Training Program for Regulatory Project Managers; Information Available to Industry, 18913 [2017-08183]
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Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
onsite registration on the day of the
public workshop will be provided
beginning at 7:30 a.m.
For those without Internet access,
please contact Scott Winiecki, (see FOR
FURTHER INFORMATION CONTACT) to
register. If you need special
accommodations due to a disability,
please contact Scott Winiecki no later
than September 1, 2017.
Transcripts: A transcript of the public
workshop will be accessible at https://
www.regulations.gov approximately 30
days after the workshop. It may also be
viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08178 Filed 4–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0179]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
send proposed agendas to the Agency by
June 23, 2017.
FOR FURTHER INFORMATION CONTACT: Dan
Brum, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5480, Silver Spring,
MD 20993–0002, 301–796–0578,
dan.brum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
VerDate Sep<11>2014
13:48 Apr 21, 2017
Jkt 241001
the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the Site Tours Program will be the
responsibility of CDER; therefore,
selection will be based on the
availability of funds and resources for
each fiscal year. Selection will also be
based on firms having a favorable
facility status as determined by FDA’s
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
18913
Office of Regulatory Affairs District
Offices in the firms’ respective regions.
Firms that want to learn more about this
training opportunity or that are
interested in offering a site tour should
respond by sending a proposed agenda
by email directly to Dan Brum (see
DATES and FOR FURTHER INFORMATION
CONTACT).
Dated: April 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08183 Filed 4–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidance for
Naloxone Hydrochloride; New Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
new draft guidance for industry on
generic naloxone hydrochloride nasal
spray entitled ‘‘Draft Guidance on
Naloxone Hydrochloride.’’ The new
draft guidance, when finalized, will
provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs) for naloxone
hydrochloride nasal spray.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final versions of the guidance, submit
either electronic or written comments
on the draft guidances by June 23, 2017.
ADDRESSES: You may submit comments
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
E:\FR\FM\24APN1.SGM
24APN1
Agencies
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Page 18913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08183]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0179]
Training Program for Regulatory Project Managers; Information
Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research (CDER) is announcing the continuation of the
Regulatory Project Management Site Tours and Regulatory Interaction
Program (the Site Tours Program). The purpose of this document is to
invite pharmaceutical companies interested in participating in this
program to contact CDER.
DATES: Pharmaceutical companies may send proposed agendas to the Agency
by June 23, 2017.
FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5480, Silver Spring, MD 20993-0002, 301-796-0578,
dan.brum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this primary goal, CDER
has initiated various training and development programs to promote high
performance in its regulatory project management staff. CDER seeks to
significantly enhance review efficiency and review quality by providing
the staff with a better understanding of the pharmaceutical industry
and its operations. To this end, CDER is continuing its training
program to give regulatory project managers the opportunity to tour
pharmaceutical facilities. The goals are to provide the following: (1)
Firsthand exposure to industry's drug development processes and (2) a
venue for sharing information about project management procedures (but
not drug-specific information) with industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day period, small groups (five or
less) of regulatory project managers, including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, tracking mechanisms, and regulatory submission
operations. The overall benefit to regulatory project managers will be
exposure to project management, team techniques, and processes employed
by the pharmaceutical industry. By participating in this program, the
regulatory project manager will grow professionally by gaining a better
understanding of industry processes and procedures.
III. Site Selection
All travel expenses associated with the Site Tours Program will be
the responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Selection
will also be based on firms having a favorable facility status as
determined by FDA's Office of Regulatory Affairs District Offices in
the firms' respective regions. Firms that want to learn more about this
training opportunity or that are interested in offering a site tour
should respond by sending a proposed agenda by email directly to Dan
Brum (see DATES and FOR FURTHER INFORMATION CONTACT).
Dated: April 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08183 Filed 4-21-17; 8:45 am]
BILLING CODE 4164-01-P