Cooperative Agreement for Research, Education, and Outreach in Support of the Food and Drug Administration Food Safety Modernization Act, 43095-43096 [2015-17795]
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Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices
occurs, and under what circumstances?
What is the role of voluntary consensus
standards in developing medical device
patient labeling?
(2) What risks or adverse outcomes
have been reported in association with
the use of medical device patient
labeling? What communication barriers
have been encountered, and how can
they be mitigated?
(3) Is there any part of the medical
device patient labeling development
process that presents a barrier to
receiving approval or clearance from
CDRH? If so, please provide examples of
the specific issues, how frequently this
occurs, and suggestions which
constructively address these barriers.
(4) What are the best ways to foster
efficient networking with patients and
advocacy groups, academic and
professional organizations, industry,
standards organizations, and
government Agencies to address
medical device patient labeling needs?
B. Medical Device Patient Labeling
Needs Assessment
(1) Describe the parameters that
should be used in determining priority
areas of development of medical device
patient labeling, including both
therapeutic and diagnostic devices.
(2) What are best practices for
conducting a needs assessment of
medical device patient labeling?
asabaliauskas on DSK5VPTVN1PROD with NOTICES
C. Advancing Development
(1) What could advance the
development and use of medical device
patient labeling?
(2) How should patient labeling be
considered in the development stages of
all medical device labeling?
(3) What resources (e.g., registries,
industry, or patient advocacy groups,)
could be tapped to advance the
development of medical device patient
labeling?
(4) What are potential changes to
guidances and regulations, or advances
in current science that may help
develop and enhance medical device
patient labeling to address the needs of
medical device manufacturers, device
suppliers, and device users?
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17800 Filed 7–20–15; 8:45 am]
BILLING CODE 4164–01–P
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17:58 Jul 20, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0411]
Cooperative Agreement for Research,
Education, and Outreach in Support of
the Food and Drug Administration
Food Safety Modernization Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for a
cooperative agreement to support the
FDA Food Safety Modernization Act
(FSMA) implementation efforts by the
Illinois Institute of Technology’s (IIT)
National Center for Food Safety and
Technology (NCFST). The estimated
amount of support in fiscal year (FY)
2015 will be for up to $5 million (direct
plus indirect costs), with the possibility
of 2 additional years of support for up
to $7 million each year, subject to the
availability of funds. This award will
improve public health by continued
support of an applied research,
education, and outreach program related
to the science behind and
implementation of preventive controls,
and on training and technical
assistance.
DATES: Important dates are as follows:
1. The application due date is August
14, 2015.
2. The anticipated start date is
September 1, 2015.
3. The opening date is August 1, 2015.
4. The expiration date is August 31,
2015.
ADDRESSES: Submit the electronic
application to: https://www.grants.gov.
For more information, see section III of
the SUPPLEMENTARY INFORMATION section
of this notice.
FOR FURTHER INFORMATION CONTACT:
Wanda Honeyblue, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition (CFSAN), 5100
Paint Branch Pkwy. (HFS–002), Rm.
4D–034, College Park, MD 20740, 301–
796–3500, email: wanda.honeyblue@
fda.hhs.gov; or Martin Bernard, Division
of State Acquisitions, Agreements and
Grants (DSAAG) (HFA–500), Food and
Drug Administration, 5630 Fishers
Lane, Rockville, MD 20857, 240–402–
7564, email: Martin.Bernard@
fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.grants.gov/.
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
43095
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA–
FD–15–035
Catalog of Federal Domestic
Assistance Number: 93.103
A. Background
FDA has supported the NCFST under
seven previously awarded cooperative
agreements (53 FR 15736, 56 FR 46189,
59 FR 24703, 64 FR 39512, 69 FR 25405,
74 FR 26408, and 79 FR 23360). NCFST
was established by IIT to bring together
the food safety and technology expertise
of academia, industry, and FDA for the
purpose of supporting research and
outreach efforts related to the safety of
foods based on a common goal of
enhancing the safety of the food supply
for U.S. consumers. NCFST has been
successful in developing research
programs such as those related to lowmoisture foods, and outreach programs
such as those related to sprout safety;
these successes were achieved as a
result of NCFST partnering with
industry, academia, and FDA.
NCFST is structured so that
representatives of participating
organizations play a role in establishing
policy and administrative procedures,
as well as identifying long- and shortterm research, outreach, and training
needs. With this organizational
structure, NCFST is able to build
cooperative food safety programs on a
foundation of knowledge about current
industrial trends in food processing and
packaging technologies, regulatory
perspectives from public health
organizations, and fundamental
scientific expertise from academia. This
award will improve public health by
continued support of an applied
research, education, and outreach
program related to the science behind
and implementation of preventive
controls associated with manufacturing,
processing, packing, and holding of
human and animal food, and on training
and technical assistance.
B. Program Objectives
With an increasingly diverse domestic
and global food supply, FDA continues
to face complex food safety issues
associated with the foods that it
regulates. Some of these complex issues
can be effectively addressed by further
strengthening the available sciencebased programs established through
NCFST/Institute for Food Safety and
Health (IFSH). FDA also believes that
innovative research and outreach
programs such as those established at
NCFST/IFSH can further support the
development of proactive approaches to
E:\FR\FM\21JYN1.SGM
21JYN1
43096
Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
the prevention of food safety problems
before they occur. With the enactment
of FSMA in 2011, the collaboration with
NCFST/IFSH has become increasingly
important as FDA works to fulfill its
mandate to develop a modern,
prevention-based food safety system.
FDA regards the development and
strengthening of public-private
partnerships for research and outreach
on preventive controls to be a key
element of its FSMA implementation
strategy.
This cooperative agreement will
provide continued support so that
NCFST/IFSH can meet the objective to
support the implementation of FSMA
through research, education, and
outreach, with particular emphasis on
identifying the science to support
implementation of preventive controls
associated with manufacturing,
processing, packing, and holding of
human and animal food, and on training
and technical assistance.
C. Eligibility Information
Competition is limited to IIT as FDA
believes IIT’s continued support of the
Food Safety Preventive Controls
Alliance (FSPCA) already established at
NCFST/IFSH uniquely qualifies IIT to
fulfill the objectives of the proposed
cooperative agreement. IIT’s Moffett
Center, where NCFST is located, is a
unique facility that includes offices,
classrooms, a distance-learning center,
and support facilities, which permit
appropriate research, development, and
training activities. The physical layout
of the facility provides maximum
versatility in the use and capability to
simultaneously operate several different
activities related to research,
development, and training to support
FSMA rules. The distance learning
facility located in room 216 in building
91 of the IIT Moffett Campus is
equipped with state-of-the-art audiovisual equipment for conducting and
broadcasting interactive training
programs and workshops to the food
industry, as well as for Webinar
communications with IFSH
stakeholders, including government,
academia, and industry.
Since 1988, IIT has provided an
environment in which scientists from
diverse backgrounds such as academia,
government, and industry have brought
their unique perspectives to focus on
contemporary issues of food safety.
NCFST/IFSH functions as a neutral
ground where scientific exchange about
generic food safety issues occurs freely
and is channeled into the design of
cooperative food safety programs.
Activities at NCFST are focused on
multiple areas associated with food
VerDate Sep<11>2014
17:58 Jul 20, 2015
Jkt 235001
safety and FSMA, including but not
limited to, preventive controls for
human and animal foods, supplier
verification, and national training.
Since 2011, IIT has served as the
coordinator of the FSPCA and, since
2012, the Sprout Safety Alliance (SSA),
leveraging the expertise of academia,
industry, and FDA for the purpose of
developing and delivering standardized
curricula related to food safety and
FSMA requirements. In addition to
alliance training, NCFST/IFSH plans to
develop the National Training and
Technical Assistance Network to
provide outreach and technical
assistance to industry in the future. The
new distance-learning training center
developed at the IIT’s Moffett Center
can be used to partially address training
and outreach needs related to FSMA.
Through this facility, training can be
provided on curricula currently being
developed by the FSPCA for human and
animal food and by the SSA for sprouts,
and for training activities related to
other appropriate FSMA activities such
as the Foreign Supplier Verification
Program.
The proposed cooperative activities
will fill existing gaps in knowledge,
food safety training, and expertise for
outreach associated with improving the
safety of foods via FSMA
implementation, and will provide
fundamental food safety information in
the public domain for use by all
segments of the food science community
for industry and regulatory training
activities.
II. Award Information/Funds Available
applicant should first review the full
announcement located at https://
www.grants.gov/. (FDA has verified the
Web site addresses throughout this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.) For the
electronically submitted application, the
following steps are required:
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With System for
Award Management (SAM)
• Step 3: Obtain Username &
Password
• Step 4: Authorized Organization
Representative (AOR) Authorization
• Step 5: Track AOR Status
• Step 6: Register With Electronic
Research Administration (eRA)
Commons
Steps 1 through 5, in detail, can be
found at https://www07.grants.gov/
applicants/organization_
registration.jsp. Step 6, in detail, can be
found at https://commons.era.nih.gov/
commons/registration/
registrationInstructions.jsp. After you
have followed these steps, submit the
electronic application to: https://
www.grants.gov.
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17795 Filed 7–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Award Amount
Food and Drug Administration
The Center for Food Safety and
Applied Nutrition (CFSAN) at FDA
intends to commit up to $5 million in
FY 2015 (direct plus indirect costs) with
the possibility of 2 additional years of
up to $ 7 million each year. Future year
amounts will depend on annual
appropriations and successful
performance.
[Docket No. FDA–2014–N–2076]
B. Length of Support
HHS.
The award will provide 1 year of
support and include future
recommended support for 2 additional
years, contingent upon satisfactory
performance in the achievement of
project and program objectives during
the preceding year and the availability
of Federal fiscal year appropriations.
III. Electronic Application,
Registration, and Submission
Only one electronic application will
be accepted. To submit an electronic
application in response to this FOA, the
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Restaurant Facility
Types
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 20,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43095-43096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0411]
Cooperative Agreement for Research, Education, and Outreach in
Support of the Food and Drug Administration Food Safety Modernization
Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for a cooperative agreement to support the
FDA Food Safety Modernization Act (FSMA) implementation efforts by the
Illinois Institute of Technology's (IIT) National Center for Food
Safety and Technology (NCFST). The estimated amount of support in
fiscal year (FY) 2015 will be for up to $5 million (direct plus
indirect costs), with the possibility of 2 additional years of support
for up to $7 million each year, subject to the availability of funds.
This award will improve public health by continued support of an
applied research, education, and outreach program related to the
science behind and implementation of preventive controls, and on
training and technical assistance.
DATES: Important dates are as follows:
1. The application due date is August 14, 2015.
2. The anticipated start date is September 1, 2015.
3. The opening date is August 1, 2015.
4. The expiration date is August 31, 2015.
ADDRESSES: Submit the electronic application to: https://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.
FOR FURTHER INFORMATION CONTACT: Wanda Honeyblue, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (CFSAN),
5100 Paint Branch Pkwy. (HFS-002), Rm. 4D-034, College Park, MD 20740,
301-796-3500, email: wanda.honeyblue@fda.hhs.gov; or Martin Bernard,
Division of State Acquisitions, Agreements and Grants (DSAAG) (HFA-
500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD
20857, 240-402-7564, email: Martin.Bernard@fda.hhs.gov.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at https://www.grants.gov/.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA-FD-15-035
Catalog of Federal Domestic Assistance Number: 93.103
A. Background
FDA has supported the NCFST under seven previously awarded
cooperative agreements (53 FR 15736, 56 FR 46189, 59 FR 24703, 64 FR
39512, 69 FR 25405, 74 FR 26408, and 79 FR 23360). NCFST was
established by IIT to bring together the food safety and technology
expertise of academia, industry, and FDA for the purpose of supporting
research and outreach efforts related to the safety of foods based on a
common goal of enhancing the safety of the food supply for U.S.
consumers. NCFST has been successful in developing research programs
such as those related to low-moisture foods, and outreach programs such
as those related to sprout safety; these successes were achieved as a
result of NCFST partnering with industry, academia, and FDA.
NCFST is structured so that representatives of participating
organizations play a role in establishing policy and administrative
procedures, as well as identifying long- and short-term research,
outreach, and training needs. With this organizational structure, NCFST
is able to build cooperative food safety programs on a foundation of
knowledge about current industrial trends in food processing and
packaging technologies, regulatory perspectives from public health
organizations, and fundamental scientific expertise from academia. This
award will improve public health by continued support of an applied
research, education, and outreach program related to the science behind
and implementation of preventive controls associated with
manufacturing, processing, packing, and holding of human and animal
food, and on training and technical assistance.
B. Program Objectives
With an increasingly diverse domestic and global food supply, FDA
continues to face complex food safety issues associated with the foods
that it regulates. Some of these complex issues can be effectively
addressed by further strengthening the available science-based programs
established through NCFST/Institute for Food Safety and Health (IFSH).
FDA also believes that innovative research and outreach programs such
as those established at NCFST/IFSH can further support the development
of proactive approaches to
[[Page 43096]]
the prevention of food safety problems before they occur. With the
enactment of FSMA in 2011, the collaboration with NCFST/IFSH has become
increasingly important as FDA works to fulfill its mandate to develop a
modern, prevention-based food safety system. FDA regards the
development and strengthening of public-private partnerships for
research and outreach on preventive controls to be a key element of its
FSMA implementation strategy.
This cooperative agreement will provide continued support so that
NCFST/IFSH can meet the objective to support the implementation of FSMA
through research, education, and outreach, with particular emphasis on
identifying the science to support implementation of preventive
controls associated with manufacturing, processing, packing, and
holding of human and animal food, and on training and technical
assistance.
C. Eligibility Information
Competition is limited to IIT as FDA believes IIT's continued
support of the Food Safety Preventive Controls Alliance (FSPCA) already
established at NCFST/IFSH uniquely qualifies IIT to fulfill the
objectives of the proposed cooperative agreement. IIT's Moffett Center,
where NCFST is located, is a unique facility that includes offices,
classrooms, a distance-learning center, and support facilities, which
permit appropriate research, development, and training activities. The
physical layout of the facility provides maximum versatility in the use
and capability to simultaneously operate several different activities
related to research, development, and training to support FSMA rules.
The distance learning facility located in room 216 in building 91 of
the IIT Moffett Campus is equipped with state-of-the-art audio-visual
equipment for conducting and broadcasting interactive training programs
and workshops to the food industry, as well as for Webinar
communications with IFSH stakeholders, including government, academia,
and industry.
Since 1988, IIT has provided an environment in which scientists
from diverse backgrounds such as academia, government, and industry
have brought their unique perspectives to focus on contemporary issues
of food safety. NCFST/IFSH functions as a neutral ground where
scientific exchange about generic food safety issues occurs freely and
is channeled into the design of cooperative food safety programs.
Activities at NCFST are focused on multiple areas associated with food
safety and FSMA, including but not limited to, preventive controls for
human and animal foods, supplier verification, and national training.
Since 2011, IIT has served as the coordinator of the FSPCA and,
since 2012, the Sprout Safety Alliance (SSA), leveraging the expertise
of academia, industry, and FDA for the purpose of developing and
delivering standardized curricula related to food safety and FSMA
requirements. In addition to alliance training, NCFST/IFSH plans to
develop the National Training and Technical Assistance Network to
provide outreach and technical assistance to industry in the future.
The new distance-learning training center developed at the IIT's
Moffett Center can be used to partially address training and outreach
needs related to FSMA. Through this facility, training can be provided
on curricula currently being developed by the FSPCA for human and
animal food and by the SSA for sprouts, and for training activities
related to other appropriate FSMA activities such as the Foreign
Supplier Verification Program.
The proposed cooperative activities will fill existing gaps in
knowledge, food safety training, and expertise for outreach associated
with improving the safety of foods via FSMA implementation, and will
provide fundamental food safety information in the public domain for
use by all segments of the food science community for industry and
regulatory training activities.
II. Award Information/Funds Available
A. Award Amount
The Center for Food Safety and Applied Nutrition (CFSAN) at FDA
intends to commit up to $5 million in FY 2015 (direct plus indirect
costs) with the possibility of 2 additional years of up to $ 7 million
each year. Future year amounts will depend on annual appropriations and
successful performance.
B. Length of Support
The award will provide 1 year of support and include future
recommended support for 2 additional years, contingent upon
satisfactory performance in the achievement of project and program
objectives during the preceding year and the availability of Federal
fiscal year appropriations.
III. Electronic Application, Registration, and Submission
Only one electronic application will be accepted. To submit an
electronic application in response to this FOA, the applicant should
first review the full announcement located at https://www.grants.gov/.
(FDA has verified the Web site addresses throughout this document, but
FDA is not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.) For the
electronically submitted application, the following steps are required:
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With System for Award Management (SAM)
Step 3: Obtain Username & Password
Step 4: Authorized Organization Representative (AOR)
Authorization
Step 5: Track AOR Status
Step 6: Register With Electronic Research Administration
(eRA) Commons
Steps 1 through 5, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit the electronic application to: https://www.grants.gov.
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17795 Filed 7-20-15; 8:45 am]
BILLING CODE 4164-01-P
