Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability; Correction, 21577 [2016-08330]
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Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
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Submit written requests for single
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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:
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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the availability of the draft guidance
VerDate Sep<11>2014
17:18 Apr 11, 2016
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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 https://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 https://
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
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
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21577
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0768]
Donor Screening Recommendations
To Reduce the Risk of Transmission of
Zika Virus by Human Cells, Tissues,
and Cellular and Tissue-Based
Products; Guidance for Industry;
Availability; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
correction.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Monday, March 7, 2016 (81
FR 11808). The document announced a
guidance for industry entitled ‘‘Donor
Screening Recommendations to Reduce
the Risk of Transmission of Zika Virus
by Human Cells, Tissues, and Cellular
and Tissue-Based Products.’’ The
document was published with an
incorrect docket number in the
ADDRESSES section. This document
corrects that error.
SUMMARY:
Lisa
Granger, Office of Policy, Planning,
Legislation, and Analysis, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3330,
Silver Spring, MD 20993–0002, 301–
796–9115.
FOR FURTHER INFORMATION CONTACT:
In FR Doc.
2016–04893, appearing on page 11808
in the Federal Register of Monday,
March 7, 2016, the following correction
is made:
1. On page 11808, in the third
column, the docket number is corrected
to read ‘‘FDA–2016–D–0768’’.
SUPPLEMENTARY INFORMATION:
Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08330 Filed 4–11–16; 8:45 am]
BILLING CODE 4164–01–P
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[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Page 21577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08330]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-0768]
Donor Screening Recommendations To Reduce the Risk of
Transmission of Zika Virus by Human Cells, Tissues, and Cellular and
Tissue-Based Products; Guidance for Industry; Availability; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of Monday, March 7, 2016 (81 FR
11808). The document announced a guidance for industry entitled ``Donor
Screening Recommendations to Reduce the Risk of Transmission of Zika
Virus by Human Cells, Tissues, and Cellular and Tissue-Based
Products.'' The document was published with an incorrect docket number
in the ADDRESSES section. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy,
Planning, Legislation, and Analysis, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-
0002, 301-796-9115.
SUPPLEMENTARY INFORMATION: In FR Doc. 2016-04893, appearing on page
11808 in the Federal Register of Monday, March 7, 2016, the following
correction is made:
1. On page 11808, in the third column, the docket number is
corrected to read ``FDA-2016-D-0768''.
Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08330 Filed 4-11-16; 8:45 am]
BILLING CODE 4164-01-P
