[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Notices]
[Pages 71009-71010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0592]


Draft Guidance for Industry on the Contents of a Complete 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.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Contents of a 
Complete Submission for the Evaluation of Proprietary Names.'' This 
draft guidance provides recommendations to industry regarding the 
submission of a complete package that FDA intends to use to assess the 
safety of proposed proprietary drug and biological product names 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:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by January 23, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The 
draft guidance may also be obtained by mail by calling CBER at 1-800-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on the draft guidance to the Division of Dockets Management (HFA-305), 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 
draft 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 draft guidance for industry 
entitled ``Contents of a Complete Submission for

[[Page 71010]]

the Evaluation of Proprietary Names.'' In performance goals agreed to 
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 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 at http://www.fda.gov/oc/pdufa4/pdufa4goals.html).
    This draft 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. In addition, FDA intends to use 
this information in the assessment of promotional aspects of proposed 
proprietary names.
    This draft guidance applies to prescription drug products, 
including biologics, that are the subject of an IND, NDA, or 
abbreviated new drug application (ANDA); nonprescription drug products 
that are the subject of an NDA or ANDA; and biological products that 
are the subject of a BLA.
    The draft 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; guidance on proprietary name 
evaluation best practices; and developing and implementing a pilot 
program for evaluating proposed proprietary names.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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.
    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.

III. Paperwork Reduction Act of 1995

    This draft 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/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.regulations.gov.

    Dated: November 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27896 Filed 11-21-08; 8:45 am]
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