Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling; Availability, 53696-53697 [E6-15058]

Download as PDF 53696 Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Notices Number of respondents Average hours per response Total hours Formative focus groups for information tools .......................................................................... Cognitive testing of information tools ...................................................................................... Clinician interviews for information tools ................................................................................. Decision aid laboratory testing ................................................................................................ Formative focus groups for decision aids ............................................................................... Automated/web-based surveys for product evaluation ........................................................... Telephone interviews for product evaluation ........................................................................... Focus groups for product evaluation ....................................................................................... 120 500 160 100 60 600 100 20 1 1 .75 1 1 .163 1 1 120 500 120 100 60 98 100 20 Totals ................................................................................................................................ 1,740 Type of survey Estimated Costs to the Federal Government DEPARTMENT OF HEALTH AND HUMAN SERVICES The maximum cost to the Federal Government is $750,000 annually for FY 2007, FY 2008, and FY 2009. Most of the work will be carried out through contracts. The costs were estimated at $200 for each face-to-face interview, $100 for each telephone interview, $5,000 for each focus group, $10,000 for Web-based surveys, and $20,000 for each laboratory testing module. Any deviation from these limits will be noted in reports made to OMB with respect to a particular study or studies conducted under the clearance. Food and Drug Administration Request for Comments sroberts on PROD1PC70 with NOTICES In accordance with the above-cited legislation, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of health care information dissemination functions of AHRQ, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: August 31, 2006. Carolyn M. Clancy, Director. [FR Doc. 06–7585 Filed 9–11–06; 8:45 am] BILLING CODE 4160–90–M VerDate Aug<31>2005 16:16 Sep 11, 2006 Jkt 208001 [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. 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. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 NA 1,186 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 https:// 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 E:\FR\FM\12SEN1.SGM 12SEN1 Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Notices on drug metabolism/transport and drugdrug 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 https:// www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/ guidelines.htm, or https://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 DEPARTMENT OF HOMELAND SECURITY [Docket No. FLETC–2006–0003] FOR FURTHER INFORMATION CONTACT: Advisory Committee to the Office of State and Local Training Reba Fischer, Designated Federal Officer, 912–267–2343, reba.fischer@dhs.gov. Federal Law Enforcement Training Center (FLETC), DHS. ACTION: Notice of Federal Advisory Committee Meeting. AGENCY: sroberts on PROD1PC70 with NOTICES VerDate Aug<31>2005 16:16 Sep 11, 2006 Jkt 208001 Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. App. 1 et seq. (Pub. L. 92–463). The mission of the Advisory Committee to the Office of State and Local Training is to advise and make recommendations on matters relating to the selection, development, content and delivery of training services by the OSL/FLETC to its State, local, campus, and tribal law enforcement customers. SUPPLEMENTARY INFORMATION: The Advisory Committee to the Office of State and Local Training (OSL) will meet on October 4, 2006, in Brunswick, GA. The meeting will be open to the public. DATES: The Advisory Committee to the Office of State and Local Training will meet Wednesday, October 4, 2006, from 8 a.m. to 3 p.m. Please note that the meeting may close early if the committee has completed its business. ADDRESSES: The meeting will be held at the Holiday Inn Express, 138 Glynco Parkway, Brunswick, GA. Send written material, comments, and/or requests to make an oral presentation to Reba Fischer, Designated Federal Officer SUMMARY: (DFO), 1131 Chapel Crossing Road (TH 396), Glynco, GA 31524. Written materials, comments, and/or requests to make an oral presentation at the meeting should reach the contact person listed below by September 22, 2006. Requests to have a copy of your material distributed to each member of the committee prior to the meeting should reach the contact person at the address below by September 22, 2006. Comments must be identified by FLETC–2006–0003 and may be submitted by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • E-mail: reba.fischer@dhs.gov. Include docket number in the subject line of the message. • Fax: (912) 267–3531. (Not a toll-free number). • Mail: Reba Fischer, Federal Law Enforcement Training Center, Department of Homeland Security, 1131 Chapel Crossing Road, Townhouse 396, Glynco, GA 31524. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and the docket number for this action. Comments received will be posted without alteration at www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received by the Advisory Committee to the Office of State and Local Training, go to www.regulations.gov. Draft Agenda The draft agenda for this meeting includes briefings and discussion on training; new initiatives; training validation; strategic goals; and the training needs of State, local, campus, and tribal law enforcement officers. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 53697 Procedural This meeting is open to the public. Please note that the meeting may close early if all business is finished. At the discretion of the Co-chairs, members of the public may make an oral presentation during the meeting. If you would like to make an oral presentation at the meeting, please notify Reba Fischer. If you would like a copy of your material distributed to each member of the Committee in advance of the meeting, please submit 25 copies to Reba Fischer by September 22, 2006. Visitors must pre-register attendance to ensure adequate seating. Please provide your name and telephone number by close of business on September 22, 2006, to Reba Fischer (contact information above). Information on Services for Individuals With Disabilities For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Reba Fischer (contact information above) as soon as possible. Dated: September 1, 2006. Seymour Jones, Deputy Assistant Director, Office of State and Local Law Enforcement Training. [FR Doc. E6–15075 Filed 9–11–06; 8:45 am] BILLING CODE 4810–32–P DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket Number DHS–2006–0047] Privacy Act; Systems of Records Office of Security, Department of Homeland Security. ACTION: Notice of Privacy Act system of records. AGENCY: SUMMARY: Pursuant to the Privacy Act of 1974, the Department of Homeland Security, Office of Security, proposes to add a new system of records to the Department’s inventory, entitled the ‘‘Personal Identity Verification Management System.’’ This system will support the administration of the HSPD–12 program that directs the use of a common identification credential for both logical and physical access to federally controlled facilities and information systems. This system will enhance security, increase efficiency, reduce identify fraud, and protect personal privacy. DATES: The established system of records will be effective October 12, E:\FR\FM\12SEN1.SGM 12SEN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 
https://www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/
guidelines.htm, or https://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

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