[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74196-74197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1005]


Draft Guidance for Industry on Safety Considerations for Product 
Design To Minimize Medication Errors; 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availability of a draft guidance for industry entitled ``Safety 
Considerations for Product Design to Minimize Medication Errors.'' The 
draft guidance provides sponsors of investigational new drug 
applications, new drug applications, biologics licensing applications, 
abbreviated new drug applications, and nonprescription drugs marketed 
without an approved application (e.g., monograph) with a set of 
principles for developing drug products using a systems approach to 
minimize medication errors relating to product design. The draft 
guidance includes recommendations intended to improve the drug product 
and container closure design at the earliest stages of product 
development for all prescription and nonprescription drug products.

[[Page 74197]]


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 comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 11, 2013.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 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. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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-
796-0171.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Safety Considerations for Product Design to Minimize 
Medication Errors.'' In Title I of the Food and Drug Administration 
Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), Congress reauthorized 
and expanded the Prescription Drug User Fee Act program for fiscal 
years (FYs) 2008 through 2012 (PDUFA IV). As part of the performance 
goals and procedures set forth in an enclosure to the letter from the 
Secretary of Health and Human Services referred to in section 101(c) of 
FDAAA, FDA committed to certain performance goals and procedures. (See 
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm). In that letter, FDA stated that it would use fees 
collected under PDUFA 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 that by the end of FY 2010, after public consultation with 
academia, industry, other stakeholders, and the general public, the 
Agency would publish draft guidance describing practices for naming, 
labeling, and packaging drugs and biologics to reduce medication 
errors. On June 24 and 25, 2010, FDA held a public workshop and opened 
a public docket (Docket No. FDA-2010-N-0168) to receive comments on 
these measures.
    This draft guidance document, which addresses safety achieved 
through drug product design, is the first in a series of planned 
guidance documents to minimize risks contributing to medication errors. 
The second guidance will focus on minimizing risks with the design of 
drug product container labels, carton labeling, and packaging 
configurations, and the third guidance will focus on minimizing risks 
with drug product nomenclature.
    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 addressing 
safety achieved through drug product design to minimize medication 
errors. 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 either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments 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, and will be posted to the docket 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 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 have been approved under 
OMB control number 0910-0338.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30034 Filed 12-12-12; 8:45 am]
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