Updates to Section I & II for PAR-15-187 - Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies

Notice Number: NOT-FD-19-004

Key Dates
Release Date: February 7, 2019   

Related Announcements

PAR-15-187  

Issued by
U.S. Food and Drug Administration (FDA)

Purpose

FDA's PAR-15-187 -  has made updates to the following Sections:

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background

FDA regulates pharmaceutical drug products to ensure a continuous supply of high quality drugs in the United States. In regulating the pharmaceutical manufacturing sector, the vision for FDA’s Pharmaceutical Quality for the 21st Century Initiative is to promote a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight. To help achieve this vision, FDA encourages development and adoption of emerging manufacturing technology to modernize pharmaceutical manufacturing. Such a modernization effort aims to result in a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance.  In other words, encouraging the development and adoption of emerging manufacturing technologies may lead to improved manufacturing, and therefore improved product quality and availability throughout a product’s lifecycle.
While the development of emerging technology is critical to modernizing pharmaceutical manufacturing and improving quality, FDA also recognizes that the implementation of emerging technology could present challenges to both industry and FDA. By the very nature of an approach being new or innovative in pharmaceutical industry, a limited knowledge and experiential base about the technology may exist. This program aims to address knowledge and experience gaps identified for emerging manufacturing technology and support the development and adoption of such technology in the pharmaceutical sector.

Project Objectives

The goal of this program is to support the advancement of regulatory science that can facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector. Emerging manufacturing technology can be defined as a technology that has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable, or cost-effective processes and with which the FDA has limited review or inspection experiences due to the relative novelty of the technology. Examples of such elements include an innovative or novel: (1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology.

Identified emerging technologies should be sufficiently developed and likely ready for industrial implementation for the purpose of product quality enhancement. The results and knowledge developed in this program can be utilized by industry, academia, and industry to support the implementation of the identified emerging technologies and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science. Specifically, the expected project outcomes should enable (1) developing tools and approaches for risk-based quality assessment, (2) establishing science-based quality standards and policies, and/or (3) providing training tools for both the industry and/or the regulatory bodies for the identified emerging technology.

Potential research projects could include:

    1. Development of in vitro tools or methods to provide a direct measure of in vivo performance for  
complex products (e.g., complex dosage forms or formulation) to support patient-focus quality
standards
2. Development of novel approaches to ensure the sterility of injectable products for product
release.
3. Development of modeling and simulation tools and approaches to analyze big data in support of
making risk-based regulatory decision on pharmaceutical quality.

Section II. Award Information

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.  Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

FDA/CDER intends to fund up to $2,000,000, for Fiscal Year 2019 in support of this grant program. Future year amounts will be contingent on availability of Federal funds but it is estimated that FDA/CDER intends to commit up to the following amounts for Fiscal Year (FY) 2019:

FY2019: $2,000,000

It is anticipated that up to two (2) awards will be made, not to exceed $1,000,000 in total costs (direct plus indirect), per award, per Fiscal Year.

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $1,000,000
YR 02: $1,000,000
YR 03: $1,000,000

Inquiries

Please direct all inquiries to:


Kathryn Hughes, Ph.D.
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Telephone: 301-796-4582
Email: kathryn.hughes@fda.hhs.gov