Cooperative Agreement To Support the Joint Institute for Food Safety and Applied Nutrition, JIFSAN (U01), 26287-26288 [2012-10648]
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Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Notices
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here. Sixty panel members
will take part in a pretest of the study,
estimated to last 30 minutes (0.5 hours),
for a total of 30 hours. Approximately
10,000 respondents will complete a
screener to determine eligibility for
participation in the study, estimated to
take 1 minute (0.0167 hours), for a total
of 167 hours. Three thousand one
hundred and fifty respondents will
complete the full study, estimated to
last 30 minutes (0.5 hours), for a total
of 1,575 hours. The total estimated
burden is 1,772 hours.
Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–10659 Filed 5–2–12; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2012–N–0009]
Cooperative Agreement To Support the
Joint Institute for Food Safety and
Applied Nutrition, JIFSAN (U01)
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of the Joint Institute for Food
Safety and Applied Nutrition (JIFSAN).
FDA believes that University of
Maryland, College Park (UMCP)–JIFSAN
is a sound investment to protect and
promote public health. FDA faces an
increasing number of critical and
complex food safety and public health
issues associated with the products that
FDA regulates. These complex issues
can be addressed most efficiently by
expanding the scientific base through
the development of collaborative
partnerships. FDA believes that
partnering with UMCP–JIFSAN will
enhance FDA’s ability to address safety
and other public health issues related to
foods, cosmetics, and animal health and
continue to stimulate the integration of
applied research, education, and
outreach programs.
DATES: Important dates are as follows:
1. The application due date is June 1,
2012.
2. The anticipated start date is August
1, 2012.
3. The opening date is May 3, 2012.
wreier-aviles on DSK7SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:32 May 02, 2012
Jkt 226001
Elizabeth M. Calvey, Center for Food
Safety and Applied Nutrition (HFS–
560), Food and Drug Administration,
CPK1, Rm. 4A007 (HFS–006), 5100
Paint Branch Pkwy., College Park, MD
20740, 240–402–1981,
elizabeth.calvey@fda.hhs.gov.
Gladys Melendez, Office of Acquisition
& Grants Services (HFA–500), Food
and Drug Administration, 5630
Fishers Lane, Rm. 1078, Rockville,
MD 20857, 301–827–7175,
gladys.bohler@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.fda.gov/food/newsevents/
default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA–
12–016.
Catalog of Federal Domestic
Assistance Number: 93.103.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
4. The expiration date is June 2, 2012.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
A. Background
FDA is announcing its intention to
receive and consider a single source
application for the award of a
cooperative agreement in fiscal year
2012 (FY12) to UMCP to support
JIFSAN.
FDA believes that the UMCP–JIFSAN
collaboration is a sound investment.
The last 15 years of FDA’s partnership
with UMCP–JIFSAN have been
successful in developing multiple
programs to support public health
policy. The goal of JIFSAN is to advance
sound strategies that improve public
health, nutrition, and food/feed safety
through three broad program areas:
research, education, and outreach.
With an increasingly diverse domestic
and global food supply, FDA continues
to face complex food safety issues
associated with products that it
regulates (i.e., conventional foods; food
ingredients; dietary supplements;
cosmetics; animal feed, feed additives,
and animal drugs). FDA believes that
some of these complex issues can be
effectively addressed by further
strengthening the available sciencebased programs established through
JIFSAN. FDA also believes that
innovative capacity-building
partnerships with various sectors of
stakeholders in conjunction with
JIFSAN’s research and training
programs can further support the
development of proactive approaches to
the prevention of problems before they
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
26287
occur. A proposal is being solicited for
meeting this need as well as FDA’s
strategic goals to protect and promote
public health.
B. Research Objectives
This cooperative agreement will
provide continued support so that
UMCP–JIFSAN can meet the following
objectives:
• Establish multi-institutional,
multidisciplinary applied research
projects to address complex food/feed
safety and public health issues
associated with products that FDA
regulates. Applied research includes not
only traditional laboratory and field
research, but also epidemiological,
educational, social and behavioral
science.
• Continue the development of
mechanisms for the exchange of
technical information and scientific
concepts between FDA and other sectors
of the international and domestic
community, through workshops, short
courses and symposia, and online
resources that focus on existing and
emerging complex food/feed safety and
public health issues.
• Continue the development and
refinement of programs based on the
application of the principles of risk
analysis to address food/feed defense
and safety issues.
• Continue the design and
improvement of domestic and
international collaborations, which
foster greater implementation of
effective food safety practices.
• Continue developing innovative
education and outreach programs that
will provide opportunities to leverage
resources among various sectors of
stakeholders to address complex safety
issues associated with an increasingly
diverse global food supply.
C. Eligibility Information
Competition is limited to UMCP–
JIFSAN because UMCP–JIFSAN is
uniquely qualified to fulfill the
objectives of the proposed cooperative
agreement. The administrative structure
and policies of UMCP–JIFSAN offer the
flexibility needed to create and operate
strategic alliances involving multiple
partners. They also allow effective
utilization of resources to plan and run
multidisciplinary and multiinstitutional research programs and
internationally-recognized food safety
training and risk analysis programs.
UMCP and FDA, through their
collaboration in JIFSAN, developed
FoodRisk.org, which is an extensive
Web-based information resource
addressing many aspects of food safety
risk analysis, as well as providing tools
E:\FR\FM\03MYN1.SGM
03MYN1
26288
Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Notices
and resources for food-borne infectious
disease epidemiology and surveillance;
developed a risk analysis professional
development training program taught
through several different modalities
(e.g., face-to-face and online); developed
international food safety education and
outreach programs that foster
implementation of effective food safety
practices (i.e., Good Agricultural
Practices, Good Aquaculture Practices,
and Commercially Sterile Packaged
Foods); and, recently, established the
first-of-its-kind full-time international
food safety laboratory training facility at
College Park, MD, to train domestic and
foreign government officials, third party
laboratory scientists, and food
producers on fit-for-purpose analytical
procedures that would meet global food
safety standards.
Since its inception, JIFSAN has
funded over 60 research projects as well
as provided over 250 internships to
undergraduate students to work with
FDA scientists. JIFSAN food safety
research topics are diverse and include
the development of methods for
detecting food pathogens; risk
assessment studies on nutrients; food
packaging materials; dietary
supplements; microbial dose-responses;
and risk communication. JIFSAN’s
unique structure permits it to reach
beyond the UMCP campus and support
research at other universities.
Moreover, UMCP–JIFSAN provides an
environment in which scientific and
regulatory experts from various sectors
can pool their resources and ideas and
promote more efficient development
and dissemination of science-based
information that can support public
policy.
II. Award Information/Funds Available
A. Award Amount
The Center for Food Safety and
Applied Nutrition (CFSAN) at FDA
intends to fund one award up to $2.2
million for FY 2012, with the possibility
of 4 additional years of support, subject
to the availability of funds. Future year
amounts will depend on annual
appropriations and successful
performance.
wreier-aviles on DSK7SPTVN1PROD with NOTICES
B. Length of Support
The award will provide 1 year of
support, with the possibility of 4
additional years of support, contingent
upon satisfactory performance in the
achievement of project and program
reporting objectives during the
preceding year and the availability of
Federal fiscal year appropriations.
VerDate Mar<15>2010
15:32 May 02, 2012
Jkt 226001
III. Paper Application, Registration,
and Submission Information
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
To submit a paper application in
response to this FOA, applicants should
first review the full announcement
located at www.fda.gov/food/
newsevents/default.htm. (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.) Persons interested in applying
for a grant may obtain an application at
https://grants2.nih.gov/GRANTS/
FORMS.HTM. For all paper application
submissions, the following steps are
required:
Food and Drug Administration
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With Central
Contractor Registration
• Step 3: Register With Electronic
Research Administration (eRA)
Commons
Steps 1 and 2, in detail, can be found
at https://www07.grants.gov/applicants/
organization_registration.jsp. Step 3, in
detail, can be found at https://commons.
era.nih.gov/commons/registration/
registrationInstructions.jsp. After you
have followed these steps, submit paper
applications to:
Applications must be prepared using
the PHS 398 research grant application
forms and instructions for preparing a
research grant application. Submit one
signed, typewritten original of the
application, including the checklist, and
five signed photocopies as follows:
Submit one original to: Gladys
Melendez, Division of Acquisition
and Grant Services, Food and Drug
Administration, 5630 Fishers Lane,
Rm. 1078, Rockville, MD 20857, 240–
731–3905, gladys.bohler@fda.hhs.gov.
Submit the five signed photocopies to:
Kevin W. Robinson, Center for Food
Safety and Applied Nutrition (HFS–
650), Food and Drug Administration,
CPK1, Rm. 4C035, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2118, kevin.robinson@fda.hhs.
gov.
Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–10648 Filed 5–2–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
[Docket No. FDA–2011–E–0156]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; HALAVEN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
HALAVEN and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6284, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
SUMMARY:
E:\FR\FM\03MYN1.SGM
03MYN1
Agencies
[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Notices]
[Pages 26287-26288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10648]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0009]
Cooperative Agreement To Support the Joint Institute for Food
Safety and Applied Nutrition, JIFSAN (U01)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the Joint Institute for
Food Safety and Applied Nutrition (JIFSAN). FDA believes that
University of Maryland, College Park (UMCP)-JIFSAN is a sound
investment to protect and promote public health. FDA faces an
increasing number of critical and complex food safety and public health
issues associated with the products that FDA regulates. These complex
issues can be addressed most efficiently by expanding the scientific
base through the development of collaborative partnerships. FDA
believes that partnering with UMCP-JIFSAN will enhance FDA's ability to
address safety and other public health issues related to foods,
cosmetics, and animal health and continue to stimulate the integration
of applied research, education, and outreach programs.
DATES: Important dates are as follows:
1. The application due date is June 1, 2012.
2. The anticipated start date is August 1, 2012.
3. The opening date is May 3, 2012.
4. The expiration date is June 2, 2012.
FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
Elizabeth M. Calvey, Center for Food Safety and Applied Nutrition (HFS-
560), Food and Drug Administration, CPK1, Rm. 4A007 (HFS-006), 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1981,
elizabeth.calvey@fda.hhs.gov.
Gladys Melendez, Office of Acquisition & Grants Services (HFA-500),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1078, Rockville,
MD 20857, 301-827-7175, gladys.bohler@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.fda.gov/food/newsevents/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA-12-016.
Catalog of Federal Domestic Assistance Number: 93.103.
A. Background
FDA is announcing its intention to receive and consider a single
source application for the award of a cooperative agreement in fiscal
year 2012 (FY12) to UMCP to support JIFSAN.
FDA believes that the UMCP-JIFSAN collaboration is a sound
investment. The last 15 years of FDA's partnership with UMCP-JIFSAN
have been successful in developing multiple programs to support public
health policy. The goal of JIFSAN is to advance sound strategies that
improve public health, nutrition, and food/feed safety through three
broad program areas: research, education, and outreach.
With an increasingly diverse domestic and global food supply, FDA
continues to face complex food safety issues associated with products
that it regulates (i.e., conventional foods; food ingredients; dietary
supplements; cosmetics; animal feed, feed additives, and animal drugs).
FDA believes that some of these complex issues can be effectively
addressed by further strengthening the available science-based programs
established through JIFSAN. FDA also believes that innovative capacity-
building partnerships with various sectors of stakeholders in
conjunction with JIFSAN's research and training programs can further
support the development of proactive approaches to the prevention of
problems before they occur. A proposal is being solicited for meeting
this need as well as FDA's strategic goals to protect and promote
public health.
B. Research Objectives
This cooperative agreement will provide continued support so that
UMCP-JIFSAN can meet the following objectives:
Establish multi-institutional, multidisciplinary applied
research projects to address complex food/feed safety and public health
issues associated with products that FDA regulates. Applied research
includes not only traditional laboratory and field research, but also
epidemiological, educational, social and behavioral science.
Continue the development of mechanisms for the exchange of
technical information and scientific concepts between FDA and other
sectors of the international and domestic community, through workshops,
short courses and symposia, and online resources that focus on existing
and emerging complex food/feed safety and public health issues.
Continue the development and refinement of programs based
on the application of the principles of risk analysis to address food/
feed defense and safety issues.
Continue the design and improvement of domestic and
international collaborations, which foster greater implementation of
effective food safety practices.
Continue developing innovative education and outreach
programs that will provide opportunities to leverage resources among
various sectors of stakeholders to address complex safety issues
associated with an increasingly diverse global food supply.
C. Eligibility Information
Competition is limited to UMCP-JIFSAN because UMCP-JIFSAN is
uniquely qualified to fulfill the objectives of the proposed
cooperative agreement. The administrative structure and policies of
UMCP-JIFSAN offer the flexibility needed to create and operate
strategic alliances involving multiple partners. They also allow
effective utilization of resources to plan and run multidisciplinary
and multi-institutional research programs and internationally-
recognized food safety training and risk analysis programs.
UMCP and FDA, through their collaboration in JIFSAN, developed
FoodRisk.org, which is an extensive Web-based information resource
addressing many aspects of food safety risk analysis, as well as
providing tools
[[Page 26288]]
and resources for food-borne infectious disease epidemiology and
surveillance; developed a risk analysis professional development
training program taught through several different modalities (e.g.,
face-to-face and online); developed international food safety education
and outreach programs that foster implementation of effective food
safety practices (i.e., Good Agricultural Practices, Good Aquaculture
Practices, and Commercially Sterile Packaged Foods); and, recently,
established the first-of-its-kind full-time international food safety
laboratory training facility at College Park, MD, to train domestic and
foreign government officials, third party laboratory scientists, and
food producers on fit-for-purpose analytical procedures that would meet
global food safety standards.
Since its inception, JIFSAN has funded over 60 research projects as
well as provided over 250 internships to undergraduate students to work
with FDA scientists. JIFSAN food safety research topics are diverse and
include the development of methods for detecting food pathogens; risk
assessment studies on nutrients; food packaging materials; dietary
supplements; microbial dose-responses; and risk communication. JIFSAN's
unique structure permits it to reach beyond the UMCP campus and support
research at other universities.
Moreover, UMCP-JIFSAN provides an environment in which scientific
and regulatory experts from various sectors can pool their resources
and ideas and promote more efficient development and dissemination of
science-based information that can support public policy.
II. Award Information/Funds Available
A. Award Amount
The Center for Food Safety and Applied Nutrition (CFSAN) at FDA
intends to fund one award up to $2.2 million for FY 2012, with the
possibility of 4 additional years of support, subject to the
availability of funds. Future year amounts will depend on annual
appropriations and successful performance.
B. Length of Support
The award will provide 1 year of support, with the possibility of 4
additional years of support, contingent upon satisfactory performance
in the achievement of project and program reporting objectives during
the preceding year and the availability of Federal fiscal year
appropriations.
III. Paper Application, Registration, and Submission Information
To submit a paper application in response to this FOA, applicants
should first review the full announcement located at www.fda.gov/food/newsevents/default.htm. (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.) Persons interested in applying for a grant may obtain an
application at https://grants2.nih.gov/GRANTS/FORMS.HTM. For all paper
application submissions, the following steps are required:
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With Central Contractor Registration
Step 3: Register With Electronic Research Administration (eRA)
Commons
Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps,
submit paper applications to:
Applications must be prepared using the PHS 398 research grant
application forms and instructions for preparing a research grant
application. Submit one signed, typewritten original of the
application, including the checklist, and five signed photocopies as
follows:
Submit one original to: Gladys Melendez, Division of Acquisition and
Grant Services, Food and Drug Administration, 5630 Fishers Lane, Rm.
1078, Rockville, MD 20857, 240-731-3905, gladys.bohler@fda.hhs.gov.
Submit the five signed photocopies to: Kevin W. Robinson, Center for
Food Safety and Applied Nutrition (HFS-650), Food and Drug
Administration, CPK1, Rm. 4C035, 5100 Paint Branch Pkwy., College Park,
MD 20740, 240-402-2118, kevin.robinson@fda.hhs.gov.
Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10648 Filed 5-2-12; 8:45 am]
BILLING CODE 4160-01-P