Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidance, 12761-12762 [2013-04251]
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Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices
developed, to assist applicants with the
content and format of the labeling for
human prescription drug and biological
products. In the Federal Register of
January 24, 2006 (71 FR 3998), FDA
announced the availability of final
guidances on the content and format of
the ‘‘Adverse Reactions’’ (https://www.
fda.gov/downloads/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/ucm075057.pdf) and
‘‘Clinical Studies’’ (https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
ucm075059.pdf) sections of labeling. In
the Federal Register of October 19, 2009
(74 FR 53507), FDA announced the
availability of final guidance on
determining established pharmacologic
class for use in the Highlights of
Prescribing Information (https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/UCM186607.
pdf). In the Federal Register of March
23, 2010 (75 FR 13766), FDA announced
the availability of final guidance on the
content and format of the ‘‘Dosage and
Administration’’ section of labeling
(https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM075066.pdf). In the Federal
Register of October 12, 2011 (76 FR
63303), FDA announced the availability
of final guidance on the content and
format of the ‘‘Warnings and
Precautions,’’ ‘‘Contraindications,’’ and
‘‘Boxed Warning’’ sections of labeling
(https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/UCM075096.
pdf) and in the Federal Register of
March 3, 2009 (74 FR 9250), FDA
announced the availability of draft
guidance on the content and format of
the ‘‘Clinical Pharmacology’’ section of
labeling (https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
UCM109739.pdf). The labeling
requirements and these guidances are
intended to make information in
prescription drug labeling easier for
health care practitioners to access, read,
and use.
On January 24, 2006, FDA announced
the availability of draft guidance
entitled ‘‘Labeling for Human
Prescription Drug and Biological
Products—Implementing the New
Content and Format Requirements’’ to
obtain public comment (71 FR 3998).
FDA received a number of comments,
most of which sought clarifications and
illustrations of the issues discussed in
individual sections of the guidance.
FDA reviewed all received comments
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17:22 Feb 22, 2013
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carefully during the finalization of the
guidance and made clarifying changes
based on input from these comments
and comments from FDA reviewers with
labeling expertise.
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 implementing the
PLR content and format requirements
for labeling for human prescription drug
and biological products. 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. 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
§§ 201.56 and 201.57 have been
approved under OMB control number
0910–0572.
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, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm or https://
www.regulations.gov.
Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–04195 Filed 2–22–13; 8:45 am]
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12761
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–D–0409] (formerly
2006D–0169)
Guidance for Industry: Guidance on
the Labeling of Certain Uses of
Lecithin Derived From Soy Under
Section 403(w) of the Federal Food,
Drug, and Cosmetic Act; Withdrawal of
Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA or we) is
announcing the withdrawal of a
guidance entitled ‘‘Guidance for
Industry: Guidance on the Labeling of
Certain Uses of Lecithin Derived From
Soy Under Section 403(w) of the Federal
Food, Drug, and Cosmetic Act,’’ dated
April 2006, that was announced in the
Federal Register on May 2, 2006. The
guidance explained FDA’s then current
thinking on the labeling of certain uses
of lecithin derived from soy under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) and was part of FDA’s
implementation of the Food Allergen
Labeling and Consumer Protection Act
(FALCPA). We are taking this action
because the policy stated in the
guidance regarding FDA’s consideration
of the exercise of enforcement discretion
no longer reflects our current thinking.
DATES: The withdrawal is effective
February 25, 2013.
FOR FURTHER INFORMATION CONTACT:
Steven M. Gendel, Center for Food
Safety and Applied Nutrition (HFS–
200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 240–402–1056.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
May 2, 2006 (71 FR 25844), we
announced the availability of a guidance
entitled ‘‘Guidance on the Labeling of
Certain Uses of Lecithin Derived From
Soy Under Section 403(w) of the Federal
Food, Drug, and Cosmetic Act.’’ The
guidance explained that, consistent with
the need to establish enforcement
priorities, we would consider the
exercise of enforcement discretion for a
food labeled on or after January 1, 2006,
in which lecithin derived from soy is
used solely as a component of a release
agent and the label for such food does
not declare the presence of soy
consistent with the requirements of
section 403(w) of the FD&C Act (21
U.S.C. 343(w)). In that guidance, the
SUMMARY:
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Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices
term ‘‘release agent’’ referred to an agent
used to facilitate the release of foods
from food contact surfaces, where the
agent has been applied directly to the
food contact surface, rather than
incorporated into the food. In that
guidance, we also stated our intention to
reconsider our enforcement priorities
with regard to the labeling of lecithin
derived from soy used as a component
of a release agent approximately 18
months after the issuance of the
guidance. Further, we stated our
expectation that, during the period in
which we considered the exercise of our
enforcement discretion, manufacturers
of foods that use lecithin derived from
soy as a component of a release agent
would revise as necessary the labels of
their relevant food products to comply
with FALCPA and begin to label their
products using the FALCPA-compliant
labels by the end of the enforcement
discretion period.
We believe that there has been
sufficient time for all manufacturers of
foods that use lecithin derived from soy
as a component of a release agent to
revise the labels for such foods to be
consistent with the requirements of
section 403(w) of the FD&C Act.
Therefore, we no longer believe it is
appropriate to consider the exercise of
our enforcement discretion with regard
to foods that use lecithin derived from
soy as a component of a release agent.
For these reasons, we are withdrawing
the April 2006 guidance entitled
‘‘Guidance on the Labeling of Certain
Uses of Lecithin Derived from Soy
Under Section 403(w) of the Federal
Food, Drug, and Cosmetic Act.’’
Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–04251 Filed 2–22–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
mstockstill on DSK4VPTVN1PROD with NOTICES
Joint Meeting of the Medical Imaging
Drugs Advisory Committee and the
Oncologic Drugs Advisory Committee;
Notice of Meeting.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
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17:22 Feb 22, 2013
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Name of Committees: Medical
Imaging Drugs Advisory Committee and
the Oncologic Drugs Advisory
Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 3, 2013, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (rm. 1503), 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Diane Goyette, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, email: MIDAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On May 3, 3013, the
committees will discuss the safety and
efficacy of currently approved leukocyte
growth factors (LGFs) as potential
treatments for radiation-induced
myelosuppression associated with a
radiological/nuclear incident.
(Myelosuppression is a reduction of
blood cell production, which can be
caused by radiation exposure.)
Currently approved LGFs are licensed
under biological license applications
(BLAs): 103353, NEUPOGEN (filgrastim,
Amgen, Inc.), 125031, NEULASTA
(pegfilgrastim, Amgen, Inc.), 103362,
LEUKINE, (sargramostim, Genzyme,
Inc.), and 125294, TBO–FILGRASTIM
(tbo-filgrastim, Sicor Biotech, UAB). The
National Institute of Allergy and
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Infectious Diseases (NIAID) has
submitted efficacy data for filgrastim,
based on treatment in an animal model
of radiation-induced myelosuppression.
Safety and other supportive information
are currently described in the labeling
for LGFs.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 19, 2013. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 11,
2013. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 12, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Diane
Goyette at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
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]]>Agencies
[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12761-12762]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04251]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-D-0409] (formerly 2006D-0169)
Guidance for Industry: Guidance on the Labeling of Certain Uses
of Lecithin Derived From Soy Under Section 403(w) of the Federal Food,
Drug, and Cosmetic Act; Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
withdrawal of a guidance entitled ``Guidance for Industry: Guidance on
the Labeling of Certain Uses of Lecithin Derived From Soy Under Section
403(w) of the Federal Food, Drug, and Cosmetic Act,'' dated April 2006,
that was announced in the Federal Register on May 2, 2006. The guidance
explained FDA's then current thinking on the labeling of certain uses
of lecithin derived from soy under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) and was part of FDA's implementation of the Food
Allergen Labeling and Consumer Protection Act (FALCPA). We are taking
this action because the policy stated in the guidance regarding FDA's
consideration of the exercise of enforcement discretion no longer
reflects our current thinking.
DATES: The withdrawal is effective February 25, 2013.
FOR FURTHER INFORMATION CONTACT: Steven M. Gendel, Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1056.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of May 2, 2006 (71 FR 25844), we announced the availability of
a guidance entitled ``Guidance on the Labeling of Certain Uses of
Lecithin Derived From Soy Under Section 403(w) of the Federal Food,
Drug, and Cosmetic Act.'' The guidance explained that, consistent with
the need to establish enforcement priorities, we would consider the
exercise of enforcement discretion for a food labeled on or after
January 1, 2006, in which lecithin derived from soy is used solely as a
component of a release agent and the label for such food does not
declare the presence of soy consistent with the requirements of section
403(w) of the FD&C Act (21 U.S.C. 343(w)). In that guidance, the
[[Page 12762]]
term ``release agent'' referred to an agent used to facilitate the
release of foods from food contact surfaces, where the agent has been
applied directly to the food contact surface, rather than incorporated
into the food. In that guidance, we also stated our intention to
reconsider our enforcement priorities with regard to the labeling of
lecithin derived from soy used as a component of a release agent
approximately 18 months after the issuance of the guidance. Further, we
stated our expectation that, during the period in which we considered
the exercise of our enforcement discretion, manufacturers of foods that
use lecithin derived from soy as a component of a release agent would
revise as necessary the labels of their relevant food products to
comply with FALCPA and begin to label their products using the FALCPA-
compliant labels by the end of the enforcement discretion period.
We believe that there has been sufficient time for all
manufacturers of foods that use lecithin derived from soy as a
component of a release agent to revise the labels for such foods to be
consistent with the requirements of section 403(w) of the FD&C Act.
Therefore, we no longer believe it is appropriate to consider the
exercise of our enforcement discretion with regard to foods that use
lecithin derived from soy as a component of a release agent. For these
reasons, we are withdrawing the April 2006 guidance entitled ``Guidance
on the Labeling of Certain Uses of Lecithin Derived from Soy Under
Section 403(w) of the Federal Food, Drug, and Cosmetic Act.''
Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04251 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P
