82 FR 122 - Federal Management Regulations; Transportation Prepayment Audit Requirements

GENERAL SERVICES ADMINISTRATION

Federal Register Volume 82, Issue 1 (January 3, 2017)

Page Range		122-122
FR Document		2016-31786

GSA has issued a guidance for agencies and wholly-owned Government corporations, which provides a deadline to comply with recent regulatory changes that prohibit agencies from using prepayment auditors that have any affiliation with, or financial interest, in the transportation company (providing the transportation services) for which a prepayment audit is being conducted.

Federal Register, Volume 82 Issue 1 (Tuesday, January 3, 2017)

[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Page 122]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31786]


=======================================================================
-----------------------------------------------------------------------

GENERAL SERVICES ADMINISTRATION

[Notice-MA-2016-08; Docket No. 2016-0002; Sequence No. 31]


Federal Management Regulations; Transportation Prepayment Audit 
Requirements

AGENCY: Office of Government-wide Policy, General Services 
Administration (GSA).

ACTION: Notice of a bulletin.

-----------------------------------------------------------------------

SUMMARY: GSA has issued a guidance for agencies and wholly-owned 
Government corporations, which provides a deadline to comply with 
recent regulatory changes that prohibit agencies from using prepayment 
auditors that have any affiliation with, or financial interest, in the 
transportation company (providing the transportation services) for 
which a prepayment audit is being conducted.

DATES: Effective: January 3, 2017.

FOR FURTHER INFORMATION CONTACT: Mr. Ron Siegel, Program Analyst, 
Office of Government-wide Policy (MAF), Office of Asset and 
Transportation Management, General Services Administration at 202-357-
9540, or via email at [email protected]. Please cite FMR Bulletin D-
03.

SUPPLEMENTARY INFORMATION: FMR Bulletin D-03 provides guidance to all 
agencies (including the Department of Defense) and wholly-owned 
Government corporations as defined in 31 United States Code (U.S.C.) 
101, et seq. and 31 U.S.C. 9101(3). This bulletin provides agencies 
notice of a governmentwide policy revision for mandatory transportation 
prepayment audit plans, and provides a deadline for compliance with 
regulatory changes provided in FMR 102-118, Transportation Payment and 
Audit. FMR Bulletin D-03 and all other FMR bulletins are located at 
http://www.gsa.gov/fmrbulletins.

Kevin Kampschroer,
Associate Administrator (Acting), Office of Government-wide Policy, 
General Services Administration.
[FR Doc. 2016-31786 Filed 12-30-16; 8:45 am]
 BILLING CODE 6820-14-P

122 Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices

further funding for clinical trials, and an assist the company in establishing its provides a deadline to comply with
extensive amount of time to even reach manufacturing capabilities. Further, the recent regulatory changes that prohibit
the stage of applying to the FDA for Order requires that the parties transfer agencies from using prepayment
approval. The regulatory approval all confidential business information to auditors that have any affiliation with,
process itself can also be time- Terumo, as well as provide access to or financial interest, in the
consuming as the FDA reviews the employees who possess or are able to transportation company (providing the
volume of material and data a company identify such information. Terumo also transportation services) for which a
submits in support of its application. will have the right to interview and offer prepayment audit is being conducted.
The Consent Agreement employment to employees associated DATES: Effective: January 3, 2017.
with St. Jude’s vascular closure device FOR FURTHER INFORMATION CONTACT: Mr.
The Consent Agreement remedies the business and Abbott’s steerable sheath Ron Siegel, Program Analyst, Office of
competitive concerns raised by Abbott’s business. Government-wide Policy (MAF), Office
proposed acquisition of St. Jude by The parties must accomplish the
requiring that the parties divest to of Asset and Transportation
divestiture no later than forty-five days Management, General Services
Terumo all of the assets and resources after the consummation of the Proposed
needed for it to become an independent, Administration at 202–357–9540, or via
Acquisition. If the Commission email at ron.siegel@gsa.gov. Please cite
viable, and effective competitor in the determines that Terumo is not an
U.S. markets for vascular closure FMR Bulletin D–03.
acceptable acquirer, or that the manner SUPPLEMENTARY INFORMATION: FMR
devices and steerable sheaths. It also of the divestiture is not acceptable, the
requires Abbott to provide notice if it Bulletin D–03 provides guidance to all
Order requires the parties to unwind the agencies (including the Department of
intends to acquire ACT’s lesion- sale and accomplish the divestiture
assessing ablation catheter assets. Defense) and wholly-owned
within 180 days of the date the Order Government corporations as defined in
Terumo possesses the industry becomes final to another Commission-
experience and reputation necessary to 31 United States Code (U.S.C.) 101, et
approved acquirer. seq. and 31 U.S.C. 9101(3). This bulletin
replace competition that would be lost To ensure compliance with the Order,
in the U.S. markets for vascular closure provides agencies notice of a
the Commission has agreed to appoint
devices and steerable sheaths. Terumo governmentwide policy revision for
an Interim Monitor to ensure that
is headquartered in Tokyo, Japan. It has mandatory transportation prepayment
Abbott and St. Jude comply with all of
been active in the U.S. medical device audit plans, and provides a deadline for
their obligations pursuant to the
market for over thirty years and has a compliance with regulatory changes
Consent Agreement and to keep the
U.S. subsidiary based in Somerset, New provided in FMR 102–118,
Commission informed about the status
Jersey. Terumo offers a portfolio of Transportation Payment and Audit.
of the transfer of the rights and assets to
products that are highly complementary FMR Bulletin D–03 and all other FMR
Terumo. Further, the Order allows the
to the vascular closure and steerable bulletins are located at http://
Commission to appoint a Divestiture
sheath products being acquired but does www.gsa.gov/fmrbulletins.
Trustee to accomplish the divestiture
not sell any competing products.
should the parties fail to comply with Kevin Kampschroer,
Through its Interventional Systems
their divestiture obligations. Lastly, the Associate Administrator (Acting), Office of
business unit, Terumo manufactures
Order terminates after ten years. Government-wide Policy, General Services
and sells guidewires, catheters, and
The purpose of this analysis is to Administration.
sheaths, as well as other vascular access
facilitate public comment on the [FR Doc. 2016–31786 Filed 12–30–16; 8:45 am]
devices. As a result, it currently sells its
proposed Consent Agreement, and it is BILLING CODE 6820–14–P
products to many of the same customers
not intended to constitute an official
as Abbott and St. Jude. Terumo is thus
interpretation of the proposed Order or
well positioned to restore the benefits of
to modify its terms in any way. OFFICE OF GOVERNMENT ETHICS
competition that would be lost through
the Proposed Acquisition. By direction of the Commission.
Pursuant to the Order, Terumo will April J. Tabor, Request for Public Input on the
receive all rights and assets related to St. Application of the Criminal Conflict of
Acting Secretary.
Jude’s vascular closure device business Interest Prohibition to Certain
[FR Doc. 2016–31800 Filed 12–30–16; 8:45 am]
and Abbott’s steerable sheath business, Beneficial Interests in Discretionary
BILLING CODE 6750–01–P
including all of the intellectual property Trusts.
used in those businesses. In addition, AGENCY: Office of Government Ethics
Terumo will take over part of the facility GENERAL SERVICES (OGE).
in Caguas, Puerto Rico where St. Jude ADMINISTRATION Notice of request for public
ACTION:
currently manufactures most of its comments.
vascular closure device products. In [Notice–MA–2016–08; Docket No. 2016–
order to ensure continuity of supply for 0002; Sequence No. 31] SUMMARY: This notice and request seeks
certain vascular closure devices and input from members of the public with
Federal Management Regulations; expertise in trust law concerning the
components that are not currently
Transportation Prepayment Audit following question: Are there any
manufactured in the Puerto Rico
Requirements circumstances under which an eligible
facility, the Order requires that St. Jude
income beneficiary of a discretionary
sradovich on DSK3GMQ082PROD with NOTICES

supply Terumo with finished vascular AGENCY: Office of Government-wide
closure devices and components for up Policy, General Services Administration trust might, in the absence of a vested
to two years while Terumo transitions to (GSA). remainder interest, be able to compel
independent manufacturing. ACTION: Notice of a bulletin. the trust to make a distribution or
To ensure that the divestiture is payment? OGE will take into
successful, the Order requires the SUMMARY: GSA has issued a guidance for consideration all relevant expert input
parties to enter into a transitional agencies and wholly-owned submitted by the public within 60 days
services agreement with Terumo to Government corporations, which of the date of this notice. To be

VerDate Sep<11>2014 22:14 Dec 30, 2016 Jkt 241001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\03JAN1.SGM 03JAN1

Document Created: 2018-02-01 14:44:29
Document Modified: 2018-02-01 14:44:29

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of a bulletin.
Dates		Effective: January 3, 2017.
Contact		Mr. Ron Siegel, Program Analyst, Office of Government-wide Policy (MAF), Office of Asset and Transportation Management, General Services Administration at 202-357- 9540, or via email at [email protected] Please cite FMR Bulletin D- 03.
FR Citation		82 FR 122