[Federal Register Volume 75, Number 25 (Monday, February 8, 2010)]
[Notices]
[Pages 6210-6211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2660]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0592]
Guidance for Industry on the Contents of a Complete Submission
for the Evaluation of Proprietary Names; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Contents of a
Complete Submission for the Evaluation of Proprietary Names''
(proprietary names submission guidance). This guidance provides
recommendations to industry regarding the submission of a complete
package that FDA intends to use to assess the safety of proposed
proprietary names for drugs, including biological products, and other
factors that, in association with the name, can contribute to
medication errors. In addition, FDA intends to use this information in
the assessment of promotional aspects of proposed proprietary names.
DATES: Submit written or electronic comments on agency guidances at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
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, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist that office in
processing your requests. Submit written comments on the guidance 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 the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: 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, 301-
796-2360; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Contents of a Complete Submission for the Evaluation of
Proprietary Names.'' In performance goals under the September 27, 2007,
reauthorization of the Prescription Drug User Fee Act (PDUFA IV), FDA
agreed to implement various measures to reduce medication errors
[[Page 6211]]
related to look-alike and sound-alike proprietary names, unclear label
abbreviations, acronyms, dose designations, and error-prone label and
packaging designs. Among these measures, FDA agreed to publish guidance
on the contents of a complete submission package for a proposed
proprietary name for a drug/biological product. FDA also agreed to
performance goals for review of proprietary names submitted during the
investigational new drug application (IND) phase or with a new drug
application (NDA) or biologics license application (BLA); the goals
stipulate that a complete submission is required to begin the review
clock. (See section IX.A of the goals letter at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm).
This proprietary names submission guidance 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. In addition, FDA intends to use
this information in the assessment of promotional aspects of proposed
proprietary names.
This proprietary names submission guidance applies to prescription
drug products, including biologics, that are the subject of an IND,
NDA, abbreviated new drug application (ANDA), or BLA; and
nonprescription drug products that are the subject of an IND, NDA, or
ANDA.
The proprietary names submission guidance does not address other
performance goals under PDUFA IV, including developing FDA internal
policies and procedures to ensure that proprietary name review goals
are met; developing guidance on best practices for naming, labeling,
and packaging drugs and biologics to reduce medication errors;
developing guidance on proprietary name evaluation best practices; and
developing and implementing a pilot program for evaluating proposed
proprietary names. These performance goals are or will be addressed
elsewhere.
In the Federal Register of November 24, 2008 (73 FR 71009), FDA
announced the availability of a draft guidance for industry entitled
``Contents of a Complete Submission for the Evaluation of Proprietary
Names'' and invited comments. Many comments discussed topics that were
beyond the scope of the proprietary names submission guidance,
including other performance goals under PDUFA IV that are addressed in
other public dockets. These comments concerned the contents of any
industry-sponsored reviews and data for submission to FDA under the
pilot program described in the FDA concept paper entitled ``PDUFA Pilot
Project Proprietary Name Review'' (concept paper) (73 FR 58604, October
7, 2008). FDA acknowledges that information in the proprietary names
submission guidance could be useful to participants in the voluntary
pilot program for proprietary name review. However, the proprietary
names submission guidance does not describe the information needed by
FDA to evaluate proposed proprietary names under the pilot program.
Rather, the purpose is limited to informing industry about what
information is needed by FDA to evaluate proposed proprietary names
within PDUFA IV goal dates under the traditional review process. We
welcome submission of comments about the tools and methods FDA uses for
its analysis of proposed proprietary names under the pilot program to
docket number FDA-2008-N-0281.
After considering comments on the draft guidance, FDA has issued
the proprietary names submission guidance. Changes made to the guidance
were editorial and primarily clarifying in response to comments. The
revisions included: (1) Clarifying that the purpose of this guidance is
to provide industry with a complete listing of the information FDA
needs to evaluate a proposed proprietary name under the traditional
review process; (2) adding the respective PDUFA IV review performance
timeframes for complete submissions of a proposed proprietary name
submitted during the IND phase or with an NDA, BLA, or supplement; and
(3) referencing the concept paper\1\ for a complete discussion of the
tools and methods used for FDA's safety evaluation that are mentioned
in the proprietary names submission guidance.
---------------------------------------------------------------------------
\1\ Available on the Internet at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072229.pdf.
---------------------------------------------------------------------------
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on the contents of a complete submission for
the evaluation of proprietary names. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 and FDA Form 1571 have
been approved under OMB control number 0910-0014. The collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001. The collections of information in 21 CFR part 601 and
FDA Form 356h have been approved under OMB control number 0910-0338.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.
Dated: February 3, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2660 Filed 2-5-10; 8:45 am]
BILLING CODE 4160-01-S