[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39710-39711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16244]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0529]


Draft Guidance for Industry on Organ-Specific Warnings: Internal 
Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-
Counter Human Use--Labeling for Products That Contain Acetaminophen; 
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availability of a draft guidance for industry entitled ``Organ-Specific 
Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug 
Products for Over-the-Counter Human Use--Labeling for Products That 
Contain Acetaminophen.'' The draft guidance is intended to inform 
manufacturers of certain over-the-counter (OTC) internal analgesic, 
antipyretic, and antirheumatic (IAAA) drug products that contain

[[Page 39711]]

acetaminophen of the circumstances in which FDA intends to exercise 
enforcement discretion with regard to the liver warning required in the 
labeling.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 4, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Tina Walther, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 5108, Silver Spring, MD 20993-0002, 301-
796-5086.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, 
and Antirheumatic Drug Products for Over-the-Counter Human Use--
Labeling for Products That Contain Acetaminophen.'' In the Federal 
Register of December 26, 2006 (71 FR 77314), FDA published a proposed 
rule on organ-specific warnings and related labeling for OTC IAAA drug 
products. In the Federal Register of April 29, 2009 (74 FR 19385), FDA 
published the final rule (2009 final rule). In the Federal Register of 
November 25, 2009 (74 FR 61512), FDA published a technical amendment to 
clarify several provisions in response to industry feedback. The 2009 
final rule, as amended, changed some of the labeling requirements for 
OTC IAAA drug products to inform consumers about the risk of liver 
injury when using acetaminophen and the risk of stomach bleeding when 
using nonsteroidal anti-inflammatory drugs. It went into effect April 
29, 2010.
    The labeling for OTC IAAA products that contain acetaminophen and 
are labeled for adults only, must include the following liver warning:

    Liver warning: This product contains acetaminophen. Severe liver 
damage may occur if you take  more than [insert maximum 
number of daily dosage units] in 24 hours, which is the maximum 
daily amount [optional: ``For this product'']  with other 
drugs containing acetaminophen  3 or more alcoholic drinks 
every day while using this product.

    Although the currently proposed total daily dose of acetaminophen 
is 4,000 milligrams (mg), some OTC IAAA products that contain 
acetaminophen have directions for use that provide a maximum daily dose 
of acetaminophen for the product that is less than 4,000 mg. For 
example, for some OTC IAAA drug products that contain both 
acetaminophen and one or more other active ingredients, the maximum 
number of daily dosage units might be limited by an active ingredient 
other than acetaminophen, which could result in a maximum daily dose of 
acetaminophen that is less than 4,000 mg for that product. The optional 
statement, ``for this product,'' in the first bullet of the liver 
warning is intended to address these situations, by clarifying that the 
maximum number of daily dosage units for a product might not reflect 
the maximum daily dose of acetaminophen.
    However, the Agency understands that in certain circumstances, 
despite this optional statement, the wording of the first bulleted 
warning might be interpreted as indicating that severe liver damage is 
associated with a total daily dose of acetaminophen that is less than 
4,000 mg. This suggestion is not the intent of the requirement that the 
liver warning be included in the labeling. To address this potential 
confusion, the Agency intends to exercise enforcement discretion with 
respect to the liver warning required in the circumstances described in 
this draft guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on this topic. 
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. 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 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16244 Filed 7-3-12; 8:45 am]
BILLING CODE 4160-01-P