80_FR_43234 80 FR 43095 - Cooperative Agreement for Research, Education, and Outreach in Support of the Food and Drug Administration Food Safety Modernization Act

80 FR 43095 - Cooperative Agreement for Research, Education, and Outreach in Support of the Food and Drug Administration Food Safety Modernization Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 139 (July 21, 2015)

Page Range43095-43096
FR Document2015-17795

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.

Federal Register, Volume 80 Issue 139 (Tuesday, July 21, 2015) 
[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43095-43096]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17795]


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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.

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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: http://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: [email protected]; 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: [email protected].
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at http://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 http://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 http://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: http://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

Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43095 occurs, and under what circumstances? DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: What is the role of voluntary consensus HUMAN SERVICES I. Funding Opportunity Description standards in developing medical device patient labeling? Food and Drug Administration Funding Opportunity Number: RFA– FD–15–035 (2) What risks or adverse outcomes [Docket No. FDA–2014–N–0411] Catalog of Federal Domestic have been reported in association with Assistance Number: 93.103 the use of medical device patient Cooperative Agreement for Research, Education, and Outreach in Support of A. Background labeling? What communication barriers the Food and Drug Administration FDA has supported the NCFST under have been encountered, and how can Food Safety Modernization Act seven previously awarded cooperative they be mitigated? AGENCY: Food and Drug Administration, agreements (53 FR 15736, 56 FR 46189, (3) Is there any part of the medical HHS. 59 FR 24703, 64 FR 39512, 69 FR 25405, device patient labeling development ACTION: Notice. 74 FR 26408, and 79 FR 23360). NCFST process that presents a barrier to was established by IIT to bring together receiving approval or clearance from SUMMARY: The Food and Drug the food safety and technology expertise CDRH? If so, please provide examples of Administration (FDA) is announcing the of academia, industry, and FDA for the the specific issues, how frequently this availability of grant funds for a purpose of supporting research and occurs, and suggestions which cooperative agreement to support the outreach efforts related to the safety of constructively address these barriers. FDA Food Safety Modernization Act foods based on a common goal of (4) What are the best ways to foster (FSMA) implementation efforts by the enhancing the safety of the food supply efficient networking with patients and Illinois Institute of Technology’s (IIT) for U.S. consumers. NCFST has been advocacy groups, academic and National Center for Food Safety and successful in developing research professional organizations, industry, Technology (NCFST). The estimated programs such as those related to low- amount of support in fiscal year (FY) moisture foods, and outreach programs standards organizations, and 2015 will be for up to $5 million (direct such as those related to sprout safety; government Agencies to address plus indirect costs), with the possibility these successes were achieved as a medical device patient labeling needs? of 2 additional years of support for up result of NCFST partnering with B. Medical Device Patient Labeling to $7 million each year, subject to the industry, academia, and FDA. Needs Assessment availability of funds. This award will NCFST is structured so that improve public health by continued representatives of participating (1) Describe the parameters that support of an applied research, organizations play a role in establishing should be used in determining priority education, and outreach program related policy and administrative procedures, areas of development of medical device to the science behind and as well as identifying long- and short- patient labeling, including both implementation of preventive controls, term research, outreach, and training therapeutic and diagnostic devices. and on training and technical needs. With this organizational assistance. structure, NCFST is able to build (2) What are best practices for conducting a needs assessment of DATES: Important dates are as follows: cooperative food safety programs on a medical device patient labeling? 1. The application due date is August foundation of knowledge about current 14, 2015. industrial trends in food processing and C. Advancing Development 2. The anticipated start date is packaging technologies, regulatory September 1, 2015. perspectives from public health (1) What could advance the 3. The opening date is August 1, 2015. organizations, and fundamental development and use of medical device 4. The expiration date is August 31, scientific expertise from academia. This patient labeling? 2015. award will improve public health by (2) How should patient labeling be ADDRESSES: Submit the electronic continued support of an applied considered in the development stages of application to: http://www.grants.gov. research, education, and outreach all medical device labeling? For more information, see section III of program related to the science behind the SUPPLEMENTARY INFORMATION section and implementation of preventive (3) What resources (e.g., registries, of this notice. industry, or patient advocacy groups,) controls associated with manufacturing, FOR FURTHER INFORMATION CONTACT: processing, packing, and holding of could be tapped to advance the Wanda Honeyblue, Food and Drug human and animal food, and on training development of medical device patient Administration, Center for Food Safety and technical assistance. labeling? and Applied Nutrition (CFSAN), 5100 (4) What are potential changes to Paint Branch Pkwy. (HFS–002), Rm. B. Program Objectives guidances and regulations, or advances 4D–034, College Park, MD 20740, 301– With an increasingly diverse domestic in current science that may help 796–3500, email: wanda.honeyblue@ and global food supply, FDA continues develop and enhance medical device fda.hhs.gov; or Martin Bernard, Division to face complex food safety issues patient labeling to address the needs of of State Acquisitions, Agreements and associated with the foods that it medical device manufacturers, device Grants (DSAAG) (HFA–500), Food and regulates. Some of these complex issues Drug Administration, 5630 Fishers can be effectively addressed by further asabaliauskas on DSK5VPTVN1PROD with NOTICES suppliers, and device users? Lane, Rockville, MD 20857, 240–402– strengthening the available science- Dated: July 15, 2015. 7564, email: Martin.Bernard@ based programs established through Leslie Kux, fda.hhs.gov. NCFST/Institute for Food Safety and Associate Commissioner for Policy. For more information on this funding Health (IFSH). FDA also believes that [FR Doc. 2015–17800 Filed 7–20–15; 8:45 am] opportunity announcement (FOA) and innovative research and outreach BILLING CODE 4164–01–P to obtain detailed requirements, please programs such as those established at refer to the full FOA located at http:// NCFST/IFSH can further support the www.grants.gov/. development of proactive approaches to VerDate Sep<11>2014 17:58 Jul 20, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1

43096 Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices the prevention of food safety problems safety and FSMA, including but not applicant should first review the full before they occur. With the enactment limited to, preventive controls for announcement located at http:// of FSMA in 2011, the collaboration with human and animal foods, supplier www.grants.gov/. (FDA has verified the NCFST/IFSH has become increasingly verification, and national training. Web site addresses throughout this important as FDA works to fulfill its Since 2011, IIT has served as the document, but FDA is not responsible mandate to develop a modern, coordinator of the FSPCA and, since for any subsequent changes to the Web prevention-based food safety system. 2012, the Sprout Safety Alliance (SSA), sites after this document publishes in FDA regards the development and leveraging the expertise of academia, the Federal Register.) For the strengthening of public-private industry, and FDA for the purpose of electronically submitted application, the partnerships for research and outreach developing and delivering standardized following steps are required: on preventive controls to be a key curricula related to food safety and • Step 1: Obtain a Dun and Bradstreet element of its FSMA implementation FSMA requirements. In addition to (DUNS) Number strategy. alliance training, NCFST/IFSH plans to • Step 2: Register With System for This cooperative agreement will develop the National Training and Award Management (SAM) provide continued support so that Technical Assistance Network to • Step 3: Obtain Username & NCFST/IFSH can meet the objective to provide outreach and technical Password support the implementation of FSMA assistance to industry in the future. The • Step 4: Authorized Organization through research, education, and Representative (AOR) Authorization new distance-learning training center outreach, with particular emphasis on • Step 5: Track AOR Status developed at the IIT’s Moffett Center • Step 6: Register With Electronic identifying the science to support can be used to partially address training implementation of preventive controls Research Administration (eRA) and outreach needs related to FSMA. Commons associated with manufacturing, Through this facility, training can be processing, packing, and holding of Steps 1 through 5, in detail, can be provided on curricula currently being found at http://www07.grants.gov/ human and animal food, and on training developed by the FSPCA for human and and technical assistance. applicants/organization_ animal food and by the SSA for sprouts, registration.jsp. Step 6, in detail, can be C. Eligibility Information and for training activities related to found at https://commons.era.nih.gov/ other appropriate FSMA activities such commons/registration/ Competition is limited to IIT as FDA as the Foreign Supplier Verification registrationInstructions.jsp. After you believes IIT’s continued support of the Program. have followed these steps, submit the Food Safety Preventive Controls The proposed cooperative activities electronic application to: http:// Alliance (FSPCA) already established at will fill existing gaps in knowledge, www.grants.gov. NCFST/IFSH uniquely qualifies IIT to fulfill the objectives of the proposed food safety training, and expertise for Dated: July 15, 2015. cooperative agreement. IIT’s Moffett outreach associated with improving the safety of foods via FSMA Leslie Kux, Center, where NCFST is located, is a Associate Commissioner for Policy. unique facility that includes offices, implementation, and will provide fundamental food safety information in [FR Doc. 2015–17795 Filed 7–20–15; 8:45 am] classrooms, a distance-learning center, and support facilities, which permit the public domain for use by all BILLING CODE 4164–01–P appropriate research, development, and segments of the food science community training activities. The physical layout for industry and regulatory training activities. DEPARTMENT OF HEALTH AND of the facility provides maximum HUMAN SERVICES versatility in the use and capability to II. Award Information/Funds Available simultaneously operate several different Food and Drug Administration activities related to research, A. Award Amount [Docket No. FDA–2014–N–2076] development, and training to support The Center for Food Safety and FSMA rules. The distance learning Applied Nutrition (CFSAN) at FDA Agency Information Collection facility located in room 216 in building intends to commit up to $5 million in Activities; Submission for Office of 91 of the IIT Moffett Campus is FY 2015 (direct plus indirect costs) with Management and Budget Review; equipped with state-of-the-art audio- the possibility of 2 additional years of Comment Request; Survey on the visual equipment for conducting and up to $ 7 million each year. Future year Occurrence of Foodborne Illness Risk broadcasting interactive training amounts will depend on annual Factors in Selected Restaurant Facility programs and workshops to the food appropriations and successful Types industry, as well as for Webinar performance. communications with IFSH AGENCY: Food and Drug Administration, stakeholders, including government, B. Length of Support HHS. academia, and industry. The award will provide 1 year of ACTION: Notice. Since 1988, IIT has provided an support and include future environment in which scientists from recommended support for 2 additional SUMMARY: The Food and Drug diverse backgrounds such as academia, years, contingent upon satisfactory Administration (FDA) is announcing government, and industry have brought performance in the achievement of that a proposed collection of their unique perspectives to focus on information has been submitted to the asabaliauskas on DSK5VPTVN1PROD with NOTICES project and program objectives during contemporary issues of food safety. the preceding year and the availability Office of Management and Budget NCFST/IFSH functions as a neutral of Federal fiscal year appropriations. (OMB) for review and clearance under ground where scientific exchange about the Paperwork Reduction Act of 1995. generic food safety issues occurs freely III. Electronic Application, DATES: Fax written comments on the and is channeled into the design of Registration, and Submission collection of information by August 20, cooperative food safety programs. Only one electronic application will 2015. Activities at NCFST are focused on be accepted. To submit an electronic ADDRESSES: To ensure that comments on multiple areas associated with food application in response to this FOA, the the information collection are received, VerDate Sep<11>2014 17:58 Jul 20, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1


Document Created: 2018-02-23 09:23:10
Document Modified: 2018-02-23 09:23:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesImportant dates are as follows:
ContactWanda 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: [email protected]; 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: [email protected]
FR Citation80 FR 43095 
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