[Federal Register Volume 74, Number 189 (Thursday, October 1, 2009)]
[Notices]
[Pages 50806-50809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23620]
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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;
Procedures To Register for Participation and Submit Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
opportunity for pharmaceutical firms (applicants) to participate in a
voluntary 2-year pilot program for the evaluation of proposed
proprietary names to be conducted by FDA's Center for Drug Evaluation
and Research (CDER) and Center for Biologics Evaluation and Research
(CBER). The pilot program will enable participating pharmaceutical
firms to evaluate proposed proprietary names and submit the data
generated from those evaluations to FDA for review, as outlined in the
FDA concept paper entitled ``PDUFA Pilot Project Proprietary Name
Review.'' This document describes procedures to register and submit
data for applicants who wish to have their proposed proprietary names
evaluated under the pilot program.
DATES: FDA will begin accepting requests to register for the voluntary
pilot program on October 1, 2009.
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, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, 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 should be identified with the docket
number found in brackets in the heading of this document. See the
SUPPLEMENTARY
[[Page 50807]]
INFORMATION section for electronic access to the concept paper.
FOR FURTHER INFORMATION CONTACT:
Carol Holquist, Center for Drug Evaluation and Research, Office of
Surveillance and Epidemiology, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4416, Silver Spring, MD 20993-0002, e-
mail: [email protected] with the subject line
identified as ``PNR Pilot Program for CDER/DMEPA;'' or
Ele Ibarra-Pratt, Center for Biologics Evaluation and Research,
Advertising and Promotional Labeling Branch (HFM-602), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, e-mail: [email protected] with the subject line identified as
``PNR Pilot Program for CBER/APLB.''
SUPPLEMENTARY INFORMATION:
I. Background
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 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
participating in the pilot program to evaluate proposed proprietary
names and submit the data generated from those evaluations to FDA for
review. (See section IX.B at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm.) 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 following: (1) The logistics of the pilot program,
(2) proposed recommendations for carrying out a proprietary name
review, and (3) the way FDA intends to review submissions made under
the pilot program. In keeping with the performance goals:
On June 5 and 6, 2008, FDA held a public technical meeting
(see meeting notice at 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. FDA considered comments received at the meeting and submitted
to the public docket.
In the Federal Register of October 7, 2008 (73 FR 58604),
FDA announced the availability of the concept paper entitled ``PDUFA
Pilot Project Proprietary Name Review.'' The concept paper provides
information to pharmaceutical firms about how to evaluate proposed
proprietary names at the new drug application (NDA) or biologics
license application (BLA) phase or investigational new drug application
(IND) phase (before NDA or BLA submission) or when an abbreviated new
drug application (ANDA) is submitted, and to submit the data generated
from those evaluations to FDA for review.
In addition to developing the concept paper for the pilot program,
FDA announced the availability of a draft guidance for industry
entitled ``Contents of a Complete Submission for the Evaluation of
Proprietary Names'' (draft proprietary names submission guidance) (73
FR 71009, November 24, 2008).\1\ FDA also announced the availability of
the source code and supporting technical documentation for the Phonetic
Orthographic Computer Analysis (POCA) software program, an analytic
tool designed to help identify drug and biologic names and medical
terminology that are phonetically and orthographically similar to one
another (74 FR 7450, February 17, 2009). POCA is one analytic tool that
FDA uses to review proposed proprietary drug and biologic names.
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\1\ The draft proprietary names submission guidance is not
intended to address the PDUFA IV performance goal of developing and
implementing a pilot program for evaluating proposed proprietary
names, or other PDUFA IV performance goals. Rather, the draft
proprietary names submission guidance, when finalized, 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.
Persons with access to the Internet may obtain the draft proprietary
names submission guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.
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II. PDUFA Pilot Program Proprietary Name Review Logistics
A. Overview
As discussed in the concept paper (section III of PDUFA Pilot
Program--Logistics), applicants should contact the appropriate FDA
center to register to participate in the pilot program before making
their proprietary name submissions (see FOR FURTHER INFORMATION CONTACT
and DATES). This document describes the following procedures for
implementing the pilot program:
Who the FDA points-of-contact are to register for
participation,
How to register by e-mail and what information to provide,
When and where to send proposed proprietary name
submissions, and
What type of information to include in a complete
submission to support parallel reviews of a proposed proprietary name.
B. Registration Is Required To Participate in the Pilot Program
As discussed in the concept paper, FDA will strive to include a
cross-section of applicants that represent large, medium, and small
companies during the 2-year program. FDA hopes that 25 to 50 proposed
proprietary name submissions will be received and reviewed under the
pilot program. To achieve this goal and to manage workload within the
PDUFA IV timelines, FDA will only be able to accept an average of one
to two submissions per month. Consequently, it will be necessary to
register to participate before making a proposed proprietary name
submission under the pilot program. To determine if space is available
for an applicant to participate in the pilot program and agree on a
date to make its planned submission, applicants should contact the
designated point-of-contact for the appropriate center by e-mail as
described in the following two sections of this document.
1. Registration for CDER Review
For proposed proprietary names that are being submitted as part of
an IND, NDA, BLA, ANDA, or supplement reviewed by CDER, contact Carol
Holquist by e-mail at [email protected]. Applicants
should provide the following information in the e-mail for
registration:
E-mail subject heading: ``PNR Pilot Program for CDER/
DMEPA,''
First sentence in e-mail should indicate: ``Request for
Registration in PNR Pilot Program,''
Company name,
Name of U.S. regulatory contact (include telephone number
and e-mail address),
Name of entity conducting proprietary name analysis
(applicant company or third-party vendor),
Application type (IND, NDA, BLA, ANDA, or supplement) and
application number,
[[Page 50808]]
Proposed proprietary name (identify primary and alternate
proprietary name, if any), and
Approximate (requested) month for intended submission.
2. Registration for CBER Review
For biological drug products that are the subject of an IND, NDA,
BLA, or supplement reviewed by CBER, contact Ele Ibarra-Pratt by e-mail
at [email protected]. Applicants should provide the same information
listed previously in section II.B.1 of this document, except that the
e-mail subject heading should be: ``PNR Pilot Program for CBER/APLB.''
C. FDA Will Confirm Registration
FDA will respond to an applicant's e-mail request for registration
to participate in the voluntary pilot program. The FDA point-of-contact
will determine if the requested date of submission, by month, is
available. If the requested date is available, FDA will e-mail the
applicant confirming the applicant's registration in the pilot program.
If the applicant's requested date of submission, by month, is not
available, FDA will propose an alternate date for the applicant to make
the proprietary name submission under the pilot program. FDA will
confirm the applicant's registration to participate once the applicant
replies to FDA's e-mail acknowledging the acceptability of the
alternate date.
If the alternate date is not acceptable to the applicant, the
applicant should promptly notify FDA by e-mail. If an alternate date
cannot be agreed upon and/or the applicant does not wish to participate
in the pilot program, the applicant should so state in the e-mail
response to FDA. An applicant that is not registered in the pilot
program will submit its proposed name to the FDA for analysis and
evaluation using FDA's traditional approach to the review of proposed
proprietary names (see the draft proprietary names submission
guidance).
D. Submissions Under the Pilot Program
1. When To Submit
Applicants registered in the pilot program should send their
submissions to FDA for receipt within the first 2 business days of the
agreed month. If the submission is not received on the first 2 business
days of the agreed month, workload priorities may affect FDA's ability
to review the proposed proprietary name as scheduled under the pilot
program and FDA may convert the submission to a traditional review.
2. What to Submit--Content of Submission for Parallel Reviews
For all proprietary name submissions, the first page of the
submission should include the statement ``REQUEST FOR PROPRIETARY NAME
REVIEW'' in bold, capital letters. This statement should be immediately
followed by the header ``PILOT PROGRAM'' in bold, capital letters.
Applicants should separate the data contained in the single
submission into two separate sections to enable parallel reviews by FDA
as follows:
Section I should be labeled ``TRADITIONAL REVIEW'' and
should contain the proposed proprietary name information that is
submitted under FDA's traditional practice. For more information, see
the draft proprietary names submission guidance and section III of
Appendix B (Proposed Template for a Pilot Program Submission) of the
concept paper. If this information is submitted as part of the pilot
program, it is not necessary to submit it to the agency again.
Section II should be labeled ``PILOT REVIEW'' and should
contain the comprehensive evaluation of the proposed proprietary name,
including the information and data listed in Appendix B of the concept
paper. Only the data for the applicant's primary proposed proprietary
name should be submitted. If the applicant has identified an alternate
proprietary name, requests for the data regarding that name will be
made only if FDA decides that the primary proposed proprietary name is
not acceptable, after the decision is communicated to the applicant
(see section II.E.1 of this document, Process to Request FDA Review of
an Alternate Proposed Proprietary Name).
Although Sections I and II are contained in a single submission,
the applicant should ensure that the data contained in each section can
be reviewed independently. Data should not be cross-referenced; each
section should encompass all of the data elements required for a
complete submission. The prominent identification of the two sections
of proposed proprietary name information will maintain the validity of
the independent parallel reviews.
All proprietary name submissions under the pilot program will be
screened for completeness (i.e., submission of information needed to
evaluate the proprietary name). Applicants will be notified in writing
if the submission does not contain all of the information needed to
conduct the parallel reviews. Once the proposed proprietary name
submission is considered complete, the submission will be reviewed
within the PDUFA IV review performance goal timeframes \2\ (i.e., IND--
180 days from receipt of complete submission; NDA or BLA--90 days from
receipt of complete submission).
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\2\ For proposed proprietary names that are submitted in an
ANDA, the PDUFA IV performance goal timeframes do not apply.
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3. How To Submit--Paper or Electronic Form
Submissions may be in paper or electronic form. For paper
submissions, applicants should submit three copies of the submission to
the same address as the original product application with which the
proposed proprietary name is associated. Submit packages for proposed
proprietary names for drugs, including biologics, that are the subject
of an IND, NDA, BLA, or supplement to be reviewed by CDER to:
Center for Drug Evaluation and Research,
Food and Drug Administration,
Documents and Records Section,
5901-B Ammendale Road,
Beltsville, MD 20705-1266.
Submit packages for proposed proprietary names for biological drug
products that are the subject of an IND, NDA, BLA, or supplement to be
reviewed by CBER to:
Center for Biologics Evaluation and Research,
Document Control Center (HFM-602),
1401 Rockville Pike, rm. 200N,
Rockville, MD 20852-1448.
For electronic submissions, applicants should refer to FDA's Web
site ``Electronic Common Technical Document (eCTD)'' at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm and at
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm163685.htm. Refer specifically to the following documents on the Web
page:
Guidance for industry on ``Providing Regulatory
Submissions in Electronic Format--Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications,''
eCTD Backbone File Specifications for Module 1, and
FDA eCTD Table of Contents Headings and Hierarchy.
Applicants are encouraged to use the Electronic Submissions Gateway
(ESG) to submit regulatory information. For information on the use of
the ESG, refer
[[Page 50809]]
to http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.
4. Communications Concerning the Planned Submission
Applicants participating in the pilot program should contact the
appropriate center point-of-contact by e-mail (see FOR FURTHER
INFORMATION CONTACT) 120 days prior to the intended date of the
proposed proprietary name submission to discuss specific details of the
planned submission. If applicants plan to use alternative or additional
methods to evaluate the safety of their proposed proprietary name(s),
they should inform the appropriate center 120 days prior to their
planned submission date. FDA does not have the resources to review the
proposed alternative methodologies with the intent of coming to
agreement with an applicant on the appropriateness of these alternative
methodologies prior to submission. In such cases, FDA will review the
alternative methodologies during the review of the actual submission.
If applicants have questions concerning the planned submission
under the pilot program, they should contact the appropriate center
point-of-contact by e-mail (see FOR FURTHER INFORMATION CONTACT) to
discuss their questions. If necessary, applicants will be asked to
submit their questions in writing; in some cases, a teleconference or
face-to-face meeting to discuss the planned submission may be
appropriate.
E. Process To Request FDA Review of an Alternate Proposed Proprietary
Name
If, after parallel reviews of the proprietary name submission, FDA
informs the applicant that the primary proposed proprietary name is
unacceptable, the applicant should confirm in writing that it would
like its previously identified alternate proposed proprietary name to
be reviewed or submit a different alternate proprietary name. At this
time, the applicant can request to have the alternate proprietary name
evaluated by FDA under the pilot program or by the traditional review
method. If the request is to have the alternate proprietary name
reviewed under the pilot program, the applicant should submit the
comprehensive evaluation of the alternate proposed proprietary name,
including the information and data described in section II.D.2 of this
document. If the request is to have the alternate proprietary name
evaluated by the traditional method, the applicant may reference the
information previously submitted for parallel review of the proposed
primary proprietary name (Section I of the pilot program submission
labeled ``TRADITIONAL REVIEW'').
A new proprietary name review clock for an alternate proposed
proprietary name will not start until:
(1) The applicant has confirmed to the appropriate center, in
writing, that it would like its alternate proprietary name evaluated by
traditional review method or
(2) FDA receives the applicant's submission of an alternate
proposed proprietary name along with the comprehensive information for
section II ``PILOT REVIEW'' described in section II.D.2 of this
document.
For either review method requested (traditional or pilot), the same
PDUFA IV review performance goal timeframes apply to the review of the
submission of an alternate proposed proprietary name (i.e., IND--180
days from receipt of complete submission; NDA or BLA--90 days from
receipt of complete submission).
If the applicant requests that its alternate proprietary name be
evaluated under the pilot program, the agency will take into account
the date of the alternate proprietary name submission as it relates to
the PDUFA IV goal for the application. The responsible center will use
discretion to determine whether the agency will conduct a parallel
review of the applicant's analysis or only a proprietary name
evaluation using FDA's traditional approach. Although FDA would ideally
also review the applicant's completed proprietary name analysis for the
alternate name under the pilot program, resources may not permit such a
review. Factors such as staffing will be used in making this
determination.
F. Duration and Evaluation of the Pilot Program
At the end of fiscal year 2011, or after 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
proprietary 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, FDA will publish a draft
guidance describing the best test methods for proprietary name
evaluation.
III. Paperwork Reduction Act of 1995
The information collection provisions of this pilot program,
excluding the submission of information that is part of the agency's
traditional review of proprietary names, have been submitted to the
Office of Management and Budget (OMB) for review, as required by
section 3507 of the Paperwork Reduction Act of 1995. The provisions
were approved and assigned OMB control number 0910-0648. This approval
expires September 30, 2012. The proprietary name information submitted
as part of the traditional review of proprietary names is approved
under OMB control numbers 0910-0001 and 0910-0338. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
IV. Electronic Access
Persons with access to the Internet may obtain the concept paper at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072229.pdf.
Dated: September 25, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23620 Filed 9-30-09; 8:45 am]
BILLING CODE 4160-01-S