
[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57394-57395]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1067]


Draft Guidance for Industry on Patient Counseling Information 
Section 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availability of a draft guidance for

[[Page 57395]]

industry entitled ``Patient Counseling Information Section of Labeling 
for Human Prescription Drug and Biological Products--Content and 
Format.'' The recommendations in the draft guidance are intended to 
help ensure that the labeling is clear, useful, informative, and to the 
extent possible, consistent in content and format.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 18, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Jonas Santiago, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6358, Silver Spring, MD 20993-0002, 301-
796-5346; 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 draft guidance for industry 
entitled ``Patient Counseling Information Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format.'' This 
draft guidance provides recommendations for the ``Patient Counseling 
Information'' section on the following: How to decide what topics to 
include in the section, how to present information within the section, 
and how to format and organize section contents.
    This guidance is one of a series of guidances FDA is developing, or 
has 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 3922), FDA published a 
final rule on labeling for human prescription drug and biological 
products. The final rule and additional guidances can be accessed at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm. 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.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the Agency's current thinking on the content and format of 
the ``Patient Counseling Information'' 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 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. The Paperwork Reduction Act of 1995

    This draft guidance also 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 201.56 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: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22644 Filed 9-17-13; 8:45 am]
BILLING CODE 4160-01-P


