[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63303-63304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26297]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0694]


Guidance for Industry on Warnings and Precautions, 
Contraindications, and Boxed Warning Sections 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 guidance for industry entitled ``Warnings and 
Precautions, Contraindications, and Boxed Warning Sections of Labeling 
for Human Prescription Drug and Biological Products--Content and 
Format.'' This guidance is intended to assist applicants and reviewers 
in drafting the ``Warnings and Precautions, Contraindications, and 
Boxed Warning'' sections of labeling for human prescription drug and 
biological products. The recommendations in this guidance will help 
ensure that the labeling is clear, useful, informative, and to the 
extent possible, consistent in content and format.

DATES: Submit either electronic or written 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, 10001 New Hampshire Ave., 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

[[Page 63304]]

    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cheryl Grandinetti, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 3244, Silver Spring, MD 20993-0002, 301-
796-3516; 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 ``Warnings and Precautions, Contraindications, and Boxed 
Warning Sections of Labeling for Human Prescription Drug and Biological 
Products--Content and Format.'' The guidance provides recommendations 
on how to determine which adverse reactions are significant enough to 
warrant inclusion in the ``Warnings And Precautions'' section; how to 
decide what situations warrant a ``Contraindication''; and when to 
include a ``Boxed Warning.'' The guidance also provides recommendations 
on how to organize each section and what information to include when 
describing warnings and precautions, in situations when the use of the 
product is contraindicated, and in a boxed warning.
    This guidance is one of a series of guidances FDA is developing, or 
has developed, to assist applicants and reviewers with the content and 
format of certain sections of the labeling for human prescription drug 
and biological products. In the Federal Register of January 24, 2006 
(71 FR 3999), FDA issued final guidances on the content and format of 
the ``Adverse Reactions'' and ``Clinical Studies'' sections of 
labeling. In the Federal Register of October 19, 2009 (74 FR 53507), 
FDA issued a final guidance on determining established pharmacologic 
class for use in the highlights of prescribing information. In the 
Federal Register of March 23, 2010 (75 FR 13766), FDA issued a final 
guidance on the content and format of the ``Dosage and Administration'' 
section of labeling and in the Federal Register of March 3, 2009 (74 FR 
9250), FDA issued a draft guidance on the content and format of the 
``Clinical Pharmacology'' section of labeling. The new labeling 
requirements (final rule, January 24, 2006, 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 January 18, 2006, FDA issued a draft of this guidance on the 
``Warnings and Precautions, Contraindications, and Boxed Warning'' 
sections of the labeling to obtain public comment (71 FR 3998). FDA 
received a number of comments, most of which focused on clarifications 
and further illustrations of issues discussed in individual sections 
and subsections of the guidance. FDA reviewed all received comments 
carefully during the finalization of the guidance. Other than 
clarifying edits, no changes of significance were made to the final 
version of the guidance.
    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 ``Warnings 
and Precautions, Contraindications, and Boxed Warning'' sections 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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 and 201.56 have been 
approved under OMB control number 0910-0572.

IV. Electronic Access

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

    Dated: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-26297 Filed 10-11-11; 8:45 am]
BILLING CODE 4160-01-P