[Federal Register Volume 75, Number 55 (Tuesday, March 23, 2010)]
[Notices]
[Pages 13766-13767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6322]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0201] (formerly Docket No. 2007D-0118)


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.

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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

[[Page 13767]]

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.
[FR Doc. 2010-6322 Filed 3-22-10; 8:45 am]
BILLING CODE 4160-01-S