[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62813-62814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26099]


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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 Proprietary Name Submissions; 
Public Meeting on Pilot Program Results Will Not Be Held

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
will not hold a public meeting to discuss the results of a 2-year 
voluntary pilot program that enabled participating pharmaceutical firms 
to evaluate proposed proprietary names and submit the data generated 
from those evaluations for FDA to review. FDA anticipated holding a 
public meeting at the end of fiscal year 2011 to discuss the results of 
the pilot program, but the Agency did not receive sufficient pilot 
submissions to form a basis for discussion. Interested parties may 
submit to the docket any additional comments on the pilot program. As 
previously announced, FDA plans to publish a draft guidance describing 
the best test methods for proprietary name evaluation.

DATES: Submit either electronic or written comments by November 10, 
2011.

ADDRESSES: Submit electronic comments on the pilot program or this 
document 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. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Regarding human drug products: 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.
    Regarding human biological products: Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In Title I of the Food and Drug Administration Amendments Act of 
2007 (Pub. L. 110-85), Congress reauthorized and expanded the 
Prescription Drug User Fee program for fiscal years 2008 to 2012 (PDUFA 
IV). In performance goals agreed to in conjunction with the 
reauthorization of PDUFA IV, FDA agreed to publish a concept paper on 
and implement a pilot program to enable pharmaceutical firms to 
evaluate proposed proprietary names and submit the data generated from 
those evaluations to FDA for review. (See IX.B at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm.).
    In June 2008, FDA held a public technical meeting (see 73 FR 27001, 
May 12, 2008) to discuss a draft concept paper describing the pilot 
program and FDA's thinking about how pharmaceutical firms could 
participate in the pilot program to evaluate proposed proprietary names 
and submit the data generated to FDA for review. After considering 
comments from the meeting and the public docket, FDA announced the 
availability of the concept paper entitled ``PDUFA Pilot Project 
Proprietary Name Review'' in the Federal Register of October 7, 2008 
(73 FR 58604). As stated in the concept paper, the goals of the pilot 
program were to minimize the use of names that are misleading or that 
are likely to lead to medication errors, to make FDA's application 
review more efficient, and to make regulatory decisions more 
transparent.
    In the Federal Register of October 1, 2009 (74 FR 50806), FDA 
announced the opportunity for firms to register for and submit data to 
the voluntary pilot program. FDA stated that at the end of fiscal year 
2011, or after accruing 2 years experience with pilot program 
submissions, the Agency would evaluate the results to determine whether 
the model of industry conducting reviews, submitting the results to 
FDA, and FDA reviewing the data is feasible and whether it is a better 
model than FDA conducting de novo reviews of proprietary names. FDA 
planned to hold a public meeting to discuss the results of the pilot 
program and recommended additions and/or changes to methods based on 
the report results. FDA also stated that, following the meeting, FDA 
would publish draft guidance on best test practices for proprietary 
name review.
    FDA began accepting requests to participate in the pilot program on 
October 1, 2009, and the pilot program ended on September 30, 2011. 
Although three applicants registered to participate during the 2-year 
period, FDA received only one complete submission for pilot program 
review, which is not a sufficient number to assess the feasibility of 
industry conducting reviews of proposed proprietary names. Therefore, 
the public meeting that was anticipated to occur at the end of fiscal 
year 2011 to assess the pilot program for evaluation of proposed 
proprietary names will not be held because of insufficient 
participation. The pilot program docket (docket number FDA-2008-N-0281) 
has remained open for comment during the 2-year pilot program, and FDA 
has invited comments on human factor testing. In lieu of a public 
meeting, interested persons may submit any additional comments to the 
docket. After the close of the public comment period, FDA intends to 
publish a draft guidance

[[Page 62814]]

describing the best test methods for proprietary name evaluation.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
pilot project or 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.

    Dated: October 4, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-26099 Filed 10-7-11; 8:45 am]
BILLING CODE 4160-01-P