Draft Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled “Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements” and “Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format.” These draft guidances are two of a series of guidance documents intended to assist applicants in complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products published elsewhere in this issue of the Federal Register. Elsewhere in this issue of the Federal Register, the agency is announcing the availability of two guidances on the content and format of the “Clinical Studies” and “Adverse Reactions” sections of labeling.

DATES:

Submit written or electronic comments on the draft guidances by April 24, 2006. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidances 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 to the Office of Communication, Training, and Manufacturers Assistance (HFD-040), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The draft guidances may also be obtained by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidances 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT:

Janet Norden, Center for Drug Evaluation and Research (HFD-40), Food and Drug Administration, 10903 New Hampshire Ave., bldg. W022, rm. 4202, Silver Spring, MD 20993, 301-796-2270, or

Toni Stifano, Center for Biologics Evaluation and Research (HFM-600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6190.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 22, 2000 (65 FR 81082), FDA published a proposed rule to revise the content and format of prescription drug labeling. The agency's final rule amending the requirements for the content and format of labeling for human prescription drug and biological products is published elsewhere in this issue of the Federal Register. The new 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. The final rule requires that labeling of new and recently approved products include highlights of prescribing information and a table of contents. It reorders certain sections of labeling, based on the importance of the information to practitioners and the frequency with which practitioners refer to a section, and makes minor content changes.

II. The Draft Guidances

FDA is developing guidance on how to implement the new requirements as well as a series of guidances on selected sections of prescription drug labeling. This document announces the availability of two draft guidances entitled “Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements” and “Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format.” FDA developed these draft guidances to accompany the publication of the final rule, published elsewhere in this issue of the Federal Register, on the content and format of prescription drug labeling.

• The draft guidance entitled “Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements” provides recommendations on issues to consider when revising labeling for approved products to meet the new requirements, issues to consider when developing highlights of prescribing information, how to format labeling, and other procedural information.
• The draft guidance entitled “Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format” provides recommendations on how to select, characterize, and organize information for inclusion in the “Warnings and Precautions” and “Contraindications” sections, as well as what information to include in a boxed warning.

Elsewhere in this issue of the Federal Register, the agency is announcing the availability of guidances on the content and format of the “Clinical Studies” and “Adverse Reactions” sections of labeling. These final guidances were previously published in draft for comment.

These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidances, when finalized, will represent the agency's current thinking on these topics. They do not create or confer any rights for or on any person and do 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.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidances. Submit a single copy of electronic commments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should identify clearly which guidance they are commenting on and should be identified with the docket number found in brackets in the heading of this document. The draft guidances and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Paperwork Reduction Act of 1995

These draft guidances contain information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection(s) of information in the draft guidances are estimated in section “VIII. Paperwork Reduction Act of 1995” of the final rule entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” published elsewhere in this issue of the Federal Register.

V. 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 .