3.0.0 28 2023-01-11T13:34:32Z 2023-01-11T13:34:32Z House HR 2017-01-03 115 [Congressional Record Volume 163, Number 1 (Tuesday, January 3, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. ROE of Tennessee:H.R. 28.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8 of the United States Constitution.[Page H46]]]> ssva00 Veterans' Affairs Committee Senate Standing Referred to 2017-01-04T18:07:49Z hsvr00 Veterans' Affairs Committee House Standing hsvr03 Health Subcommittee Referred to 2017-01-03T17:09:23Z Referred to 2017-01-03T17:04:30Z Biological Implant Tracking and Veteran Safety Act of 2017 115 23 S 2017-05-17 Committee on Veterans' Affairs. Hearings held. Hearings printed: S.Hrg. 115-299. Related bill CRS 2017-01-04 ssva00 Veterans' Affairs Committee Senate Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs. IntroReferral 2017-01-03 17:59:41 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2017-01-03 17:59:38 On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H31-32) Floor H37300 2 House floor actions 2017-01-03 17:59:38 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H31-32) Floor 8000 9 Library of Congress 2017-01-03 17:52:42 DEBATE - The House proceeded with forty minutes of debate on H.R. 28. Floor H8D000 2 House floor actions 2017-01-03 17:52:27 Considered under suspension of the rules. (consideration: CR H31-33) Floor H30000 2 House floor actions 2017-01-03 17:52:11 Mr. Roe (TN) moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2017-01-03 hsvr03 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2017-01-03 Referred to the House Committee on Veterans' Affairs. IntroReferral H11100 2 House floor actions hsvr00 Veterans' Affairs Committee 2017-01-03 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-01-03 Introduced in House IntroReferral 1000 9 Library of Congress R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 N Armed Forces and National Security Business records Cell biology and embryology Congressional oversight Department of Veterans Affairs Drug safety, medical device, and laboratory regulation Government ethics and transparency, public corruption Health information and medical records Health technology, devices, supplies Licensing and registrations Organ and tissue donation and transplantation Product safety and quality Public contracts and procurement Veterans' medical care Armed Forces and National Security 00 2017-01-03 Introduced in House 2017-04-06T20:32:27Z Biological Implant Tracking and Veteran Safety Act of 2017

This bill directs the Department of Veterans Affairs (VA) to:

  • adopt the unique device identification system developed for medical devices by the Food and Drug Administration (FDA), or implement a comparable standard identification system, for identifying biological implants intended for use in VA medical facilities;
  • permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency;
  • implement (within 180 days after enactment of this bill) a compatible system for tracking implants from human donor or animal source to implantation; and
  • implement compatible inventory controls so that patients who have received a biological implant in a VA medical facility subject to FDA recall can be appropriately notified.

The bill prescribes requirements for vendors from which the VA may procure biological implants of human and non-human origin. The VA shall: (1) procure such implants under General Services Administration Federal Supply Schedules unless they are not available under such Schedules, (2) accommodate reasonable vendor requests to undertake specified outreach efforts to educate VA medical professionals about the use and efficacy of implants, and (3) procure biological implants that are unavailable under such Schedules using competitive procedures in accordance with the Federal Acquisition Regulation.

Certain biological implants may be temporarily procured by the VA without relabeling under the standard identification system.

]]> 81 2017-01-03 Passed House without amendment 2017-04-06T20:59:36Z (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Biological Implant Tracking and Veteran Safety Act of 2017

(Sec. 2) This bill directs the Department of Veterans Affairs (VA) to: (1) adopt the unique device identification system developed for medical devices by the Food and Drug Administration (FDA), or implement a comparable standard identification system, for identifying biological implants intended for use in VA medical facilities; (2) permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency; (3) implement (within 180 days after enactment of this bill) a compatible system for tracking implants from human donor or animal source to implantation; and (4) implement compatible inventory controls compatible with such tracking system so that patients who have received a biological implant in a VA medical facility subject to FDA recall can be appropriately notified.

If the biological implant tracking system is not operational within 180 days, the VA shall report to Congress explaining why the system is not operational each month until it is operational.

(Sec. 3) The bill prescribes requirements for vendors from which the VA may procure biological implants of human and non-human origin and for vendors from which the VA may procure biological implants of non-human origin. Such a vendor must: (1) use the standard identification system adopted or implemented by the VA under this Act; (2) be registered as required by FDA procedures; (3) consent to periodic VA inspections and audits regarding records and product handling; (4) agree to cooperate with all biological implant recalls conducted on the vendor's initiative, on the initiative of the original product manufacturer used by the vendor, or by FDA request or statutory order; (5) agree to notify the VA within 60 days of providing any adverse event report to the FDA or receiving any warning letter from the FDA; and (6) agree to retain all records associated with the procurement of a biological implant by the VA for at least 10 years.

The VA shall: (1) procure such implants under General Services Administration Federal Supply Schedules unless they are not available under such schedules, (2) accommodate reasonable vendor requests to undertake specified outreach efforts to educate VA medical professionals about the use and efficacy of implants, and (3) procure biological implants that are unavailable under such schedules using competitive procedures in accordance with the Federal Acquisition Regulation.

Any VA procurement employee responsible for making a biological implant procurement transaction with intent to avoid, or with reckless disregard of, the requirements of this bill 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.

Certain biological implants may be temporarily procured by the VA without relabeling under the standard identification system.

]]> Biological Implant Tracking and Veteran Safety Act of 2017 Display Title Biological Implant Tracking and Veteran Safety Act of 2017 Short Titles as Introduced Biological Implant Tracking and Veteran Safety Act of 2017 Short Titles as Passed House Biological Implant Tracking and Veteran Safety Act of 2017 H House Official Title as Introduced 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. Referred in Senate 2017-01-04T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr28rfs/xml/BILLS-115hr28rfs.xml Engrossed in House 2017-01-03T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr28eh/xml/BILLS-115hr28eh.xml 2017-01-04 Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.