Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors; Availability, 74196-74197 [2012-30034]

Download as PDF 74196 Federal Register / Vol. 77, No. 240 / Thursday, December 13, 2012 / Notices srobinson on DSK4SPTVN1PROD with Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov.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. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For information concerning the guidance as it relates to devices regulated by CDRH: Mary Brady, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5426, Silver Spring, MD 20993–0002, 301–796–6089. For information concerning the guidance as it relates to devices regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301– 827–6210. I. Background For a variety of reasons, use of devices outside professional healthcare facilities or clinical laboratories is on the rise. First, the U.S. population is aging, and the elderly are more likely to live with chronic diseases that require daily medical care at home. Second, due to medical advancements, many individuals with chronic diseases are living longer, but are dependent on home medical care. Finally, an increasing focus on reducing healthcare costs for patients of all ages has spurred the growth of the home health care market. Integral to the home health care market are home use devices. Although home use devices provide significant benefits to patients and families, including quality of life improvements and cost savings, home use devices are also associated with unique risks. Reducing or minimizing the risks posed by home use devices can greatly improve the public health. This draft guidance provides recommendations for designing and developing medical devices intended for home use through considerations involving the physical environment, the user, the device or system, the labeling, VerDate Mar<15>2010 16:21 Dec 12, 2012 Jkt 229001 and the utilization of human factors. This should result in a safe and easierto-use device, minimize use error, and reduce the likelihood that adverse events will occur. The recommendations in the guidance apply to both prescription and over-thecounter medical devices that are intended for home use. II. Significance of Guidance 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 total product life cycle for devices intended for home use. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or from CBER at https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Design Considerations for Devices Intended for Home Use’’ from CDRH, you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1750 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to currently 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 801 and 21 CFR 809.10 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910–0437; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 814 have been approved under PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 OMB control number 0910–0231; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073; and the collections of information in Form FDA 3500A have been approved under OMB control number 0910–0291. V. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// 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 https:// www.regulations.gov. Dated: December 5, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30033 Filed 12–12–12; 8:45 am] BILLING CODE 4160–01–P 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. 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. SUMMARY: E:\FR\FM\13DEN1.SGM 13DEN1 Federal Register / Vol. 77, No. 240 / Thursday, December 13, 2012 / Notices 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 https:// 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: srobinson on DSK4SPTVN1PROD with DATES: 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 https://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 VerDate Mar<15>2010 16:21 Dec 12, 2012 Jkt 229001 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 https:// 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 https:// 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 9990 74197 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 https://www. fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: December 7, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30034 Filed 12–12–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, December 7, 2012 (77 FR 73034). The product name in the document was incorrect. This document corrects that error. SUMMARY: FOR FURTHER INFORMATION CONTACT: Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301– 796–5290, Natasha.Facey@fda.hhsgov. In FR doc. 2012–29538, appearing on page 73034 in the Federal Register of Friday, December 7, 2012, the following correction is made: 1. On page 73034, in the second column under the section entitled ‘‘Agenda’’, the product name ‘‘NeuroPace Responsive Neurostimulation (RNS) System’’ is corrected to read ‘‘NeuroPace RNS System’’. SUPPLEMENTARY INFORMATION: Dated: December 7, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–30024 Filed 12–12–12; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\13DEN1.SGM 13DEN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 
https://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 https://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 https://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 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: December 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30034 Filed 12-12-12; 8:45 am]
BILLING CODE 4160-01-P
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