
[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73322-73323]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28888]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Patient Counseling Information Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format; Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a guidance for industry entitled 
``Patient Counseling Information Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format.'' The 
recommendations in this guidance are intended to assist applicants in 
developing the ``Patient Counseling Information'' section of labeling 
and to help ensure that this section of labeling is clear, useful, 
informative, and to the extent possible, consistent in content and 
format. This guidance finalizes the draft guidance issued on September 
18, 2013.

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., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993, or the Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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.
    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: Jonas Santiago, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6348, Silver Spring, MD 20993-0002, 301-
796-5346; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Patient Counseling Information Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format.'' This 
guidance is intended to assist applicants in developing the Patient 
Counseling Information section of labeling required under 21 CFR 
201.57(c)(18). Recommendations include the following: (1) How to decide 
what topics to include in the section, (2) how to present information 
within the section, and (3) 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 
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 guidance finalizes the draft guidance issued on September 18, 
2013 (78 FR 57394). 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

[[Page 73323]]

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 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 201.56 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/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28888 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P


