[Federal Register Volume 73, Number 195 (Tuesday, October 7, 2008)]
[Notices]
[Pages 58604-58605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0281]


Pilot Program To Evaluate Proposed Name Submissions; Concept 
Paper

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice; availability.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a concept paper entitled ``PDUFA Pilot Project 
Proprietary Name Review.'' The concept paper provides information to 
pharmaceutical firms about how to evaluate proposed propriety names and 
submit the data generated from those evaluations to FDA for review 
under an anticipated pilot program. FDA plans to begin enrollment in 
the pilot program in fiscal year (FY) 2009.

[[Page 58605]]


DATES: Submit written or electronic comments on the pilot program at 
any time.

ADDRESSES: Submit written requests for single copies of the concept 
paper 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, Training, and Manufacturers Assistance (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD, 20852-
1448. The concept paper may also be obtained by mail by calling CBER at 
1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels 
to assist the office in processing your requests. Requests and comments 
should be identified with the docket number found in brackets in the 
heading of this document. Submit written comments on the pilot program 
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 I. 
Background of the SUPPLEMENTARY INFORMATION section for electronic 
access to the concept paper.

FOR FURTHER INFORMATION CONTACT:
    Lana Pauls, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg, 51, rm. 6196, Silver 
Spring, MD 20993, 301-796-0518, FAX: 301-847-8753, e-mail: 
[email protected], or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17),Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In its 2006 report ``Preventing Medication Errors,'' the Institute 
of Medicine noted that ``[i]n particular, drug names that look or sound 
alike increase the risk of medication errors.'' FDA also has determined 
that many of the medication errors reported to the agency result from 
proprietary names that look or sound like the names of other medical 
products. Reducing the potential for medication errors due to 
proprietary name confusion is part of FDA's ongoing medical product 
risk management effort. In 2003, FDA held two public meetings that 
explored many of the issues involved in proprietary name review:
     The June 26, 2003, public meeting on ``Minimizing 
Medication Errors--Methods for Evaluating Proprietary Names for Their 
Confusion Potential,''(Docket No. 2002N-0201) (68 FR 32529; May 30, 
2003); information about the meeting is available at http://www.fda.gov/cder/meeting/drugNaming.htm.
     The December 4, 2003, meeting of the Drug Safety and Risk 
Management Advisory Committee (68 FR 65075; November 18, 2003); 
transcripts, presentations, and materials from the meeting are 
available at http://www.fda.gov/ohrms/dockets/ac/cder03.html#DrugSafetyRiskManagement.
     On June 5 and 6, 2008, FDA held a public technical meeting 
to discuss a draft concept paper (see meeting notice at 73 FR 27001; 
May 12, 2008) describing the pilot and FDA's thinking about how 
pharmaceutical firms could participate in the pilot to evaluate 
proposed proprietary names and submit the data generated to FDA for 
review. Transcripts, presentations, and materials from the meeting are 
available at http://www.fda.gov/cder/drug/MedErrors/meeting_2008.htm.
    In title I of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) (Public Law 110-85), Congress reauthorized and expanded 
the Prescription Drug User Fee program for FYs 2008 to 2012 (PDUFA IV). 
As part of the performance goals and procedures set forth in an 
enclosure to the letter from the Secretary of the Health and Human 
Services referred to in section 101(c) of FDAAA, FDA agreed to publish 
a concept paper on and implement a pilot program to enable 
pharmaceutical firms participating in the pilot to evaluate proposed 
proprietary names and submit the data generated from those evaluations 
to FDA for review. This process is consistent with other areas of drug 
review in which FDA evaluates data generated by firms rather than 
producing such data independently. FDA agreed to conduct a public 
meeting to discuss the content of the concept paper, which describes 
the logistics of the pilot program, proposed recommendations for 
carrying out a proprietary name review, and the way FDA intends to 
review submissions made under the pilot program. FDA issued the draft 
concept paper for discussion at the June 5 and 6, 2008, meeting, and 
after considering comments received at the meeting and to the public 
docket, FDA finalized the concept paper. Changes made to the final 
concept were editorial and primarily clarifying. There were two 
substantive changes: (1) Participation in the portion of the pilot 
addressing review of promotional aspects of proposed proprietary names 
has been made optional for applicants who choose to participate in the 
pilot, so that they may choose to submit only safety-related 
assessments and (2) additional information has been provided to explain 
how the agency recommends reviews be undertaken for names intended for 
over-the-counter drugs.
    FDA expects to begin enrollment into the pilot program no later 
than the end of FY 2009. At the end of FY 2011, or subsequent to 
accruing 2 years of experience with pilot program submissions, FDA 
intends to evaluate the pilot program to determine whether to have 
applicants perform their own name analysis and submit resulting data to 
FDA for review. The results of this pilot program and recommended 
additions and/or changes to methods based on the reported results will 
be discussed in a future public meeting. Following that meeting, a 
draft guidance will be published describing the best test methods for 
proprietary name evaluation.

II. Comments

    FDA welcomes suggestions for and comments regarding the pilot 
program. Interested persons may submit to the Division of Dockets 
Management (see ADDRESSES) written or electronic comments regarding the 
pilot program. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23715 Filed 10-6-08; 8:45 am]
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