Federal Management Regulations; Improved Management of Undeliverable-as-Addressed Mail, 51810 [2015-21187]
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51810
Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices
rmajette on DSK7SPTVN1PROD with NOTICES
version of a drug product for which Par
is seeking FDA approval to sell a generic
counterpart; and (2) the limitation
extends beyond the expiration of any
Orange-Book listed patents for the drug
in question.6
In the Concordia order, Paragraph II
requires Concordia to relinquish any
and all rights to payment under the
License Agreement and to provide
written notice to Par and the FTC of that
relinquishment. Paragraph III bars
Concordia from entering any agreement
with a generic applicant for a referencelisted drug for which Concordia holds
the NDA, if the agreement (1) limits
marketing of an authorized generic
version of that drug and (2) the
limitation extends beyond the
expiration of any Orange-Book listed
patents for the drug in question.
The proposed orders’ prohibitions on
future agreements limiting an
authorized generic cover only
agreements in which the restraint
extends beyond patent expiration.
Agreements to restrict the sale of an
authorized generic sometimes appear in
patent litigation settlements and can
serve as a means of compensating the
generic patent challenger for agreeing to
stay off the market for a period of time.7
These arrangements can raise the same
antitrust concerns that the Supreme
Court addressed in FTC v. Actavis, 133
S. Ct. 2223 (2013).8 That is not this case,
however, and the proposed orders are
not designed to address that type of
conduct. As discussed above, the
challenged agreement here did not arise
out of pending or threatened patent
litigation and nearly the entire five-year
term of the agreement covered the
period after expiration of the Kapvay
patent.
For purposes of these proposed
orders, ‘‘authorized generic’’ means a
drug product distributed by or on behalf
of an NDA holder, but marketed as a
generic, regardless of whether it is
manufactured pursuant to an NDA, an
ANDA, or a 505(b)(2) application.9
6 This provision applies to actions taken on behalf
of Par Pharmaceutical, Inc., and Par Pharmaceutical
Holdings, Inc., but would not apply to conduct by
Respondent TPG Partners VI, L.P. that is not taken
on behalf of the Par entities.
7 See, e.g., Authorized Generic Study at 139–53.
8 See King Drug Co. of Florence Inc.v. Smithkline
Beecham Corp., No. 14–1243 (3rd Cir. June 26,
2015). See also Brief of Federal Trade Commission
as Amicus Curiae, American Sales Co.v. WarnerChilcott Co., LLC, Nos. 14–2071 and 15–1250 (1st
Cir. June 16, 2015).
9 A company seeking to market a generic product
typically files an abbreviated new drug application
(ANDA). In that case, instead of providing
independent evidence of safety and effectiveness,
the applicant must demonstrate that its drug is
bioequivalent to its branded counterpart. In some
circumstances, a generic drug manufacturer may
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The proposed orders each include a
notice provision designed to assist in
monitoring the respondents’ future
conduct with respect to an agreement to
restrict the sale of an authorized generic
product—without regard to whether the
agreement extends beyond expiration of
any listed patent. Par is required to
notify the Commission and provide
certain specified information if it enters
certain agreements with a party that
markets a brand-name drug for which
Par has filed an application to sell a
generic equivalent. Covered agreements
are those that (1) limit the sale of an
authorized generic and (2) take effect
before the expiration of all Orange-Book
listed patents for the relevant brandname drug. A comparable provision in
the Concordia order requires Concordia
to provide such notice for agreements
with a party seeking FDA approval to
market a generic version of a brandname drug for which Concordia holds
the NDA. Both notice provisions
terminate ten years after issuance of the
orders.
These notice provisions differ from
the filing requirements contained in
Section 1112 of the Medicare
Prescription Drug, Improvement and
Modernization Act of 2003 (MMA). The
notice required by the orders must be
filed at least 30 days prior to the
effective date of the agreement; MMA
filings must be made within ten days
after execution of the agreement.
The proposed orders also require that
for five years Par and Concordia
maintain compliance programs with
certain prescribed features. Finally, the
proposed orders contain certain
reporting and other provisions that are
designed to assist the Commission in
monitoring compliance and are standard
provisions in Commission orders. The
proposed orders will expire in 20 years.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2015–21071 Filed 8–25–15; 8:45 am]
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need to submit reports of investigations of the safety
and effectiveness of its product in addition to
relying on existing data, under what is known as
a ‘‘505(b)(2)’’ application.
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GENERAL SERVICES
ADMINISTRATION
[Notice–MA–2015–04; Docket No. 2015–
0002; Sequence 22]
Federal Management Regulations;
Improved Management of
Undeliverable-as-Addressed Mail
Office of Government-Wide
Policy, General Services Administration
(GSA).
ACTION: Notice of a bulletin.
AGENCY:
The General Services
Administration has issued Federal
Management Regulation (FMR) Bulletin
G–05, which provides guidance to
Executive Branch agencies for
improving management of
undeliverable-as-addressed (UAA) mail.
The bulletin provides agencies with
information on the tools and best
practices associated with UAA mail.
The FMR Bulletin G–05 and all other
FMR bulletins are located at https://
www.gsa.gov/fmrbulletins.
DATES: Effective Date: August 26, 2015.
FOR FURTHER INFORMATION CONTACT: Ms.
Cynthia Patterson, Office of
Government-wide Policy (MAF), Office
of Asset and Transportation
Management, General Services
Administration, at 703–589–2641 or via
email at cynthia.patterson@gsa.gov.
Please cite FMR Bulletin G–05.
SUPPLEMENTARY INFORMATION: FMR
Bulletin G–05 consolidates information
regarding tools and best practices for
management of UAA mail from a
number of sources. Better management
of UAA mail reduces mailing costs and
associated personnel costs, improves
community outreach and relations,
supports sustainability efforts by
reducing printing, paper use, and energy
consumption, and is consistent with the
goals of Executive Orders 13589 and
13693, and the Federal Management
Regulation. The four suggestions
described in this bulletin are: (1)
Establish internal policies to obtain and
verify address correction, (2) prior to
mailing, use USPS® certified vendors’
address management tools, (3) actively
manage returned mail with barcodes
and scanning technology, and (4) track,
monitor, and report returned mail on an
annual basis to help the Federal
community avoid UAA mail.
SUMMARY:
Dated: August 7, 2015.
Christine Harada,
Associate Administrator, Office of
Government-wide Policy, General Services
Administration.
[FR Doc. 2015–21187 Filed 8–25–15; 8:45 am]
BILLING CODE 6820–14–P
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[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Notices]
[Page 51810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21187]
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GENERAL SERVICES ADMINISTRATION
[Notice-MA-2015-04; Docket No. 2015-0002; Sequence 22]
Federal Management Regulations; Improved Management of
Undeliverable-as-Addressed Mail
AGENCY: Office of Government-Wide Policy, General Services
Administration (GSA).
ACTION: Notice of a bulletin.
-----------------------------------------------------------------------
SUMMARY: The General Services Administration has issued Federal
Management Regulation (FMR) Bulletin G-05, which provides guidance to
Executive Branch agencies for improving management of undeliverable-as-
addressed (UAA) mail. The bulletin provides agencies with information
on the tools and best practices associated with UAA mail. The FMR
Bulletin G-05 and all other FMR bulletins are located at https://www.gsa.gov/fmrbulletins.
DATES: Effective Date: August 26, 2015.
FOR FURTHER INFORMATION CONTACT: Ms. Cynthia Patterson, Office of
Government-wide Policy (MAF), Office of Asset and Transportation
Management, General Services Administration, at 703-589-2641 or via
email at cynthia.patterson@gsa.gov. Please cite FMR Bulletin G-05.
SUPPLEMENTARY INFORMATION: FMR Bulletin G-05 consolidates information
regarding tools and best practices for management of UAA mail from a
number of sources. Better management of UAA mail reduces mailing costs
and associated personnel costs, improves community outreach and
relations, supports sustainability efforts by reducing printing, paper
use, and energy consumption, and is consistent with the goals of
Executive Orders 13589 and 13693, and the Federal Management
Regulation. The four suggestions described in this bulletin are: (1)
Establish internal policies to obtain and verify address correction,
(2) prior to mailing, use USPS[supreg] certified vendors' address
management tools, (3) actively manage returned mail with barcodes and
scanning technology, and (4) track, monitor, and report returned mail
on an annual basis to help the Federal community avoid UAA mail.
Dated: August 7, 2015.
Christine Harada,
Associate Administrator, Office of Government-wide Policy, General
Services Administration.
[FR Doc. 2015-21187 Filed 8-25-15; 8:45 am]
BILLING CODE 6820-14-P
