[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12760-12761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0153; formerly 2005D-0011]


Guidance for Industry on Labeling for Human Prescription Drug and 
Biological Products--Implementing the Physician Labeling Rule Content 
and Format Requirements; 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 ``Labeling for Human 
Prescription Drug and Biological Products--Implementing the PLR Content 
and Format Requirements.'' This guidance is intended to assist 
applicants in complying with the content and format requirements 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. It will assist applicants in developing labeling 
for new products, revising existing labeling, and implementing the 
requirements on content and format of labeling for human prescription 
drug and biological products (71 FR 3922), which appeared in the 
Federal Register of January 24, 2006. The rule is commonly referred to 
as the ``Physician Labeling Rule'' (PLR) because it addresses 
prescription drug labeling that is used by prescribers and other health 
care practitioners.

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, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002 or 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. 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.
    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: Lori Bickel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993-0002, 301-
796-0210; 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 ``Labeling for Human Prescription Drug and Biological 
Products--Implementing the PLR Content and Format Requirements.'' The 
guidance provides recommendations on how to create professional 
labeling consistent with the requirements on content and format of 
labeling for human prescription drug and biological products under 
Sec. Sec.  201.56 and 201.57 (21 CFR 201.56 and 201.57) (71 FR 3922). 
The guidance also provides recommendations on how to organize labeling 
sections and what information should be included in each.
    This guidance is one of a series of guidances FDA is developing, or 
has

[[Page 12761]]

developed, to assist applicants with the content and format of the 
labeling for human prescription drug and biological products. In the 
Federal Register of January 24, 2006 (71 FR 3998), FDA announced the 
availability of final guidances on the content and format of the 
``Adverse Reactions'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075057.pdf) and 
``Clinical Studies'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075059.pdf) 
sections of labeling. In the Federal Register of October 19, 2009 (74 
FR 53507), FDA announced the availability of final guidance on 
determining established pharmacologic class for use in the Highlights 
of Prescribing Information (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM186607.pdf). In 
the Federal Register of March 23, 2010 (75 FR 13766), FDA announced the 
availability of final guidance on the content and format of the 
``Dosage and Administration'' section of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075066.pdf). In the Federal Register of October 12, 2011 (76 FR 
63303), FDA announced the availability of final guidance on the content 
and format of the ``Warnings and Precautions,'' ``Contraindications,'' 
and ``Boxed Warning'' sections of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075096.pdf) and in the Federal Register of March 3, 2009 (74 FR 
9250), FDA announced the availability of draft guidance on the content 
and format of the ``Clinical Pharmacology'' section of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM109739.pdf). The labeling requirements and these guidances 
are intended to make information in prescription drug labeling easier 
for health care practitioners to access, read, and use.
    On January 24, 2006, FDA announced the availability of draft 
guidance entitled ``Labeling for Human Prescription Drug and Biological 
Products--Implementing the New Content and Format Requirements'' to 
obtain public comment (71 FR 3998). FDA received a number of comments, 
most of which sought clarifications and illustrations of the issues 
discussed in individual sections of the guidance. FDA reviewed all 
received comments carefully during the finalization of the guidance and 
made clarifying changes based on input from these comments and comments 
from FDA reviewers with labeling expertise.
    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 implementing the PLR content and format 
requirements for 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

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 Sec. Sec.  201.56 and 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 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04195 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P