[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Draft Guidance for Industry on the Contents of a Complete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availability of a draft guidance for industry entitled ``Contents of a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draft guidance provides recommendations to industry regarding the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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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draft guidance may also be obtained by mail by calling CBER at 1-800-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on the draft guidance to the Division of Dockets Management (HFA-305),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draft guidance document.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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