[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Pages 38053-38055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0010]
Regulatory Systems Strengthening
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the Office of
International Programs. The goal of the Cooperative Agreement is to
strengthen global regulatory capacity through activities that may
include: Development of global norms and standards for product
regulation; generation and analysis of evidence of regulatory systems
performance; and provision of technical support to national regulatory
systems strengthening efforts.
DATES: Important dates are as follows:
1. The application due date is August 9, 2013.
2. The anticipated start date is September 10, 2013.
3. The opening date is July 10, 2013.
4. The expiration date is August 10, 2013.
ADDRESSES: Submit electronic applications to: http://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.
FOR FURTHER INFORMATION CONTACT: Charles Preston, Office of Science
Policy Analysis/Office of International Programs, HFG-1, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Silver Spring, MD
20993, 301-796-0654, [email protected]; or Daniel Lukash,
Office of Acquisitions and Grants Services, Food and Drug
Administration, 5630 Fishers Lane, Rm. 2028, Rockville, MD 20857, 301-
827-6771, [email protected].
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://www.fda.gov/InternationalPrograms/CapacityBuilding/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-13-024
93.103
[[Page 38054]]
A. Background
The World Health Organization (WHO) has responsibility for helping
to ensure access to essential medical products of assured safety,
quality, and efficacy within its 193 Member States. It does so in three
primary areas: (1) Setting global norms and standards; (2) articulating
evidence-based policy options, including those relating to regulatory
systems performance; and (3) providing technical support to national
regulatory authorities and governments. These activities help to
strengthen national regulatory systems. In this era of globalization,
products can be imported from anywhere in the world within increasingly
complex supply chains. As national and global health programs work to
scale up access to medicines and health products, strong national
regulatory systems are more important than ever before.
What are the necessary constituents of an effective medical
products regulatory system? This is an important question, and one
which the U.S. Institute of Medicine recently addressed, identifying
some core elements of a successful regulatory system. These include
sound government; good manufacturing, clinical, and laboratory
practices; staff development and professionalization; monitoring and
evaluation of product quality using laboratories; inspection and
surveillance of products throughout the supply chain; risk assessment,
analysis, and management; and emergency response. WHO helps to
strengthen medical products regulatory systems through activities that
include disseminating global quality norms and standards; facilitating
the exchange of regulatory information; assessing regulatory
authorities; providing training; distributing scientific materials and
information on aspects of regulation from regional and global
perspectives; expanding the global monitoring and surveillance system
for falsified and substandard products; supporting national
pharmacovigilance programs; and building capacity as a component of
WHO's prequalification programs.
Another important area of work on regulatory systems strengthening
is through a new Member State Mechanism (MSMech) on Substandard,
Spurious, Falsified, Falsely-labeled, and Counterfeit (SSFFC) medical
products, which was established as part of a resolution at the 65th
World Health Assembly in May 2012. The MSMech is designed to address
SSFFC issues and advance medical product safety and quality through the
strengthening of national regulatory capacities. The first meeting of
the MSMech occurred in Buenos Aires, Argentina, in November 2012, and
the representatives agreed to form a global steering committee with
representation from the WHO regions to support implementation of the
workplan; the creation and management of selected work groups to
address specific work areas; and the development of data-driven
approaches to SSFFC issues. Participants also stressed the need for
initiatives to educate consumers on the threats of SSFFC, for
methodologies and instruments to obtain more accurate information about
the nature and magnitude of the SSFFC problem, and for guidelines on
how to better respond to the detection of SSFFC medical products.
FDA has been actively engaged with WHO on a number of these fronts.
FDA experts participate in WHO drug and vaccine safety advisory
committees, which develop important international norms and standards
for the regulation of medical products. In addition, FDA has
implemented a number of Cooperative Agreements with WHO on medical
product safety and quality in recent years. In 2010, the Office of
International Programs (OIP)/FDA set up a Cooperative Agreement with
WHO to develop a global monitoring platform for SSFFC medical products.
A steering group of experts from relevant FDA Centers provides
guidance, direction, and advice regarding this cooperative effort. The
overarching priority is the exchange of information about and expertise
on matters relating to SSFFC so that data can be collected and
contribute to the formulation of policies and programs that combat the
problem. The system allows participating countries to report SSFFC
information using a simple, electronic rapid alert form. Once the
information has been submitted, WHO can take the appropriate first-
response measures to circulate such information to governments, WHO
regional offices, and other stakeholders as necessary. Analyses, threat
assessments, thematic reporting, and bulletins based on the reported
data may also be completed and shared.
B. Research Objectives
The Cooperative Agreement announced in this FOA represents the
further expansion of well-established collaborations between WHO and
OIP/FDA in support of data-driven and science-based public health
strategies and approaches. These collaborations align well with FDA
domestic and global goals, as outlined in its 2011 Pathway Report to
Global Product Safety and Quality, including addressing medical product
safety and quality problems. Relevant strategies include: (1)
Developing global norms and standards; (2) generating and analyzing
evidence on regulatory systems performance; and (3) providing technical
support to national regulatory systems strengthening efforts. This
Cooperative Agreement is expected to support the following types of
collaboration:
Developing global norms and standards
Enabling the sharing of scientific findings and data
through expert meetings and technical consultations;
Assisting Member States in the implementation and
subsequent evaluation of internationally recognized standards and
guidelines, e.g. WHO guidelines and standards and those emerging from
standards development venues such as the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH);
Utilizing WHO's convening power to engage with relevant
stakeholders on science-based norms and standards;
Generating and analyzing evidence of regulatory systems
performance
Contributing to the knowledge base of the current state of
medical product regulation globally, including challenges, risks, and
emerging trends;
Enabling and/or further strengthening the development of
data/information systems as sources of inputs for evidence-based
regulatory decisions and actions and enhanced knowledge management
systems, coalitions, and networks;
Providing technical support to national regulatory systems
strengthening efforts
Enabling the strengthening of regulatory systems at the
national and international levels in such critical domains as good
manufacturing, clinical, and laboratory practices; developing curricula
that supports regulatory professionalization; monitoring and evaluating
product quality; laboratory capacity; inspection and surveillance of
products throughout the supply chain; pharmacovigilance systems
building and analyses; risk assessment, analysis, and
[[Page 38055]]
management; and making the business case for investments in regulatory
systems.
C. Eligibility Information
This is a Single Source Cooperative Agreement.
II. Award Information/Funds Available
A. Award Amount
An award of up to $1,500,000 for this cooperative agreement will be
available the first year (fiscal year (FY) 2013) based on available
appropriations. Funding for subsequent years for this 5-year award will
be contingent on the availability of appropriations and successful
performance in the award not to exceed $1,500,000 per year.
B. Length of Support
The initial period of performance is 1 year. Contingent upon
successful performance, additional awards may be available in FYs 2014,
2015, 2016, and 2017.
III. Electronic Application, Registration, and Submission
Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at http://www.fda.gov/InternationalPrograms/CapacityBuilding/default.htm. (FDA has verified
the Web site addresses throughout this document, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.) For all electronically
submitted applications, the following steps are required.
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With System for Award Management (SAM)
Step 3: Obtain Username & Password
Step 4: Obtain Authorized Organization Representative (AOR)
Authorization
Step 5: Track AOR Status
Step 6: Register With Electronic Research Administration (eRA)
Commons
Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov.
Dated: June 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15101 Filed 6-24-13; 8:45 am]
BILLING CODE 4160-01-P