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

20 procurement of biological implants. 

21 ‘‘(b) PENALTIES.—In addition to any applicable pen22 alty under any other provision of law, any procurement 

23 employee of the Department who is found responsible for 

24 a biological implant procurement transaction with intent 

25 to avoid or with reckless disregard of the requirements of 


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1 this section shall be ineligible to hold a certificate of ap2 pointment as a contracting officer or to serve as the rep3 resentative of an ordering officer, contracting officer, or 

4 purchase card holder. 

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

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

7 meaning given such term in section 7330B(d) of this 

8 title. 

9 ‘‘(2) The term ‘distinct identifier’ means a dis10 tinct identification code that— 

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

12 human donor of the implant and to all records 

13 pertaining to the implant; 

14 ‘‘(B) includes information designed to fa15 cilitate effective tracking, using the distinct 

16 identification code, from the donor to the recipi17 ent and from the recipient to the donor; and 

18 ‘‘(C) satisfies the requirements of section 

19 1271.290(c) of title 21, Code of Federal Regu20 lations, or any successor regulation. 

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

22 means an agency that acquires and stores human 

23 tissue for further distribution and performs no other 

24 tissue banking functions. 


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1 ‘‘(4) The term ‘tissue processor’ means an enti2 ty processing human tissue for use in biological im3 plants, including activities performed on tissue other 

4 than donor screening, donor testing, tissue recovery 

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

6 (2) CLERICAL AMENDMENT.—The table of sec7 tions at the beginning of such chapter is amended 

8 by inserting after the item relating to section 8128 

9 the following new item: 

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

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

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

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

13 the tracking system required under section 7330B(b) of 

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

15 (c) SPECIAL RULE FOR CRYOPRESERVED PROD16 UCTS.—During the three-year period beginning on the ef17 fective date of section 8129 of title 38, United States 

18 Code, as added by subsection (a), biological implants pro19 duced and labeled before that effective date may be pro20 cured by the Department of Veterans Affairs without re21 labeling under the standard identification system adopted 

22 or implemented under section 7330B of such title, as 

23 added by section 2(a). 

Æ 


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