Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry, 30751-30752 [2018-14006]
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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
Dated: June 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14005 Filed 6–28–18; 8:45 am]
BILLING CODE 4164–01–P
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.
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: Tara.Gooen@
fda.hhs.gov 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:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:58 Jun 28, 2018
Jkt 244001
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
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
1 See ‘‘FDA Pharmaceutical Quality Oversight:
One Quality Voice’’ at https://www.fda.gov/
downloads/AboutFDA/CentersOffices/Officeof
MedicalProductsandTobacco/CDER/
UCM442666.pdf.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
30751
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 nonapplication 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).
E:\FR\FM\29JNN1.SGM
29JNN1
30752
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
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
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:58 Jun 28, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1772]
Oncology Therapeutic
Radiopharmaceuticals: Nonclinical
Studies and Labeling
Recommendations; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Oncology Therapeutic
Radiopharmaceuticals: Nonclinical
Studies and Labeling
Recommendations.’’ The purpose of this
draft guidance is to assist sponsors in
designing appropriate nonclinical
studies before initiation of first-inhuman (FIH) trials and through product
approval. In addition, this draft
guidance provides recommendations for
product labeling, such as duration of
contraception to minimize potential risk
to a developing embryo/fetus and
recommendations for lactating women
to minimize potential risk to a nursing
infant. This draft guidance intends to
provide recommendations for
nonclinical programs in a unique and
challenging area of product
development, provide a more consistent
approach in nonclinical studies and
product labeling, and reduce the
conduct of nonclinical studies that are
not informative for product use.
DATES: Submit either electronic or
written comments on the draft guidance
by August 28, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1772 for ‘‘Oncology
Therapeutic Radiopharmaceuticals:
Nonclinical Studies and Labeling
Recommendations; Draft Guidance for
Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[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
