[Federal Register Volume 75, Number 158 (Tuesday, August 17, 2010)]
[Notices]
[Page 50770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20252]



[[Page 50770]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0404]


Guidance for Industry on Organ-Specific Warnings: Internal 
Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-
Counter Human Use--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 ``Organ 
Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic 
Drug Products for Over-the-Counter Use--Small Entity Compliance 
Guide.'' This guidance is intended to help small businesses understand 
and comply with FDA's regulation entitled ``Organ-Specific Warnings: 
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for 
Over-the-Counter Use; Final Monograph'' (74 FR 19385, April 29, 
2009).\1\ The guidance describes the organ-specific labeling 
requirements in plain language and provides answers to common questions 
on how to comply with the rule. This guidance was prepared in 
accordance with the Small Business Regulatory Fairness Act.
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    \1\ As amended November 25, 2009 (74 FR 61512).

DATES:  Submit either electronic or written comments on agency 
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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:  Arlene Solbeck, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5426, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a new guidance for small 
business entities entitled ``Organ-Specific Warnings: Internal 
Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-
Counter Human Use--Small Entity Compliance Guide.'' This small entity 
compliance guide applies to over-the-counter (OTC) internal analgesic, 
antipyretic, and antirheumatic (IAAA) drug products that contain 
acetaminophen or nonsteroidal anti-inflammatory drug ingredients 
(NSAIDs). The labeling of those products must include specific warnings 
about the risks of liver injury when using acetaminophen, and stomach 
bleeding when using nonsteroidal NSAIDs, as well as related information 
appearing on the principal display panel. Manufacturers must be in 
compliance with the rule beginning on April 29, 2010.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on organ-specific labeling requirements for 
OTC IAAA drug 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 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: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20252 Filed 8-16-10; 8:45 am]
BILLING CODE 4160-01-S