Cooperative Agreement To Support the North Carolina State University, Prestage Department of Poultry Science and the Piedmont Research Station, 37549-37551 [2013-14824]
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37549
Federal Register / Vol. 78, No. 120 / Friday, June 21, 2013 / Notices
a demand for MNPs; (6) returning to
normal operations and conducting a
post-execution assessment of the
execution outcomes; and (7) testing the
Plan. The guidance recommends
developing a Plan for each individual
manufacturing facility as well as a
broader Plan that addresses multiple
sites within the organization. For
purposes of this information collection
analysis, we consider the Plan for an
individual manufacturing facility as
well as the broader Plan to comprise one
Plan for each manufacturer. Based on
FDA’s data on the number of
manufacturers that would be covered by
the guidance, we estimate that
approximately 70 manufacturers will
develop a Plan as recommended by the
guidance (i.e., 1 Plan per manufacturer
to include all manufacturing facilities,
sites, and drug products), and that each
Plan will take approximately 500 hours
to develop, maintain, and update.
The guidance also encourages
manufacturers to include a procedure in
their Plan for notifying the Center for
Drug Evaluation and Research (CDER)
when the Plan is activated and when
returning to normal operations. The
guidance recommends that these
notifications occur within 1 day of a
Plan’s activation and within 1 day of a
Plan’s deactivation. The guidance
specifies the information that should be
included in these notifications, such as
which drug products will be
manufactured under altered procedures,
which products will have
manufacturing temporarily delayed, and
any anticipated or potential drug
shortages. We expect that approximately
two notifications (for purposes of this
analysis, we consider an activation and
a deactivation notification to equal one
notification) will be sent to CDER by
approximately two manufacturers each
year, and that each notification will take
approximately 16 hours to prepare and
submit.
The guidance also refers to previously
approved collections of information
found in FDA regulations. Under the
guidance, if a manufacturer obtains
information after releasing an MNP
under its Plan leading to suspicion that
the product might be defective, CDER
should be contacted immediately at
drugshortages@fda.hhs.gov in
adherence to existing recall reporting
regulations (21 CFR 7.40; OMB control
number 0910–0249), or defect reporting
requirements for drug application
products (21 CFR 314.81(b)(1)) and
therapeutic biological products
regulated by CDER (21 CFR 600.14)
(OMB control numbers 0910–0001 and
0910–0458, respectively).
In addition, the following collections
of information found in FDA current
good manufacturing practice (CGMP)
regulations in part 211 (21 CFR part
211) are approved under OMB control
number 0190–0139. The guidance
encourages manufacturers to maintain
records, in accordance with the CGMP
requirements (see, e.g., § 211.180) that
support decisions to carry out changes
to approved procedures for
manufacturing and release of products
under the Plan. The guidance states that
a Plan should be developed, written,
reviewed, and approved within the
site’s change control quality system in
accordance with the requirements in
§§ 211.100(a) and 211.160(a); execution
of the Plan should be documented in
accordance with the requirements
described in § 211.100(b); and standard
operating procedures should be
reviewed and revised or supplementary
procedures developed and approved to
enable execution of the Plan.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Absenteeism guidance
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notify FDA of Plan Activation and Deactivation ..................
2
1
2
16
32
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
Absenteeism guidance
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Develop Initial Plan ..............................................................
70
1
70
500
35,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–14812 Filed 6–20–13; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2013–N–0010]
BILLING CODE 4160–01–P
TKELLEY on DSK3SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Cooperative Agreement To Support the
North Carolina State University,
Prestage Department of Poultry
Science and the Piedmont Research
Station
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing its
SUMMARY:
VerDate Mar<15>2010
18:32 Jun 20, 2013
Jkt 229001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
intention to receive and consider a
single-source application for the award
of a cooperative agreement in fiscal year
2013 (FY13) to the North Carolina State
University, Prestage Department of
Poultry Science and the Piedmont
Research Station Poultry Unit located in
Salisbury, NC. Egg-associated illness
due to Salmonella is a major public
health concern, with table eggs being
the primary source of Salmonella
Enteritidis. Therefore, an FDA priority
is to implement preventative measures
to reduce the vertical and horizontal
transmission of Salmonella Enteritidis
and other Salmonella serovars to table
eggs and poultry products. The goal of
E:\FR\FM\21JNN1.SGM
21JNN1
37550
Federal Register / Vol. 78, No. 120 / Friday, June 21, 2013 / Notices
this collaborative project between FDA
and the North Carolina State University,
Prestage Department of Poultry Science
and the Piedmont Research Station is to
utilize a commercial research facility to
parallel the transmission (vertical and
horizontal) of Salmonella found within
the egg-production industry and how
alterations in physical feed
characteristics and housing may
influence vertical and horizontal
transmission. Additionally, this study
aims to examine how commercially
utilized disinfection protocols affect
horizontal transmission of Salmonella
in alternative versus traditionally
housed layer hens. Moreover, this study
may reveal other serovars of Salmonella
present within the commercial egg
industry which may pose a potential
health risk to consumers. While
historically the concern over Salmonella
has focused on Salmonella Enteritidis,
there is a potential concern that other
Salmonella serovars could be a source
for egg-transmitted human
salmonellosis. Hence, this study aims to
investigate the occurrence,
transmission, and virulence of varying
Salmonella serovars.
DATES: Important dates are as follows:
1. The application due date is July 15,
2013.
2. The anticipated start date is
September 2013.
3. The expiration date is July 16,
2013.
Submit electronic
applications to: https://www.grants.gov.
For more information, see section III of
the SUPPLEMENTARY INFORMATION section
of this notice.
FOR FURTHER INFORMATION CONTACT:
Scientific/Programmatic Contact:
Ondulla Toomer, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 8301 Muirkirk Rd.,
MOD–1 (HFS–025), Laurel, MD 20708,
240–402–3430, email:
ondulla.toomer@fda.hhs.gov.
Grants Management Contact:
Kimberly Pendleton Chew, Office of
Acquisitions and Grant Services, Food
and Drug Administration, 5630 Fishers
Lane, Rm. 2105 (HFA 500), Rockville,
MD 20857, 301–827–9363, email:
kimberly.pendleton@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
www.fda.gov/food/newsevents/
default.htm.
TKELLEY on DSK3SPTVN1PROD with NOTICES
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA–FD–13–031 93.103
VerDate Mar<15>2010
18:32 Jun 20, 2013
Jkt 229001
A. Background
Egg-associated illness due to
Salmonella is a major public health
concern, with table eggs being the
primary source of Salmonella
Enteritidis. Infected individuals may
suffer gastrointestinal distress, shortterm or chronic arthritis, or even death.
Salmonella Enteritidis is transmitted
vertically (due to bacterial infection of
the reproductive organs infecting the
yolk, albumen, and/or membranes) or
horizontally (due to microbial
contamination post-oviposition from
environmental or cloacal
contamination). Upon the horizontal
transmission of Salmonella, the microorganism penetrates the eggshell
infecting the yolk, albumen, and egg
membranes. Therefore, an FDA priority
is to implement preventative measures
to reduce the vertical and horizontal
transmission of Salmonella Enteritidis
and potentially other Salmonella
serovars to table eggs and poultry
products (tissues). Intensive genetic
selection for enhanced egg production
has altered the ability to resist microbial
contamination within laying hen
breeders. Thus, it is imperative that
interventional strategies be studied to
ensure the safety of egg and poultry
products for consumption.
Various studies (Bjerrum et al., 2005;
Huang et al., 2006, Santos, 2006) have
demonstrated that increasing the grain
particle size in the diet reduced the
vertical transmission of Salmonella.
Bjerrum et al. (2005) reported that
broilers fed a finely ground pelleted
corn diet had a higher Salmonella
population in the gizzard than broilers
fed a coarsely ground corn pelleted diet.
In parallel, Huang et al. (2006) reported
a higher incidence of Salmonella
Typhimurium in the gizzard and cecal
contents of broilers fed a finely ground
corn pelleted diet, suggesting that feed
structure may influence Salmonella
colonization by altering the
gastrointestinal microenvironment.
B. Research Objectives
Research objectives include utilizing a
commercial research facility to parallel
the transmission (vertical and
horizontal) of Salmonella found within
the egg production industry; indicating
how alterations in physical feed
characteristics and housing (traditional
caging versus free-range) may influence
vertical and horizontal transmission;
and examining how commercially
utilized disinfection protocols affect
horizontal transmission of Salmonella
in free-range versus traditionally housed
layer hens. All research and
microbiological analysis will be
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
conducted at facilities housed at North
Carolina State University, Prestage
Department of Poultry Science and
Piedmont Research Station, Salisbury,
NC, using North Carolina State
University Institutional Animal Care
and Use Committee (IACUC) approved
protocol #11–024–A. This cooperative
agreement will provide support for
collaborative research conducted
between FDA–CFSAN–OARSAImmunobiology and North Carolina
State University, Prestage Department of
Poultry Science utilizing the
commercial research facility Piedmont
Research Station to meet the following
projected milestones:
1. Assess the routes of Salmonella
transmission to eggs, egg and poultry
products (tissues), and examine tissue
colonization.
2. Assess the immunological
responses of the layer hen to Salmonella
challenge post- and pre-molting.
3. Examine the prevalence of differing
Salmonella serovars in various
environmental layer hen housing
systems (conventional cage, enriched
cage systems, and free-range).
4. Examine the effect of various
nutritional intervention strategies
(physical feed characteristics,
antimicrobials, immuno-enhancing feed
ingredients) on vertical transmission
rates in a commercial-style
environment.
5. Examine the use of differing
disinfection protocols on the rates of
horizontal transmission in various
environmental layer hen housing
systems (conventional cage, enriched
cage systems, and free-range).
C. Eligibility Information
Competition is limited to the North
Carolina State University, Prestage
Department of Poultry Science and the
Piedmont Research Station because FDA
finds that the North Carolina State
University Department of Poultry
Science and the Piedmont Research
Station are uniquely qualified to fulfill
the objectives outlined in the proposed
cooperative agreement.
The goal of this collaborative project
is to utilize a commercial research
facility to parallel the transmission
(vertical and horizontal) of Salmonella
found within the egg production
industry and how alterations in physical
feed characteristics and housing may
influence vertical and horizontal
transmission.
The Piedmont Research Station
Poultry Unit is a unique facility that has
housing for over 15,000 commercial
layers, 8,000 broiler breeders, and
incubation capacity to hatch more than
52,000 eggs at one time utilizing both
E:\FR\FM\21JNN1.SGM
21JNN1
TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 120 / Friday, June 21, 2013 / Notices
multistage and single-stage incubation.
The Prestage Department of Poultry
Science Research and Teaching Units in
Raleigh, NC conduct research at the
Piedmont Research Station. Research at
both unit locations includes commercial
layers, commercial broiler breeders,
broilers, and commercial-style
incubation. Piedmont Research Station
routinely conducts the Layer
Performance Management Test in North
America, with studies in applied
production practices and nutrition
management. These facilities are able to
evaluate the effects of a research project
on a size and scale that mimics
commercial poultry operations.
The North Carolina State University
feed mill is a research and educational
feed mill that is designed and equipped
to manufacture a variety of feed mix
characteristics, formulations, and feed
forms. It is currently used by FDA for
training purposes associated with the
safe feed-safe food program, and is
among the few research feed mills in the
country that is associated with animal
research facilities. The mill has all of
the typical process equipment found in
commercial feed mills, including an 8
ton/hr CPM hammer mill, 8 ton/hr RMS
roller mill, micro bin-batching system, a
500 lb horizontal ribbon mixer, a 2 ton
double-shaft ribbon mixer, a 1 ton/hr
CPM pellet mill with counter-flow
cooler, a 10 ton/hr Bliss pellet mill with
counter-flow cooler, pellet screener,
bagger, bulk ingredient bins, finished
feed bins, and an automated computercontrolled batch mixing and process
operation. This feed mill is able to
manufacture feed of various feed
ingredient grind size in mash or pellet
forms.
While other academic institutions
also have outstanding poultry and egg
research programs, they do not have
commercial style research facilities, feed
mill, and resources to conduct largescale commercial size research projects.
Moreover, the North Carolina State
University, Prestage Department of
Poultry Science and Piedmont Research
Facility are within close geographic
proximity for collaboration with FDA’s
Department of Immunobiology. This
will allow FDA’s investigational
scientists to travel by automobile on key
experimental dates to initiate research
experiments and to collect tissue and
environmental samples. These samples
will be transported within 24 hours
back to FDA’s Department of
Immunobiology for microbiological
testing and analysis.
VerDate Mar<15>2010
18:32 Jun 20, 2013
Jkt 229001
II. Award Information/Funds Available
A. Award Amount
The Center for Food Safety and
Applied Nutrition (CFSAN) intends to
fund one award up to $50,000 total costs
(direct plus indirect costs) for FY 2013.
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 4 additional
years, 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.
37551
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Request for Nominations for Voting
and/or Nonvoting Consumer
Representatives on Public Advisory
Committees or Panels and Request for
Notification From Consumer
Organizations Interested in
Participating in the Selection Process
for Nominations for Voting and/or
Nonvoting Consumer Representatives
on Public Advisory Committees or
Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of
Only electronic applications will be
voting and/or nonvoting consumer
accepted. To submit an electronic
representatives to serve on its advisory
application in response to this FOA,
committees or panels notify FDA in
applicants should first review the full
writing. FDA is also requesting
announcement located at www.fda.gov/
food/newsevents/default.htm. (FDA has nominations for voting and/or
nonvoting consumer representatives to
verified the Web site addresses
serve on advisory committees and/or
throughout this document, but FDA is
panels for which vacancies currently
not responsible for any subsequent
exist or are expected to occur in the near
changes to the Web sites after this
future. Nominees recommended to serve
document publishes in the Federal
as a voting or nonvoting consumer
Register.) For all electronically
representative may either be selfsubmitted applications, the following
nominated or may be nominated by a
steps are required.
consumer organization. Nominations
• Step 1: Obtain a Dun and Bradstreet
will be accepted for current vacancies
(DUNS) Number
and for those that will or may occur
through December 2013.
• Step 2: Register With System for
DATES: Any consumer organization
Award Management (SAM)
interested in participating in the
• Step 3: Obtain Username & Password
selection of an appropriate voting or
• Step 4: Authorized Organization
nonvoting member to represent
Representative (AOR) Authorization
consumer interests on an FDA advisory
committee or panel may send a letter or
• Step 5: Track AOR Status
email stating that interest to FDA (see
• Step 6: Register With Electronic
ADDRESSES) by July 22, 2013, for
Research Administration (eRA)
vacancies listed in this notice.
Commons
Concurrently, nomination materials for
prospective candidates should be sent to
Steps 1 through 5, in detail, can be
FDA (see ADDRESSES) by July 22, 2013.
found at https://www07.grants.gov/
applicants/organization_registration.jsp. ADDRESSES: All statements of interest
Step 6, in detail, can be found at
from consumer organizations interested
https://commons.era.nih.gov/commons/ in participating in the selection process
registration/registrationInstructions.jsp. and consumer representative
After you have followed these steps,
nominations should be sent
submit electronic applications to:
electronically to CV@OC.FDA.GOV, by
https://www.grants.gov.
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Dated: June 17, 2013.
Hampshire Ave., WO32 Rm. 5129,
Leslie Kux,
Silver Spring Maryland 20993–0002, or
Assistant Commissioner for Policy.
by fax to 301–847–8640. Information
[FR Doc. 2013–14824 Filed 6–20–13; 8:45 am]
about becoming a member of an FDA
advisory committee can be obtained by
BILLING CODE 4160–01–P
III. Electronic Application,
Registration, and Submission
PO 00000
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Fmt 4703
Sfmt 4703
SUMMARY:
E:\FR\FM\21JNN1.SGM
21JNN1
]]>Agencies
[Federal Register Volume 78, Number 120 (Friday, June 21, 2013)]
[Notices]
[Pages 37549-37551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14824]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0010]
Cooperative Agreement To Support the North Carolina State
University, Prestage Department of Poultry Science and the Piedmont
Research Station
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to receive and consider a single-source application for the
award of a cooperative agreement in fiscal year 2013 (FY13) to the
North Carolina State University, Prestage Department of Poultry Science
and the Piedmont Research Station Poultry Unit located in Salisbury,
NC. Egg-associated illness due to Salmonella is a major public health
concern, with table eggs being the primary source of Salmonella
Enteritidis. Therefore, an FDA priority is to implement preventative
measures to reduce the vertical and horizontal transmission of
Salmonella Enteritidis and other Salmonella serovars to table eggs and
poultry products. The goal of
[[Page 37550]]
this collaborative project between FDA and the North Carolina State
University, Prestage Department of Poultry Science and the Piedmont
Research Station is to utilize a commercial research facility to
parallel the transmission (vertical and horizontal) of Salmonella found
within the egg-production industry and how alterations in physical feed
characteristics and housing may influence vertical and horizontal
transmission. Additionally, this study aims to examine how commercially
utilized disinfection protocols affect horizontal transmission of
Salmonella in alternative versus traditionally housed layer hens.
Moreover, this study may reveal other serovars of Salmonella present
within the commercial egg industry which may pose a potential health
risk to consumers. While historically the concern over Salmonella has
focused on Salmonella Enteritidis, there is a potential concern that
other Salmonella serovars could be a source for egg-transmitted human
salmonellosis. Hence, this study aims to investigate the occurrence,
transmission, and virulence of varying Salmonella serovars.
DATES: Important dates are as follows:
1. The application due date is July 15, 2013.
2. The anticipated start date is September 2013.
3. The expiration date is July 16, 2013.
ADDRESSES: Submit electronic applications to: https://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.
FOR FURTHER INFORMATION CONTACT:
Scientific/Programmatic Contact: Ondulla Toomer, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 8301
Muirkirk Rd., MOD-1 (HFS-025), Laurel, MD 20708, 240-402-3430, email:
ondulla.toomer@fda.hhs.gov.
Grants Management Contact: Kimberly Pendleton Chew, Office of
Acquisitions and Grant Services, Food and Drug Administration, 5630
Fishers Lane, Rm. 2105 (HFA 500), Rockville, MD 20857, 301-827-9363,
email: kimberly.pendleton@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 www.fda.gov/food/newsevents/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-13-031 93.103
A. Background
Egg-associated illness due to Salmonella is a major public health
concern, with table eggs being the primary source of Salmonella
Enteritidis. Infected individuals may suffer gastrointestinal distress,
short-term or chronic arthritis, or even death.
Salmonella Enteritidis is transmitted vertically (due to bacterial
infection of the reproductive organs infecting the yolk, albumen, and/
or membranes) or horizontally (due to microbial contamination post-
oviposition from environmental or cloacal contamination). Upon the
horizontal transmission of Salmonella, the micro-organism penetrates
the eggshell infecting the yolk, albumen, and egg membranes. Therefore,
an FDA priority is to implement preventative measures to reduce the
vertical and horizontal transmission of Salmonella Enteritidis and
potentially other Salmonella serovars to table eggs and poultry
products (tissues). Intensive genetic selection for enhanced egg
production has altered the ability to resist microbial contamination
within laying hen breeders. Thus, it is imperative that interventional
strategies be studied to ensure the safety of egg and poultry products
for consumption.
Various studies (Bjerrum et al., 2005; Huang et al., 2006, Santos,
2006) have demonstrated that increasing the grain particle size in the
diet reduced the vertical transmission of Salmonella. Bjerrum et al.
(2005) reported that broilers fed a finely ground pelleted corn diet
had a higher Salmonella population in the gizzard than broilers fed a
coarsely ground corn pelleted diet. In parallel, Huang et al. (2006)
reported a higher incidence of Salmonella Typhimurium in the gizzard
and cecal contents of broilers fed a finely ground corn pelleted diet,
suggesting that feed structure may influence Salmonella colonization by
altering the gastrointestinal microenvironment.
B. Research Objectives
Research objectives include utilizing a commercial research
facility to parallel the transmission (vertical and horizontal) of
Salmonella found within the egg production industry; indicating how
alterations in physical feed characteristics and housing (traditional
caging versus free-range) may influence vertical and horizontal
transmission; and examining how commercially utilized disinfection
protocols affect horizontal transmission of Salmonella in free-range
versus traditionally housed layer hens. All research and
microbiological analysis will be conducted at facilities housed at
North Carolina State University, Prestage Department of Poultry Science
and Piedmont Research Station, Salisbury, NC, using North Carolina
State University Institutional Animal Care and Use Committee (IACUC)
approved protocol 11-024-A. This cooperative agreement will
provide support for collaborative research conducted between FDA-CFSAN-
OARSA-Immunobiology and North Carolina State University, Prestage
Department of Poultry Science utilizing the commercial research
facility Piedmont Research Station to meet the following projected
milestones:
1. Assess the routes of Salmonella transmission to eggs, egg and
poultry products (tissues), and examine tissue colonization.
2. Assess the immunological responses of the layer hen to
Salmonella challenge post- and pre-molting.
3. Examine the prevalence of differing Salmonella serovars in
various environmental layer hen housing systems (conventional cage,
enriched cage systems, and free-range).
4. Examine the effect of various nutritional intervention
strategies (physical feed characteristics, antimicrobials, immuno-
enhancing feed ingredients) on vertical transmission rates in a
commercial-style environment.
5. Examine the use of differing disinfection protocols on the rates
of horizontal transmission in various environmental layer hen housing
systems (conventional cage, enriched cage systems, and free-range).
C. Eligibility Information
Competition is limited to the North Carolina State University,
Prestage Department of Poultry Science and the Piedmont Research
Station because FDA finds that the North Carolina State University
Department of Poultry Science and the Piedmont Research Station are
uniquely qualified to fulfill the objectives outlined in the proposed
cooperative agreement.
The goal of this collaborative project is to utilize a commercial
research facility to parallel the transmission (vertical and
horizontal) of Salmonella found within the egg production industry and
how alterations in physical feed characteristics and housing may
influence vertical and horizontal transmission.
The Piedmont Research Station Poultry Unit is a unique facility
that has housing for over 15,000 commercial layers, 8,000 broiler
breeders, and incubation capacity to hatch more than 52,000 eggs at one
time utilizing both
[[Page 37551]]
multistage and single-stage incubation. The Prestage Department of
Poultry Science Research and Teaching Units in Raleigh, NC conduct
research at the Piedmont Research Station. Research at both unit
locations includes commercial layers, commercial broiler breeders,
broilers, and commercial-style incubation. Piedmont Research Station
routinely conducts the Layer Performance Management Test in North
America, with studies in applied production practices and nutrition
management. These facilities are able to evaluate the effects of a
research project on a size and scale that mimics commercial poultry
operations.
The North Carolina State University feed mill is a research and
educational feed mill that is designed and equipped to manufacture a
variety of feed mix characteristics, formulations, and feed forms. It
is currently used by FDA for training purposes associated with the safe
feed-safe food program, and is among the few research feed mills in the
country that is associated with animal research facilities. The mill
has all of the typical process equipment found in commercial feed
mills, including an 8 ton/hr CPM hammer mill, 8 ton/hr RMS roller mill,
micro bin-batching system, a 500 lb horizontal ribbon mixer, a 2 ton
double-shaft ribbon mixer, a 1 ton/hr CPM pellet mill with counter-flow
cooler, a 10 ton/hr Bliss pellet mill with counter-flow cooler, pellet
screener, bagger, bulk ingredient bins, finished feed bins, and an
automated computer-controlled batch mixing and process operation. This
feed mill is able to manufacture feed of various feed ingredient grind
size in mash or pellet forms.
While other academic institutions also have outstanding poultry and
egg research programs, they do not have commercial style research
facilities, feed mill, and resources to conduct large-scale commercial
size research projects. Moreover, the North Carolina State University,
Prestage Department of Poultry Science and Piedmont Research Facility
are within close geographic proximity for collaboration with FDA's
Department of Immunobiology. This will allow FDA's investigational
scientists to travel by automobile on key experimental dates to
initiate research experiments and to collect tissue and environmental
samples. These samples will be transported within 24 hours back to
FDA's Department of Immunobiology for microbiological testing and
analysis.
II. Award Information/Funds Available
A. Award Amount
The Center for Food Safety and Applied Nutrition (CFSAN) intends to
fund one award up to $50,000 total costs (direct plus indirect costs)
for FY 2013. 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 4 additional years, 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. Electronic Application, Registration, and Submission
Only electronic applications will be accepted. To submit an
electronic 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.) For
all electronically submitted applications, 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 electronic applications to: https://www.grants.gov.
Dated: June 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14824 Filed 6-20-13; 8:45 am]
BILLING CODE 4160-01-P
