Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry, 42903-42904 [2018-18305]
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Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
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Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or Office of Communication,
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Biologics Evaluation and Research,
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New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Julia
Beaver, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2100, Silver Spring,
MD 20993–0002, 240–402–0489; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in 21 CFR part 312
(Investigational New Drug Application)
has been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR parts 50 and 56
(Protection of Human Subjects:
Informed Consent; Institutional Review
Boards) have been approved under OMB
control number 0910–0755.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: August 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18339 Filed 8–23–18; 8:45 am]
BILLING CODE 4164–01–P
daltland on DSKBBV9HB2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Hematologic Malignancy and
Oncologic Disease: Considerations for
Use of Placebos and Blinding in
Randomized Controlled Clinical Trials
for Drug Product Development.’’ This
draft guidance provides
recommendations to industry regarding
the use of placebos and blinding in
randomized controlled clinical trials in
development programs for drug or
biological products for the treatment of
hematologic malignancies and oncologic
diseases regulated by CDER and CBER.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the use of placebos and blinding in
randomized controlled clinical trials for
drug product development for
hematologic malignancy and oncologic
disease. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
VerDate Sep<11>2014
19:17 Aug 23, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3030]
Site Visit Training Program for Office
of Pharmaceutical Quality Staff;
Information Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Center for Drug
Evaluation and Research (CDER) in the
Food and Drug Administration (FDA) is
announcing the Fiscal Year 2019 CDER
Office of Pharmaceutical Quality (OPQ)
Staff Experiential Learning Site Visit
Program. The purpose of this document
is to invite pharmaceutical companies
interested in participating in this
program to submit a site visit proposal
to CDER’s OPQ.
DATES: Submit either an electronic or
written proposal to participate in this
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
42903
program by November 23, 2018. See
section IV of this document for
information on what to include in such
proposals.
FOR FURTHER INFORMATION CONTACT:
Janet Wilson, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 4642, Silver Spring,
MD 20993–0002, 240–402–3969, email:
CDEROPQSiteVisits@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A critical part of the commitment by
CDER to make safe and effective highquality drugs available to the American
public is gaining an understanding of all
aspects of a drug’s development and
commercial life cycle, including the
variety of drug manufacturing
operations. To support this
commitment, CDER has initiated
various training and development
programs including the FY2019
Experiential Learning Site Visit
program. This site visit program is
designed to offer experiential and
firsthand learning opportunities that
will provide OPQ staff with a better
understanding of the pharmaceutical
industry and its operations, as well as
the challenges that impact a drug’s
developmental program and commercial
life cycle. The goal of these visits is to
enhance OPQ staff exposure to the drug
development and manufacturing
processes in industry; therefore, a tour
of pharmaceutical company facilities,
including manufacturing and laboratory
operations, is an integral part of the
experience.
II. The Site Visit Program
In this site visit program, groups on
average of 15 to 20 OPQ staff—who have
experience in a variety of backgrounds,
including science, medicine, statistics,
manufacturing, engineering, testing, and
project management—will observe
operations of commercial
manufacturing, pilot plants (if
applicable), and testing over a 1- to 2day period. To facilitate the learning
process for OPQ staff, overview
presentations by industry related to
drug development, manufacturing and
testing may be included.
OPQ encourages companies engaging
in the development and manufacturing
of both active pharmaceutical
ingredients (small and large molecules)
and drug products to respond. Please
note that this site visit program is not
intended to supplement or replace a
regulatory inspection, e.g., a
preapproval inspection, prelicense
inspection, or a surveillance inspection.
E:\FR\FM\24AUN1.SGM
24AUN1
42904
Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
OPQ staff participating in this
program will benefit by gaining a better
understanding of current industry
practices, processes, and procedures.
Participating sites will have an
opportunity to showcase their
technologies and their actual
manufacturing and testing facilities.
Although observation of all aspects of
drug development and production
would be beneficial to OPQ staff, OPQ
has identified a number of areas of
particular interest to its staff. The
following list identifies some examples
of these areas but is not intended to be
exhaustive, mutually exclusive, or to
limit industry response:
• Drug products
Æ Solutions, suspensions, emulsions,
and semisolids
Æ Modified- and immediate-release
formulations
Æ Drug-device combination products
(e.g., inhalation products, transdermal
systems, implants intended for drug
delivery, and prefilled syringes)
• Active pharmaceutical ingredients
manufactured by
Æ Chemical synthesis
Æ Fermentation
Æ Biotechnology
• Design, development, manufacturing
and controls
Æ Engineering controls for aseptic
processes
Æ Novel delivery technologies
Æ Hot melt extrusion
Æ Soft-gel encapsulation
Æ Lyophilization
Æ Blow-Fill-Seal and isolators
Æ Spray-drying
Æ Process analytical technology,
measurement systems, and real-time
release testing
• Emerging technologies
Æ Continuous manufacturing
Æ 3-dimensional printing
Æ Nanotechnology
daltland on DSKBBV9HB2PROD with NOTICES
III. Site Selection
Selection of potential facilities will be
based on the priorities developed for
OPQ 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 OPQ; therefore,
selection will be based on the
availability of funds and resources for
the fiscal year. OPQ 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
VerDate Sep<11>2014
19:17 Aug 23, 2018
Jkt 244001
submitting a proposal directly to Janet
Wilson (see DATES and FOR FURTHER
INFORMATION CONTACT sections of this
document for more information). To aid
in OPQ’s site selection and planning,
your proposal should include the
information below:
• 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 20),
• A proposed agenda outlining the
learning objectives and associated
activities for the site visit,
• Maximum number of site visits (no
more than 2) that your site would be
willing to host by the close of the
government fiscal year, September 30,
2019, and
• Proposed dates for each site visit
(i.e. month and week).
Please note that the requested
proposed agenda will be reviewed to
determine the educational benefit to
OPQ in conducting the visit, and
selected sites may be asked to refine the
agenda to maximize the educational
benefit. After a site is selected, OPQ will
communicate with the contact person
for the site to determine the actual dates
for the visit.
Proposals submitted without this
minimum information will not be
considered. Based on response rate and
type of responses, OPQ may or may not
consider alternative pathways to
meeting our training goals.
Dated: August 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18305 Filed 8–23–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0567]
Designating Additions to the Current
List of Tropical Diseases in the Federal
Food, Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Federal Food, Drug, and
Cosmetic Act (FD&C Act) authorizes the
Food and Drug Administration (FDA or
Agency) to award priority review
vouchers (PRVs) to tropical disease
product applicants when the
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
applications meet certain criteria. The
FD&C Act lists the diseases that are
considered tropical diseases for
purposes of obtaining PRVs and
provides for Agency expansion of that
list to include other diseases that satisfy
the definition of ‘‘tropical diseases’’ as
set forth in the FD&C Act. The Agency
has determined that chikungunya virus
disease, Lassa fever, rabies, and
cryptococcal meningitis satisfy this
definition and is therefore adding them
to the list of designated tropical diseases
whose product applications may result
in the award of PRVs. Sponsors
submitting certain drug or biological
product applications for the prevention
or treatment of chikungunya virus
disease, Lassa fever, rabies, and
cryptococcal meningitis may be eligible
to receive a PRV if such applications are
approved by FDA.
DATES:
This order is effective August 24,
2018.
Submit electronic
comments on additional diseases
suggested for designation to https://
www.regulations.gov. Submit written
comments on additional diseases
suggested for designation to the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
All comments should be identified with
the docket number found in brackets in
the heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Katherine Schumann, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242,
Silver Spring, MD 20993–0002, 301–
796–1300, Katherine.Schumann@
fda.hhs.gov; or Office of
Communication, Outreach and
Development (OCOD), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 1–800–835–4709 or 240–
402–8010, ocod@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background: Priority Review Voucher
Program
II. Diseases Being Designated
A. Chikungunya Virus Disease
B. Lassa Fever
C. Rabies
D. Cryptococcal Meningitis
III. Process for Requesting Additional
Diseases To Be Added to the List
IV. Paperwork Reduction Act
V. References
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42903-42904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18305]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3030]
Site Visit Training Program for Office of Pharmaceutical Quality
Staff; Information Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Center for Drug Evaluation and Research (CDER) in the Food
and Drug Administration (FDA) is announcing the Fiscal Year 2019 CDER
Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site
Visit Program. The purpose of this document is to invite pharmaceutical
companies interested in participating in this program to submit a site
visit proposal to CDER's OPQ.
DATES: Submit either an electronic or written proposal to participate
in this program by November 23, 2018. See section IV of this document
for information on what to include in such proposals.
FOR FURTHER INFORMATION CONTACT: Janet Wilson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4642, Silver Spring, MD 20993-0002, 240-
402-3969, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A critical part of the commitment by CDER to make safe and
effective high-quality drugs available to the American public is
gaining an understanding of all aspects of a drug's development and
commercial life cycle, including the variety of drug manufacturing
operations. To support this commitment, CDER has initiated various
training and development programs including the FY2019 Experiential
Learning Site Visit program. This site visit program is designed to
offer experiential and firsthand learning opportunities that will
provide OPQ staff with a better understanding of the pharmaceutical
industry and its operations, as well as the challenges that impact a
drug's developmental program and commercial life cycle. The goal of
these visits is to enhance OPQ staff exposure to the drug development
and manufacturing processes in industry; therefore, a tour of
pharmaceutical company facilities, including manufacturing and
laboratory operations, is an integral part of the experience.
II. The Site Visit Program
In this site visit program, groups on average of 15 to 20 OPQ
staff--who have experience in a variety of backgrounds, including
science, medicine, statistics, manufacturing, engineering, testing, and
project management--will observe operations of commercial
manufacturing, pilot plants (if applicable), and testing over a 1- to
2-day period. To facilitate the learning process for OPQ staff,
overview presentations by industry related to drug development,
manufacturing and testing may be included.
OPQ encourages companies engaging in the development and
manufacturing of both active pharmaceutical ingredients (small and
large molecules) and drug products to respond. Please note that this
site visit program is not intended to supplement or replace a
regulatory inspection, e.g., a preapproval inspection, prelicense
inspection, or a surveillance inspection.
[[Page 42904]]
OPQ staff participating in this program will benefit by gaining a
better understanding of current industry practices, processes, and
procedures. Participating sites will have an opportunity to showcase
their technologies and their actual manufacturing and testing
facilities.
Although observation of all aspects of drug development and
production would be beneficial to OPQ staff, OPQ has identified a
number of areas of particular interest to its staff. The following list
identifies some examples of these areas but is not intended to be
exhaustive, mutually exclusive, or to limit industry response:
Drug products
[cir] Solutions, suspensions, emulsions, and semisolids
[cir] Modified- and immediate-release formulations
[cir] Drug-device combination products (e.g., inhalation products,
transdermal systems, implants intended for drug delivery, and prefilled
syringes)
Active pharmaceutical ingredients manufactured by
[cir] Chemical synthesis
[cir] Fermentation
[cir] Biotechnology
Design, development, manufacturing and controls
[cir] Engineering controls for aseptic processes
[cir] Novel delivery technologies
[cir] Hot melt extrusion
[cir] Soft-gel encapsulation
[cir] Lyophilization
[cir] Blow-Fill-Seal and isolators
[cir] Spray-drying
[cir] Process analytical technology, measurement systems, and real-time
release testing
Emerging technologies
[cir] Continuous manufacturing
[cir] 3-dimensional printing
[cir] Nanotechnology
III. Site Selection
Selection of potential facilities will be based on the priorities
developed for OPQ 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 OPQ; therefore, selection will be based on the
availability of funds and resources for the fiscal year. OPQ 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 Janet Wilson (see DATES and FOR FURTHER INFORMATION CONTACT
sections of this document for more information). To aid in OPQ's site
selection and planning, your proposal should include the information
below:
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 20),
A proposed agenda outlining the learning objectives and
associated activities for the site visit,
Maximum number of site visits (no more than 2) that your
site would be willing to host by the close of the government fiscal
year, September 30, 2019, and
Proposed dates for each site visit (i.e. month and week).
Please note that the requested proposed agenda will be reviewed to
determine the educational benefit to OPQ in conducting the visit, and
selected sites may be asked to refine the agenda to maximize the
educational benefit. After a site is selected, OPQ will communicate
with the contact person for the site to determine the actual dates for
the visit.
Proposals submitted without this minimum information will not be
considered. Based on response rate and type of responses, OPQ may or
may not consider alternative pathways to meeting our training goals.
Dated: August 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18305 Filed 8-23-18; 8:45 am]
BILLING CODE 4164-01-P
