Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction, 74197 [2012-30024]
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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considers your comments on this draft
guidance before it begins work on the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on the draft guidance by February 11,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single copies of this draft guidance to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access to the draft guidance document.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draft guidance to https://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:
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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a draft guidance for industry entitled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
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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
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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
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[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Page 74197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30024]
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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.
-----------------------------------------------------------------------
SUMMARY: 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.
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.
SUPPLEMENTARY INFORMATION: 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''.
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
