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Draft Guidance for Industry on the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability

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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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” This draft guidance is one of a series of guidance documents intended to assist applicants in complying with new FDA regulations on the content and format of labeling for human prescription drug and biological products. The draft guidance describes the recommended information to include in the Clinical pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products.

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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by June 1, 2009.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels to assist the 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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

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FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: Paul Hepp, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 1270, Silver Spring, MD 20993-0002, 301-796-1538; or

Lei Zhang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3106, Silver Spring, MD 20993-0002, 301-796-1635; or

Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17),Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

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SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” to revise the agency's previous regulations on labeling (effective June 30, 2006). The new FDA regulations are designed to make information in prescription drug labeling easier for health care practitioners to access, read, and use, thereby increasing the extent to which practitioners rely on labeling for prescribing decisions. Among other things, the new FDA regulations require that the Clinical pharmacology section of the labeling contain the following subsections: Mechanism of action, Pharmacodynamics, and Pharmacokinetics (§ 201.57(c)(13)(i) (21 CFR 201.57(c)(13)(i)).

FDA is announcing the availability of a draft guidance for industry entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” The draft guidance is intended to assist applicants in producing the Clinical pharmacology section of labeling for human prescription drug and biological products that is consistent, understandable, organized, clinically useful, and in compliance with the new requirements of § 201.57(c)(13)(i). The ultimate goal of the guidance is to optimize patient drug therapy.

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 on the content and format of the clinical pharmacology section of labeling for human prescription drug and biological products. 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 this document. 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. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Start Printed Page 9251Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information related to the content and format of labeling have been approved under OMB control no. 0910-0572; the collections of information related to pharmacogenomic data have been approved under OMB control no. 0910-0557.

IV. 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.regulations.gov.

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Dated: February 20, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E9-4372 Filed 3-2-09; 8:45 am]

BILLING CODE 4160-01-S