ATTACHMENTS_updated_via_Amendment_1.pdf

REVISED ATTACHMENTS 1, 3, 5, and 6

(These RFP attachments have been revised in conjunction with Amendment 1 to RFP-NIAID-DMID-NIHAI2015039. Changes appear in yellow highlights.

All other attachments to the original solicitation remain unchanged.)

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

November 10, 2014 Page 1 of 4

Packaging and Delivery of the Proposal for Research and Development and Research and Development Support—for Use with eCPS

I. PROPOSAL SUBMISSION

A. The National Institute of Allergy and Infectious Diseases (NIAID) currently requires proposals to be submitted via two methods:

1. Online

2. Disc (CD or DVD)

Notes:

• Submission of proposals by facsimile or e-mail is not acceptable.

• Online and disc proposals must be exactly the same.

II. ONLINE SUBMISSION OF ELECTRONIC PROPOSALS

A. eCPS PROPOSAL SUBMISSION PROCESS:

1. In addition to discs, offerors are required to submit an electronic copy of proposals online through the NIAID electronic Contract Proposal Submission (eCPS) website at: https://ecps.nih.gov/ .

2. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/NIAID/home/howto .

3. Please note that creating an account to submit can take up to three (3) business days.

Please register early to allow enough time for the registration process.

III. DISCS (i.e., CD or DVD)

A. Delivery Instructions:

If Hand Delivery or Express Service If using U.S. Postal Service

Frank Vidergar Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 5601 Fishers Lane Rockville, MD 20852

Frank Vidergar Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 5601 Fishers Lane Bethesda, MD 20892-9821

1. Mark each package with the following items:

The solicitation number: Example NIHAI2012001

“TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY”

https://ecps.nih.gov/ https://ecps.nih.gov/NIAID/home/howto

November 10, 2014 Page 2 of 4

2. All material sent to this office by courier should be sent to the Hand Delivery or

Express Service address.

3. Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal”, in accordance with FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition.

B. Discs – Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. The Business Proposal must be comprised of the following files:

a. The first file must be a PDF of your Business Proposal, with all attachments, including the Solicitation Section J, Attachment entitled “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet.” The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned and merged into the Business Proposal PDF file.

b. The remaining file(s) must be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” in its original Excel format, not PDF.

Multiple Excel files may be included, as necessary.

3. A separate Disc must be submitted for the Technical Proposal and Business Proposal.

Offerors who submit both Technical and Business Proposals on the same Disc will be required to resubmit the proposals on separate Discs.

4. Each of the proposals, Technical and Business, must be separate and complete in itself, so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

5. File naming convention: It is required that the filenames for both your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number, and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls

November 10, 2014 Page 3 of 4

IV. FORMATTING, NUMBER OF COPIES, AND PAGE LIMITATIONS:

A. Formatting for discs and proposals submitted online through eCPS

1. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

2. Font size must be 10 to 12 points. (Exception: Offerors may use 8 or 9 point font within graphics and tables.)

3. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

4. Margins must be at least one-inch on all sides.

5. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in entirety.

B. Number of copies and applicable page limitations:

1. Total page count does not include: Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section.

2. Pages in excess of this limitation will be removed from the proposal and will not be considered.

NUMBER OF COPIES AND APPLICABLE PAGE LIMITATIONS

Document Number of Copies

Page Limits

Technical Proposal ONLINE (using the eCPS website) One (1) electronic copy of the Technical Proposal (including all Attachments)

DISC (i.e., CD or DVD) One (1) Disc containing one electronic copy of the Technical Proposal (including all Attachments)

Not to Exceed 175 pages (inclusive of all Attachments)

Business Proposal ONLINE (using the eCPS website) One (1) submission containing two files, as instructed below.

1. One (1) electronic PDF copy of the

Business Proposal (with all Attachments including the PDF rendering of the Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet).

2. One (1) Electronic Cost Proposal Excel Workbook See Solicitation Section J, N/A

November 10, 2014 Page 4 of 4

Attachment entitled Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook. Microsoft Excel 2007 version or later is required.

DISC (i.e., CD or DVD) One (1) Disc containing two files, as instructed in section III.B above.

Microbiology and Infectious Diseases Biological Research Repository (MID-BRR) ATTACHMENT 3 RFP-NIAID-DMID-NIHAI2015039 Statement of Work

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ATTACHMENT 3: STATEMENT OF WORK (Version 5-22-15)

MICROBIOLOGY AND INFECTIOUS DISEASES BIOLOGICAL RESOURCE

REPOSITORY (MID-BRR)

RFP NIAID-DMID-NIHAI2015039

1) BACKGROUND AND INTRODUCTION:

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by all infectious agents, other than HIV. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that is funded through a variety of research grants and contracts.

Toward this aim, the NIAID supports an array of research services. Included are programs that make preclinical and clinical translational research services, as well as organisms and state of the art reagents, genomic technologies, data and analytic tools, and biocontainment and core facilities, available to investigators (http://www3.niaid.nih.gov/research/resources/dmid/). DMID has adopted an integrated approach to the provision of services by creating unified, comprehensive, and coordinated programs. The strategy was employed to: advance science by promoting cross-fertilization across and within disciplines and approaches; serve the research community more conveniently; achieve efficient use of resources through economy of scale and avoidance of duplication; and provide the flexibility needed to respond to changing priorities.

The Microbiology and Infectious Diseases Biological Research Resources Program (hereinafter called the Biological Research Resources Program) serves as a central repository that provides one-stop shopping for the broad community of microbiology and infectious diseases researchers; the purpose of this solicitation is to re-compete this program. The Microbiology and Infectious Diseases Biological Resources Repository (MID- BRR) is a vital resource and central to NIAID’s mission. The MID-BRR receives, acquires, authenticates, produces, preserves, stores and distributes most of the organisms and reagents needed to comprise the comprehensive resource. The MID-BRR may also serve as a repository for research materials produced by other Government-supported research projects and research service programs, at the discretion of NIAID. The MID-BRR Contractor is expected to interact with these programs as well. Currently, there are 4328 registered users with the repository and over 13,300 unique items in the MID-BRR catalog.

Moreover, the Biological Research Resources Program is designed not only to meet the currently defined needs of scientific communities, but also to meet emerging needs for research materials as they are identified.

A separate and complementary Contract for the Animal Models of Infectious Diseases program http://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/Pages/default.as px provides a resource for the development and refinement of animal models of infectious diseases as well as in vivo screening and efficacy testing of countermeasures for these http://www3.niaid.nih.gov/research/resources/dmid/ http://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/Pages/default.aspx http://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/Pages/default.aspx

RFP-NIAID-DMID-NIHAI2015039 Statement of Work

p. 2 of 21 infectious diseases. MID-BRR provides organisms and reagents that are integral to this research program.

Sharing research resources is fundamental to progress in science. The NIH is interested in ensuring that research resources developed with NIH funding are made available to the research community for further research, development, and application, in the expectation that this will further the research enterprise and accelerate the development of products and knowledge of benefit to the public. Sharing resources across the scientific community promotes the development of standards, leading to more rigorous and reproducible research findings. The NIH endorses the sharing of final research data and resources to expedite the translation of research results into knowledge, products, and procedures to improve human health. The Biological Research Resources Program has been designed to ensure that the research community will have access to a myriad of research materials developed through numerous sources.

2) SCOPE:

The MID-BRR will provide NIAID with a central repository for the acquisition, authentication, production, preservation, storage, and distribution of a broad range of unique and quality-assured research materials for the infectious disease research community that will aid in the development and evaluation of vaccines, therapeutics, and diagnostics. This program will include biodefense, non-biodefense, and emerging infectious disease research materials covering the more than 270 organisms in DMID’s research portfolio, allowing NIAID to respond to changing priorities as scientific research and public health needs shift. The repository inventory will include organisms as well as reagents developed from, and integral to, research on those organisms. This program will utilize a quality assurance program for the operation of a biological resource center that includes the facilities, equipment, qualified personnel, and all other necessary resources and services for importing and acquiring, authenticating, producing, storing, and distributing research materials.

For the purposes of this solicitation, research materials include both organisms and reagents:

• Organisms include, for example, bacteria, viruses, parasites, arthropod vectors, and fungi, including NIAID Category A, B and C Priority Pathogens and NIAID designated emerging infectious disease agents or organisms (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Pages/CatA.aspx).

• Reagents include, for example, biochemical, biologic, cellular, genomic, immunologic and molecular specimens and/or resources integral to research on these organisms.

Reagents may also refer to toxins and other agents such as prions; to antiviral and anti-infective drugs and therapeutics, chemicals, agents that modulate the immune system, vaccines, vaccine constructs and vaccine adjuvants, and diagnostic tools and kits for detection and measurement.

3) TECHNICAL REQUIREMENTS:

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the requirements stated in this Statement of Work.

RFP-NIAID-DMID-NIHAI2015039 Statement of Work

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A. MAINTENANCE OF BIOLOGICAL RESOURCE REPOSITORY

1. Biological Resource Repository

Upon receipt of organisms and reagents the Contractor shall:

1) Confirm that the number and authentication of organisms and reagents match those stated to be transferred from the existing repository contractor.

2) Process all received organisms and reagents and ensure that all vials or containers are labeled with barcode-readable labels identifying the contents.

3) If necessary, add labels that will overwrap existing labels to include original information, as well as the MID-BRR reagent tracking barcode number.

4) Enter all received organisms and reagents into the MID-BRR inventory and tracking system.

5) Store organisms and reagents under appropriate conditions.

2. Facilities, Equipment, and Other Resources

The contractor shall provide and maintain the following facilities, equipment, space and other resources necessary to carry out the technical requirements set forth in the Statement of Work for the entire contract period of performance in compliance with all Federal, NIH, and state and local regulations and guidelines, to include:

a. Aseptic and/or sterile conditions, as appropriate.

b. A clean agent fire suppression system that is environmentally acceptable and leaves no residues.

c. Temperature-controlled floor space with the capacity to maintain a room temperature of 66°F to 72°F, especially when all equipment is operational. Space must be sufficient for the installation, storage and maintenance of equipment, including refrigerators, freezers, and vapor-phase liquid nitrogen Tank, and have sufficient working space for the receipt, processing, packaging, storage, and distribution of materials.

d. Sufficient space and equipment for weighing or dispensing solid and liquid materials into aliquots and labeling vials. For some non-infectious materials, automated processing and aliquotation equipment may be appropriate. Because of the nature of some of the materials, secure facilities shall be available for the appropriate handling and storage of infectious agents and for hazardous materials.

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e. An automated temperature monitoring system for all refrigerator, freezer, and liquid nitrogen storage units. The system shall be composed of individual temperature probes for each unit monitored 24 hours per day/7 days per week by a dedicated computer. This monitoring system should be capable of maintaining the performance history (temperature, repairs, initial validation) for every storage unit in the facility, and should interact with the facility’s inventory and tracking system, so that equipment performance and storage history data are linked to sample history as part of overall quality assurance and quality control.

f. Immediate notification of necessary on- or off-site personnel by telephone/beeper/computer in the event of a storage unit malfunction.

g. Twenty-four hour turn-around for repair of malfunctioning equipment.

h. A central alarm system to monitor for power failure 24 hours per day/7 days per week. Should power failure occur, complete and automatic back-up power shall be immediately available, such that all equipment, including all refrigerators and freezers, computers, temperature monitoring systems, all back-up systems, and security systems, shall remain functional.

i. An auxiliary electric generator capable of operating all storage equipment, security systems and necessary lighting with adequate back-up power supply (diesel, gasoline, or natural gas-powered generators with a minimum 72-hour fuel supply on hand at all times) on-site to minimize effects of electric power failure. The back-up generator shall be tested monthly under continuous full load for at least one hour.

j. Emergency stand-by refrigerators and freezers shall be available in case of mechanical failure of storage space.

k. Storage for bulk and/or packaged reagents at:

Storage Type Estimated cubic feet

Estimated # freezers, refrigerators, tanks based on estimated cubic feet

-80 ºC Freezers 1100 total cubic feet 45-50

-20 ºC Freezer 25 cubic feet 1 Refrigerators 400 cubic feet 8-10 Liquid Nitrogen Tanks 450 total cubic feet 10-15

Walk In

9,000 Cubic Foot (5,000 cubic Feet -20 ºC/ 4,000 cubic feet 8 ºC)

RFP-NIAID-DMID-NIHAI2015039 Statement of Work

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l. Storage for materials produced under cGMP (current Good Manufacturing Practice), or materials that may be destined for pre-clinical use as specified by the Contracting Officer Representative (COR).

B. BIOLOGICAL RESOURCE REPOSITORY ACTIVITIES

1. Inventory and tracking system: The Contractor shall maintain and update the information system to monitor the receipt, processing, storage and distribution of all research materials managed by the MID-BRR.

a. The system shall be housed in an environment with an adequate level of redundancy in power, connectivity and cooling, including:

1) Secure web-based access to the system by registered requesters, the COR and designees.

2) Industry-standard authentication and authorization subsystem with confidential access codes that shall be known and accessible to the COR and designees. The COR will determine the information to be disseminated and to whom it shall be made available.

3) Security against loss of data, to include an off-site secure facility for storage of back-ups of all database files and programs. A comprehensive Backup Plan (BP) that specifies the procedures used to ensure against data loss shall be provided to the COR for approval within 30 days after the effective date of the contract.

4) Continuity of Operations - a comprehensive Operational Recovery Plan (ORP) and Disaster Recovery Plan (DRP) that specifies the procedures used to restore operations following a natural or man-made disaster shall be provided to the COR for approval within 30 days after the effective date of the

5) Capability of being transferred to the NIAID or subsequent contractor without interruption.

6) A System User’s Manual that documents the system in its entirety for use by MID-BRR staff. The Manual shall be posted at a designated place, and be updated as needed.

7) Use of software and computer-based systems that are compatible with DMID computer-based systems and platform support for both Windows and Macintosh operating systems providing 100% feature parity.

8) Use of a robust, scalable and commercially-available relational database and web environment.

b. Assign a unique identifier to each individual container of material processed in the MID-BRR to assist in the inventory and tracking of materials, from receipt through ultimate disposition. Use state-of-the-art bar coding software and hardware.

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c. Record the complete history by individual container of all materials in the MID-

BRR from receipt through ultimate disposition. Provide, within 60 calendar days after the effective date of the contract, an updated plan for tracking the complete history by individual container for approval by the Contracting Officer Representative.

d. Monitor usage of Biological Research Resource Program materials in the MID-

BRR. On a Quarterly basis, generate data extracts to the COR that contain the materials usage information (for example, per institution, laboratory) to be used for planning and/or evaluation. The content shall be agreed upon by the Contractor and the COR within 60 calendar days after the effective date of the

e. In addition to standard reports (See Reporting Requirements and Other

Deliverables), prepare and generate ad hoc reports and data extracts requested by the COR and/or designees.

f. As requested by the COR, transfer all information stored` in the inventory and tracking system, from the Contractor’s in-house inventory and tracking system to a Government-owned, secure database. The Contractor shall work with the COR and the NIAID database developer on plans to transfer data and data structure to the NIAID database. Thereafter, the Contractor shall continue to support data collection and/or data entry and quality assurance/quality control activities as needed for the data uploaded into the NIAID database.

g. Follow COR instructions for continued assessment of inventory over the life of the contract making adjustments to the catalog as necessary.

h. Follow COR instructions for phase de-accessioning of any inventory that is deemed to be no longer of scientific interest.

2. Identification and Acquisition

a. Identify strains and clones of other organisms, including strains and clones of NIAID Category A, B and C Priority Pathogens and emerging infectious disease agents (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Pages/CatA.aspx ), and reagents that are not readily available, as requested by the COR. Prioritize acquisition of these additional materials based on the needs of the microbiology and infectious diseases research community, availability, and cost. These potential acquisitions will be reviewed by NIAID prior to acquisition, and decisions will be communicated by the COR in writing.

b. Acquire, authenticate, produce, store, and make available for distribution additional materials throughout the performance period of the contract, including materials created by contractors participating in the Animal Models of Infectious Diseases program, and other Government-supported grantees and contractors, as requested by the COR. These acquisitions will also go through the NIAID review process.

http://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/pages/default.aspx http://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/pages/default.aspx

RFP-NIAID-DMID-NIHAI2015039 Statement of Work

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c. Purchase additional materials through a competitive process at the request of the

COR.

d. Maintain documentation that supports the justification and the criteria for evaluating and selecting reagents to be included in the repository.

e. At the request of the COR, receive, acquire, authenticate, store, and distribute any materials produced under current Good Manufacturing Practice (cGMP, 21 CFR, Parts 210 & 211) conditions in compliance with cGMP. Qualify (or audit) each manufacturer of such products before acquisition of materials.

f. Handle all materials at the appropriate biosafety level (BSL-1, BSL- 2, BSL-3, or

BSL-4) (http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf).

3. Authentication

Authenticate new materials following quality assurance/quality control procedures, including the following specific requirements. Additional requirements will be specified as necessary by the COR. The COR can require that some reagents be acquired, produced, and distributed to the research community with little to no authentication.

a. Authenticate organisms (bacteria, viruses, parasites, and fungi, etc.) by typing and strain validation to verify genus and species identification. Examples include assays to establish identity by sequencing or typing (e.g., using genetic markers of clonal identity and virulence genes, or sequencing of flagellin and toxin genes to subtype strains) purity, viability, growth characteristics, concentration, and virulence. The number and types of assays to be performed shall require prior approval by the COR.,

b. Authenticate biological and biochemical reagents, which include for example, cells, tissues, cell lines, lysates, nucleic acids, protein and peptide preparations, including antibodies, antimicrobials, and other compounds or natural materials that may be used for developing therapies against pathogens, including NIAID Category A, B and C Priority Pathogens and emerging infectious disease agents.

Authentication parameters shall include as appropriate, but not be limited to:

• Clonality

• Purity

• Sterility

• Stability

• Chemical composition

• Biological activity

• Solubility

c. Techniques used to establish the above qualities shall include but not be limited to the following examples:

• Spectrophotometry

• Neutralization and infectivity assays

• High performance liquid chromatography (HPLC) http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf

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• Mass spectrometry

• Restriction enzyme analysis

• Polymerase chain reactions

• Immunoblotting

• In-situ hybridizations

4. Production

a. Produce materials to inventory levels as recommended by the COR, in consultation with the scientific community, and/or as demand dictates.

Production of materials includes, but is not limited to, expansion of renewable materials, e.g., cell lines, viruses, microorganisms, and recombinant DNA.

b. Identify key indicators and associated measures for monitoring and assessing the performance of the facilities, equipment, operations, and personnel with respect to production. Provide acceptable and non-acceptable (upper and lower) specification limits for all key indicators. Analyze performance of key indicators quarterly, and submit Production Performance Reports to the COR for review.

Monitor out-of-specification and error rates, and implement procedures to reduce these rates to be as low as reasonably achievable. Implement corrective actions if specification limits are not met. Notify COR in writing of non-acceptable specification limits, and success or failure of corrective actions, and proceed based upon COR recommendations.

c. Weigh or dispense solid and liquid materials into aliquots in barcode-labeled vials.

d. Use automated processing and dispensing equipment for non-infectious materials, as appropriate.

e. Handle infectious agents and hazardous materials within appropriate secure facilities, following all applicable Federal regulatory procedures and guidelines.

(http://oma1.od.nih.gov/manualchapters/intramural/3035/).

5. Storage

a. Provide, maintain, and operate facilities for the storage of bulk and packaged reagents and organisms, as appropriate (refer to table in section A.2.k. for range of storage temperatures and conditions).

b. Store materials at the appropriate biosafety level (BSL-1, BSL-2, BSL-3, or

BSL-4). Refer to link in Section 2.f.

c. Store materials produced under cGMP, or those materials that may be destined for pre-clinical use, separately from infectious biologics.

6. Receipt and Distribution

Receive shipments and retrieve from storage, package, and distribute organisms and reagents.

a. Licenses, permits and compliance with regulations http://oma1.od.nih.gov/manualchapters/intramural/3035/

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1) Obtain the appropriate licenses and permits required by local, state and

Federal authorities for the safe import, storage and shipping of diagnostics, therapeutics and reagents.

2) Obtain the appropriate interstate, intrastate and foreign import/export shipping licenses and permits for transporting biohazardous and/or radioactive reagents and drugs.

3) Obtain appropriate shipping licenses and permits from Federal, state and local authorities for the safe import, storage, and distribution of appropriate organisms, according to current regulatory guidelines as applicable.

4) Comply with all Federal and State regulations governing access, distribution within a facility, transport, and use of Select Agents.

(http://www.selectagents.gov/Regulations.html)

b. Receive Shipments

1) Provide 24 hour per day, 7 days per week availability of MID-BRR personnel to receive, accept, and store incoming shipments of materials from the specified carrier, receipt site (e.g., airport), or other contract site.

2) Receive and accept shipments within 24 hours of notification from carrier or other contract site to ensure viability of organisms and preservation of reagents.

3) In instances when third party direct delivery to the Contractor’s site cannot be accomplished, MID-BRR personnel shall transport shipments from the point of pickup to the MID-BRR at the temperatures necessary to maintain stability and viability of materials.

4) Update airport shipping/receiving procedures and requirements as needed to remain in compliance with Department of Transportation regulations (http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title49/49tab_02.tpl) and International Air Transport Association/International Civil Aviation Organization (IATA) Dangerous Goods Regulations (http://www.iata.org/whatwedo/cargo/dgr/Pages/index.aspx).

c. Shipping and Distribution

1) The Contractor shall not fulfill any requests that result in inventory dropping below a minimum inventory level, as recommended by the COR and based on the type of material and needs for that material. The Contractor shall alert the COR for a decision as whether or not to replenish low inventory materials.

2) Retrieve samples from storage locations and perform any necessary discrepancy reporting and corrective action processing on vials with incongruent information. Conduct reporting and corrective action within 24 hours of the discovery of any discrepancies. The Contractor shall inform the COR in questionable cases.

3) Provide for safe packaging, shipping and distribution of materials by a certified air courier provider to eligible domestic and non-domestic research http://www.selectagents.gov/Regulations.html http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title49/49tab_02.tpl http://www.iata.org/whatwedo/cargo/dgr/Pages/index.aspx

RFP-NIAID-DMID-NIHAI2015039 Statement of Work

p. 10 of 21 investigators so that such shipments are coordinated for timely receipt. A secure package tracking system shall be utilized to ensure that all materials are delivered only to the intended recipient.

1) Provide, packaged with outgoing materials, material safety and data sheets containing technical information, references and citations of the relevant information for safe handling and use of the materials (e.g., proper reconstitution of freeze-dried organisms), and delineated applicable standards for the safe handling and use of specific materials in compliance with all local, state, and Federal regulations and guidelines.

2) Perform 100 percent documented inspection and verification of all outgoing shipments at the vial level. Verify that all requested vials have been retrieved and are correctly identified on the shipping manifest.

Enter all necessary shipping information in the inventory and tracking system. For example, ship to investigator, institution and address, codes for catalog number, number of vials in shipment, ship date, etc.

3) Use safe and appropriate validated packaging, shipping and distribution containers for materials that comply with current domestic and international transport regulations and pertinent Department of Transportation regulations and International Air Transport Association/International Civil Aviation Organization (IATA) Dangerous Goods Regulations (http://www.iata.org/whatwedo/Pages/index.aspx).

The shipping containers must provide a sufficient margin of safety for maintaining appropriate environmental safeguards and desired refrigeration levels for specific materials in transit, depending on the mode of transportation employed.

4) Ship materials and charge the domestic recipient for shipping costs. Ship materials and assume shipping costs using the MID-BRR contract for international shipments.

5) Ship available materials within 48 hours of receipt of completed request.

Monitor shipments and receipt by the receiving agent to minimize delay or loss. If a shipment is not received within eight hours of expected delivery, immediately follow-up with the courier service for shipment tracking and inform the COR or designee by electronic mail. A telephone number for the Contractor’s on-call staff member shall be available to assist in this follow-up, and the staff member shall be available at that number.

6) Coordinate all shipments so that viability, biological activity or purity of the materials will not be adversely affected. Send notification to all investigators to coordinate shipping and receiving of frozen and refrigerated materials. Handle all issues for customs brokerage.

C. QUALITY ASSURANCE PROGRAM

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Provide an institutional Quality Assurance Program (QAP) that comprises the design, establishment, maintenance, and updating of interrelated Programs for Quality Assurance/Quality Control, and Biosafety/Biosecurity and Security.

1. Quality Assurance/Quality Control (QA/QC)

a. QA/QC Plan

The Contractor shall, within 60 calendar days after the effective date of the contract, provide a Quality Assurance/Quality Control (QA/QC) Plan that describes procedures for establishing and maintaining a comprehensive QA/QC Program to monitor all laboratory management processes. The QA/QC Plan shall address:

1) standard operating procedures (SOPs) for all activities related to handling materials;

2) measures/metrics to be used to assess performance and quality of contract– produced materials;

3) approaches/methods to document and address problems and deficiencies, including improvements in the QA/QC Plan;

4) plans for training Contractor staff on all SOPs and measures used for QA/QC.

The QA/QC Plan shall be reviewed and approved by the COR prior to the initiation of any activities related to its execution and identify and describe key indicators or measures to monitor laboratory management processes, including the facilities, equipment, operations, and personnel. The list of these key indicators for the QAP is to be provided as an Initial Deliverable for this contract There should be separate data quality assurance protocols for processes associated with molecular biology laboratory procedures, e.g. for DNA and RNA extraction. At a minimum, a list of such indicators shall include:

(i) reconciliation procedures between organisms/reagents sent and organisms/reagents that were supposed to be sent, establishment of physical and electronic “orphanages” for materials and data that cannot be immediately reconciled, confirmatory practices with respect to sample distribution;

(ii) insertion of QA samples into freezers to be analyzed for impact of freeze time and conditions on the analytes of future interest, and monitoring of synchrony between physical sample location and electronic designation of sample location

(iii) total number of discrepancies

(iv) data entry or technician processing errors

(v) excessive turn-around times on receiving, processing, retrieval activities

(vi) missing or incorrect tracking numbers for incoming and outgoing shipments

(vii) acquisition, validation, repair, and replacement histories of storage equipment

(viii) integration of temperature monitoring of storage unit and records of abnormal temperature event notifications

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(ix) cycle count inventory system where a select number of items in a specific location are accounted for annually on a rotating basis such that all items are accounted for over the life of the contract.

b. QA/QC Program

Develop and implement a comprehensive QA/QC Program that includes:

1) A Quality Assurance (QA) Officer with responsibility for monitoring and managing all aspects of the comprehensive QA/QC Program.

2) Developing and submitting Standard Operating Procedures (SOPs) for all aspects of the comprehensive QA/QC Program for COR review and approval within 60 calendar days after the effective date of the contract.

1) All SOPs shall be maintained by the QA Officer. SOPs shall be reviewed annually and updated as necessary, with proper version control maintained on electronic copies.

2) Updated SOPs are required to be approved by the COR before implementation.

3) Ensuring the accuracy and integrity of monitoring and tracking of all MID-BRR activities.

4) Corrective Action Reports, submitted to the COR on a quarterly basis that describe problems and deviations from specifications, along with appropriate follow-up actions taken to remediate and correct discrepancies.

c. Audits

1) Internal Audits: Conduct an internal audit, no less than semiannually or at the request of the COR, to evaluate the current status of MID-BRR operations, including listing non-conformance with SOPs, repository policies and procedures, and Federal, state or local regulations and guidelines.

2) External Audits: Prepare for and comply with the requirements of all externally conducted audits of the Contractor’s and subcontractor’s facilities and operations. External audits will be conducted by the COR or designee annually, or as determined by the COR, to review and evaluate the repository’s management, operations, and QA/QC procedures. Ensure that all necessary Contractor and/or subcontractor personnel, facilities, equipment, records, and documents, including SOPs, are available.

3) For both Internal and External Audits, identify and correct errors, modify policies and procedures to prevent the re-occurrence of cited errors and behaviors, and remediate deficiencies within 30 calendar days after completion of the audit.

4) Within 20 calendar days after completion of each audit, submit interim audit reports/responses to the COR and Contracting Officer.

http://en.wikipedia.org/wiki/Inventory_control_system

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5) Within 30 calendar days after completion of corrective actions, submit final audit reports/responses to the COR and Contracting Officer.

2. Biosafety/Biosecurity and Security

a. Biosafety/Biosecurity and Security Plan

1) Within 60 calendar days after the effective date of the contract, provide an updated Biosafety/Biosecurity and Security Plan that describes procedures for establishing and maintaining a comprehensive Biosafety/Biosecurity and Security Program. Ensure that all personnel safety training, and adverse incident occurrence with remediation documentation is described in the Biosafety/Biosecurity and Security Plan and is incorporated in the overall QAP.

2) The updated Biosafety/Biosecurity and Security Plan shall be reviewed and approved by the COR prior to the initiation of any activities related to its execution.

b. Biosafety/Biosecurity

Requirements for the Biosafety/Biosecurity component of the comprehensive Biosafety/Biosecurity and Security Program include:

1) Biosafety (BSL-1, BSL-2, BSL-3, and BSL-4) containment of potentially hazardous organisms and reagents.

2) Provision of a safe working environment for all staff to the Contractor site and any subcontractor sites in compliance with the guidelines outlined in Biosafety in Microbiological and Biomedical Laboratories (http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf), and as required by all applicable Federal, state, and local regulations and guidelines.

3) Provision that all personnel who access and handle Select Agents have appropriate training, and meet the following requirements prior to beginning work on this contract:

1) all Federal Regulations and registrations for access and handling licensing requirements for select agents;

2) the Patriot Act (USA Patriot Act: Section 817 - Expansion of Biological

Weapons Statute (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ056.107.pd

f) and

3) Access to Select Agents (Appendix A to Part 72, CFR 42) (http://www.cdc.gov/od/sap/).

4) Provision of a Biosafety Officer with responsibility for monitoring and managing all aspects of the comprehensive Biosafety/Biosecurity and Security Program, including both Biosafety/Biosecurity and Security components.

http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ056.107.pdf http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ056.107.pdf http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ056.107.pdf http://www.cdc.gov/od/sap/

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5) Within 24 hours, informing the COR and Contracting Officer of all accidents and incidents resulting in death, traumatic injury, occupational disease, and/or damage to property incidental to work performed under the contract.

Maintain accurate records of all incidents, and make such records available upon request to the COR and Contracting Officer.

6) Perform corrective actions, either in response to requests by the COR or as necessary to maintain compliance with all applicable guidelines, and Federal, state and local regulations. The COR will approve all corrective actions before implementation of these activities by the Contractor.

7) Provide protective garments, equipment and monitoring to assure safe handling of infectious, toxic, biohazardous, and potentially hazardous materials, including both chemical and radioactive materials, for all involved personnel, including visitors to the facility. Comply with all applicable health and safety regulations while conducting the work set forth herein and follow the standards in accordance with HHSAR 352.223-70.

c. Security

Requirements for the Security component of the comprehensive Biosafety/Biosecurity and Security Program include the following features and systems:

1) Multiple-level security maintained and operated 24 hours per day/7days per week to provide a secure environment for employees, materials, and equipment within the facility, including storage rooms, material handling areas, and computing environments. A minimum of three separate levels or layers of physical and electronic security shall be employed. These levels of security may be increased at any time during the performance period of the contract if Federal security guidelines for facilities are modified. The Contractor should utilize a state-of-the-art electronic security system with fail-secure locking hardware to ensure controlled access to all secure repository areas.

2) Security surveillance systems maintained and operated 24 hours per day/7 days per week to ensure that the stored materials remain accessible only to authorized personnel.

3) Systems for electronic controlled monitoring and access to all the USDA

APHIS (Animal and Plant Health Inspection Service) and CDC Select Agents, NIAID Category A, B, and C Priority Pathogens, Highly Pathogenic Agents, and emerging infectious disease agent-related materials. Catalog and track access to and handling of these materials by all and any persons.

4) Separate, locked, electronic-controlled restricted-access storage units with approximately 15 cubic foot capacity and the capability to maintain controlled temperature within the range specified for any materials designated by the Drug Enforcement Administration as a dangerous and/or controlled substance compound. These materials will be subject to cataloging and tracking as described for the NIAID Category A, B, and C Priority Pathogens and Schedule

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I of the Schedules of Controlled Substances established by Section 202 of the Controlled Substances Act ( http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm).

5) Implementation of additional biosafety/biosecurity and security measures as directed by the COR.

D. COMMUNICATIONS AND COLLABORATIONS WITH THE SCIENTIFIC COMMUNITY

1. Scientific Working Group (SWG)

Establish and manage the activities of a Scientific Working Group (SWG) composed of a representative cross section of investigators, not directly associated with the MID-BRR, or any Biological Research Resources Program key personnel. The SWG shall provide advice to the NIAID on the comprehensive needs of the microbiology and infectious diseases research community, including acquisition of additional organisms and reagents, recommended approaches to advertising the availability of materials, discontinuing reagents no longer used and the need for training not otherwise available. The recommendations of the SWG must be approved by the COR prior to the implementation of any activities associated with their advice.

a. SWG Membership Selection

The Contractor shall recommend the names of individuals for SWG membership to the COR for review and approval and provide information on their area of expertise and other relevant selection factors within 3 months after the effective date of the contract. SWG members shall be individuals with broad vision regarding the ever-evolving state of microbiology and infectious diseases research and/or in the operation of large repositories. The Contractor shall NOT contact individuals regarding service on the SWG until final approval by the COR.

b. SWG Membership Representation

1) The SWG shall establish the following organism-specific membership representation to advise the SWG on the needs of the community:

• Bacteria, including mycobacteria

• Fungi

• Parasitic protists, other than Plasmodium

• Viruses

• Malaria

• Arthropod Vectors

• Ad hoc Emerging and/or High Priority Pathogens

c. SWG Meeting and Virtual Reporting

1) The introductory SWG meeting shall be conducted via computer based teleconference thereafter, all SWG interactions will be virtual. The SWG members will provide advice virtually via the webpage that will be set up by the Contractor for them to communicate. The Contractor shall set up the http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm) http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm)

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p. 16 of 21 webpage and orient the SWG members on the navigation during the introductory meeting. Monthly checks to the webpage will be conducted by the Contractor and semiannual reminders will be sent to the SWG members asking for additional recommendations. SWG members will communicate with their respective NIAID Program Officers who play an active role in the NIAID review process and will be encouraged to utilize them as a means of communication and collaboration to their communities as well.

2) SWG members will be sent monthly reports by the Contractor with an itemized list of newly added materials that have been added to the repository for them to share with their communities.

2. Training

On occasion, the COR may recommend training for the scientific community based on the Biological Research Resources Program materials and resources. If approved by NIAID, the Contractor will develop and organize the training to be held in the Bethesda, Maryland area.

3. Web Portal

The Contractor will be responsible for developing and subsequently maintaining and managing a web-based material ordering system, the data for which will be provided initially by the Government but updated by the Contractor. The web portal, which is to be used for ordering and depositing materials to/from the MID-BRR, shall have the same look as the current website. NIAID will provide the contractor screenshots of the mandatory web-portal design to ensure continuity of the website appearance.

The Contractor shall incorporate the following features and capacities into the website:

a. Provide one-stop shopping for all materials, whether stored onsite or at a subcontractor or other designated storage facility.

b. Include all associated forms and instructions needed to support the ordering system.

c. Include a multi-level registration system organized and categorized according to the level of biosafety/biosecurity and security as determined by the materials.

For materials requiring permits:

1) Require and obtain verification for BSL-3 and BSL-4 facilities that all investigators and institutions requesting NIAID Category A, B, or C Priority Pathogens or reagents are in compliance with the requirements of the Patriot Act (USA Patriot Act: Sec. 817. –Expansion of Biological Weapons Statute (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ056.107.pdf) and

2) Require written agreement that, in addition to other assurances required, the institution will comply with the following:

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ056.107.pdf http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ056.107.pdf

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1) All relevant standards for safe and secure handling and use of the research reagents;

2) Agreement not to use the reagents in any unauthorized or unsafe way including compliance with: Protection of Human Subjects, Title 45, Code of Federal Regulations, Part 26; and Public Health Service Policy on Human Care and Use of Laboratory Animals, implementing 1996 revisions of the Guide for the Care and Use of Laboratory Animals;

http://grants.nih.gov/grants/olaw/references/phspol.htm

3) Agreement that if…