[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30852-30853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0622]


Draft Guidance for Industry on Best Practices in Developing 
Proprietary Names for Drugs; 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availability of a draft guidance for industry entitled ``Best Practices 
in Developing Proprietary Names for Drugs.'' The draft guidance focuses 
on the safety aspects in the development and selection of proposed 
proprietary names for all prescription and nonprescription human drug 
products and biological products. The draft guidance describes naming 
design practices to help avoid medication errors and provides a 
qualitative systematic framework for evaluating proprietary names 
before submitting them for FDA review. FDA is issuing this draft 
guidance to help drug and biologic product sponsors develop proprietary 
names that do not cause or contribute to medication errors or otherwise 
contribute to the misbranding of the drug.

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 comments 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 28, 2014.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 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, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your requests. The draft guidance may also be obtained by 
calling CBER at 1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Kellie Taylor, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993-0002, 301-
796-0157, or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Best Practices in Developing Proprietary Names for Drugs.'' 
FDA has long recognized the importance of proprietary name confusion as 
a potential cause of medication errors, and has addressed this issue 
repeatedly in recent decades. Our primary focus has been to develop and 
communicate to sponsors a systematic, standardized, and transparent 
approach to proprietary name evaluation within the product review and 
approval process. As part of this initiative, FDA held public meetings 
in June and December 2003 to discuss the methods used for proprietary 
name evaluation. In 2007, FDA formally committed to certain performance 
goals (under the reauthorization of the Prescription Drug User Fee Act 
(PDUFA IV) (Public Law 110-85), including implementing measures to 
reduce medication errors related to look-alike and sound-alike 
proprietary names (PDUFA IV performance goals). In 2008, FDA held a 
public meeting to further discuss testing and evaluating proprietary 
names, and initiating a pilot project on proprietary name review. The 
2008 meeting focused on advances and current limitations in the science 
of proprietary name evaluation, FDA's recommendations for best 
practices in the absence of a ``gold standard,'' and details of the 
proposed pilot project. The participating expert panel judged all the 
evaluation methods proposed by FDA to be complementary and of value in 
the proprietary name testing process. We are issuing this guidance in 
partial fulfillment of the PDUFA IV performance goals.
    This draft guidance document, which addresses minimizing risks 
through the design of drug product naming, is the last in a series of 
three guidance documents that FDA is issuing to help sponsors minimize 
the potential for medication errors when designing and developing 
products. The first draft guidance, published in the Federal Register 
on December 13, 2012 (77 FR 74196), focuses on minimizing risks 
associated with the design of the drug product and its container 
closure system. The second draft guidance, published in the Federal 
Register on April 24, 2013 (78 FR 24211), focuses on safety aspects of 
the container label and carton labeling design.
    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 best 
practices for developing and selecting proposed proprietary names to 
minimize medication errors. 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. Paperwork Reduction Act of 1995

    This draft guidance 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). 
Proprietary name information submitted under 21 CFR part 314 has been 
approved under OMB control number 0910-0001, and proprietary name 
information submitted under 21 CFR part 601 has been

[[Page 30853]]

approved under OMB control number 0910-0338.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12348 Filed 5-28-14; 8:45 am]
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