[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