[Federal Register Volume 74, Number 40 (Tuesday, March 3, 2009)]
[Notices]
[Pages 9250-9251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0095]


Draft Guidance for Industry on the Clinical Pharmacology Section 
of Labeling for Human Prescription Drug and Biological Products--
Content and Format; 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availability of a draft guidance for industry entitled ``Clinical 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 This draft guidance is one 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 The draft 
guidance describes the recommended information to include in the 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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comments on the draft guidance to the Division of Dockets Management 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.

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.

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(Sec.  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 Sec.  
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

[[Page 9251]]

Management 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.

    Dated: February 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4372 Filed 3-2-09; 8:45 am]
BILLING CODE 4160-01-S