[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Draft Guidance for Industry on Best Practices in Developing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availability of a draft guidance for industry entitled ``Best Practices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 The draft guidance focuses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 The draft guidance describes naming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 FDA is issuing this draft
guidance to help drug and biologic product sponsors develop proprietary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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 28, 2014.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug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 The draft guidance may also be obtained by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Submit electronic comments on the draft guidance to http://www.regulations.gov.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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