Document ID: FDA-2010-N-0495-0001
Agency: fda
Document Type: Notice
Title: Cooperative Agreement With Pan American Health Organization for Development of an Information Hub for Medical Products and Related Regulatory Processes and Systems in Americas Region
Posted Date: 2010-10-05T04:00Z

[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Notices]               
[Page 61502-61503]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc10-112]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0495]

 
Cooperative Agreement With the Pan American Health Organization 
for the Development of an Information Hub for Medical Products and 
Related Regulatory Processes and Systems in the Americas Region

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) announces its intention 
to accept and consider a single source application to award a 
cooperative agreement to the Pan American Health Organization (PAHO) 
for the development of an information hub in the areas of medical 
products and related regulatory processes and systems (e.g., including 
drugs, biologics, vaccines, medical devices, and other medical products 
as appropriate) in the region of the Americas.

FOR FURTHER INFORMATION CONTACT:
    Management Contact: Katherine C. Bond, Office of International 
Programs, Office of the Commissioner, Food and Drug Administration, 
White Oak Bldg. 32, rm. 3300, 10903 New Hampshire Ave., Silver Spring, 
MD 20993, 301-796-8318, FAX: 301-595-5058, email: 
Katherine.Bond@fda.hhs.gov.
    Grants Contact: Kimberly Pendleton, Division of Acquisition and 
Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm. 
2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, email: 
kimberly.pendleton@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please contact Kimberly Pendleton.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-10-009
Catalog of Federal Domestic Assistance Number(s): 93.103 https://
www.cfda.gov

A. Background

    FDA announces its intention to accept and consider a single source 
application to award a cooperative agreement to the PAHO for the 
development of an information hub in the areas of medical products and 
related regulatory processes and systems (e.g., including drugs, 
biologics, vaccines, medical devices, and other medical products as 
appropriate) in the region of the Americas.

B. Research Objectives

     The development of an online database (e.g., Web-based) in 
English and Spanish for a series of countries providing:
    [cir] Overview of the regulated sector including description and 
specific data relating to the medical products and related regulatory 
processes and systems market;
    [cir] Structural overview of the national regulatory process(es) 
including information relating to national entities participating in 
the regulatory process;
    [cir] Data presented by specific regulatory areas (for example, 
biologics, vaccines, drugs, medical devices) on processes relating to 
product registration, licensing (manufacturer, wholesaler and pharmacy/
vendor), quality control assessment and postmarketing surveillance;
    [cir] Data presented on other regulatory areas such as clinical 
trials and supply chains;
    [cir] Key regulations governing the areas of medical products and 
related regulatory processes and systems (e.g., including drugs, 
biologics, vaccines, medical devices, and other medical products as 
appropriate) per country and/or links to sources where such information 
is available.
    [cir] Data collected and presented in such a way that ensures 
consistency of terminology, consistency in data collection methods, and 
robustness, comprehensiveness, and comparability of data.
     The establishment of information exchange mechanisms with 
the active participation of national regulatory agencies (NRAs) in the 
region of the Americas that facilitates the process by which the 
information hub and database is populated with information that is 
reviewed and maintained in an up-to-date and continual basis.
    [cir] A detailed mechanism to maintain and update the hub 
information is developed detailing the responsibilities of PAHO and its 
Members States in keeping the data and information contained therein 
relevant, up-to-date, and comprehensive to encompass the future growth 
and complexity in the areas of medical products and related regulatory 
processes and systems.
     As appropriate, PAHO would work to align or link the 
information hub with other ongoing global initiatives of the World 
Health Organization (WHO) or its regional offices in regulatory aspects 
relating to medical products and related regulatory processes and 
systems.
     As appropriate, PAHO would work to enable effective 
linkage(s) of the information hub with other ongoing initiatives in 
regulatory aspects relating to medical products and related regulatory 
processes and systems including harmonization efforts, such as the Pan 
American Network for Drug Regulatory Harmonization (PANDRH), the ICH 
Global Cooperation Group; the Global Health Task Force on Health 
Technologies; the Asia-Pacific Economic Cooperation (APEC) 
harmonization efforts, and other relevant efforts and initiatives as 
appropriate.
     The utilization of the data and information contained 
within the information hub by NRAs to enable harmonized approaches, 
standards and guidelines for regulatory systems. It will support 
evidence-based decisionmaking by NRAs and regulated industry sectors, 
facilitate the exchange of timely and accurate data, and promote 
transparency of regulated approaches and efforts.

[[Page 61503]]

     As appropriate, explore with the WHO, the possibility of 
expanding this information hub to other WHO Regions.

C. Eligibility Information

    The following organizations/institutions are eligible to apply: the 
PAHO.

II. Award Information/Funds Available

A. Award Amount

    FDA anticipates providing one award of $904,000 (total costs 
including indirect costs) in FY 2010 in support of this project.

B. Length of Support

    The support will be 1 year with the possibility of an additional 3 
years of noncompetitive support. Continuation beyond the first year 
will be based on satisfactory performance during the preceding year, 
receipt of a non-competing continuation application and available 
Federal FY appropriations.

    Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24906 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S