[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Pages 32364-32366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13885]



Food and Drug Administration

[Docket No. FDA-2011-N-0375]

Collaboration in Regulatory Science and Capacity To Advance 
Global Access to Safe Vaccines and Biologicals

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 for award of a 
cooperative agreement to the World Health Organization (WHO) in support 
of collaboration in regulatory science and capacity of National 
Regulatory Authorities (NRAs) to advance global access to safe and 
effective vaccines and other biologicals that meet international 
standards. The goal of FDA's Center for Biologics Evaluation and 
Research (FDA/CBER) is to enhance technical collaboration and 
cooperation between FDA, WHO, and its Member States.

DATES: Important dates are as follows:
    1. The application due date is July 8, 2011.
    2. The anticipated start date is August 15, 2011.

[[Page 32365]]

    3. The expiration date is July 9, 2011.


Gopa Raychaudhuri, Center for Biologics and Evaluation and Research, 
Liaison to the World Health Organization, Food and Drug Administration, 
1401 Rockville Pike (HFM-30), suite 200N, Rockville, MD 20852, 301-827-
6352, [email protected];
Leslie Haynes, Foreign Regulatory Capacity Building Coordinator, 
International Affairs, Food and Drug Administration, 1401 Rockville 
Pike (HFM-30), suite 200N, Rockville, MD 20852, 301-827-3114, 
[email protected]; or
Vieda Hubbard, Grants Management Specialist, Office of Acquisitions and 
Grants Services, Food and Drug Administration, 5630 Fishers Lane (HFA 
500), rm. 2141, Rockville, MD 20857, 301-827-7177, 
[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.grants.gov and/or http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm251665.htm.


I. Funding Opportunity Description


A. Background

    The U.S. Department of Health and Human Services (HHS) has invested 
significantly in developing sustainable global influenza vaccines 
production capacity. These financial and intellectual investments in 
vaccine development and manufacture should not be made in a regulatory 
vacuum. Adequate regulatory oversight is essential in assuring the 
safety, efficacy and quality of vaccines.
    WHO is the directing and coordinating authority for health within 
the United Nations (U.N.) system. It is responsible for providing 
leadership on global health matters, shaping the health research 
agenda, setting norms and standards, articulating evidence-based policy 
options, providing technical support to countries, and monitoring and 
assessing health trends. It is the only organization with the mandate, 
technical expertise, and broad reach to meet the stated objectives.
    WHO plays a key role in establishing the WHO International 
Biological Reference Preparations and in developing WHO guidelines and 
recommendations on the production and control of influenza and other 
vaccines, biological products and technologies. These norms and 
standards are based on wide scientific consultation and on 
international consensus and are intended to ensure the consistent 
quality and safety of biological medicines and related in vitro 
diagnostic tests worldwide. Advancement of these efforts requires close 
collaboration with the international scientific and professional 
communities, regional and national regulatory authorities, 
manufacturers, and expert laboratories worldwide.
    FDA/CBER has worked with WHO in the global community to improve 
human public health worldwide for many years. A core principle of FDA/
CBER's international engagements to protect global public health is the 
fact that efforts to address infectious disease threats anywhere in the 
world translates to protection of the U.S. population which benefits 
U.S. public health overall. Indeed, in 2011, improving global public 
health through international collaboration, including promoting 
research and information sharing, is one of FDA/CBER's six primary 
strategic goals. FDA generally, and more specifically FDA/CBER, has 
long-standing productive collaborations with WHO in the area of 
vaccines and other biologics.
    FDA/CBER is a Pan American Health Organization (PAHO)/WHO 
Collaborating Center for Biological Standardization. In this capacity, 
FDA/CBER contributes significantly through participation as expert 
consultants, as members of advisory and other expert committees, in 
laboratory collaborations for establishing physical standards, and 
other activities. An important additional area of work is FDA/CBER's 
engagement with the WHO Vaccine Prequalification Program. The WHO 
provides advice to the United Nations Children's Fund (UNICEF) and 
other United Nations (U.N.) Agencies on the acceptability of vaccines 
considered for purchase by such Agencies for vaccination programs which 
they administer globally. In 2009, FDA/CBER was assessed by WHO and 
recognized as a functional national regulatory authority (NRA). FDA 
entered into a confidentiality arrangement with WHO/QSS to enable FDA/
CBER to serve as a reference NRA for the Vaccine Prequalification 
Program, and FDA/CBER is currently a reference NRA for eight U.S. 
licensed vaccines including five influenza vaccines.
    The establishment of strong regulatory systems is very important 
for FDA's ability to fulfill its mission to better monitor and ensure 
the safety of the supply chain for food, feed, medical products, and 
cosmetics that enter the United States from other parts of the world. 
Strengthening regulatory capacity in the developing world is equally 
important for improving the health and quality of life of individuals 
and communities in those countries. Strong regulatory systems reinforce 
and secure public and private investments in development and 
manufacture of new drugs and vaccines, as well as agriculture and food 
production--all of which are vulnerable in the absence of functional 
regulatory frameworks.
    FDA, with other U.S. Government Agencies at HHS, WHO, and other 
regulatory counterparts, are working to strategize on approaches to 
enhance the regulatory capabilities of NRAs in developing countries so 
that they can meet the needs for providing oversight of vaccines 
manufactured in their countries, specifically influenza vaccines. 
Sustainable vaccine production capacity cannot be achieved in the 
absence of robust and functional national regulatory systems. Thus, 
investments for improving manufacturing facilities must be accompanied 
in parallel with strengthening regulatory oversight for the 
manufactured products. Additionally, NRAs are encouraged to build 
relationships with the policymakers to gain support so that 
advancements in regulatory capabilities in these countries can be 
sustained. The aim is to bolster resources for regulatory oversight, 
thus maximizing the returns on total investments with the production 
and availability of high quality, effective influenza vaccines that can 
be deployed worldwide quickly and equitably in future pandemics. In 
doing so, it is anticipated that strengthening regulatory capacity will 
benefit the broader arena of access to, and supply of, vaccines 

B. Research Objectives

    The project has the following goals:
     Contribute to the knowledge base of the current state of 
regulatory oversight of influenza and other vaccines and biologicals by 
supporting analysis, synthesis, and application of assessments of 
associated regulatory frameworks and processes in select countries/
regions. For example, this could include but is not limited to, 
analyses and synthesis of existing data from assessments of vaccine 
regulatory capabilities of different NRAs, and new applications of 
assessment frameworks to specific areas, such as pharmacovigilance 
(e.g., following vaccination with seasonal or pandemic influenza 
vaccines). Expected outputs

[[Page 32366]]

could include analyses, reports and data-driven strategy papers, among 
     Enable the timely and effective sharing of scientific 
findings and data, e.g., on safety and effectiveness of adjuvanted 
influenza and other vaccines and other emerging technologies in support 
of developing WHO guidance where appropriate, the utility of new 
technologies for assessment of product safety, among other areas.
     Support the sharing and application of knowledge, data, 
and information through active participation in regional and global 
networks, such as the African Vaccine Regulatory Forum (AVAREF) and the 
Developing Countries' Vaccine Regulators Network (DCVRN).

C. Eligibility Information

    The following organizations/institutions are eligible to apply: The 
World Health Organization.

II. Award Information/Funds Available

A. Award Amount

    FDA/CBER anticipates providing in Fiscal Year (FY) 2011 up to 
$800,000 (total costs including indirect costs for one award subject to 
availability of funds) in support of this project. With the possibility 
of four additional years of support up to $2,000,000 of funding 
contingent upon successful performance and the availability of funding.

B. Length of Support

    The support will be 1 year with the possibility of an additional 4 
years of noncompetitive support. Continuation beyond the first year 
will be based on satisfactory performance during the preceding year, 
receipt of a noncompeting continuation application and available 
Federal FY appropriations.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants 
should first review the full announcement located at http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm251665.htm and/or 
http://www.grants.gov. (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.) Persons interested in applying for a grant may obtain an 
application at http://grants.nih.gov/grants/funding/phs398/phs398.html. 
For all paper application submissions, the following steps are 
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register With Central Contractor Registration.
     Step 3: Register With Electronic Research Administration 
(eRA) Commons.
    Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be 
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, 
submit paper applications to: Vieda Hubbard, Grants Management, 5630 
Fishers Lane (HFA-500), rm. 1079, Rockville, MD 20857 and Leslie 
Haynes, Center for Biologics Evaluation and Research, Office of the 
Director, 1401 Rockville Pike (HFM-30), suite 200N, Rockville, Maryland 

    Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13885 Filed 6-3-11; 8:45 am]