
[Federal Register: December 23, 2008 (Volume 73, Number 247)]
[Notices]               
[Page 78813-78814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de08-97]                         


[[Page 78813]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0648]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; PDUFA Pilot Project Proprietary Name Review

AGENCY: Food and Drug Administration, HHS

ACTION: Notice

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
associated with the evaluation of proposed propriety names by 
pharmaceutical firms and the submission of the data generated from 
those evaluations to FDA for review under a pilot program. FDA plans to 
begin enrollment in the pilot program by the end of fiscal year (FY) 
2009.

DATES: Submit written or electronic comments on the collection of 
information by February 23, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information that they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 
3506(c)(2)(A)), requires Federal agencies to provide a 60-day notice in 
the Federal Register for each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing this notice of the proposed collection 
of information set forth in this document.
    With respect to the collection of information associated with the 
pilot program, FDA invites comments on the following topics: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of FDA's functions, including whether the 
information will have practical utility; (2) the accuracy of FDA's 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.

PDUFA Pilot Project Proprietary Name Review

    In the Federal Register of October 7, 2008 (73 FR 58604), FDA 
announced the availability of a concept paper entitled ``PDUFA Pilot 
Project Proprietary Name Review.'' The concept paper describes how 
pharmaceutical firms may evaluate proposed proprietary names and submit 
the data generated from those evaluations to FDA for review under a 
pilot program to begin by the end of FY 2009.
    On September 27, 2007, the President signed into law the Food and 
Drug Administration Amendments Act of 2007 (Public Law 110-85, 121 
Stat. 823), which includes the reauthorization and expansion of the 
Prescription Drug User Fee Act (PDUFA IV). As part of the 
reauthorization of PDUFA IV, FDA committed to certain performance 
goals, including the goal of using user fees to implement various 
measures to reduce, among other things, medication errors related to 
look-alike and sound-alike product proprietary names. FDA also agreed 
to develop and implement a voluntary pilot program to enable 
pharmaceutical firms participating in the pilot to evaluate proposed 
proprietary names and to submit the data generated from those 
evaluations to FDA for review. The concept paper is intended to help 
pharmaceutical firms choose appropriate proprietary names for their 
drug and biological products before submitting marketing applications 
to FDA and describes how pharmaceutical firms may use ``best 
practices'' to carry out their own proprietary name reviews and provide 
FDA with the data that result from those reviews. The goals of the 
concept paper and the voluntary pilot program are to minimize the use 
of names that are misleading or that are likely to lead to medication 
errors, to make FDA's marketing application review more efficient, and 
to make regulatory decisions more transparent. The concept paper 
explains how an applicant who chooses to participate in the pilot 
program could assess a proposed proprietary name for safety (i.e., 
potential for medication errors) and, at the applicant's option, for 
promotional implications, before marketing application approval and 
subsequent marketing of a drug or biological product in the United 
States, and how to submit the results of the assessment for review 
under the pilot program.
    As required by the PRA, this document is the first of two Federal 
Register notices that FDA must publish to provide an opportunity for 
public comment on the information collection that will result from the 
pilot program. The information described in the concept paper and the 
data collected may not be submitted to FDA until OMB has approved the 
information collection associated with the pilot program. After OMB 
approval, FDA will accept requests to register for the pilot program. 
FDA will announce OMB's approval and other details on participating in 
the pilot program in the Federal Register. FDA expects that the pilot 
program will begin by the end of FY 2009.
    The information collection that will result from the voluntary 
pilot program, as described in the concept paper, consists of the 
following:
     Applicants should contact FDA to register and indicate the 
approximate date of their proprietary name submission, as described in 
the concept paper and as will be described in more detail when FDA 
announces OMB's approval and the specific information on participating 
in the pilot program.
     Applicants should contact the appropriate FDA Center 120 
days prior to the intended date of the proposed proprietary name 
submission to discuss the specific details of the planned submission. 
Applicants should communicate with the Director in the Division of 
Medication Error Prevention and Analysis in the Office of

[[Page 78814]]

Surveillance and Epidemiology in the Center for Drug Evaluation and 
Research, or the Branch Chief at the Advertising and Promotion Labeling 
Branch of the Division of Case Management in the Office of Compliance 
and Biologics Quality in the Center for Biologics Evaluation and 
Research, concerning any questions about their proposed submissions. 
For prescription products, applicants should inform the appropriate 
center at the 120-day pre-submission discussion if they plan to use 
alternative or additional methods to evaluate the safety of their 
proposed proprietary name. For nonprescription products, sponsors 
should discuss with FDA different protocols that could be used for 
their specific drug products prior to the submission of the proprietary 
name.
     Applicants should submit two separate sets of product 
name-related information to enable parallel reviews by FDA as follows: 
(1) A comprehensive evaluation of the proposed proprietary name 
including the information and data listed in Appendix B (``Proposed 
Template For A Pilot Program Submission'') of the concept paper; and 
(2) the proprietary name information that they would ordinarily submit 
under FDA's current practice. (Note: The proprietary name information 
ordinarily submitted under FDA's current practice is not included in 
the estimates in table 1 of this document because this information 
collection is already approved under OMB Control Numbers 0910-0001 and 
0910-0338).
     After review of the proprietary name submissions, and if 
FDA informs the applicant that the proposed first-choice proprietary 
name is unacceptable, the applicant should confirm in writing that it 
would like its originally submitted second-choice name reviewed, or the 
applicant should submit an alternative second-choice name along with 
the information described in the concept paper. At that time, FDA will 
begin review of the second-choice name. If an applicant has submitted a 
complete proprietary name analysis for the second-choice name, the 
responsible center will use discretion to determine whether to review 
the applicant's analysis in addition to conducting its own analysis 
using the traditional approach. Although FDA would ideally review the 
applicant's completed proprietary name analysis for the second-choice 
name, factors such as staffing and timelines will be used in making 
this determination.
    FDA estimates the burden of this collection of information in table 
1 of this document. The ``hours per response'' is for all of the 
submissions and notifications to FDA described under the bulleted 
paragraphs above and is based on information provided by industry as 
well as FDA's familiarity with the time required for this information 
collection.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                                                           Respondents         per Response          Responses           Response         Total Hours
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Pilot Project Proprietary Name Review                                  20                     1                 20                480              9,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30587 Filed 12-22-08; 8:45 am]

BILLING CODE 4160-01-S
