[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Notices]
[Pages 35986-35987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14632]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0544]
Guidance for Industry on Toll-Free Number Labeling and Related
Requirements for Over-the-Counter and Prescription Drugs Marketed With
Approved Applications; Small Entity Compliance Guide; 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 small business entities entitled ``Toll-
Free Number Labeling and Related Requirements for Over-the-Counter and
Prescription Drugs Marketed With Approved Applications; Small Entity
Compliance Guide.'' This guidance is intended to help small businesses
understand and comply with the requirements of the final rule regarding
labeling of drugs with a toll-free number for adverse event reporting,
which was published in the Federal Register on October 28, 2008 (final
rule). The guidance describes certain requirements of the final rule in
plain language and provides answers to common questions on how to
comply with the rule. FDA prepared this guidance in accordance with the
Small Business Regulatory Fairness Act.
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. 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: Alisea Crowley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5196, Silver Spring, MD 20993-0002, 301-
796-3110.
[[Page 35987]]
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for small business
entities entitled ``Toll-Free Number Labeling and Related Requirements
for Over-the-Counter and Prescription Drugs Marketed With Approved
Applications; Small Entity Compliance Guide.''
This guidance summarizes the final rule published in the Federal
Register of October 28, 2008 (73 FR 63886), which requires the labeling
of each human drug product for which an application is approved under
section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to
include: (1) The toll-free number maintained by FDA for the purpose of
receiving reports of adverse events regarding drugs and (2) a statement
that the number is to be used for reporting purposes only, and not to
receive medical advice. The final rule requires that the toll-free
number and reporting information be:
Included in all FDA-approved Medication Guides for
products approved under section 505,
Provided to patients by authorized dispensers or
pharmacies with each prescription drug product approved under section
505, and
Included in the labeling of certain over-the-counter drugs
approved under section 505.
FDA has previously issued a guidance for industry entitled
``Medication Guides--Adding a Toll-Free Number for Reporting Adverse
Events'' (June 2009) to assist new drug application holders with
revising FDA-approved Medication Guides to comply with the first of
these requirements. This guidance is intended to assist small
businesses and others with implementing the two other requirements in
the final rule: Distribution of the toll-free number information to
patients with each prescription (or refill) and adding the toll-free
number information to the labeling of certain OTC drugs.
FDA is issuing this small entity compliance guide as level 2
guidance consistent with FDA's good guidance practices regulation (21
CFR 10.115). The guidance represents the Agency's current thinking on
side effects statement requirements as set forth in the final rule. 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 to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: June 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14632 Filed 6-14-12; 8:45 am]
BILLING CODE 4160-01-P