[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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