
[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]


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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.

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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: http://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 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 electronic applications to: http://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


