[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4288-4289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01409]


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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.

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    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, 
[email protected].
    AAPS: For questions related to this event, please contact AAPS at 
[email protected].
    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 http://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 [email protected]. 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 http://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]
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