American Association of Pharmaceutical Scientists/American College of Clinical Pharmacology/American Society for Clinical Pharmacology and Therapeutics/Food and Drug Administration Cosponsored Workshop on “Evaluating and Modernizing Our Approaches for Food-Effect Assessment”, 4288-4289 [2015-01409]
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4288
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
the United States. It is not controlled
internationally under the Convention on
Psychotropic Substances or the Single
Convention on Narcotic Drugs. The
WHO Expert Committee on Drug
Dependence reviewed ketamine at its
34th, 35th, and 36th meetings. Ketamine
is controlled in schedule III of the CSA
in the United States, and additional
controls may be necessary to fulfill U.S.
obligations if ketamine is controlled
under Schedule I of the Psychotropic
Convention. FDA, on behalf of the
Secretary of HHS, invites interested
persons to submit comments on the
notifications from the United Nations
concerning these drug substances. FDA,
in cooperation with the National
Institute on Drug Abuse, will consider
the comments on behalf of HHS in
evaluating the WHO scheduling
recommendations. Then, under section
201(d)(2)(B) of the CSA, HHS will
recommend to the Secretary of State
what position the United States should
take when voting on the
recommendations for control of
substances under the Psychotropic
Convention at the CND meeting in
March 2015.
Comments regarding the WHO
recommendations for control of AH7921 under the 1961 Single Convention
will also be forwarded to the relevant
Agencies for consideration in
developing the U.S. position regarding
narcotic substances at the CND meeting.
IV. Submission of Comments and
Opportunity for Public Meeting
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
FDA does not presently plan to hold
a public meeting. If any person believes
that, in addition to written comments, a
public meeting would contribute to the
development of the U.S. position on the
substances to be considered for control
under the Psychotropic Convention, a
request for a public meeting and the
reasons for such a request should be
sent to James R. Hunter (see FOR
FURTHER INFORMATION CONTACT) on or
before February 6, 2015.
The short time period for the
submission of comments and requests
for a public meeting is needed to ensure
VerDate Sep<11>2014
18:01 Jan 26, 2015
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that HHS may, in a timely fashion, carry
out the required action and be
responsive to the United Nations.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01408 Filed 1–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
American Association of
Pharmaceutical Scientists/American
College of Clinical Pharmacology/
American Society for Clinical
Pharmacology and Therapeutics/Food
and Drug Administration Cosponsored
Workshop on ‘‘Evaluating and
Modernizing Our Approaches for FoodEffect Assessment’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Evaluating and Modernizing
our Approaches for Food-Effect
Assessment,’’ cosponsored with the
American Association of
Pharmaceutical Scientists (AAPS), the
American College of Clinical
Pharmacology (ACCP), and the
American Society for Clinical
Pharmacology and Therapeutics
(ASCPT). The goals of this public
workshop are to facilitate discussion on
current scientific approaches on
assessing the effect of food on the
pharmacokinetics and
pharmacodynamics of drugs and to
initiate constructive discussion and
information sharing among relevant
stakeholders on the influence of foodeffects on the pharmacokinetic
properties of therapeutics in order to
optimize dose and dosing regimens.
Date and Time: The workshop will be
held on February 2, 2015, from 8 a.m.
to 5 p.m., February 3, 2015, from 8 a.m.
to 5 p.m., and February 4, 2015, from 8
a.m. to 12:15 p.m.
Location: The workshop will be held
at the Renaissance Baltimore
Harborplace Hotel, 202 East Pratt St.,
Baltimore, MD 21202.
Contacts: FDA: Padmaja Mummaneni,
Food and Drug Administration, Center
for Drug Evaluation and Research,
10903 New Hampshire Ave., Bldg. 51,
Rm. 2164, Silver Spring, MD 20993,
301–796–2027, padmaja.mummaneni@
fda.hhs.gov.
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Fmt 4703
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AAPS: For questions related to this
event, please contact AAPS at
registration@aaps.org.
Registration: Workshop information
and the registration link are posted at
the AAPS meetings and professional
development conference site. To register
for the workshop, please visit https://
www.aaps.org/Meetings_and_
Professional_Development/Conference_
Mini_Sites/AAPS_WS_Food/Register/.
The cost of registration is as follows:
Member $1,690
Nonmember $2,070
Government $650
Student $100
The registration fee will be waived for
50 FDA employees. If you need special
accommodations because of disability,
please contact AAPS at registration@
aaps.org. Onsite registration on the day
of the workshop is available.
Additional Information about the
Workshop: The workshop agenda and
additional background materials will be
accessible at https://www.fda.gov/Drugs/
NewsEvents/ucm428914.htm to all
registrants.
SUPPLEMENTARY INFORMATION:
I. Background
FDA’s guidance for industry entitled
‘‘Food-Effect Bioavailability and Fed
Bioequivalence Studies’’ (Food-Effect
Guidance) is an important tool in the
development of new oral therapeutics.
Studies are conducted according to the
principles described for every new drug
that is intended to be administered by
the oral route. The Food-Effect
Guidance was first published in 2002.
Since that time, numerous studies have
been reported in the literature in an
effort to address a number of different
aspects related to assessing the effect of
food on the pharmacokinetics and
pharmacodynamics of drugs.
Predominantly, these studies have
addressed the impact of food
composition on the physiology of drug
absorption. In vitro studies have aimed
at elucidating the individual
mechanism(s) of drug absorption, and a
number of in vivo studies have
addressed the effects of different meal
compositions on the pharmacokinetics
of drugs.
FDA has undertaken an effort to
revise the 2002 Food-Effect Guidance
and is seeking feedback from academia,
industry, and other stakeholders on
several issues. FDA, AAPS, ACCP, and
ASCPT agreed to cosponsor this
workshop to provide a forum for input
on the best available science on this
topic from academia, industry, other
stakeholders, and regulators.
E:\FR\FM\27JAN1.SGM
27JAN1
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
II. Goals and Objectives
• To provide a forum for open
discussion between industry, academia,
other stakeholders, and FDA around
proposed changes to the Food-Effect
Guidance.
• To seek feedback from industry,
academia, and other stakeholders on
FDA’s proposals and to seek any
additional input that will benefit
decision making on a guidance revision
on the topic.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01409 Filed 1–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Food and Drug Administration/Xavier
University PharmaLink Conference—
Leadership in a Global Supply Chain
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) Cincinnati
District, in cosponsorship with Xavier
University, is announcing a public
conference entitled ‘‘FDA/Xavier
University PharmaLink Conference:
Leadership in a Global Supply Chain.’’
The PharmaLink conference seeks
solutions to important and complicated
issues by aligning with the strategic
priorities of FDA and includes
presentations from key FDA officials,
global regulators, and industry experts.
Each presentation challenges the status
quo and conventional wisdom to create
synergies focused on finding solutions
which make a difference. The
experience level of the audience has
fostered engaged dialog that has led to
innovative initiatives.
Dates and Times: The public
conference will be held on March 25,
2015, from 8:30 a.m. to 5 p.m.; March
26, 2015, from 8:30 a.m. to 5 p.m.; and
March 27, 2015, from 8:30 a.m. to 12:45
p.m.
Location: The public conference will
be held on the campus of Xavier
University, 3800 Victory Pkwy.,
SUMMARY:
4289
Cincinnati, OH 45207, 513–745–3073 or
513–745–3020.
Contact Persons: For information
regarding this notice: Steven Eastham,
Food and Drug Administration,
Cincinnati South Office, 36 East 7th
Street, Cincinnati, OH 45202, 513–246–
4134, email: steven.eastham@fda.
hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier University, 3800
Victory Pkwy., Cincinnati, OH 45207–
5471, 513–745–3073, email:
phillipsm4@xavier.edu.
Registration: There is a registration
fee. The conference registration fees
cover the cost of the presentations,
training materials, receptions,
breakfasts, lunches, and dinners for the
21⁄2 days of the conference. There will
be onsite registration. The cost of
registration is as follows:
TABLE 1—REGISTRATION FEES 1
Early rate
(on or before 1/24/15)
Attendee type
Industry ....................................................................................................
Small Business (<100 employees) ..........................................................
Startup Manufacturer ...............................................................................
Academic .................................................................................................
Media .......................................................................................................
Government .............................................................................................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1 The
Advanced rate
(1/25/15 to 2/24/15)
$1,295
995
200
200
Free
Free
$1,695
1,195
250
250
Free
Free
Standard rate
(after 2/24/15)
$1,895
1,295
300
300
Free
Free
fourth registration from the same company is free—all four attendees must register at the same time.
The following forms of payment will
be accepted: American Express, Visa,
Mastercard, and company checks.
To register online for the public
conference, please visit the
‘‘Registration’’ link on the conference
Web site at https://
www.XavierPharmaLink.com. FDA has
verified the Web site address, but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register.
To register by mail, please send your
name, title, firm name, address,
telephone and fax numbers, email, and
payment information for the fee to
Xavier University, Attention: Mason
Rick, 3800 Victory Pkwy., Cincinnati,
OH 45207–5471. An email will be sent
confirming your registration.
Attendees are responsible for their
own accommodations. The conference
headquarter hotel is the Downtown
VerDate Sep<11>2014
18:01 Jan 26, 2015
Jkt 235001
Cincinnati Hilton Netherlands Plaza, 35
West 5th Street, Cincinnati, OH 45202,
513–421–9100. To make reservations
online, please visit the ‘‘Venue &
Logistics’’ link at https://
www.XavierPharmaLink.com. The hotel
is expected to sellout during this
timeframe, so early reservation in the
conference room-block is encouraged.
If you need special accommodations
due to a disability, please contact Marla
Phillips (see Contact Persons) at least 7
days in advance of the conference.
SUPPLEMENTARY INFORMATION: The
public conference helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
conference will engage those involved
in FDA-regulated global supply chain
quality and management through the
following topics:
• Major Changes at FDA Affecting You
PO 00000
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Sfmt 4703
• FDA-Driven Initiatives through Food
and Drug Administration Safety and
Innovation Act Implementation
• Held at the Border? Understand Why
• Toyota Production System—Cultural
Requirements
• Barriers to Quality and Supply Chain
Excellence
• Establishing Good Supply Practices
• Medicines and Healthcare Products
Regulatory Agency Perspective on
Global Supply Chain Challenges
• Systematic Approach to Managing
Your Global Supply Chain
• Deep Dive Lunch Session—Clinically
Relevant Metrics
• Deep Dive Lunch Session—Data
Integrity: How To Verify You Are
Okay
• Deep Dive Lunch Session—Integrity
of Supply Workshop
• Nobel Prize-Based Alignment
Optimization
E:\FR\FM\27JAN1.SGM
27JAN1
Agencies
[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4288-4289]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01409]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
American Association of Pharmaceutical Scientists/American
College of Clinical Pharmacology/American Society for Clinical
Pharmacology and Therapeutics/Food and Drug Administration Cosponsored
Workshop on ``Evaluating and Modernizing Our Approaches for Food-Effect
Assessment''
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Evaluating and Modernizing our Approaches for Food-
Effect Assessment,'' cosponsored with the American Association of
Pharmaceutical Scientists (AAPS), the American College of Clinical
Pharmacology (ACCP), and the American Society for Clinical Pharmacology
and Therapeutics (ASCPT). The goals of this public workshop are to
facilitate discussion on current scientific approaches on assessing the
effect of food on the pharmacokinetics and pharmacodynamics of drugs
and to initiate constructive discussion and information sharing among
relevant stakeholders on the influence of food-effects on the
pharmacokinetic properties of therapeutics in order to optimize dose
and dosing regimens.
Date and Time: The workshop will be held on February 2, 2015, from
8 a.m. to 5 p.m., February 3, 2015, from 8 a.m. to 5 p.m., and February
4, 2015, from 8 a.m. to 12:15 p.m.
Location: The workshop will be held at the Renaissance Baltimore
Harborplace Hotel, 202 East Pratt St., Baltimore, MD 21202.
Contacts: FDA: Padmaja Mummaneni, Food and Drug Administration,
Center for Drug Evaluation and Research, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 2164, Silver Spring, MD 20993, 301-796-2027,
padmaja.mummaneni@fda.hhs.gov.
AAPS: For questions related to this event, please contact AAPS at
registration@aaps.org.
Registration: Workshop information and the registration link are
posted at the AAPS meetings and professional development conference
site. To register for the workshop, please visit https://www.aaps.org/Meetings_and_Professional_Development/Conference_Mini_Sites/AAPS_WS_Food/Register/. The cost of registration is as follows:
Member $1,690
Nonmember $2,070
Government $650
Student $100
The registration fee will be waived for 50 FDA employees. If you
need special accommodations because of disability, please contact AAPS
at registration@aaps.org. Onsite registration on the day of the
workshop is available.
Additional Information about the Workshop: The workshop agenda and
additional background materials will be accessible at https://www.fda.gov/Drugs/NewsEvents/ucm428914.htm to all registrants.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's guidance for industry entitled ``Food-Effect Bioavailability
and Fed Bioequivalence Studies'' (Food-Effect Guidance) is an important
tool in the development of new oral therapeutics. Studies are conducted
according to the principles described for every new drug that is
intended to be administered by the oral route. The Food-Effect Guidance
was first published in 2002. Since that time, numerous studies have
been reported in the literature in an effort to address a number of
different aspects related to assessing the effect of food on the
pharmacokinetics and pharmacodynamics of drugs. Predominantly, these
studies have addressed the impact of food composition on the physiology
of drug absorption. In vitro studies have aimed at elucidating the
individual mechanism(s) of drug absorption, and a number of in vivo
studies have addressed the effects of different meal compositions on
the pharmacokinetics of drugs.
FDA has undertaken an effort to revise the 2002 Food-Effect
Guidance and is seeking feedback from academia, industry, and other
stakeholders on several issues. FDA, AAPS, ACCP, and ASCPT agreed to
cosponsor this workshop to provide a forum for input on the best
available science on this topic from academia, industry, other
stakeholders, and regulators.
[[Page 4289]]
II. Goals and Objectives
To provide a forum for open discussion between industry,
academia, other stakeholders, and FDA around proposed changes to the
Food-Effect Guidance.
To seek feedback from industry, academia, and other
stakeholders on FDA's proposals and to seek any additional input that
will benefit decision making on a guidance revision on the topic.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01409 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P