Sixth Annual Sentinel Initiative; Public Workshop, 67168-67169 [2013-26855]
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67168
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices
information. Four comments were
received. Three comments pertain to the
information collection. One comment
addressed an issue unrelated to the
proposed collection of information,
such as pet food safety; therefore, we do
not address this issue in this document.
One comment expressed concern that
the estimated hours to collect the
information required to implement and
maintain the requirements in the draft
feed standards is low. Two comments
expressed concern that implementing
and maintaining the draft feed standards
would require more State program
employees and financial support from
FDA.
Regarding the comment asserting that
the total estimated hours reported in
Table 1 is low; we recognize the number
of hours needed to implement and
maintain the draft feed standards will
vary among States depending on the
size of the State’s feed program, the
number of staff, and the State’s short
and long term goals for implementing
the draft feed standards. The burden
estimates are reasonable given the
variation among State programs and
their current ability to implement the
draft feed standards.
Regarding the comment expressing
concern that the State feed programs
would need additional employees and
funding from FDA to implement and
maintain the requirements in the draft
feed standards; FDA recognizes that
State feed programs may need
additional resources to implement and
maintain the draft feed standards.
Therefore, FDA will pursue funding for
the draft feed standards; however, the
level of funding may vary each year and
is contingent on budget approval.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
State Feed Regulatory Programs in the
United States ................................................
50
1
50
3,000
150,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated to
3,000 hours per respondent. The
estimate includes time for reviewing the
draft feed standards, gathering and
maintaining the data and documents for
each standard, and completing and
reviewing the data and documents that
would be spent to fully implement the
11 standards. FDA recognizes that full
use and implementation of the draft
feed standards by State feed programs
will occur over many years and the
number of years to fully implement the
draft feed standards will vary among
States. This burden was determined by
averaging the burden estimates received
from five respondents. The five
respondents are representative of the
State feed programs in the United
States.
Dated: November 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–26778 Filed 11–7–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TKELLEY on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Sixth Annual Sentinel Initiative; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
VerDate Mar<15>2010
18:08 Nov 07, 2013
Jkt 232001
The Food and Drug Administration
(FDA) is announcing the following
public workshop entitled ‘‘Sixth Annual
Sentinel Initiative.’’ Convened by the
Engelberg Center for Health Care Reform
at the Brookings Institution and
supported by a cooperative agreement
with FDA, this 1-day workshop will
bring the stakeholder community
together to discuss a variety of topics on
active medical product surveillance.
Topics will include an overview of the
status of FDA’s Sentinel Initiative and
future plans, highlights from key MiniSentinel and related activities, and an
update on active surveillance
collaborations and program extensions.
In addition, this workshop will engage
stakeholders to discuss current and
emerging Sentinel projects and facilitate
stakeholder feedback and input on
Sentinel projects that would be
appropriate to determine the feasibility
of using Sentinel to evaluate drug safety
issues that may require regulatory action
(e.g., labeling changes, postmarketing
requirements (PMRs), or postmarketing
commitments (PMCs)). This workshop
satisfies an FDA commitment that is
part of the fifth authorization of the
Prescription Drug User Fee Act (PDUFA
V).
Date and Time: The public workshop
will be held on January 14, 2014, from
9 a.m. to 4 p.m.
Location: The public workshop will
be held at the Washington Marriott at
Metro Center, 775 12th Street NW.,
Washington, DC 20001. For additional
travel and hotel information, please
refer to https://www.cvent.com/d/jcqhyy.
PO 00000
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Fmt 4703
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(FDA has verified the Web site
addresses throughout this notice, but
FDA is not responsible for subsequent
changes to the Web sites after this
document publishes in the Federal
Register).
Contact Person: Carlos Bell, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6358,
Silver Spring, MD 20993, 301–796–
3714, FAX: 301–847–3529, email:
SentinelInitiative@fda.hhs.gov.
Registration: To attend the public
workshop, you must register before
January 14, 2014, by visiting https://
www.cvent.com/d/jcqhyy. Early
registration is recommended. There will
be no onsite registration. When
registering, please provide the following
information: Your name, title, company
or organization (if applicable), postal
address, telephone number, and email
address. There is no registration fee for
the public workshop; but because
seating is limited, registration will be on
a first-come, first-served basis. A 1-hour
lunch break is scheduled; however, food
will not be provided. There are multiple
restaurants within walking distance of
the hotel.
If you need special accommodations
due to a disability, please contact
Joanna Klatzman at the Brookings
Institution (email: jKlatzman@
brookings.edu) at least 7 days in
advance.
Meeting Materials: All event materials
will be available to registered attendees
via email prior to the workshop and will
be posted after the event on the
E:\FR\FM\08NON1.SGM
08NON1
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices
Brookings Institution event Web site at
https://www.brookings.edu//health/
events.
Transcripts: Please be advised that
transcripts will not be available.
SUPPLEMENTARY INFORMATION: On July 9,
2012, the President signed into law the
Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L.
112–144). Title I of FDASIA
reauthorizes PDUFA and provides FDA
with the user fee resources necessary to
maintain an efficient review process for
human drug and biological products.
The reauthorization of PDUFA includes
performance goals and procedures for
the Agency that represent FDA’s
commitments during fiscal years 2013–
2017 (PDUFA V). These commitments
are fully described in the document
entitled ‘‘PDUFA Reauthorization
Performance Goals and Procedures
Fiscal Years 2013 Through 2017’’
(PDUFA Goals Letter), available on
FDA’s Web site at https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM270412.pdf. Section XI of the
PDUFA Goals Letter, entitled
‘‘Enhancement and Modernization of
the FDA Drug Safety System,’’ includes
Sentinel as a tool for evaluating drug
safety issues that may require regulatory
action. As part of this enhancement,
FDA committed to hold a public
meeting to engage stakeholders in a
discussion of current and emerging
Sentinel projects and facilitate
stakeholder feedback and input to
determine the feasibility of using
Sentinel to evaluate drug safety issues
that may require regulatory action, e.g.,
labeling changes, PMRs, or PMCs. The
public workshop announced by this
notice will fulfill this commitment.
Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–26855 Filed 11–7–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
TKELLEY on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2013–N–1317]
Tentative Determination Regarding
Partially Hydrogenated Oils; Request
for Comments and for Scientific Data
and Information
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for comments
and for scientific data and information.
ACTION:
VerDate Mar<15>2010
18:08 Nov 07, 2013
Jkt 232001
Based on new scientific
evidence and the findings of expert
scientific panels, the Food and Drug
Administration (FDA) has tentatively
determined that partially hydrogenated
oils (PHOs), which are the primary
dietary source of industrially-produced
trans fatty acids, or trans fat, are not
generally recognized as safe (GRAS) for
any use in food based on current
scientific evidence establishing the
health risks associated with the
consumption of trans fat, and therefore
that PHOs are food additives. Although
FDA has not listed the most commonly
used PHOs, they have been used in food
for many years based on selfdeterminations by industry that such
use is GRAS. If finalized, this would
mean that food manufacturers would no
longer be permitted to sell PHOs, either
directly or as ingredients in another
food product, without prior FDA
approval for use as a food additive.
DATES: Submit either electronic or
written comments and scientific data
and information by January 7, 2014.
ADDRESSES: Submit electronic
comments and scientific data and
information to https://
www.regulations.gov. Submit written
comments and scientific data and
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
submissions must include the Agency
name and the docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Mical Honigfort, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1278, FAX: 301–436–2972,
email: mical.honigfort@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Introduction
In accordance with the process set out
in § 170.38(b)(1) (21 CFR 170.38(b)(1)),
we are issuing this document
announcing our tentative determination
that PHOs are no longer GRAS under
any condition of use in food and
therefore are food additives subject to
section 409 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
348). If finalized, this would mean that
food manufacturers would no longer be
permitted to sell PHOs, either directly
or as ingredients in another food
product, without prior FDA approval for
use as a food additive.
FDA’s evaluation of the GRAS status
of PHOs is centered on the trans fatty
acid (also referred to as ‘‘trans fat’’)
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67169
component of these oils. This document
addresses PHOs because they are the
primary dietary source of industriallyproduced trans fat (Ref. 1). Although all
refined edible oils contain some trans
fat as an unintentional byproduct of
their manufacturing process, trans fats
are an integral component of PHOs and
are purposely produced in these oils to
affect the properties of the oil and the
characteristics of the food to which they
are added.
The current scientific evidence,
which is discussed in section IV of this
document, identifies significant health
risks caused by the consumption of
trans fat. This evidence includes the
opinions of expert panels and the 2005
recommendation of the Institute of
Medicine (IOM) to limit trans fat
consumption as much as possible while
consuming a nutritionally adequate diet,
recognizing that trans fat occurs
naturally in meat and dairy products
from ruminant animals and that
naturally-occurring trans fat is
unavoidable in ordinary, nonvegan diets
without significant dietary adjustments
that may introduce undesirable effects
(Ref. 2). In addition, according to the
Centers for Disease Control and
Prevention (CDC), elimination of PHOs
from the food supply could prevent
10,000 to 20,000 coronary events and
3,000 to 7,000 coronary deaths annually,
if the marginal benefits of continuing to
remove trans fats from food items
remain constant (Ref. 3). (See
accompanying economic analysis for
more information on this estimate.)
Given this evidence, we have tentatively
determined that there is no longer a
consensus among qualified scientific
experts that PHOs, the primary dietary
source of industrially-produced trans
fatty acids, are safe for human
consumption, either directly or as
ingredients in other food products.
II. Background
A. Hydrogenation Process and Trans
Fatty Acids
Chemical hydrogenation is the
process by which hydrogen atoms are
added to unsaturated sites on the carbon
chains of fatty acids, in the presence of
catalysts, thereby reducing the number
of double bonds. ‘‘Partial
hydrogenation’’ describes an incomplete
saturation of the double bonds, in which
some double bonds remain but may
shift to a different position along the
carbon chain and alter their
configuration from cis to trans. The
trans arrangement of hydrogen atoms
results in a relatively straight
configuration of the fatty acids and
increases the melting point, shelf life,
E:\FR\FM\08NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67168-67169]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26855]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Sixth Annual Sentinel Initiative; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Sixth Annual Sentinel Initiative.'' Convened
by the Engelberg Center for Health Care Reform at the Brookings
Institution and supported by a cooperative agreement with FDA, this 1-
day workshop will bring the stakeholder community together to discuss a
variety of topics on active medical product surveillance. Topics will
include an overview of the status of FDA's Sentinel Initiative and
future plans, highlights from key Mini-Sentinel and related activities,
and an update on active surveillance collaborations and program
extensions. In addition, this workshop will engage stakeholders to
discuss current and emerging Sentinel projects and facilitate
stakeholder feedback and input on Sentinel projects that would be
appropriate to determine the feasibility of using Sentinel to evaluate
drug safety issues that may require regulatory action (e.g., labeling
changes, postmarketing requirements (PMRs), or postmarketing
commitments (PMCs)). This workshop satisfies an FDA commitment that is
part of the fifth authorization of the Prescription Drug User Fee Act
(PDUFA V).
Date and Time: The public workshop will be held on January 14,
2014, from 9 a.m. to 4 p.m.
Location: The public workshop will be held at the Washington
Marriott at Metro Center, 775 12th Street NW., Washington, DC 20001.
For additional travel and hotel information, please refer to https://www.cvent.com/d/jcqhyy. (FDA has verified the Web site addresses
throughout this notice, but FDA is not responsible for subsequent
changes to the Web sites after this document publishes in the Federal
Register).
Contact Person: Carlos Bell, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6358, Silver Spring, MD 20993, 301-796-3714, FAX: 301-847-3529,
email: SentinelInitiative@fda.hhs.gov.
Registration: To attend the public workshop, you must register
before January 14, 2014, by visiting https://www.cvent.com/d/jcqhyy.
Early registration is recommended. There will be no onsite
registration. When registering, please provide the following
information: Your name, title, company or organization (if applicable),
postal address, telephone number, and email address. There is no
registration fee for the public workshop; but because seating is
limited, registration will be on a first-come, first-served basis. A 1-
hour lunch break is scheduled; however, food will not be provided.
There are multiple restaurants within walking distance of the hotel.
If you need special accommodations due to a disability, please
contact Joanna Klatzman at the Brookings Institution (email:
jKlatzman@brookings.edu) at least 7 days in advance.
Meeting Materials: All event materials will be available to
registered attendees via email prior to the workshop and will be posted
after the event on the
[[Page 67169]]
Brookings Institution event Web site at https://www.brookings.edu//health/events.
Transcripts: Please be advised that transcripts will not be
available.
SUPPLEMENTARY INFORMATION: On July 9, 2012, the President signed into
law the Food and Drug Administration Safety and Innovation Act (FDASIA)
(Pub. L. 112-144). Title I of FDASIA reauthorizes PDUFA and provides
FDA with the user fee resources necessary to maintain an efficient
review process for human drug and biological products. The
reauthorization of PDUFA includes performance goals and procedures for
the Agency that represent FDA's commitments during fiscal years 2013-
2017 (PDUFA V). These commitments are fully described in the document
entitled ``PDUFA Reauthorization Performance Goals and Procedures
Fiscal Years 2013 Through 2017'' (PDUFA Goals Letter), available on
FDA's Web site at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. Section XI of the PDUFA Goals
Letter, entitled ``Enhancement and Modernization of the FDA Drug Safety
System,'' includes Sentinel as a tool for evaluating drug safety issues
that may require regulatory action. As part of this enhancement, FDA
committed to hold a public meeting to engage stakeholders in a
discussion of current and emerging Sentinel projects and facilitate
stakeholder feedback and input to determine the feasibility of using
Sentinel to evaluate drug safety issues that may require regulatory
action, e.g., labeling changes, PMRs, or PMCs. The public workshop
announced by this notice will fulfill this commitment.
Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26855 Filed 11-7-13; 8:45 am]
BILLING CODE 4160-01-P
