For Nominations on the Food Advisory Committee; Extension of Closing Date, 5559-5560 [2015-01881]
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Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
made to OPPI on a reimbursement basis.
OPPI has not submitted a request for
reimbursement under the FY 2014
PADD grant award leaving the entire
amount of the award unspent. It is
unclear, then, how OPPI is exercising
the P&A authorities and conducting
P&A activities without utilizing the
federal financial assistance.
Dated: January 27, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2015–01857 Filed 1–30–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1497]
Toxicological Principles for the Safety
Assessment of Food Ingredients;
Public Meeting on Updates and Safety
and Risk Assessment Considerations;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notification of public meeting;
request for comments; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
notification of public meeting and
request for comments that appeared in
the Federal Register of October 30,
2014. The notification requested
comments on certain topics related to
our guidance titled ‘‘Toxicological
Principles for the Safety Assessment of
Food Ingredients,’’ known less formally
as the ‘‘Redbook’’. We are taking this
action in response to requests for an
extension to allow interested persons
additional time to submit comments.
DATES: FDA is extending the comment
period on the notification of public
meeting and request for comments
published October 30, 2014 (79 FR
64603). Submit either electronic or
written comments by May 11, 2015.
ADDRESSES: You may submit comments
by any of the following methods:
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SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
VerDate Sep<11>2014
19:24 Jan 30, 2015
Jkt 235001
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Docket No. (FDA–
2014–N–1497) for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jeremiah Fasano, Center for Food Safety
and Applied Nutrition (HFS–255), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1173, jeremiah.fasano@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 30,
2014 (79 FR 64603), we published a
notification of public meeting and
requested comments on certain topics
related to the Redbook. The Redbook
provides guidance to industry and other
stakeholders (e.g., academia and other
regulatory groups) regarding the
information used by FDA’s Center for
Food Safety and Applied Nutrition to
evaluate the safety of food additives and
color additives. The Redbook is
intended to help interested parties
understand FDA’s expectations
regarding:
• Determining the human exposure
that will occur from the use of the
ingredient in foods;
• Determining which toxicity studies
are appropriate;
• Designing, conducting, and
reporting the results of toxicity studies;
and
• Submitting the information to FDA
as part of a safety assessment.
Comments on the Redbook will
inform our future efforts on what should
be included, changed, or even excluded
from the updated Redbook. We are
interested in expanding the scope of the
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5559
Redbook to emphasize the principles of
safety and risk assessment that are
shared across different regulatory
contexts for foods and cosmetics, while
still providing specific guidance for
applying these principles in particular
contexts such as the requirements for
premarket safety submissions or for risk
assessments conducted on foods and
cosmetics already on the market.
We have received a request for a 90day extension of the comment period for
the notification of public meeting and
request for comments. The request
conveyed-concern that the current 90day comment period (which would
otherwise expire on February 9, 2015)
does not allow sufficient time to
develop meaningful or thoughtful
responses to the notification of public
meeting and request for comments.
We have considered the request and
are extending the comment period for
90 days, until May 10, 2015. We believe
that a 90-day extension allows adequate
time for interested persons to submit
comments without significantly
delaying further action on these
important issues.
II. Request for 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.
Dated: January 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01858 Filed 1–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2031]
For Nominations on the Food Advisory
Committee; Extension of Closing Date
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of closing
date.
The Food and Drug
Administration (FDA) is extending the
closing date for the notice that appeared
SUMMARY:
E:\FR\FM\02FEN1.SGM
02FEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
5560
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
in the Federal Register of December 8,
2014. In the notice, FDA requested that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Food Advisory Committee
(the Committee) for the Center for Food
Safety and Applied Nutrition (CFSAN)
notify FDA in writing. FDA is also
requesting nominations for a nonvoting
industry representative(s) to serve on
the Committee. The Agency is taking
this action in response to requests for an
extension to allow interested persons
additional time to submit letters of
interests and nominations.
DATES: FDA is extending the closing
date in the notice published December
8, 2014 (79 FR 72690). Any industry
organization interested in participating
in the selection of an appropriate
nonvoting member to represent industry
interests must send a letter stating that
interest to FDA by February 27, 2015.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by February 27, 2015.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Karen
Strambler (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives may
be submitted electronically by accessing
the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://www.
fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Karen Strambler, Office of Regulations,
Policy, and Social Science, Center for
Food Safety and Applied Nutrition,
5100 Paint Branch Pkwy., Rm. 1C–016,
College Park, MD 20740, 240–402–2589,
karen.strambler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
I. CFSAN Advisory Committee, Food
Advisory Committee
The Committee reviews and evaluates
emerging food safety, nutrition and
other food- or cosmetic-related health
issues that FDA considers of primary
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19:24 Jan 30, 2015
Jkt 235001
importance for its food and cosmetics
programs. The Committee may be
charged with reviewing and evaluating
available data and making
recommendations on matters such as
those relating to: (1) Broad scientific and
technical food- or cosmetic-related
issues; (2) the safety of food ingredients
and new foods; (3) labeling of foods and
cosmetics; (4) nutrient needs and
nutritional adequacy; and (5) safe
exposure limits for food contaminants.
The Committee may also be asked to
provide advice and make
recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current curriculum vitae. The
letter will also state that it is the
responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
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FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01881 Filed 1–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0175]
Determination That LYMPHAZURIN
(Isosulfan Blue) Injectable and Other
Drug Products Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that the drug products listed
in this document were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Amy Hopkins, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223,
Silver Spring, MD 20993–0002, 301–
796–5418, Amy.Hopkins@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
SUMMARY:
E:\FR\FM\02FEN1.SGM
02FEN1
Agencies
[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Pages 5559-5560]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01881]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2031]
For Nominations on the Food Advisory Committee; Extension of
Closing Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of closing date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending the
closing date for the notice that appeared
[[Page 5560]]
in the Federal Register of December 8, 2014. In the notice, FDA
requested that any industry organizations interested in participating
in the selection of a nonvoting industry representative to serve on the
Food Advisory Committee (the Committee) for the Center for Food Safety
and Applied Nutrition (CFSAN) notify FDA in writing. FDA is also
requesting nominations for a nonvoting industry representative(s) to
serve on the Committee. The Agency is taking this action in response to
requests for an extension to allow interested persons additional time
to submit letters of interests and nominations.
DATES: FDA is extending the closing date in the notice published
December 8, 2014 (79 FR 72690). Any industry organization interested in
participating in the selection of an appropriate nonvoting member to
represent industry interests must send a letter stating that interest
to FDA by February 27, 2015. Concurrently, nomination materials for
prospective candidates should be sent to FDA by February 27, 2015.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Karen Strambler
(see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives may be submitted electronically by accessing
the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail
to Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002. Information about becoming a member of an FDA
advisory committee can also be obtained by visiting FDA's Web site at
https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Karen Strambler, Office of
Regulations, Policy, and Social Science, Center for Food Safety and
Applied Nutrition, 5100 Paint Branch Pkwy., Rm. 1C-016, College Park,
MD 20740, 240-402-2589, karen.strambler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. CFSAN Advisory Committee, Food Advisory Committee
The Committee reviews and evaluates emerging food safety, nutrition
and other food- or cosmetic-related health issues that FDA considers of
primary importance for its food and cosmetics programs. The Committee
may be charged with reviewing and evaluating available data and making
recommendations on matters such as those relating to: (1) Broad
scientific and technical food- or cosmetic-related issues; (2) the
safety of food ingredients and new foods; (3) labeling of foods and
cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe
exposure limits for food contaminants. The Committee may also be asked
to provide advice and make recommendations on ways of communicating to
the public the potential risks associated with these issues and on
approaches that might be considered for addressing the issues.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current curriculum vitae. The letter will also state
that it is the responsibility of the interested organizations to confer
with one another and to select a candidate, within 60 days after the
receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for the committee. The interested
organizations are not bound by the list of nominees in selecting a
candidate. However, if no individual is selected within 60 days, the
Commissioner will select the nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication of this document (see DATES). FDA will forward
all nominations to the organizations expressing interest in
participating in the selection process for the committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process).
FDA seeks to include the views of women, and men, members of all
racial and ethnic groups and individuals with and without disabilities
on its advisory committees and, therefore encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01881 Filed 1-30-15; 8:45 am]
BILLING CODE 4164-01-P