2011-26099. 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.

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 As previously announced, FDA plans to publish a draft guidance describing the best test methods for proprietary name evaluation.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 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.