2010-6322. Guidance for Industry on the Content and Format of the Dosage and Administration Section 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 a guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” This guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and in complying with the requirements in the final rule on the content and format of labeling for prescription drug and biological products. This guidance is intended to help applicants select information for inclusion in the “Dosage and Administration” section of labeling and to help them organize that information.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this 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 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 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 guidance document.

FOR FURTHER INFORMATION CONTACT:

Joseph P. Griffin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993-0002, 301-796-2270; or

Stephen 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

FDA is announcing the availability of a guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” The guidance provides recommendations on how to select information for inclusion in the “Dosage and Administration” section of labeling and how to organize information within the section. This guidance is one of a series of guidances FDA is developing, or has developed, to assist applicants with the format and content of certain sections of the labeling for prescription drugs. In the Federal Register of January 24, 2006 (71 FR 3998), FDA issued final guidances on the format and content of the “Adverse Reactions” and “Clinical Studies” sections of labeling and draft guidances on implementing the new labeling requirements for prescription drugs and the format and content of the “Warnings and Precautions,” “Contraindications,” and “Boxed Warning” sections of labeling. In the Federal Register of March 3, 2009 (74 FR 9250), FDA issued a draft guidance on the format and content of the “Clinical Pharmacology” section of labeling. The labeling requirements (71 FR 3922) and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use.

On April 9, 2007, FDA issued a draft of this guidance on the dosage and administration section of labeling to obtain public comment (72 FR 17561). FDA received 10 comments—9 from the pharmaceutical industry (individual companies, a trade association, and a consultant) and 1 from an academic medical center. The comments offered generally favorable impressions of the guidance and its goals. The bulk of the comments focused on clarifications and further illustrations of issues discussed in individual sections and subsections of the guidance. FDA made an effort to address as many of the identified concerns as possible. A recurring general concern in many industry comments was that the guidance should more clearly differentiate content that is required when relevant to a given drug from content that is recommended. FDA has attempted to make the distinction as clear as possible by using the word “must” and citing the relevant section of the regulation whenever the guidance is discussing required content and using the word “should” when discussing recommended content.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the content and format of the “Dosage and Administration” 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 guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information in 21 CFR 201.57 have been approved under OMB control number 0910-0572.

IV. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm, http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm, or http://www.regulations.gov.

Dated: March 18, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.