81 FR 21576 - Safety Considerations for Product Design To Minimize Medication Errors; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 70 (April 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 70 (April 12, 2016)
| Page Range | 21576-21577 | |
| FR Document | 2016-08335 |
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)] [Notices] [Pages 21576-21577] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08335] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1005] Safety Considerations for Product Design To Minimize Medication Errors; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors.'' The guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), and abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides sponsors, applicants, and manufacturers with a set of principles to consider while developing drug products using a systems approach to minimize medication errors relating to product design and container closure design. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. This guidance also provides examples of product designs that resulted in postmarketing error. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal:http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-D-1005 for ``Safety Considerations for Product Design to Minimize Medication Errors.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the [[Page 21577]] ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, 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 guidance document. FOR FURTHER INFORMATION CONTACT: Irene Z. Chan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993-0002, 301- 796-3962. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors.'' The guidance is intended for sponsors of INDs; applicants of NDAs, BLAs, and ANDAs; and manufacturers of prescription drugs marketed without an approved application or OTC monograph drugs. This guidance provides sponsors, applicants, and manufacturers with a set of principles to consider while developing drug products using a systems approach to minimize medication errors relating to product design and container closure design. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. The guidance also provides examples of product designs that resulted in postmarketing error. This guidance document, which focuses on minimizing risks associated with the design of the drug product and its container closure system, is the first in a series of three planned guidances to minimize or eliminate hazards contributing to medication errors. The second guidance focuses on minimizing risks with the design of drug product container labels and carton labeling. The third guidance focuses on minimizing risks when developing and selecting proposed proprietary names for drugs. In the Federal Register of December 13, 2012 (77 FR 74196), FDA announced the availability of the draft guidance entitled ``Safety Considerations for Product Design to Minimize Medication Errors.'' The Agency has carefully reviewed and considered the comments it received in developing this final version of the guidance. The Agency has made revisions to the guidance to address public comments requesting clarifications and implement formatting changes for improved readability as it deemed appropriate. The Agency also moved recommendations appropriate for labels and labeling to a separate guidance. The guidance announced in this notice finalizes the draft guidance dated December 2012. 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 addressing safety achieved through drug product design to minimize medication errors. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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 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 You may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-08335 Filed 4-11-16; 8:45 am] BILLING CODE 4164-01-P
![21576 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
The applicant claims March 29, 2009 as guidance for industry entitled ‘‘Safety • Mail/Hand delivery/Courier (for
the date the NDA for APTIOM was Considerations for Product Design to written/paper submissions): Division of
initially submitted. However, FDA Minimize Medication Errors.’’ The Dockets Management (HFA–305), Food
records indicate that NDA 22–416 was guidance is intended for sponsors of and Drug Administration, 5630 Fishers
submitted on March 30, 2009. investigational new drug applications Lane, Rm. 1061, Rockville, MD 20852.
3. The date the application was (INDs); applicants of new drug • For written/paper comments
approved: November 8, 2013. FDA has applications (NDAs), biologics licensing submitted to the Division of Dockets
verified the applicant’s claim that NDA applications (BLAs), and abbreviated Management, FDA will post your
22–416 was approved on November 8, new drug applications (ANDAs); and comment, as well as any attachments,
2013. manufacturers of prescription drugs except for information submitted,
This determination of the regulatory marketed without an approved marked and identified, as confidential,
review period establishes the maximum application or over-the-counter (OTC) if submitted as detailed in
potential length of a patent extension. monograph drugs. This guidance ‘‘Instructions.’’
However, the USPTO applies several provides sponsors, applicants, and Instructions: All submissions received
statutory limitations in its calculations manufacturers with a set of principles to must include the Docket No. FDA–
of the actual period for patent extension. consider while developing drug 2012–D–1005 for ‘‘Safety Considerations
In its application for patent extension, products using a systems approach to for Product Design to Minimize
this applicant seeks 1,826 days of patent minimize medication errors relating to Medication Errors.’’ Received comments
term extension. product design and container closure will be placed in the docket and, except
design. The recommendations in this for those submitted as ‘‘Confidential
III. Petitions Submissions,’’ publicly viewable at
guidance document are intended to
Anyone with knowledge that any of provide best practices on how to http://www.regulations.gov or at the
the dates as published are incorrect may improve the drug product and container Division of Dockets Management
submit either electronic or written closure design for all prescription and between 9 a.m. and 4 p.m., Monday
comments and ask for a redetermination nonprescription drug products. This through Friday.
(see DATES). Furthermore, any guidance also provides examples of • Confidential Submissions—To
interested person may petition FDA for product designs that resulted in submit a comment with confidential
a determination regarding whether the postmarketing error. information that you do not wish to be
applicant for extension acted with due DATES: Submit either electronic or made publicly available, submit your
diligence during the regulatory review written comments on Agency guidances comments only as a written/paper
period. To meet its burden, the petition at any time. submission. You should submit two
must be timely (see DATES) and contain copies total. One copy will include the
ADDRESSES: You may submit comments
sufficient facts to merit an FDA information you claim to be confidential
as follows:
investigation. (See H. Rept. 857, part 1, with a heading or cover note that states
98th Cong., 2d sess., pp. 41–42, 1984.) Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Petitions should be in the format Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
specified in 21 CFR 10.30. following way: Agency will review this copy, including
Submit petitions electronically to • Federal eRulemaking Portal:http:// the claimed confidential information, in
http://www.regulations.gov at Docket www.regulations.gov. Follow the its consideration of comments. The
No. FDA–2013–S–0610. Submit written instructions for submitting comments. second copy, which will have the
petitions (two copies are required) to the Comments submitted electronically, claimed confidential information
Division of Dockets Management (HFA– including attachments, to http:// redacted/blacked out, will be available
305), Food and Drug Administration, www.regulations.gov will be posted to for public viewing and posted on http://
5630 Fishers Lane, Rm. 1061, Rockville, the docket unchanged. Because your www.regulations.gov. Submit both
MD 20852. comment will be made public, you are copies to the Division of Dockets
Dated: April 6, 2016. solely responsible for ensuring that your Management. If you do not wish your
comment does not include any name and contact information to be
Leslie Kux,
confidential information that you or a made publicly available, you can
Associate Commissioner for Policy. provide this information on the cover
third party may not wish to be posted,
[FR Doc. 2016–08334 Filed 4–11–16; 8:45 am] sheet and not in the body of your
such as medical information, your or
BILLING CODE P
anyone else’s Social Security number, or comments and you must identify this
confidential business information, such information as ‘‘confidential.’’ Any
as a manufacturing process. Please note information marked as ‘‘confidential’’
DEPARTMENT OF HEALTH AND will not be disclosed except in
HUMAN SERVICES that if you include your name, contact
information, or other information that accordance with 21 CFR 10.20 and other
Food and Drug Administration identifies you in the body of your applicable disclosure law. For more
comments, that information will be information about FDA’s posting of
[Docket No. FDA–2012–D–1005] posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
Safety Considerations for Product the information at: http://www.fda.gov/
with confidential information that you
Design To Minimize Medication Errors; regulatoryinformation/dockets/
asabaliauskas on DSK3SPTVN1PROD with NOTICES
do not wish to be made available to the
Guidance for Industry; Availability default.htm.
public, submit the comment as a
AGENCY: Food and Drug Administration, written/paper submission and in the Docket: For access to the docket to
HHS. manner detailed (see ‘‘Written/Paper read background documents or the
ACTION: Notice. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to http://
SUMMARY: The Food and Drug Written/Paper Submissions www.regulations.gov and insert the
Administration (FDA or the Agency) is Submit written/paper submissions as docket number, found in brackets in the
announcing the availability of a follows: heading of this document, into the
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![Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices 21577
‘‘Search’’ box and follow the prompts entitled ‘‘Safety Considerations for Dated: April 6, 2016.
and/or go to the Division of Dockets Product Design to Minimize Medication Leslie Kux,
Management, 5630 Fishers Lane, Rm. Errors.’’ The Agency has carefully Associate Commissioner for Policy.
1061, Rockville, MD 20852. reviewed and considered the comments [FR Doc. 2016–08335 Filed 4–11–16; 8:45 am]
Submit written requests for single it received in developing this final
BILLING CODE 4164–01–P
copies of this guidance to the Division version of the guidance. The Agency has
of Drug Information, Center for Drug made revisions to the guidance to
Evaluation and Research, Food and address public comments requesting
DEPARTMENT OF HEALTH AND
Drug Administration, 10001 New clarifications and implement formatting
changes for improved readability as it HUMAN SERVICES
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993– deemed appropriate. The Agency also
Food and Drug Administration
0002. Send one self-addressed adhesive moved recommendations appropriate
label to assist that office in processing for labels and labeling to a separate
your requests. See the SUPPLEMENTARY guidance. The guidance announced in [Docket No. FDA–2016–D–0768]
INFORMATION section for electronic this notice finalizes the draft guidance
dated December 2012. Donor Screening Recommendations
access to the guidance document.
This guidance is being issued To Reduce the Risk of Transmission of
FOR FURTHER INFORMATION CONTACT:
consistent with FDA’s good guidance Zika Virus by Human Cells, Tissues,
Irene Z. Chan, Center for Drug
practices regulation (21 CFR 10.115). and Cellular and Tissue-Based
Evaluation and Research, Food and
The guidance represents the Agency’s Products; Guidance for Industry;
Drug Administration, 10903 New
current thinking on addressing safety Availability; Correction
Hampshire Ave., Bldg. 22, Rm. 4420,
Silver Spring, MD 20993–0002, 301– achieved through drug product design
to minimize medication errors. It does AGENCY: Food and Drug Administration,
796–3962.
not establish any rights for any person HHS.
SUPPLEMENTARY INFORMATION:
and is not binding on FDA or the public. ACTION: Notice of availability;
I. Background You can use an alternative approach if correction.
FDA is announcing the availability of it satisfies the requirements of the
a guidance for industry entitled ‘‘Safety applicable statutes and regulations.
SUMMARY: The Food and Drug
Considerations for Product Design to II. Comments Administration (FDA) is correcting a
Minimize Medication Errors.’’ The Interested persons may submit either notice that appeared in the Federal
guidance is intended for sponsors of electronic comments regarding this Register of Monday, March 7, 2016 (81
INDs; applicants of NDAs, BLAs, and document to http://www.regulations.gov FR 11808). The document announced a
ANDAs; and manufacturers of or written comments to the Division of guidance for industry entitled ‘‘Donor
prescription drugs marketed without an Dockets Management (see ADDRESSES). It Screening Recommendations to Reduce
approved application or OTC is only necessary to send one set of the Risk of Transmission of Zika Virus
monograph drugs. This guidance comments. Identify comments with the by Human Cells, Tissues, and Cellular
provides sponsors, applicants, and docket number found in brackets in the and Tissue-Based Products.’’ The
manufacturers with a set of principles to heading of this document. Received document was published with an
consider while developing drug comments may be seen in the Division
products using a systems approach to incorrect docket number in the
of Dockets Management between 9 a.m. ADDRESSES section. This document
minimize medication errors relating to and 4 p.m., Monday through Friday, and
product design and container closure corrects that error.
will be posted to the docket at http://
design. The recommendations in this www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Lisa
guidance document are intended to Granger, Office of Policy, Planning,
provide best practices on how to III. Paperwork Reduction Act of 1995 Legislation, and Analysis, Food and
improve the drug product and container This guidance refers to previously Drug Administration, 10903 New
closure design for all prescription and approved collections of information Hampshire Ave., Bldg. 32, Rm. 3330,
nonprescription drug products. The found in FDA regulations. These Silver Spring, MD 20993–0002, 301–
guidance also provides examples of collections of information are subject to 796–9115.
product designs that resulted in review by the Office of Management and
postmarketing error. Budget (OMB) under the Paperwork SUPPLEMENTARY INFORMATION: In FR Doc.
This guidance document, which Reduction Act of 1995 (44 U.S.C. 3501– 2016–04893, appearing on page 11808
focuses on minimizing risks associated 3520). The collections of information in in the Federal Register of Monday,
with the design of the drug product and 21 CFR part 312 have been approved March 7, 2016, the following correction
its container closure system, is the first under OMB control number 0910–0014. is made:
in a series of three planned guidances to The collections of information in 21 1. On page 11808, in the third
minimize or eliminate hazards CFR part 314 have been approved under column, the docket number is corrected
contributing to medication errors. The OMB control number 0910–0001. The to read ‘‘FDA–2016–D–0768’’.
second guidance focuses on minimizing collections of information in 21 CFR
risks with the design of drug product Dated: April 6, 2016.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
part 601 have been approved under
container labels and carton labeling. OMB control number 0910–0338. Leslie Kux,
The third guidance focuses on Associate Commissioner for Policy.
minimizing risks when developing and IV. Electronic Access
[FR Doc. 2016–08330 Filed 4–11–16; 8:45 am]
selecting proposed proprietary names You may obtain the document at
BILLING CODE 4164–01–P
for drugs. http://www.fda.gov/Drugs/Guidance
In the Federal Register of December ComplianceRegulatoryInformation/
13, 2012 (77 FR 74196), FDA announced Guidances/default.htm or http://
the availability of the draft guidance www.regulations.gov.
VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 E:\FR\FM\12APN1.SGM 12APN1](https://thefederalregister.org/doc/81_FR_21646/page/2.svg)
Document Created: 2016-04-12 00:47:06
Document Modified: 2016-04-12 00:47:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Irene Z. Chan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993-0002, 301- 796-3962. | |
| FR Citation | 81 FR 21576 |
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