Document ID: FDA-2013-N-0010-0004
Agency: fda
Document Type: Notice
Title: Regulatory Systems Strengthening
Posted Date: 2013-06-25T04:00Z

[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Pages 38053-38055]
From the Federal Register Online via the Government Printing 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, charles.preston@fda.hhs.gov; or Daniel Lukash, 
Office of Acquisitions and Grants Services, Food and Drug 
Administration, 5630 Fishers Lane, Rm. 2028, Rockville, MD 20857, 301-
827-6771, Daniel.Lukash@fda.hhs.gov.
    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