[Federal Register Volume 75, Number 25 (Monday, February 8, 2010)]
[Notices]
[Pages 6210-6211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2660]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0592]


Guidance for Industry on the Contents of a Complete Submission 
for the Evaluation of Proprietary Names; 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 industry entitled ``Contents of a 
Complete Submission for the Evaluation of Proprietary Names'' 
(proprietary names submission guidance). This guidance provides 
recommendations to industry regarding the submission of a complete 
package that FDA intends to use to assess the safety of proposed 
proprietary names for drugs, including biological products, and other 
factors that, in association with the name, can contribute to 
medication errors. In addition, FDA intends to use this information in 
the assessment of promotional aspects of proposed proprietary names.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of the 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 (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Carol Holquist, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4416, Silver Spring, MD 20993-0002, 301-
796-2360; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Contents of a Complete Submission for the Evaluation of 
Proprietary Names.'' In performance goals under the September 27, 2007, 
reauthorization of the Prescription Drug User Fee Act (PDUFA IV), FDA 
agreed to implement various measures to reduce medication errors

[[Page 6211]]

related to look-alike and sound-alike proprietary names, unclear label 
abbreviations, acronyms, dose designations, and error-prone label and 
packaging designs. Among these measures, FDA agreed to publish guidance 
on the contents of a complete submission package for a proposed 
proprietary name for a drug/biological product. FDA also agreed to 
performance goals for review of proprietary names submitted during the 
investigational new drug application (IND) phase or with a new drug 
application (NDA) or biologics license application (BLA); the goals 
stipulate that a complete submission is required to begin the review 
clock. (See section IX.A of the goals letter at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm).
    This proprietary names submission guidance is intended to promote 
prevention of medication errors by assisting industry in the submission 
of complete product information that will help FDA to evaluate the 
safety of proposed proprietary drug and biological product names, 
taking into account other factors that, in association with the name, 
can contribute to medication errors. In addition, FDA intends to use 
this information in the assessment of promotional aspects of proposed 
proprietary names.
    This proprietary names submission guidance applies to prescription 
drug products, including biologics, that are the subject of an IND, 
NDA, abbreviated new drug application (ANDA), or BLA; and 
nonprescription drug products that are the subject of an IND, NDA, or 
ANDA.
    The proprietary names submission guidance does not address other 
performance goals under PDUFA IV, including developing FDA internal 
policies and procedures to ensure that proprietary name review goals 
are met; developing guidance on best practices for naming, labeling, 
and packaging drugs and biologics to reduce medication errors; 
developing guidance on proprietary name evaluation best practices; and 
developing and implementing a pilot program for evaluating proposed 
proprietary names. These performance goals are or will be addressed 
elsewhere.
    In the Federal Register of November 24, 2008 (73 FR 71009), FDA 
announced the availability of a draft guidance for industry entitled 
``Contents of a Complete Submission for the Evaluation of Proprietary 
Names'' and invited comments. Many comments discussed topics that were 
beyond the scope of the proprietary names submission guidance, 
including other performance goals under PDUFA IV that are addressed in 
other public dockets. These comments concerned the contents of any 
industry-sponsored reviews and data for submission to FDA under the 
pilot program described in the FDA concept paper entitled ``PDUFA Pilot 
Project Proprietary Name Review'' (concept paper) (73 FR 58604, October 
7, 2008). FDA acknowledges that information in the proprietary names 
submission guidance could be useful to participants in the voluntary 
pilot program for proprietary name review. However, the proprietary 
names submission guidance does not describe the information needed by 
FDA to evaluate proposed proprietary names under the pilot program. 
Rather, the purpose is limited to informing industry about what 
information is needed by FDA to evaluate proposed proprietary names 
within PDUFA IV goal dates under the traditional review process. We 
welcome submission of comments about the tools and methods FDA uses for 
its analysis of proposed proprietary names under the pilot program to 
docket number FDA-2008-N-0281.
    After considering comments on the draft guidance, FDA has issued 
the proprietary names submission guidance. Changes made to the guidance 
were editorial and primarily clarifying in response to comments. The 
revisions included: (1) Clarifying that the purpose of this guidance is 
to provide industry with a complete listing of the information FDA 
needs to evaluate a proposed proprietary name under the traditional 
review process; (2) adding the respective PDUFA IV review performance 
timeframes for complete submissions of a proposed proprietary name 
submitted during the IND phase or with an NDA, BLA, or supplement; and 
(3) referencing the concept paper\1\ for a complete discussion of the 
tools and methods used for FDA's safety evaluation that are mentioned 
in the proprietary names submission guidance.
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    \1\ Available on the Internet at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072229.pdf.
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    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 the contents of a complete submission for 
the evaluation of proprietary names. 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) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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. Paperwork Reduction Act of 1995

    This 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). The 
collections of information in 21 CFR part 312 and FDA Form 1571 have 
been approved under OMB control number 0910-0014. The collections of 
information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001. The collections of information in 21 CFR part 601 and 
FDA Form 356h have been approved under OMB control number 0910-0338.

IV. Electronic Access

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

    Dated: February 3, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2660 Filed 2-5-10; 8:45 am]
BILLING CODE 4160-01-S