[Federal Register Volume 79, Number 130 (Tuesday, July 8, 2014)]
[Notices]
[Pages 38538-38539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15870]



[[Page 38538]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0012]


Fostering Cooperation and Strengthening Medical Product 
Regulatory Systems in the Americas

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Office of 
International Programs (OIP) is announcing the availability of grant 
funds for the support of a single source cooperative agreement to the 
Pan American Health Organization (PAHO) for fostering cooperation and 
strengthening medical product regulatory systems in the Americas. The 
goal of the cooperative agreement is to build upon existing cooperation 
between OIP/FDA and PAHO to foster regulatory collaboration and 
strengthen regulatory capacity throughout the Americas.

DATES: Important dates are as follows:
    1. The application due date is August 1, 2014.
    2. The anticipated start date is October 1, 2014.
    3. The expiration date is August 2, 2014.

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 M. Preston, Office of 
Strategy, Partnerships and Analytics, Office of International Programs, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 
3309, Silver Spring, MD 20993, 301-796-0654; or Kimberly Pendleton-
Chew, Food and Drug Administration, Division of Acquisitions and Grants 
(HFA 500), 5630 Fishers Lane, Rm. 2031, Rockville, MD 20857, 240-402-
7610.
    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-13-039

93.103

A. Background

    PAHO is the Regional Office for the Americas of the World Health 
Organization (WHO). 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 and 
regional regulatory authorities and governments. These activities help 
to strengthen regulatory systems which, in this era of globalization, 
where the supply chain of medicines has become a global network, and as 
national, regional, and global health programs work to scale up access 
to medicines and health products, strong regulatory systems, are 
imperative.
    The necessary constituents of a medical products regulatory system 
have been defined by PAHO and WHO. They include regulatory frameworks, 
marketing authorization, import/export control and postmarket 
surveillance, licensing of manufacturers, inspections, laboratories, 
pharmacovigilance, clinical trials, and vaccine lot release. 
Specifically, PAHO helps to strengthen medical products regulatory 
systems through activities that include disseminating quality norms and 
standards, facilitating the exchange of regulatory information, 
evaluating regulatory authorities, providing training and technical 
assistance, distributing scientific materials and information on 
aspects of regulation, strengthening regional monitoring and 
surveillance for falsified and substandard products (including 
supporting national pharmacovigilance programs), and building capacity 
as a component of WHO's prequalification programs.
    In recent years, OIP/FDA has been actively engaged with PAHO on a 
number of areas related to regulatory systems strengthening. OIP/FDA 
and PAHO are currently involved in a 4-year cooperative agreement which 
began in September 2010 that promotes medical product regulatory system 
strengthening in the Americas. The centerpiece of the agreement is the 
development of the Regional Platform for Access and Innovation of 
Health Technologies (PRAIS), an electronic platform for regulatory 
exchange. The site was launched by PAHO in 2012 and the cooperative 
agreement is managed by OIP, with additional strategic and technical 
guidance provided by a steering group of FDA Center subject matter 
experts. PRAIS includes features such as communities of practice, where 
regulators can share information and engage in real-time dialogue 
around regulatory issues, and an ``observatory'', where information on 
the basic structures and functions of participating regulatory 
authorities is housed.
    PAHO envisions PRAIS to be a cornerstone of its regulatory system 
strengthening activities in the Americas. Beyond the immediate 
functionalities, PRAIS is also being used to prioritize and coordinate 
activities related to the Pan American Network for Drug Regulatory 
Harmonization. In addition, PRAIS is being used to develop regional 
models for regulatory systems; for example, data from the observatory 
have been used in research to assess strengths and weaknesses of 
regulatory systems in the Caribbean towards a regional system. Another 
initiative related to PRAIS is a secure platform for sharing non-public 
information, called PRAISsec, and FDA has been engaged in its 
governance and assessing agency needs and requirements. At this time, 
the platform is not yet built and no non-public information has been 
shared. A next phase of development for PRAIS may include global scale-
up, which will enhance the platform's utility to other parts of the 
world that are in critical need of regulatory information exchange and 
capacity building tools.
    OIP/FDA entered a similar cooperative agreement on regulatory 
systems strengthening with WHO in fiscal year (FY) 2014. Activities 
include work that WHO is undertaking at the global level, including 
advancement of a member state mechanism on substandard, spurious, 
falsified, falsely-labeled, and counterfeit medical products (SSFFC), 
enhancement of another FDA-supported cooperative agreement to develop a 
global monitoring system for SSFFC medical products, and specific work 
to improve regulation of active pharmaceutical ingredients among 
regulators in WHO's member states.

B. Research Objectives

    The cooperative agreement announced in this FOA represents the 
further expansion of well-established collaborations between OIP/FDA 
and PAHO in support of data-driven and science-based public health 
strategies and approaches. The objective is to build upon existing 
cooperation to foster regulatory collaboration and

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strengthen regulatory capacity throughout the Americas in ways that 
provide benefit and contribution to the FDA regulatory and public 
health mission. This partnership aligns with FDA's domestic and global 
goals of addressing medical product safety and quality challenges.
    This cooperative agreement will support collaboration and 
investigation in the following areas:
1. Developing and Applying Regional/Global Norms and Standards
     Enable the sharing of scientific findings and data through 
expert meetings and technical consultations;
     assist 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);
     utilize PAHO's convening power to engage with relevant 
stakeholders on science-based norms and standards; and
     facilitate the alignment and convergence of standards 
between PAHO, other regions, and/or global bodies.
2. Researching Regulatory Systems Performance
     Contribute to the knowledge base of the current state of 
medical product regulation globally, including challenges, risks, and 
emerging trends, and making the business case for investments in 
regulatory systems; and
     enable and/or further strengthen 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.
3. Providing Technical Support to Regulatory Systems Strengthening 
Efforts and Expand Awareness of the Role of Regulatory Systems in the 
Broader Global Health Development Framework
     Enable the strengthening of regulatory systems at the 
regional and global levels in such critical domains as: Regulatory 
frameworks; marketing authorization; import/export control and 
postmarket surveillance; inspections; laboratories; pharmacovigilance; 
clinical trials and vaccine lot release; staff development and 
training, including the professionalization of the regulatory 
workforce; monitoring and evaluation of product quality; inspection and 
surveillance of products throughout the supply chain; and risk 
assessment, analysis, and management; and
     contribute strategies to expand the knowledge and 
awareness of the essential role of regulatory systems within the 
broader global health and development frameworks, including ways that 
can leverage existing initiatives, investments and partnerships or 
catalyze new ones.

C. Eligibility Information

    This is a single source cooperative agreement. PAHO is eligible to 
apply for this award. PAHO is the Regional Office for the Americas of 
WHO. 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 and regional regulatory 
authorities and governments. In recent years, OIP/FDA has been actively 
engaged with PAHO on a number of areas related to regulatory systems 
strengthening. OIP/FDA and PAHO are currently involved in a 4-year 
cooperative agreement which began in September 2010 that promotes 
medical product regulatory system strengthening in the Americas.

II. Award Information/Funds Available

A. Award Amount

    This award is contingent upon FDA appropriations and meritorious 
application. FDA/OIP can fund one award in the amount up to $2 million 
for FY 2015 based on available appropriations.

B. Length of Support

    The total project period may not exceed 5 years. Funding in future 
years will be contingent on the availability of appropriations and 
successful performance in the award not to exceed $2 million per year.

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 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: 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: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15870 Filed 7-7-14; 8:45 am]
BILLING CODE 4164-01-P