Food and Drug Administration/Xavier University Global Medical Device Conference, 15957-15958 [2013-05727]
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Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices
no standards or regulatory requirements
that specifically address scoring of
tablets, the Agency recognizes the need
for consistent scoring between a generic
product and its RLD.
Consistent scoring ensures that the
patient is able to adjust the dose, by
splitting the tablet, in the same manner
as the RLD. This enables the patient to
switch between products made by
different manufacturers without
encountering problems related to the
dose. In addition, consistent scoring
ensures that neither the generic product
nor the RLD has an advantage in the
marketplace because one is scored and
one is not.
The Center for Drug Evaluation and
Research’s Drug Safety Oversight Board
considered the practice of tablet
splitting at its October 2009 and
November 2010 meetings. During those
meetings, they discussed how insurance
companies and doctors are increasingly
recommending that patients split
tablets, either to adjust the patients’
dose or as a cost-saving measure.
Because of this, the Agency conducted
internal research on tablet splitting and
concluded that in some cases, there are
possible safety issues, especially when
tablets are not scored or evaluated for
splitting. The Agency’s concerns with
splitting a tablet included variations in
the tablet content, weight,
disintegration, or dissolution, which can
affect how much drug is present in a
split tablet and available for absorption.
In addition, there may be stability issues
with splitting tablets.
Tablet splitting also is addressed in
pharmacopeial standards. The European
Pharmacopeia currently applies
accuracy of subdivision standards for
scored tablets—and has at various times
also included standards for content
uniformity, weight variation, and loss of
mass—while the United States
Pharmacopeia published a Stimuli
article in 2009 proposing criteria for loss
of mass and accuracy of subdivision for
split tablets.
As an outgrowth of these discussions,
FDA is providing recommendations for
application content regarding the
scientific basis for functional scoring on
solid oral dosage form products to
ensure the quality of both NDA and
ANDA scored tablet products. To
accomplish this, the Agency has
developed consistent and meaningful
criteria by which scored tablets can be
evaluated and labeled by: (1) Providing
a harmonized approach to chemistry,
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manufacturing, and controls reviews of
scored tablets; (2) ensuring consistency
in nomenclature (e.g., score versus
bisect) and labeling; and (3) providing
information through product labeling or
other means to health care providers.
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 tablet scoring:
Nomenclature, labeling, and data for
evaluation. 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
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. The 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
§ 201.57 (21 CFR 201.57) and 21 CFR
314.50 and 314.70 have been approved
under OMB control numbers 0910–0572
(for § 201.57) and 0910–0001 (for 21
CFR part 314).
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05725 Filed 3–12–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Food and Drug Administration/Xavier
University Global Medical Device
Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) Cincinnati
District, in cosponsorship with Xavier
University, is announcing a public
conference entitled ‘‘FDA/Xavier
University Global Medical Device
Conference.’’ This 3-day public
conference includes presentations from
key FDA officials and industry experts
with small group breakout sessions. The
conference is intended for companies of
all sizes and employees at all levels.
Date and Time: The public conference
will be held on May 1, 2013, from 8:30
a.m. to 5 p.m.; May 2, 2013, from 8:30
a.m. to 5 p.m.; and May 3, 2013, from
8:30 a.m. to 1 p.m.
Location: The public conference will
be held on the campus of Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207, 513–745–3073 or
513–745–3396.
Contact Persons: For information
regarding this notice: Gina Brackett,
Food and Drug Administration, 6751
Steger Dr., Cincinnati, OH 45237, 513–
679–2700, Fax: 513–679–2771,
Gina.Brackett@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier University, 3800
Victory Pkwy., Cincinnati, OH 45207,
513–745–3073, phillipsm4@xavier.edu.
Registration: There is a registration
fee. The conference registration fees
cover the cost of the presentations,
training materials, receptions,
breakfasts, and lunches for the 3 days of
the conference. Early registration ends
March 13, 2013. Standard registration
ends April 9, 2013. There will be onsite
registration. The cost of registration is as
follows:
SUMMARY:
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Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices
TABLE 1—REGISTRATION FEES 1
Advanced rate
(March 13, 2013
to April 8, 2013)
Attendee type
Standard rate
(April 9, 2013
to May 3, 2013)
$1,295
900
600
250
250
$1,495
1,000
700
300
300
Free
Industry ............................................................................................................................................................
Small Business (<100 employees) ..................................................................................................................
Consultant ........................................................................................................................................................
Startup Manufacturer .......................................................................................................................................
Academic .........................................................................................................................................................
FDA/Government Employee ............................................................................................................................
(2)
1 The
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following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.
2 Free.
To register online for the public
conference, please visit the ‘‘Register
Now’’ link on the conference Web site
at https://www.XavierMedCon.com. FDA
has verified the Web site address, but is
not responsible for subsequent changes
to the Web site after this document
publishes in the Federal Register.
To register by mail, please send your
name, title, firm name, address,
telephone and fax numbers, email, and
payment information for the fee to
Xavier University, Attention: Sue
Bensman, 3800 Victory Pkwy.,
Cincinnati, OH 45207. An email will be
sent confirming your registration.
Attendees are responsible for their
own accommodations. The conference
headquarter hotel is the Downtown
Cincinnati Hilton Netherlands Plaza, 35
West Fifth St., Cincinnati, OH, 45202,
513–421–9100. Special Conference
Block rates are available through April
9, 2013. To make reservations online,
please visit the ‘‘Venue & Logistics’’ link
at https://www.XavierMedCon.com.
If you need special accommodations
due to a disability, please contact Marla
Phillips (see Contact Persons) at least 7
days in advance of the conference.
SUPPLEMENTARY INFORMATION: The
public conference helps fulfill the
Department of Health and Human
Services and FDA’s important mission
to protect the public health. The
conference will provide those engaged
in FDA-regulated medical devices (for
humans) with information on the
following topics:
• CDRH Future Vision and Strategy
Keynote Address
• U.S. Congressman Erik Paulsen
Keynote Dinner
• EU Regulations: New Regulations,
Company Strategy, and Open
Discussion Forum
• FDA Safety and Innovation Act
• Unique Device Identification
• Update from the Office of Device
Evaluation
• Total Product Life Cycle: Interactive
Workshop
• Pre-Submission Program and
Meetings with the FDA
VerDate Mar<15>2010
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Jkt 229001
• 510(k): New FDA Guidance and
Industry Regulations
• PMAs: New Guidance and
Compliance Initiatives
• Software and Mobile Apps
• Combination Products
• Entering the EU Market and CE
Mark Hot Topics
• Global Product Strategy
• Success in Central and South
America
• FDA Inspectional Approach—Panel
with Current FDA Investigators
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The conference helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which includes working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. The
conference also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121)
by providing outreach activities by
Government Agencies to small
businesses.
Dated: March 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05727 Filed 3–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request: Pediatric Palliative
Care Campaign Pilot Survey
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Nursing Research (NINR),
the National Institutes of Health (NIH)
has submitted to the Office of
Management and Budget (OMB) a
SUMMARY:
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request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on December 26, 2012, page
76053 and allowed 60-days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institute of
Nursing Research (NINR), National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Ms. Adrienne Burroughs,
Health Communications Specialist,
Office of Communications and Public
Liaison, NINR, NIH, Building 31, Room
5B10, 31 Center Drive, Bethesda, MD
20892 or call non-toll-free number (301)
496–0256 or Email your request,
including your address to:
adrienne.burroughs@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Pediatric
Palliative Care Campaign Pilot Survey,
E:\FR\FM\13MRN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15957-15958]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05727]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Food and Drug Administration/Xavier University Global Medical
Device Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
cosponsorship with Xavier University, is announcing a public conference
entitled ``FDA/Xavier University Global Medical Device Conference.''
This 3-day public conference includes presentations from key FDA
officials and industry experts with small group breakout sessions. The
conference is intended for companies of all sizes and employees at all
levels.
Date and Time: The public conference will be held on May 1, 2013,
from 8:30 a.m. to 5 p.m.; May 2, 2013, from 8:30 a.m. to 5 p.m.; and
May 3, 2013, from 8:30 a.m. to 1 p.m.
Location: The public conference will be held on the campus of
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or 513-745-3396.
Contact Persons: For information regarding this notice: Gina
Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH
45237, 513-679-2700, Fax: 513-679-2771, Gina.Brackett@fda.hhs.gov.
For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, phillipsm4@xavier.edu.
Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, and lunches for the 3 days of the
conference. Early registration ends March 13, 2013. Standard
registration ends April 9, 2013. There will be onsite registration. The
cost of registration is as follows:
[[Page 15958]]
Table 1--Registration Fees \1\
------------------------------------------------------------------------
Advanced rate
(March 13, 2013 Standard rate
Attendee type to April 8, (April 9, 2013
2013) to May 3, 2013)
------------------------------------------------------------------------
Industry............................ $1,295 $1,495
Small Business (<100 employees)..... 900 1,000
Consultant.......................... 600 700
Startup Manufacturer................ 250 300
Academic............................ 250 300
FDA/Government Employee............. (2) Free
------------------------------------------------------------------------
\1\ The following forms of payment will be accepted: American Express,
Visa, Mastercard, and company checks.
\2\ Free.
To register online for the public conference, please visit the
``Register Now'' link on the conference Web site at https://www.XavierMedCon.com. FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.
To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, email, and payment information for
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory
Pkwy., Cincinnati, OH 45207. An email will be sent confirming your
registration.
Attendees are responsible for their own accommodations. The
conference headquarter hotel is the Downtown Cincinnati Hilton
Netherlands Plaza, 35 West Fifth St., Cincinnati, OH, 45202, 513-421-
9100. Special Conference Block rates are available through April 9,
2013. To make reservations online, please visit the ``Venue &
Logistics'' link at https://www.XavierMedCon.com.
If you need special accommodations due to a disability, please
contact Marla Phillips (see Contact Persons) at least 7 days in advance
of the conference.
SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will provide those engaged in
FDA-regulated medical devices (for humans) with information on the
following topics:
CDRH Future Vision and Strategy Keynote Address
U.S. Congressman Erik Paulsen Keynote Dinner
EU Regulations: New Regulations, Company Strategy, and
Open Discussion Forum
FDA Safety and Innovation Act
Unique Device Identification
Update from the Office of Device Evaluation
Total Product Life Cycle: Interactive Workshop
Pre-Submission Program and Meetings with the FDA
510(k): New FDA Guidance and Industry Regulations
PMAs: New Guidance and Compliance Initiatives
Software and Mobile Apps
Combination Products
Entering the EU Market and CE Mark Hot Topics
Global Product Strategy
Success in Central and South America
FDA Inspectional Approach--Panel with Current FDA
Investigators
FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The conference helps to achieve objectives set forth
in section 406 of the Food and Drug Administration Modernization Act of
1997 (21 U.S.C. 393), which includes working closely with stakeholders
and maximizing the availability and clarity of information to
stakeholders and the public. The conference also is consistent with the
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121) by providing outreach activities by Government Agencies to
small businesses.
Dated: March 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05727 Filed 3-12-13; 8:45 am]
BILLING CODE 4160-01-P
