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Federal Register
Vol. 75, No. 192
Tuesday, October 5, 2010
Animal and Plant Health Inspection Service
Notice of Availability of Biotechnology Quality Management System Audit Standard and
Evaluation of Comments
ACTION: Notice
[TEXT] [PDF]
SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service has
developed an audit standard for its biotechnology compliance assistance program. The audit standard,
which was made available in draft form for comment in an earlier notice, will be used by participating
regulated entities to develop and implement sound management practices, thus enhancing compliance
with the regulatory requirements for field trials and movement of genetically engineered organisms in 7
CFR part 340. We are also making available a document containing our evaluation of the comments we
received on the draft audit standard.
Background
The Animal and Plant Health Inspection Service (APHIS) regulates the introduction--the importation,
interstate movement, and environmental release--of genetically engineered (GE) organisms that are, or
may be, plant pests. In September 2007, APHIS' Biotechnology Regulatory Services announced it was
developing a voluntary, audit-based compliance assistance program known as the Biotechnology
Quality Management System Program (BQMS Program) to assist regulated entities in achieving and
maintaining compliance with the regulatory requirements for field trials and movements of GE
organisms in 7 CFR part 340.
--------------------------------------------------------------------------\1\ All notices mentioned in this docket, as well as comments received and supporting and related
materials, can be viewed at
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0098.
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Food and Drug Administration
Cooperative Agreement To Support Capacity Building Activities Through the World Health
Organization Global Foodborne Infections Network ,
ACTION: Notice
[TEXT] [PDF]
SUMMARY: The Food and Drug Administration (FDA) is announcing its intention to accept and
consider a single source application to award a cooperative agreement to the World Health Organization
(WHO) Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) and in
support of the WHO Global Foodborne Infections Network (GFN) and to provide guidance to the WHO
on a framework for the development of an international network to promote and enhance collaboration
on harmonization and data sharing among countries with Antimicrobial Resistance (AMR) surveillance
programs.
Cooperative Agreement With the World Health Organization for a Plan to Develop a Global
Integrated Food Safety Information Platform ,
ACTION: Notice
[TEXT] [PDF]
SUMMARY: The Food and Drug Administration (FDA) announces its intention to accept and consider
a single source application for awarding a cooperative agreement to the World Health Organization
(WHO), Department of Food Safety and Zoonoses, to develop a plan for a global integrated food safety
information system or platform in partnership with the WHO Secretariat and the Member States.
Global Implementation of the Veterinary Medicinal Products Guidelines
ACTION: Notice
[TEXT] [PDF]
SUMMARY: The Food and Drug Administration (FDA) announces its intention to accept and consider
a single source application for a cooperative agreement to the World Organization for Animal Health
(OIE). The OIE is the intergovernmental organization responsible for improving animal health
worldwide and is recognized by the World Trade Organization (WTO) as a reference for international
sanitary rules, with 175 Member Countries and Territories. The purpose of this agreement is to continue
outreach that began in fiscal year (FY) 2009 to expand capacity building to support OIE's services and
activities that are needed to carry out OIE's Veterinary International Conference on Harmonization
(VICH) Global Outreach to disseminate and implement VICH guidelines at the country level.
National Oceanic and Atmospheric Administration
Availability of Seats for the Monterey Bay National Marine Sanctuary Advisory Council
ACTION: Notice and request for applications
[TEXT] [PDF]
SUMMARY: The ONMS is seeking applications for the following vacant seats on the Monterey Bay
National Marine Sanctuary Advisory Council: At-Large (1), Education, Diving, and Tourism.
Applicants are chosen based upon their particular expertise and experience in relation to the seat for
which they are applying; community and professional affiliations; philosophy regarding the protection
and management of marine resources; and possibly the length of residence in the area affected by the
sanctuary. Applicants who are chosen should expect to serve until February 2014.
DATES: Applications are due by November 12, 2010.