83 FR 30751 - Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 126 (June 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 126 (June 29, 2018)
| Page Range | 30751-30752 | |
| FR Document | 2018-14006 |
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)] [Notices] [Pages 30751-30752] From the Federal Register Online [www.thefederalregister.org] [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: 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: 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
![Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30751
Dated: June 25, 2018. I. Background Quality Metrics Program. Another goal
Leslie Kux, More than a decade ago, FDA is to provide a forum for industry to
Associate Commissioner for Policy. launched an initiative to encourage the engage in the process and provide
[FR Doc. 2018–14005 Filed 6–28–18; 8:45 am] implementation of a modern, risk-based additional feedback into improving the
BILLING CODE 4164–01–P pharmaceutical quality assessment FDA Quality Metrics Program.
system. As part of this initiative, and in II. The Site Visit Program
recognition of the increasing complexity
DEPARTMENT OF HEALTH AND of pharmaceutical manufacturing, FDA During a quality metrics site visit,
HUMAN SERVICES developed a 21st century vision for CDER and CBER staff will observe how
manufacturing and quality with input quality metrics data are gathered,
Food and Drug Administration from academia and industry. The collected, and reported to management.
desired state was described as follows: We anticipate 5 to 10 FDA
[Docket No. FDA–2018–N–1896] ‘‘A maximally efficient, agile, flexible representatives (involved in the
pharmaceutical manufacturing sector development of FDA’s Quality Metrics
Quality Metrics Site Visit Program for that reliably produces high-quality drug Program) would participate in a site
Center for Drug Evaluation and products without extensive regulatory visit taking place over a 1- to 2-day
Research and Center for Biologics oversight.’’ 1 period. To facilitate the learning
Evaluation and Research Staff; There has been significant progress process, the host establishment may
Information Available to Industry toward this vision in the intervening present overviews of the development
years as evidenced by programs and and management of their quality metrics
AGENCY: Food and Drug Administration, program. The presentation(s) will allow
guidances from FDA around major
HHS. the participating establishments an
initiatives such as pharmaceutical
ACTION: Notice. development and quality by design, opportunity to showcase technologies
quality risk management and that support their program.
SUMMARY: The Center for Drug CDER and CBER encourage covered
Evaluation and Research (CDER) and the pharmaceutical quality systems, process
validation, and emerging technology, establishments, including
Center for Biologics Evaluation and establishments that do not perform
Research (CBER) in the Food and Drug among others. These programs and
guidances are intended to promote physical manipulation of drugs,
Administration (FDA or Agency) are engaging in the development and
announcing a 2018 CDER and CBER effective use of the modern
pharmaceutical science and engineering manufacturing of both active
staff experiential learning site visit pharmaceutical ingredients (small and
program specific to FDA’s Quality principles and knowledge throughout
the life cycle of a product. large molecules) and drug products to
Metrics Program. FDA is proposing this submit quality metrics site visit
FDA sought input from industry on
program, in part, in response to input proposals. A covered establishment is
the establishment of an FDA Quality
from a variety of stakeholders over the an owner or operator of an
Metrics Program as another mechanism
past couple of years. The purpose of this establishment that is engaged in the
to promote continual improvement in
2018 Quality Metrics Site Visit Program manufacture, preparation, propagation,
manufacturing quality. FDA has also
is to provide experiential and firsthand compounding, or processing of a
consulted with other stakeholders to
learning opportunities to FDA staff covered drug product, or an active
identify mutually useful and objective
involved in the development of the FDA pharmaceutical ingredient (API) used in
quality metrics. The Agency heard that
Quality Metrics Program and to provide the manufacture of a covered drug
it should perform further studies of
stakeholders with an opportunity to product. CDER and CBER staff
existing quality metrics programs and
explain the advantages and challenges participating in this program will
conduct additional discussions with
associated with implementing and benefit by gaining a better
stakeholders. Based on this input, CDER
managing a robust Quality Metrics understanding of current industry
and CBER are initiating this 2018
Program. This notice invites practices, processes, and procedures for
Quality Metrics Site Visit Program to
pharmaceutical companies interested in quality metrics programs.
assist the Agency in understanding
participating in this program to submit
existing programs. This voluntary site CDER and CBER identified a number
a Quality Metrics Site Visit proposal.
visit program is designed to offer of establishment types that are of
DATES: Submit either an electronic or experiential and firsthand learning particular interest to their staff. The
written proposal to participate in this opportunities to CDER and CBER staff following list identifies some examples
program by August 28, 2018. See section involved in the development of FDA’s of these establishments but is not
IV of this notice for information on what Quality Metrics Program and to provide intended to be exhaustive, mutually
to include in such proposals. stakeholders with an opportunity to exclusive, or to limit industry response
FOR FURTHER INFORMATION CONTACT: Tara explain the advantages and challenges to the notice:
Gooen Bizjak, Center for Drug associated with implementing and • Manufacturer of brand, generic,
Evaluation and Research, Food and managing a robust quality metrics biotechnology, APIs, and non-
Drug Administration, 10903 New program. One goal of these visits is to application product(s) marketed under
Hampshire Ave., Bldg. 51, Rm. 2109, provide CDER and CBER staff exposure the over-the-counter (OTC) monograph
Silver Spring, MD 20993–0002, 301– to existing quality metrics programs system, and any combination of these
796–3257, email: Tara.Gooen@ through onsite visits, tour of operations, products;
sradovich on DSK3GMQ082PROD with NOTICES
fda.hhs.gov or Stephen Ripley, Center and discussions with establishments to • contract development and
for Biologics Evaluation and Research, assist staff in further developing FDA’s manufacturing organizations;
Food and Drug Administration, 10903 • establishments with small and large
New Hampshire Ave., Bldg. 71, Rm. 1 See ‘‘FDA Pharmaceutical Quality Oversight:
portfolios; and
One Quality Voice’’ at https://www.fda.gov/
7268, Silver Spring, MD 20993–0002,
downloads/AboutFDA/CentersOffices/Officeof
• establishments with past or current
240–402–7911. MedicalProductsandTobacco/CDER/ product availability issues (e.g., history
SUPPLEMENTARY INFORMATION: UCM442666.pdf. of a drug supply issue, recall).
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![30752 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
The Quality Metrics Site Visit DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
Program does not supplement or replace HUMAN SERVICES confidential business information, such
a regulatory inspection (e.g., a as a manufacturing process. Please note
preapproval inspection, pre-license Food and Drug Administration that if you include your name, contact
inspection, or a surveillance [Docket No. FDA–2018–D–1772] information, or other information that
inspection). identifies you in the body of your
Oncology Therapeutic comments, that information will be
III. Site Selection Radiopharmaceuticals: Nonclinical posted on https://www.regulations.gov.
Studies and Labeling • If you want to submit a comment
Selection of potential facilities will be with confidential information that you
Recommendations; Draft Guidance for
based on the priorities developed for do not wish to be made available to the
Industry; Availability
CDER and CBER staff training, the public, submit the comment as a
facility’s current compliance status with AGENCY: Food and Drug Administration, written/paper submission and in the
FDA, and in consultation with the HHS. manner detailed (see ‘‘Written/Paper
appropriate FDA district office. All ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’).
travel expenses associated with this
SUMMARY: The Food and Drug Written/Paper Submissions
program will be the responsibility of
Administration (FDA or Agency) is Submit written/paper submissions as
FDA; therefore, selection will be based
announcing the availability of a draft follows:
on the availability of funds and
resources for the fiscal year. FDA will
guidance for industry entitled • Mail/Hand Delivery/Courier (for
‘‘Oncology Therapeutic written/paper submissions): Dockets
not provide financial compensation to Radiopharmaceuticals: Nonclinical Management Staff (HFA–305), Food and
the pharmaceutical site as part of this Studies and Labeling Drug Administration, 5630 Fishers
program. Recommendations.’’ The purpose of this Lane, Rm. 1061, Rockville, MD 20852.
IV. Proposals for Participation draft guidance is to assist sponsors in • For written/paper comments
designing appropriate nonclinical submitted to the Dockets Management
Companies interested in offering a site studies before initiation of first-in- Staff, FDA will post your comment, as
visit or learning more about this site human (FIH) trials and through product well as any attachments, except for
visit program should respond by approval. In addition, this draft information submitted, marked and
submitting a proposal directly to Tara guidance provides recommendations for identified, as confidential, if submitted
Gooen Bizjak or Stephen Ripley (see FOR product labeling, such as duration of as detailed in ‘‘Instructions.’’
FURTHER INFORMATION CONTACT). To aid contraception to minimize potential risk Instructions: All submissions received
in FDA’s site selection and planning, to a developing embryo/fetus and must include the Docket No. FDA–
your proposal should include the recommendations for lactating women 2018–D–1772 for ‘‘Oncology
following information: to minimize potential risk to a nursing Therapeutic Radiopharmaceuticals:
infant. This draft guidance intends to Nonclinical Studies and Labeling
• A contact person; provide recommendations for Recommendations; Draft Guidance for
• site visit location(s); nonclinical programs in a unique and Industry; Availability.’’ Received
• Facility Establishment Identifier challenging area of product comments will be placed in the docket
and Data Universal Numbering System development, provide a more consistent and, except for those submitted as
numbers, as applicable; approach in nonclinical studies and ‘‘Confidential Submissions,’’ publicly
product labeling, and reduce the viewable at https://www.regulations.gov
• maximum number of FDA staff that conduct of nonclinical studies that are or at the Dockets Management Staff
can be accommodated during a site visit not informative for product use. between 9 a.m. and 4 p.m., Monday
(maximum of 10), DATES: Submit either electronic or through Friday.
• a description of the development, written comments on the draft guidance • Confidential Submissions—To
history, and ongoing management of the by August 28, 2018 to ensure that the submit a comment with confidential
quality metrics program; Agency considers your comment on this information that you do not wish to be
draft guidance before it begins work on made publicly available, submit your
• a sample agenda outlining the comments only as a written/paper
the final version of the guidance.
proposed learning objectives and submission. You should submit two
ADDRESSES: You may submit comments
associated activities for the site visit; copies total. One copy will include the
and on any guidance at any time as follows:
information you claim to be confidential
• preferred dates for a quality metrics Electronic Submissions with a heading or cover note that states
site visit. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Proposals submitted without this following way: CONFIDENTIAL INFORMATION.’’ The
minimum information will not be • Federal eRulemaking Portal: Agency will review this copy, including
https://www.regulations.gov. Follow the the claimed confidential information, in
considered.
instructions for submitting comments. its consideration of comments. The
Dated: June 25, 2018. Comments submitted electronically, second copy, which will have the
Leslie Kux, including attachments, to https:// claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
sradovich on DSK3GMQ082PROD with NOTICES
Associate Commissioner for Policy.
[FR Doc. 2018–14006 Filed 6–28–18; 8:45 am] the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
BILLING CODE 4164–01–P
solely responsible for ensuring that your both copies to the Dockets Management
comment does not include any Staff. If you do not wish your name and
confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
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Document Created: 2018-06-29 01:13:17
Document Modified: 2018-06-29 01:13:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 30751 |
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