[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Notices]
[Pages 14103-14106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04919]


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DEPARTMENT OF HOMELAND SECURITY

[Docket No. DHS-2013-0018]


Request for Information (RFI) Regarding the Planned Biotechnology 
Development Module (BDM) as Part of the National Bio and Agro-Defense 
Facility (NBAF) and Notice of Public Workshop

AGENCY: Department of Homeland Security, Science and Technology 
Directorate.

ACTION: Request for Information and Notice of Workshop.

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SUMMARY: The Department of Homeland Security (DHS) Science and 
Technology Directorate (S&T), Office of National Laboratories (ONL) and 
the United States Department of Agriculture (USDA), Agricultural 
Research Service (ARS) and Animal and Plant Health Inspection Service 
(APHIS) are requesting information regarding utilization alternatives 
for the planned Biotechnology Development Module (BDM) a planned 
component of the National Bio and Agro-Defense Facility (NBAF). The BDM 
will provide a distinct environment for scientific synergy, attract 
animal health industry involvement and serve to encourage public-
private partnerships as countermeasures developed for agricultural 
biodefense emerge from NBAF. The information provided by industry and 
other interested stakeholders in response to this RFI will be used by 
DHS and USDA to better plan the scope, capacity, and utilization 
alternatives for the BDM facility. DHS and USDA are requesting that 
this information be provided in writing per the guidelines below. There 
will also be an opportunity for interested parties to participate in a 
workshop with DHS and USDA.

DATES: The Request for Information period will be 60 days (March 5 to 
May 3, 2013). Please submit written information no later than May 3, 
2013.
    The workshop will be held on March 22, 2013 from 8:30 a.m.-4:00 
p.m. CST.

ADDRESSES: Written Information should be submitted via email to: 
[email protected] ATTN: Mary Goobic.
    The workshop will be held at the Kansas State University Olathe 
Campus (Forum Hall), 22201 W. Innovation Drive, Olathe, KS 66061.
    If you are interested in participating in the public workshop, 
please register at www.dhs.gov/nbaf by March 18, 2013.

FOR FURTHER INFORMATION CONTACT: Mary Goobic, 202-254-6144.

[[Page 14104]]


SUPPLEMENTARY INFORMATION: 

Request for Information Instructions

    Written information should be submitted via email to: 
[email protected], subject line should read: `BDM RFI 
Response, ATTN: Mary Goobic' no later than May 2, 2013. Submissions 
should be limited to 5 pages and should address the following four main 
topics:
     Scope of the BDM (requirements, program drivers, 
technology).
     Operational Requirements (staffing, regulatory, equipment 
needs).
     Utilization Alternatives (collaboration space, user 
facility, work for others, etc).
     Mechanisms to Facilitate Collaboration Between Industry 
and Government (joint venture).
    The written information should provide feedback on the above 
information and address the following questions (please see below for 
additional details on the plans for the BDM):
    1. Are there additional or different perceived needs for the BDM?
    2. How much interest is there for utilizing the BDM?
    3. Is the BDM right sized for capacity?
    4. What are the proposed utilization alternatives for the BDM?
    5. What are the possible mechanisms to enhance collaboration 
between the BDM and the animal health biologics industry?
    6. Provide lessons learned for DHS to consider regarding the BDM.

Workshop

    To further facilitate the information exchange between the 
government and the biologics industry, DHS will conduct a public 
workshop as part of the RFI process. The goals of the workshop are: (1) 
Provide an overview of the planned mission requirements of the BDM; (2) 
Provide the proposed BDM design; (3) Review analogous current and 
planned biological countermeasure development initiatives; (4) Gauge 
industry interest in the utilization of the BDM to enhance 
collaboration. This workshop is designed to provide information on the 
NBAF BDM and how it fits within the broader context of countermeasure 
development for protecting U.S. agriculture. A panel discussion is 
scheduled to give industry an opportunity to share lessons learned and 
insights on BDM related operations.
    The workshop will be held from 8:30 a.m.-4:00 p.m. CST on March 22, 
2013 in Olathe, KS at the Kansas State University Olathe campus. If you 
are interested in attending, please register at the following link: 
www.dhs.gov/nbaf by March 18, 2013. This workshop will include several 
panel discussions and we encourage participation from industry 
representatives to present their perspectives and lessons learned on 
this opportunity for collaboration with the federal government. If you 
are interested in participating in the panel discussions, please 
indicate a representative from your organization to serve as a panel 
member when you register online. Early registration is recommended due 
to limited seating. There is no registration fee for the workshop. If 
you need special accommodations due to a disability, please contact 
Mary Goobic at 202-254-6144 at least 7 days in advance of the workshop.
    Additional information such as design layouts, schematics, any 
other significant questions and any amendments or changes to the RFI 
will be posted on the NBAF Web site (www.dhs.gov/nbaf). Questions 
regarding the workshop may be submitted by email to 
[email protected] ATTN: Mary Goobic.

Scope of the BDM

    The BDM is designed to support the early development and eventual 
license of products/reagents discovered at the NBAF laboratory. The 
goal of the BDM is to provide product quality assurance, master cell 
and seed stocks, upscale validation, and assay development to support 
the development of biologics, which will allow quicker regulatory 
reviews and approvals of materials and products to respond to potential 
emergencies and threats to national and global food stocks. The BDM 
would address critical needs, including pilot manufacturing processes 
to effectively transfer new technologies to the veterinary biologics 
and biopharmaceutical industries and, in some emergency situations, to 
the end users in the field to control and eradicate a foreign animal 
disease outbreak.
    One of the limitations of moving animal health research results to 
agribusiness is the cost and inefficiencies in developing the 
manufacturing process; this is an even a bigger issue for foreign 
animal diseases since there is a limited market for countermeasures 
developed to control diseases that do not exist in the United States. 
The BDM will enable the federal government (USDA-ARS, USDA-APHIS, and 
DHS) to implement early product development initiatives in partnership 
with private sector greatly increase the rate of success of technology 
transfers. The BDM will be constructed to enable Good Manufacturing 
Practices (GMP) and support translational studies by producing test 
materials to develop potential therapeutic and preventive 
countermeasures for animal agriculture. The BDM will support customers 
from all three NBAF user groups (DHS S&T, ARS, and APHIS) as well as 
potential industry collaborators. The proposed BDM is intended to 
produce small scale GMP-compliant biological countermeasures for 
supporting efficacy studies and early phase clinical trials in response 
to DHS and USDA program requests. The BDM has been designed to 
manufacture experimental diagnostics, biologics, and therapeutics 
designed for the detection, control, and eradication of foreign animal 
diseases in the United States. These countermeasures may also be used 
to help developing countries control and where feasible eradicate 
endemic agents that pose a threat to United States animal agriculture. 
The model for the GMP/BDM facility, and its supporting areas, is to 
create small quantities of materials beyond proof of concept, using 
clinical processing to provide consistent/reproducible products and 
processes to confirm product safety and effectiveness. The design of 
the GMP/BDM Suite will support clinical investigations focusing on 
product safety, purity, potency, and efficacy that will lead to 
licensed products in compliance with U.S. regulations as well as 
international standards. The BDM's design will provide flexibility for 
a variety of product types and manufacturing processes, including 
production of monoclonal antibodies, recombinant proteins for 
therapeutics/diagnostic applications, and live or inactivated 
recombinant viral and bacterial vaccines, and dedicated areas for 
formulations and aseptic fill-finish operations. The development of 
qualified master cell and seed stocks (for manufacturing viral and 
bacterial vaccines) will be a critical activity to accomplish the 
mission. In addition, the facility will support the evolution of 
existing countermeasures (vaccine and diagnostic) programs by providing 
small scale production of experimental test materials for use in the 
clinical and analytical components of late stage discovery and early 
stage development of countermeasures discovered by NBAF scientists.

Operational Requirements

    The BDM is designed as part of the NBAF laboratory to support the 
growth, collection, and purification of products in individual 
Production and Diagnostic Reagent Production Suites. The BDM is

[[Page 14105]]

8,300 square feet and consists of production suites and general support 
spaces for small scale production of biological countermeasure 
materials for supporting efficacy studies and early phase clinical 
trials. By implementing validated processes to reproduce materials 
consistently, the program will hasten candidate technology transfer and 
countermeasure product candidate transition from NBAF to industry 
partners for scale-up and commercial manufacturing. This will also 
allow for more targeted outsourcing of countermeasures development 
processes, as candidates emerging from the NBAF will be more attractive 
to the animal biologics industry.
    The BDM will meet the APHIS Center for Veterinary Biologics 
requirements for manufacturing biological products and will have the 
flexibility, when necessary, to operate in accordance with current GMP 
regulations as described in Title 21 CFR Parts 210, and 211, such as 
during the production of master seeds, drug substances (DS), and drug 
products (DP). The NBAF BDM will allow the production of pilot lots of 
veterinary biological candidates to be tested to assess their potential 
for successful licensure by the APHIS Center of Veterinary Biologics, 
and will be produced under APHIS manufacturing requirements. APHIS has 
issued a comprehensive set of regulations governing the licensing of 
viruses, serums, toxins, or analogous products (9 CFR Parts 101-123). 
These regulations broadly categorize viruses, serums, toxins or 
analogous products as ``biological products'' at any stage of 
production intended for use in the treatment of animals and act 
primarily through the direct stimulation, supplementation, enhancement, 
or modulation of the immune system or immune response. Additional 
veterinary drugs or products will be submitted to and licensed by the 
FDA Center for Veterinary Medicine. Candidates will be manufactured in 
compliance with the appropriate CFR requirements for the conduct of 
controlled and uncontrolled studies utilizing active components in 
animal models.
    The BDM will operate to enable positive and negative air flows, as 
well as BSL-2 containment with BSL-3 enhanced production areas to 
support the development of inactivated and attenuated recombinant viral 
products. The BDM will be utilized 24 hours a day, based on a year-
round production schedule once fully operational. The facility will 
also allow simultaneous production of small amounts of multiple vaccine 
candidates. The BDM is attached to the NBAF laboratory to assure 
proximity. Card/Access Security Control will be established to maintain 
access control to the building as well as each of the manufacturing 
suites and access corridors of the GMP/BDM. Proximity Card access will 
be established to assure that only properly trained and security 
authorized personnel are allowed in each of the zoned areas of the 
module. Card access will also be used to maintain the clean zones and 
material and equipment transfer into the manufacturing suites.
    Air cleanliness classifications are established in the GMP/BDM per 
ISO and International EU requirements for possible DS and DP exposure. 
Open product manufacturing, processing, and fill-finish will be 
performed under laminar flow classified room air or within containment 
via biosafety cabinets (BSC) or laminar flow (LAF) hoods to assure 
product integrity. Air cleanliness will be maintained within the 
product exposure areas under Class 100/A, ISO 5 conditions. Cleanliness 
of this air will be maintained through cascade of classifications in 
adjacent areas required to maintain flow of material, equipment, and 
personnel through the space. These classifications will be maintained 
for cleanliness requirements and containment requirements of the CDC, 
and the FDA for materials in use and products manufactured or finished. 
Pressurization of spaces to supplement air flows will also be utilized 
to assure containment of particulates, contaminants, and regulated 
agents.

Utilization Alternatives

    DHS plans to operate the BDM as a government owned, government 
operated (GOGO) laboratory. However, DHS is evaluating utilization 
alternatives for the BDM that will maximize the use of the facility. 
DHS is seeking feedback from industry on utilization alternatives or 
alternative approaches such as privatizing the construction and 
operations of the BDM.
    The key criteria that DHS is considering in its evaluation are:
     Facility and Scientific Oversight.
     Ability to Respond to Changing Mission.
     Facility Availability.
     Ability to Establish Collaborations.
     Safety and Security.
     Technology Transfer.
     Cost Effectiveness.
     Outside Funding.
     Risk of Failure/Bankruptcy.
     Liability.
    DHS would like feedback on other criteria that should be considered 
in the decision making process.

Mechanisms To Facilitate Collaboration With Industry

    The BDM presents opportunities to further collaborate with industry 
partners in the development of countermeasures to protect animal 
agriculture in the United States, as well as developing countries that 
are endemic for priority diseases that pose a threat to global food 
security. The BDM will enable and facilitate technology transfer to 
national and multinational industry partners and contract manufacturing 
organizations (CMO) for scale-up and quicker turnover to commercial 
product manufacturing. The importance of on-site potential for 
development and scale-up production of material has been recognized by 
DHS and USDA as an important capability for the site as an integral 
step towards the development of countermeasures. Additional feedback or 
suggestions on other potential opportunities for collaboration are 
welcome.

NBAF Mission

    The United States' food and animal agriculture supply is a highly 
integrated, open, global, and complex infrastructure. Increased imports 
of agricultural products, climate change, and growing numbers of 
international travelers to and from the U.S. have opened our food 
supply to possible intentional, natural, or accidental foreign animal 
disease outbreaks. The recent pandemic H1N1 outbreak and other regional 
foot-and-mouth disease outbreaks have demonstrated the vulnerabilities 
present when there is a lack of available countermeasures, and other 
rapid response capabilities to curb outbreak disease. The food and 
agriculture industries are a significant contributor to U.S. economic 
prosperity; therefore, the loss of a significant food market would have 
dire economic and potentially human health consequences. To supply the 
needed capabilities, the DHS and the USDA have the joint responsibility 
to protect our Nation's animal agriculture and public health from these 
threats. The DHS is leading these efforts through the construction of 
the NBAF in Manhattan, Kansas.
    NBAF will be a state-of-the-art biocontainment facility for the 
study of foreign animal, emerging and zoonotic (transmitted from 
animals to humans) diseases that threaten the U.S. animal agriculture 
and public health. NBAF will provide and strengthen our nation with 
critical capabilities to conduct research, develop vaccines and other 
countermeasures, and train veterinarians in preparedness and response 
against these diseases. For the

[[Page 14106]]

past 50 years, the Plum Island Animal Disease Center (PIADC) has served 
our nation as the primary facility to conduct research on livestock 
diseases. However, PIADC is nearing the end of its life-cycle and needs 
to be replaced in order to meet U.S. research requirements and ensure 
the timely development of countermeasures in the event of an outbreak. 
NBAF meets that need and will serve as a replacement for the PIADC 
facility. Strategically, NBAF will boast of new and expanded 
capabilities, specifically, Biosafety Level (BSL) 4 containment for the 
study of high-consequence diseases affecting livestock and people. 
Specifically, NBAF will meet its mission by (1) providing enhanced 
capabilities to research, rapidly detect, and provide training on 
foreign animal, emerging and zoonotic diseases in livestock; (2) 
providing expanded vaccine and countermeasure development capabilities; 
and (3) replacing and expanding research currently performed at the 
PIADC in Orient Point, New York while continuing the partnership 
between the DHS and the USDA-ARS and USDA-APHIS.
    NBAF will serve as a U.S. government facility capable of rapidly 
producing experimental biological, diagnostic, and vaccine related 
products for potential use by USDA in an outbreak of an emerging or 
foreign animal disease. Initially, the following diseases would be 
studied at NBAF and would also require BSL-3 and BSL-4 laboratory 
capabilities: Nipah Virus, Hendra Virus, African Swine Fever, Rift 
Valley Fever, Japanese Encephalitis Virus, Foot and Mouth Disease, 
Classical Swine Fever, and Contagious Bovine Pleuropneumonia. The 
pathogens studied at the NBAF may change based upon continued 
evaluation of risks to U.S. agricultural system.

    Dated: February 26, 2013.
Daniel M. Gerstein,
Deputy Under Secretary, Science and Technology Directorate, U.S. 
Department of Homeland Security.
[FR Doc. 2013-04919 Filed 3-1-13; 8:45 am]
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