81 FR 34349 - Collaboration in Regulatory Systems Strengthening and Standardization Activities To Increase Access to Safe and Effective Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

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 systems strengthening, development of norms and standards, and innovative research to advance global access to safe and effective biological products 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 the FDA, WHO, and its member states to facilitate strengthening regulatory capacity and support product development and standardization activities to increase access to safe and effective biologicals globally.

[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34349-34351]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12685]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1269]


Collaboration in Regulatory Systems Strengthening and 
Standardization Activities To Increase Access to Safe and Effective 
Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 systems strengthening, development of 
norms and standards, and innovative research to advance global access 
to safe and effective biological products 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 the FDA, WHO, and its member states to facilitate 
strengthening regulatory capacity and support product development and 
standardization activities to increase access to safe and effective 
biologicals globally.

DATES: The application due date is July 5, 2016.

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: Gopa Raychaudhuri, CBER Liaison to 
WHO, Office of the Director, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7250, Silver Spring, MD 20993, 240-402-
8000, [email protected]; or Leslie Haynes, Foreign 
Regulatory Capacity Building Coordinator, International Affairs, Office 
of the Director, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 71, Rm. 7222, Silver Spring, MD 20993, 240-402-8074, 
[email protected]; or Bryce Jones, Grants Management 
Specialist, Division of Acquisition and Grants, Office of Acquisitions 
and Grants Services, Food and Drug Administration, 5630 Fishers Lane, 
Rm. 2026, Rockville, MD 20857, 240-402-2111, [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. Search by Funding Opportunity Number: 
RFA-FD-16-044.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

RFA-FD-16-044
93.103

A. Background

    WHO is the directing and coordinating authority on international 
health within the United Nations' (UN) 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. WHO assists countries in 
building capacity to increase and sustain access to medical products to 
prevent, detect, and treat communicable diseases, including reducing 
vaccine-preventable diseases. WHO also coordinates efforts to respond 
to public health emergencies by monitoring the health situation, 
undertaking risk assessments, identifying priorities, and providing 
technical guidance and other forms of support to countries and regions.
    Providing adequate regulatory oversight throughout the product life 
cycle (pre- and post-licensure) is essential for assuring the safety, 
purity, and potency of vaccines and other biologicals. However, this is 
a major challenge for many National Regulatory Authorities (NRAs) 
confronted by a steadily increasing number of novel products, complex 
quality concerns, new regulatory issues arising from rapid technical 
and technological advances, and emerging infectious diseases (e.g., 
pandemic influenza, Middle East Respiratory Syndrome, Ebola, Zika). WHO 
has an important role in strengthening regulatory systems and other 
supportive activities to increase access to high quality, safe, and 
effective biological products especially in low-and-middle-income 
countries. It is the only organization with the mandate, access to 
technical expertise, and broad reach to meet the research objectives.
    FDA/CBER has been a leader and active participant in the global 
community to improve human health in the world's populations over many 
years. Its international engagements have been informed by the 
knowledge that protection of global public health against infectious 
disease threats translates into protection of public health in the 
United States. FDA, through CBER, has longstanding collaborations with 
WHO in the area of biologicals (vaccines, blood and blood products, 
relevant in vitro diagnostics, and cell and tissue therapies).
    FDA/CBER has been a Pan American Health Organization/WHO 
Collaborating Center for Biological Standardization since 1998 with the 
current commitment running until 2020 and expectation of future 
extensions. As a WHO Collaborating Center for Biological 
Standardization, CBER has provided scientific and technical support to 
WHO for development of

[[Page 34350]]

international standards, strengthening regulatory systems, advancing 
product safety and vigilance, vaccine prequalification, and research 
activities to advance development and improve standardization of 
vaccines and other biologicals. These areas of collaboration reflect 
FDA/CBER's longstanding commitment to increasing global access of high 
quality, safe and effective biological products that meet international 
standards.
1. Development of Norms and Standards
    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 vaccines and other 
biological products and technologies. The WHO Expert Committee on 
Biological Standardization (ECBS) is commissioned by WHO to advise the 
Organization on international standards setting activities. 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 products and related in vitro 
diagnostic tests worldwide.
    Blood products are inherently variable due to the nature of the 
source materials as well as the methods used to test them. The 
objective is to ensure that only blood products of acceptable quality, 
safety, and efficacy are used in the patient population. Similarly, 
ensuring the quality, safety, and effectiveness of vaccines is one of 
WHO's highest priorities. The WHO works in close collaboration with the 
international scientific and professional communities, regional and 
national regulatory authorities, manufacturers, and expert laboratories 
worldwide to ensure that global standards are developed and made 
readily available to assess the quality, safety, and effectiveness of 
biological products, and to support monitoring safety throughout the 
product life cycle.
2. Regulatory Systems Strengthening
    NRAs play a vital role in the national health care system. 
Providing regulatory oversight throughout the product life cycle (pre- 
and post-licensure) is a major challenge for many NRAs confronted by a 
steadily increasing number of novel products, complex quality concerns, 
new regulatory issues arising from rapid technical and technological 
advances, and emerging infectious diseases (e.g., pandemic influenza, 
MERS, Ebola, Zika). WHO has an important role in strengthening 
regulatory systems to increase access to high quality, safe, and 
effective biological products especially in low-and-middle-income 
countries. In this era of globalization, establishment of robust 
regulatory systems in other regions of the world also benefits the U.S. 
population as it facilitates FDA's ability to better monitor and ensure 
the safety of the supply chain for medical and other products entering 
the United States from other countries.
3. WHO Prequalification Program
    The WHO prequalification program was established in response to the 
need to supply quality health products, including vaccines and in vitro 
diagnostic tests for the prevention, diagnosis, and treatment of 
priority diseases in low-and-middle-income countries. Through the 
prequalification program, WHO assures the quality, safety, and 
effectiveness/performance of these products, and suitability for use in 
the target settings.
    As part of the vaccine prequalification program, WHO provides 
advice to the United Nations Children's Fund (UNICEF) and other UN 
agencies on the acceptability, in principle, of vaccines considered for 
purchase by such agencies for vaccination programs they administer. An 
important part of the vaccine prequalification program is WHO's 
reliance upon a stringent NRA to provide regulatory oversight of the 
vaccine throughout the product's life cycle. In 2009, FDA entered into 
a confidentiality arrangement with WHO to enable FDA/CBER to serve as a 
NRA of record in the vaccine prequalification program and currently 
serves in this capacity for nine U.S. licensed, WHO prequalified 
vaccines.
4. Product Safety and Vigilance
    The safety of medical products depends on a variety of factors that 
range from good manufacturing practices to strong national systems able 
to monitor the products in domestic markets. However, with increasing 
globalization of trade, overall effective surveillance of medical 
products depends on international regulatory cooperation and 
information sharing. WHO promotes the global safety of medical products 
by coordinating global networks for information sharing, such as data 
bases and monitoring and alert systems, and by supporting countries to 
develop national capacities for the post-marketing surveillance of 
biological products.
    WHO and partners have developed a strategic framework (``Global 
Vaccine Safety Blueprint'') to promote the establishment of effective 
vaccine pharmacovigilance systems globally. The Blueprint proposes a 
strategic plan for strengthening vaccine safety activities worldwide, 
focusing on building national capacity for vaccine safety in the 
world's poorest countries through the coordinated efforts of major 
stakeholders.
    WHO advisory bodies also play a significant role in reviewing and 
assessing product safety data and making recommendations to WHO 
regarding use of vaccines and other biological products. For example, 
the Global Advisory Committee on Vaccine Safety (GACVS) provides 
independent, authoritative, scientific advice to WHO on vaccine safety 
issues of global or regional concern, and the Blood Regulators' Network 
(BRN) serves as an advisory body to WHO on matters related to safety 
and availability of blood and blood products.
5. Regulatory Science to Promote Development and Increased Access to 
Safe and Effective Biological Products
    Regulatory science aims to contribute to the development of new 
tools, standards, and approaches to assess the safety, efficacy, 
quality, and performance of regulated biological products. Examples 
include tools to standardize assays used for regulatory purposes (e.g., 
development of correlates of immunity; correlates of safety; improved 
methods for product characterization; new or alternative potency assays 
etc.). Results generated through methods and tools developed through 
regulatory science efforts such as adaptive clinical trial designs, 
benefit/risk assessment, novel pharmacovigilance methodologies, and 
other tools inform regulatory decisionmaking processes. Knowledge 
gained through regulatory science can play a significant role in 
regulatory decisionmaking, policy development, and preparedness to 
address threats from existing or emerging infectious diseases.
    FDA, with other HHS technical agencies and offices, WHO, and other 
regulatory counterparts, are strategizing on approaches to increase 
access of the global population to safe and effective biological 
products for the prevention, diagnosis, and treatment of priority 
diseases, especially for use in low-and-middle-income countries. This 
project represents a collaborative effort between FDA and WHO (and 
complements and builds upon the U.S. Government's existing commitments 
with WHO) to support scientific collaboration and enhance regulatory 
capabilities of NRAs and networks to advance global access to safe and 
effective vaccines and other biologicals that meet international 
standards. This project will further

[[Page 34351]]

support science-based and data-driven public health strategies and 
approaches, and lead to improved technical cooperation between FDA, 
WHO, and its member states.

B. Research Objectives

    The project has the following goals:
1. Contribute to the Knowledge Base of the Current State of Regulatory 
Oversight of Vaccines and Other Biological Products
     Support NRA assessments and analyses and synthesis of the 
data, and development of an institutional development plan to enhance 
regulatory performance in low-and-middle-income countries. Assessment 
of regulatory systems 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., 
monitoring safety and effectiveness of new vaccines following 
introduction in a specific country or regional setting). NRA 
assessments also support WHO's vaccine prequalification program;
     Analysis of regulatory systems performance can include 
assessment of challenges, risks, and emerging trends, with the aim of 
further strengthening the development of data/information systems as 
sources of inputs for evidence-based regulatory decisions and actions; 
and
     Expected outputs could include analyses, reports, and 
data-driven strategy papers, among others.
2. Providing Technical Support to Regulatory Systems Strengthening 
Efforts
     Enable the strengthening of regulatory systems at the 
national and regional levels in such critical domains as good 
manufacturing, clinical, and laboratory practices; monitoring and 
evaluation of product quality; lot release; inspection and surveillance 
of products throughout the supply chain; pharmacovigilance systems 
building and analyses; risk assessment, analysis, and management etc.;
     Support the diffusion and application of knowledge, data, 
and information through active participation in regional and global 
committees and networks, such as the African Vaccine Regulatory Forum, 
ECBS, GACVS, BRN etc.; and
     Expected outputs could include analyses, reports, and 
data-driven strategy papers, among others.
3. Development of Global Norms and Standards
     Enable the timely and effective sharing of scientific 
findings and data through international collaboration to develop WHO 
International Biological Reference Preparations and WHO guidelines and 
recommendations on the production and control of vaccines and other 
biological products and technologies;
     Assist Member States in the implementation of 
internationally-recognized standards and guidelines, e.g. WHO 
guidelines and standards and those emerging from standards development 
venues such as the International Council for Harmonisation of the 
Technical Requirements for Pharmaceuticals for Human Use;
     Utilize WHO's convening power to engage with relevant 
stakeholders in support of data-driven and science-based public health 
strategies and approaches to enhancing global regulatory capacity and 
cooperation; and
     Expected outputs could include guideline documents, 
physical standards (e.g., reference reagents, reference panels etc.), 
reports, and data-driven strategy papers, among others.
4. Support Regulatory Science and Other Activities To Promote 
Development and increased Access to Safe and Effective Biological 
Products
     Enable development of new tools, standards, and approaches 
to assess the safety, efficacy, quality, and performance of regulated 
biological products;
     Support programs, including but not limited to WHO 
prequalification, that increase access to safe and effective biological 
products; and
     Expected outputs could include analyses, reports, and 
data-driven strategy papers, among others.

C. Eligibility Information

    The following organization is eligible to apply: WHO.

II. Award Information/Funds Available

A. Award Amount

    FDA/CBER anticipates providing in FY2016 up to $2 million (total 
costs including indirect costs) for one award (subject to availability 
of funds) in support of this project. Future year amounts will depend 
on annual appropriations, availability of funding, and awardee 
performance. CBER anticipates providing four additional years of 
support up to the following amounts:

FY 2017: $2 million
FY 2018: $2 million
FY 2019: $2 million
FY 2020: $2 million

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 Fiscal Year appropriations.

III. Electronic Application, Registration, and Submission Information

    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.grants.gov. Search 
by Funding Opportunity Number: RFA-FD-16-044. (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)(formerly CCR).
     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://www.grants.gov/web/grants/applicants/organization-registration.html. 
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: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12685 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P