[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57394-57395]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on Patient Counseling Information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availability of a draft guidance for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 The recommendations in the draft guidance are intended to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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 18, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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