[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30751-30752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14006]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1896]


Quality Metrics Site Visit Program for Center for Drug Evaluation 
and Research and Center for Biologics Evaluation and Research Staff; 
Information Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER) in the Food and 
Drug Administration (FDA or Agency) are announcing a 2018 CDER and CBER 
staff experiential learning site visit program specific to FDA's 
Quality Metrics Program. FDA is proposing this program, in part, in 
response to input from a variety of stakeholders over the past couple 
of years. The purpose of this 2018 Quality Metrics Site Visit Program 
is to provide experiential and firsthand learning opportunities to FDA 
staff involved in the development of the FDA Quality Metrics Program 
and to provide stakeholders with an opportunity to explain the 
advantages and challenges associated with implementing and managing a 
robust Quality Metrics Program. This notice invites pharmaceutical 
companies interested in participating in this program to submit a 
Quality Metrics Site Visit proposal.

DATES: Submit either an electronic or written proposal to participate 
in this program by August 28, 2018. See section IV of this notice for 
information on what to include in such proposals.

FOR FURTHER INFORMATION CONTACT: Tara Gooen Bizjak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301-
796-3257, email: [email protected] or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    More than a decade ago, FDA launched an initiative to encourage the 
implementation of a modern, risk-based pharmaceutical quality 
assessment system. As part of this initiative, and in recognition of 
the increasing complexity of pharmaceutical manufacturing, FDA 
developed a 21st century vision for manufacturing and quality with 
input from academia and industry. The desired state was described as 
follows: ``A maximally efficient, agile, flexible pharmaceutical 
manufacturing sector that reliably produces high-quality drug products 
without extensive regulatory oversight.'' \1\
---------------------------------------------------------------------------

    \1\ See ``FDA Pharmaceutical Quality Oversight: One Quality 
Voice'' at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf.
---------------------------------------------------------------------------

    There has been significant progress toward this vision in the 
intervening years as evidenced by programs and guidances from FDA 
around major initiatives such as pharmaceutical development and quality 
by design, quality risk management and pharmaceutical quality systems, 
process validation, and emerging technology, among others. These 
programs and guidances are intended to promote effective use of the 
modern pharmaceutical science and engineering principles and knowledge 
throughout the life cycle of a product.
    FDA sought input from industry on the establishment of an FDA 
Quality Metrics Program as another mechanism to promote continual 
improvement in manufacturing quality. FDA has also consulted with other 
stakeholders to identify mutually useful and objective quality metrics. 
The Agency heard that it should perform further studies of existing 
quality metrics programs and conduct additional discussions with 
stakeholders. Based on this input, CDER and CBER are initiating this 
2018 Quality Metrics Site Visit Program to assist the Agency in 
understanding existing programs. This voluntary site visit program is 
designed to offer experiential and firsthand learning opportunities to 
CDER and CBER staff involved in the development of FDA's Quality 
Metrics Program and to provide stakeholders with an opportunity to 
explain the advantages and challenges associated with implementing and 
managing a robust quality metrics program. One goal of these visits is 
to provide CDER and CBER staff exposure to existing quality metrics 
programs through onsite visits, tour of operations, and discussions 
with establishments to assist staff in further developing FDA's Quality 
Metrics Program. Another goal is to provide a forum for industry to 
engage in the process and provide additional feedback into improving 
the FDA Quality Metrics Program.

II. The Site Visit Program

    During a quality metrics site visit, CDER and CBER staff will 
observe how quality metrics data are gathered, collected, and reported 
to management. We anticipate 5 to 10 FDA representatives (involved in 
the development of FDA's Quality Metrics Program) would participate in 
a site visit taking place over a 1- to 2-day period. To facilitate the 
learning process, the host establishment may present overviews of the 
development and management of their quality metrics program. The 
presentation(s) will allow the participating establishments an 
opportunity to showcase technologies that support their program.
    CDER and CBER encourage covered establishments, including 
establishments that do not perform physical manipulation of drugs, 
engaging in the development and manufacturing of both active 
pharmaceutical ingredients (small and large molecules) and drug 
products to submit quality metrics site visit proposals. A covered 
establishment is an owner or operator of an establishment that is 
engaged in the manufacture, preparation, propagation, compounding, or 
processing of a covered drug product, or an active pharmaceutical 
ingredient (API) used in the manufacture of a covered drug product. 
CDER and CBER staff participating in this program will benefit by 
gaining a better understanding of current industry practices, 
processes, and procedures for quality metrics programs.
    CDER and CBER identified a number of establishment types that are 
of particular interest to their staff. The following list identifies 
some examples of these establishments but is not intended to be 
exhaustive, mutually exclusive, or to limit industry response to the 
notice:
     Manufacturer of brand, generic, biotechnology, APIs, and 
non-application product(s) marketed under the over-the-counter (OTC) 
monograph system, and any combination of these products;
     contract development and manufacturing organizations;
     establishments with small and large portfolios; and
     establishments with past or current product availability 
issues (e.g., history of a drug supply issue, recall).

[[Page 30752]]

    The Quality Metrics Site Visit Program does not supplement or 
replace a regulatory inspection (e.g., a preapproval inspection, pre-
license inspection, or a surveillance inspection).

III. Site Selection

    Selection of potential facilities will be based on the priorities 
developed for CDER and CBER staff training, the facility's current 
compliance status with FDA, and in consultation with the appropriate 
FDA district office. All travel expenses associated with this program 
will be the responsibility of FDA; therefore, selection will be based 
on the availability of funds and resources for the fiscal year. FDA 
will not provide financial compensation to the pharmaceutical site as 
part of this program.

IV. Proposals for Participation

    Companies interested in offering a site visit or learning more 
about this site visit program should respond by submitting a proposal 
directly to Tara Gooen Bizjak or Stephen Ripley (see FOR FURTHER 
INFORMATION CONTACT). To aid in FDA's site selection and planning, your 
proposal should include the following information:
     A contact person;
     site visit location(s);
     Facility Establishment Identifier and Data Universal 
Numbering System numbers, as applicable;
     maximum number of FDA staff that can be accommodated 
during a site visit (maximum of 10),
     a description of the development, history, and ongoing 
management of the quality metrics program;
     a sample agenda outlining the proposed learning objectives 
and associated activities for the site visit; and
     preferred dates for a quality metrics site visit.
    Proposals submitted without this minimum information will not be 
considered.

    Dated: June 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14006 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P