[Federal Register Volume 71, Number 176 (Tuesday, September 12, 2006)]
[Notices]
[Pages 53696-53697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0344]


Draft Guidance for Industry on Drug Interaction Studies--Study 
Design, Data Analysis, and Implications for Dosing and Labeling; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Drug 
Interaction Studies--Study Design, Data Analysis, and Implications for 
Dosing and Labeling.'' This document is intended to provide 
recommendations to sponsors of new drug applications (NDAs), and 
biologic license applications (BLAs) for therapeutic biologics (drugs) 
on carrying out in vitro or in vivo drug-drug interaction studies. The 
draft guidance reflects the current view that the metabolism and 
transport of a new drug should be defined during drug development and 
that its interactions with other drugs should be explored as part of an 
adequate assessment of the safety and effectiveness of the drug.

DATES: Submit written or electronic comments on the draft guidance by 
November 13, 2006. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857; or the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the draft guidance 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Shiew-Mei Huang, Center for Drug Evaluation and Research (HFD-850), 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 
4550, Silver Spring, MD 20993-0002, 301-796-1541, or
    Toni Stifano, Center for Biologics Evaluation and Research (HFM-
600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-6190.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Drug Interaction Studies--Study Design, Data Analysis, and 
Implications for Dosing and Labeling.'' FDA previously published two 
guidance documents on the use of in vitro and in vivo approaches to 
study metabolism and metabolic drug-drug interactions entitled ``Drug 
Metabolism/Drug Interaction Studies in the Drug Development Process: 
Studies in Vitro'' and ``In Vivo Drug Metabolism/Drug Interaction 
Studies--Study Design, Data Analysis, and Recommendations for Dosing 
and Labeling.'' The draft guidance, when finalized, will replace these 
guidance documents. This draft guidance discusses study design, choice 
of interacting drugs, data analysis, and provides recommendations for 
dosing and labeling.
    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 agency's current thinking

[[Page 53697]]

on drug metabolism/transport and drug-drug interactions. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 5, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-15058 Filed 9-11-06; 8:45 am]
BILLING CODE 4160-01-S