80 FR 51810 - Federal Management Regulations; Improved Management of Undeliverable-as-Addressed Mail
GENERAL SERVICES ADMINISTRATION Federal Register Volume 80, Issue 165 (August 26, 2015)
Federal Register Volume 80, Issue 165 (August 26, 2015)
| Page Range | 51810-51810 | |
| FR Document | 2015-21187 |
[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)] [Notices] [Page 51810] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21187] ======================================================================= ----------------------------------------------------------------------- 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 http://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 [email protected]. 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
![51810 Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices
version of a drug product for which Par The proposed orders each include a GENERAL SERVICES
is seeking FDA approval to sell a generic notice provision designed to assist in ADMINISTRATION
counterpart; and (2) the limitation monitoring the respondents’ future
extends beyond the expiration of any conduct with respect to an agreement to [Notice–MA–2015–04; Docket No. 2015–
Orange-Book listed patents for the drug restrict the sale of an authorized generic 0002; Sequence 22]
in question.6 product—without regard to whether the
In the Concordia order, Paragraph II Federal Management Regulations;
agreement extends beyond expiration of Improved Management of
requires Concordia to relinquish any any listed patent. Par is required to
and all rights to payment under the Undeliverable-as-Addressed Mail
notify the Commission and provide
License Agreement and to provide AGENCY: Office of Government-Wide
certain specified information if it enters
written notice to Par and the FTC of that Policy, General Services Administration
relinquishment. Paragraph III bars certain agreements with a party that
markets a brand-name drug for which (GSA).
Concordia from entering any agreement
Par has filed an application to sell a ACTION: Notice of a bulletin.
with a generic applicant for a reference-
listed drug for which Concordia holds generic equivalent. Covered agreements
SUMMARY: The General Services
the NDA, if the agreement (1) limits are those that (1) limit the sale of an
Administration has issued Federal
marketing of an authorized generic authorized generic and (2) take effect
Management Regulation (FMR) Bulletin
version of that drug and (2) the before the expiration of all Orange-Book
G–05, which provides guidance to
limitation extends beyond the listed patents for the relevant brand- Executive Branch agencies for
expiration of any Orange-Book listed name drug. A comparable provision in improving management of
patents for the drug in question. the Concordia order requires Concordia undeliverable-as-addressed (UAA) mail.
The proposed orders’ prohibitions on to provide such notice for agreements The bulletin provides agencies with
future agreements limiting an with a party seeking FDA approval to information on the tools and best
authorized generic cover only market a generic version of a brand- practices associated with UAA mail.
agreements in which the restraint name drug for which Concordia holds The FMR Bulletin G–05 and all other
extends beyond patent expiration. the NDA. Both notice provisions FMR bulletins are located at http://
Agreements to restrict the sale of an terminate ten years after issuance of the www.gsa.gov/fmrbulletins.
authorized generic sometimes appear in orders. DATES: Effective Date: August 26, 2015.
patent litigation settlements and can
serve as a means of compensating the These notice provisions differ from FOR FURTHER INFORMATION CONTACT: Ms.
generic patent challenger for agreeing to the filing requirements contained in Cynthia Patterson, Office of
stay off the market for a period of time.7 Section 1112 of the Medicare Government-wide Policy (MAF), Office
These arrangements can raise the same Prescription Drug, Improvement and of Asset and Transportation
antitrust concerns that the Supreme Modernization Act of 2003 (MMA). The Management, General Services
Court addressed in FTC v. Actavis, 133 notice required by the orders must be Administration, at 703–589–2641 or via
S. Ct. 2223 (2013).8 That is not this case, filed at least 30 days prior to the email at cynthia.patterson@gsa.gov.
however, and the proposed orders are effective date of the agreement; MMA Please cite FMR Bulletin G–05.
not designed to address that type of filings must be made within ten days SUPPLEMENTARY INFORMATION: FMR
conduct. As discussed above, the after execution of the agreement. Bulletin G–05 consolidates information
challenged agreement here did not arise The proposed orders also require that regarding tools and best practices for
out of pending or threatened patent for five years Par and Concordia management of UAA mail from a
litigation and nearly the entire five-year number of sources. Better management
maintain compliance programs with
term of the agreement covered the of UAA mail reduces mailing costs and
certain prescribed features. Finally, the
period after expiration of the Kapvay associated personnel costs, improves
proposed orders contain certain
patent. community outreach and relations,
For purposes of these proposed reporting and other provisions that are supports sustainability efforts by
orders, ‘‘authorized generic’’ means a designed to assist the Commission in reducing printing, paper use, and energy
drug product distributed by or on behalf monitoring compliance and are standard consumption, and is consistent with the
of an NDA holder, but marketed as a provisions in Commission orders. The goals of Executive Orders 13589 and
generic, regardless of whether it is proposed orders will expire in 20 years. 13693, and the Federal Management
manufactured pursuant to an NDA, an By direction of the Commission. Regulation. The four suggestions
ANDA, or a 505(b)(2) application.9 Donald S. Clark, described in this bulletin are: (1)
Secretary.
Establish internal policies to obtain and
6 This provision applies to actions taken on behalf
verify address correction, (2) prior to
of Par Pharmaceutical, Inc., and Par Pharmaceutical [FR Doc. 2015–21071 Filed 8–25–15; 8:45 am]
Holdings, Inc., but would not apply to conduct by
mailing, use USPS® certified vendors’
BILLING CODE 6750–01–P address management tools, (3) actively
Respondent TPG Partners VI, L.P. that is not taken
on behalf of the Par entities. manage returned mail with barcodes
7 See, e.g., Authorized Generic Study at 139–53.
and scanning technology, and (4) track,
8 See King Drug Co. of Florence Inc.v. Smithkline
monitor, and report returned mail on an
Beecham Corp., No. 14–1243 (3rd Cir. June 26,
2015). See also Brief of Federal Trade Commission
annual basis to help the Federal
as Amicus Curiae, American Sales Co.v. Warner- community avoid UAA mail.
rmajette on DSK7SPTVN1PROD with NOTICES
Chilcott Co., LLC, Nos. 14–2071 and 15–1250 (1st Dated: August 7, 2015.
Cir. June 16, 2015).
9 A company seeking to market a generic product Christine Harada,
typically files an abbreviated new drug application Associate Administrator, Office of
(ANDA). In that case, instead of providing Government-wide Policy, General Services
independent evidence of safety and effectiveness, need to submit reports of investigations of the safety
Administration.
the applicant must demonstrate that its drug is and effectiveness of its product in addition to
bioequivalent to its branded counterpart. In some relying on existing data, under what is known as [FR Doc. 2015–21187 Filed 8–25–15; 8:45 am]
circumstances, a generic drug manufacturer may a ‘‘505(b)(2)’’ application. BILLING CODE 6820–14–P
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Document Created: 2015-12-15 10:58:23
Document Modified: 2015-12-15 10:58:23
| 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. | |
| 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 [email protected] Please cite FMR Bulletin G-05. | |
| FR Citation | 80 FR 51810 |
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