AWARDLETTERREGRANT2006-ST-091-000003-09FROMUSDHS.PDF
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U.S. Department of Homeland Security Washington, DC 20528 July 23, 2014 Maricopa County Air Quality Department Attn: David Bruce 1001 North Central Ave., Suite 125 Phoenix, AZ 85004 Re: Award Number 2006-ST-091-000003-09 (BioWatch Program) Dear Mr. Bruce: The Department of Homeland Security has approved your non-competing continuation application under the BioWatch Program: Field Operations & Sample Collection Activities. Your application was awarded with new funding of $680,962. If you have questions concerning this award, please contact me at (202) 447-5869. Sincerely, Sean Lilly Grants Officer Grants and Financial Assistance Division Office of Procurement Operations Office of the Chief Procurement Officer Sheet has been unlocked on 7/15/2014 4:11:07 PM U. S. DEPARTMENT OF HOMELAND SECURITY NOTICE OF FINANCIAL ASSISTANCE AWARD 1. FOA No.: DHS-2014-OHA-Biowatch Effective Date: September 1, 2014 2. PROJECT TITLE: Homeland Security Biowatch Program 3. AWARDING OFFICE 4. INSTRUMENT TYPE 5. AWARD NUMBER 6. MODIFICATION NUMBER GFAD COOPERATIVE AGREEMENT 2006-ST-091-000003-09 0 7. BUDGET PERIOD: 8. PROJECT PERIOD From: 09/01/14 To: 08/31/15 From: 9/1/2006 To: 8/31/2015 9. RECIPIENT ORGANIZATION 10. PROGRAM DIRECTOR or PRINCIPAL INVESTIGATOR Maricopa County Air Quality Department Heather Ellis/602-506-5043/HeatherEllis@mail.maricopa.gov 1001 N Central Ave., Suite 125 11. AWARD AUTHORITY Phoenix, AZ: Arizona 85004 Fiscal Year (FY) 2014 Department of Homeland Security (DHS) Appropriations Act (P.L. 113-76) 12. TYPE OF AWARD ACTION New Revision Continuation Supplement 13. EIN NUMBER 14. DUNS NUMBER 15. CONGRESSIONAL DISTRICT 16. CFDA NUMBER 86‐6000472 3612776550000 11 97.091 17. RECIPIENT TYPE State Government Indian Tribal Government Hospital For Profit Organization Individual Institution of Higher Education Other Nonprofit Organization Other (Please Specify) ACCOUNTING AND APPROPRIATIONS DATA DHS OFFICIALS 18. APPROPRIATION SYMBOL 19. ACCOUNT NUMBER 20. GRANTS OFFICER 21. PROGRAM OFFICER ROHB‐14‐00044 HTR0014‐000‐HA‐13‐14‐04‐000‐ Sean Lilly CPT Dan Yereb 05‐00‐00‐00‐00‐0000‐GE‐OE‐41‐ Sean.Lilly@hq.dhs.gov O 202‐254‐6712 02 202-447-5869 C 202‐253‐5188 22. APPROVED BUDGET daniel.yereb@hq.dhs.gov a. Personnel $285,166.00 23. CURRENT BUDGET PERIOD INFORMATION b. Fringe Benefits $97,098.00 a. DHS Funds Obligated This Action $680,962.00 c. Travel $6,300.00 b. DHS Funds Previously Obligated $0.00 d. Equipment $90,000.00 c. DHS Share of Total Approved Budget $680,962.00 e. Supplies $18,650.00 d. Total Approved Budget $680,962.00 f. Contractual $0.00 24. CUMMULATIVE DHS OBLIGATIONS g. Facilities/Construction $0.00 a. This Budget Period $680,962.00 h. Other $74,810.00 b. Prior Budget Periods $3,859,937.00 i. Total Direct Costs $572,024.00 c. Project Period to Date $4,540,899.00 j. Indirect Costs $108,938.00 25. AWARD TERMS AND CONDITIONS k. Recipient Share $0.00 This award/agreement consists of this form plus the following: a. Standard Financial Assistance Terms and Conditions; b. Applicable program regulations; c. DHS Financial Assistance Policies and Guidelines; I. Total Approved Budget $680,962.00 d. Application/proposal as submitted or revised on: 5/8/2014 e. Code of Federal Domestic Assistance; and f. Funding Opportunity Announcement. Remarks: A. This Award is subject to the availability of funds and the administration and completion of an approved Homeland Security program/project within the Period of Performance. Funds provided by this Award shall not be used for other purposes. B. The Recipient’s drawing or requesting project funds indicates acceptance of this Award and its associated terms and conditions. If the Recipient cannot accept this Award, including the legal obligation to perform in accordance with its provisions, the Recipient should notify the DHS Grants Officer immediately upon receipt of this Award. If resolution cannot be reached, the DHS Grants Officer will void the Award. COOPERATIVE AGREEMENT TERMS AND CONDITIONS GRANTS AND FINANCIAL ASSISTANCE DIVISION (GFAD) In addition to the DHS Standard Terms and Conditions as outlined here: http://www.dhs.gov/publication/fy14‐ dhs‐standard‐terms‐and‐conditions, the following Terms and Conditions apply specifically to this award as administered by the Grants and Financial Assistance Division (GFAD): ARTICLE I. GENERAL ADMINISTRATIVE TERMS AND CONDITIONS A. AWARD SPECIFIC TERMS AND CONDITIONS A. Site location of field samplers. 1. This Award provides funds for activities related to the Recipient’s BioWatch site location of field collectors/samplers as of the Budget Period start date of this Award, unless amended. 2. Prior DHS written concurrence is required for any new, deleted, or relocated site locations of the BioWatch collectors/samplers. If DHS non‐concurs, DHS will provide expert technical assistance in the development and/or revision of the site locations based on population coverage. 3. Site locations lists or requests for new, deleted, or relocated site locations shall be transmitted via password protected or encrypted e‐mail to the DHS Program Officer, daniel.yereb@hq.dhs.gov. B. Protocols/Procedures. 1. The Recipient will use the current DHS approved BioWatch Standard Operating Procedures (SOPs) (BioWatch Field Ops SOP, v1‐2‐FINAL, December 2007) for conducting field operations to ensure the integrity of the sample collection and delivery to the laboratory facility. 2. Any and all deviations from these procedures must be approved in advance by the DHS Program Officer. 3. This document may be updated during the Performance Period and/or Budget Period. When this occurs the Recipient will be notified by the DHS Grants Officer 60 days prior to the effective date of the implementation. 4. The Recipient is encouraged to provide feedback concerning the protocols/procedures during the implementation of this project. Feedback should be provided to the DHS Program Officer. C. Transport of Exposed Filter Holders. The Recipient must transport samples and filter holders back to the designated Laboratory Response Network (LRN) laboratory office by a mutually agreed upon time between the affected LRN laboratory manager and the field operations program manager. D. Surge Sampling. 1. In the event of elevated threat or in specific instances, DHS may direct the Recipient to perform supplemental sampling for biological agents (e.g., twice daily sampling or sampling at locations not routinely serviced). Estimated costs associated with this increased activity must be reported to the DHS Program Officer within two (2) business days. 2. The Recipient is not precluded from conducting sampling outside the DHS approved BioWatch site locations. However costs incurred or maintenance required as a result of the sampling conducted at locations not approved by DHS shall not be charged to this Award. E. Equipment. 1. The Recipient must inform the DHS Program Officer within 48 hours by e‐mail or other written correspondence as soon as Recipient obtains knowledge of any of the following conditions: 1) sampler failures or downtimes; 2) samplers removed from DHS approved sites; 3) samplers placed into service at new DHS approved sites; and 4) intelligence or other information about sampler placement that would facilitate the effectiveness of this BioWatch program. 2. Each award Recipient must use the types of BioWatch aerosol samplers, component parts, and associated audit devices approved on the DHS BioWatch Portal. 3. Prior to the purchase of equipment in the amount of $5,000 or more per unit cost, the Recipient must obtain the written approval from DHS. 4. Maintenance and insurance of the equipment will be the responsibility of the Recipient. 5. Title of equipment will remain with the Recipient until closeout when disposition will be provided in writing by DHS within 120 days of submission of final reports. 3. Prior to the purchase of equipment in the amount of $5,000 or more per unit cost, the Recipient must obtain the written approval from DHS. 4. Maintenance and insurance of the equipment will be the responsibility of the Recipient. 5. Title of equipment will remain with the Recipient until closeout when disposition will be provided in writing by DHS within 120 days of submission of final reports. B. DHS PROGRAMMATIC INVOLVEMENT A. DHS will provide technical assistance in reference to the Standard Operating Procedures (Field Operations SOP) (20071219 BioWatch Field SOP‐Version 1‐1b‐FINAL), including the technologies being evaluated in the program, Recipient’s security procedures, network design and collector siting. B. DHS Program Officer will provide technical guidance, assistance, and direction in the form of email and teleconferences (to include regularly scheduled teleconferences), as the Program Officer deems necessary. C. DHS will review and provide a final determination for changes requested in collector network design and siting. D. DHS will provide national guidance for notification protocols and post‐BioWatch Actionable Result (BAR) activities. E. DHS will notify the Recipient when special event monitoring and/or increased sampling is required for periods of elevated security threat. F. DHS will review and approve publications developed under this project prior to their submission for publication. G. DHS will provide the Recipient the opportunity to comment on any proposed changes to the Field Operations SOP. If these documents are revised, the Recipient will be notified by the DHS Grants Officer 60 days prior to the effective date of the implementation. H. DHS will review and provide approval or comments on any feedback from the applicant regarding findings of the annual BioWatch Exercise and Evaluation Program. I. National Incident Management System (NIMS). Each state is coordinating the implementation of NIMS and can provide assistance and guidance to local jurisdictions. The applicant should contact the State Administrative Agency responsible for homeland security for information about how NIMS is being implemented in your state. C. AMENDMENTS AND REVISIONS 1. Budget Revisions a. Transfers of funds between direct cost categories in the approved budget when such cumulative transfers among those direct cost categories exceed ten percent of the total budget approved in this Award require prior written approval by the DHS Grants Officer. b. The Recipient shall obtain prior written approval from the DHS Grants Officer for any budget revision that would result in the need for additional resources/funds. c. The Recipient is not authorized at any time to transfer amounts budgeted for direct costs to the indirect costs line item or vice versa, without prior written approval of the DHS Grants Officer. 2. Extension Request a. Extensions to the Period of Performance can only be authorized in writing by the DHS Grants Officer. b. The extension request shall be submitted to the DHS Grants Officer sixty (60) days prior to the expiration date of the performance period. c. Requests for time extensions to the Period of Performance will be considered, but will not be granted automatically, and must be supported by adequate justification to be processed. The justification is a written explanation of the reason or reasons for the delay; an outline of remaining resources/funds available to support the extended Period of Performance; and a description of performance measures necessary to complete the project. Without performance and financial status reports current and justification submitted, extension requests shall not be processed. d. DHS has no obligation to provide additional resources/funding as a result of an extension. D. EQUIPMENT 1. Title to equipment acquired by the Recipient with Federal funds provided under this Award shall vest in the Recipient, subject to the conditions pertaining to equipment in the applicable OMB circulars: http://www.whitehouse.gov/omb/circulars_default 2. Prior to the purchase of Equipment in the amount of $5,000 or more per unit cost, the recipient must obtain the written approval from DHS. 3. For equipment purchased with Award funds having a $5,000 or more per unit cost, the Recipient shall submit an inventory that will include a description of the property; manufacturer model number, serial number or other identification number; the source of property; name on title; acquisition date; and cost of the unit; the address of use; operational condition of the property; and, disposition data, if applicable. This report will be due with the Final Progress Report 90 days after the expiration of the Project Period, and may be emailed to DHS‐GrantReports@hq.dhs.gov E. FINANCIAL REPORTS 1. Quarterly Federal Financial Reports – the Recipient shall submit a Federal Financial Report (SF425) to the DHS Grants Officer no later than 30 days after the end of the reporting period end date. Reports are due on 1/31, 4/30, 7/31, 10/31. The report shall be emailed to DHS‐GrantReports@hq.dhs.gov and include the grant program name and number in the subject line. 2. Final Federal Financial Report – the Recipient shall submit the final Federal Financial Report (SF425) to the DHS Grants Officer no later than 90 days after the end of the Project Period end date. The report shall be emailed to DHS‐GrantReports@hq.dhs.gov and include the grant program name and number in the subject line. 3. Quarterly Federal Financial Reports (Cash Transaction) – the Recipient shall submit the Federal Financial Report (SF425) Cash Transaction Report to the Department of Health and Human Services, Payment Management System. Quarterly Cash Transaction reports shall be submitted no later than 1/30, 4/30, 7/30, and 10/30. F. PAYMENT The Recipient shall be paid in advance using the U.S. Department of Heath and Human Services/Payment Management System, provided it maintains or demonstrates the willingness and ability to maintain procedures to minimize the time elapsing between the transfer of the funds from the DHS and expenditure disbursement by the Recipient. When these requirements are not met, the Recipient will be required to be on a reimbursement for costs incurred method. Any overpayment of funds must be coordinated with the U.S. Department of Health and Human Services/Payment Management System. G. PERFORMANCE REPORTS 1. Quarterly Performance Reports – the Recipient shall submit performance reports to the DHS Grants Officer no later than 30 days after the end of the reporting period end date. Reports are due on 1/31, 4/30, 7/31, 10/31. The report shall be emailed to DHS‐GrantReports@hq.dhs.gov and include the grant program name and number in the subject line a. Performance reports must provide information on the overall progress by quarter. These reports shall include: * A comparison of actual accomplishments with the goals and objectives established for the period. * Reasons why established objectives were not met, if applicable. * Other pertinent information including, when appropriate, analysis and explanation of cost overruns. b. If the performance report contains any information that is deemed proprietary, the Recipient will denote the beginning and ending of such information with asterisks (******) 2. Final Performance Report – the Recipient shall submit the Final Performance Report to the DHS Grants Officer no later than 90 days after the expiration of the Project Period. The report Final Performance Report shall be emailed to DHS‐GrantReports@hq.dhs.gov and include the grant program name and number in the subject line. H. PERIOD OF PERFORMANCE The approved Project and Budget Periods for the supported activity is contingent on the following: 1. Acceptable performance of the project as determined by the Department of Homeland Security (DHS); 2. If applicable, acceptance and approval of each non‐competing continuation application by the DHS; 3. Subject to the availability of annual DHS appropriated funds. I. PRIOR APPROVAL REQUIRED The Recipient shall not, without the prior written approval of the DHS, request reimbursement, incur costs or obligate funds for any purpose pertaining to the operation of the project, program, or activities prior to the approved Budget Period. ARTICLE II. GENERAL TERMS AND CONDITIONS A. ACCESS TO RECORDS. The Recipient shall retain financial records, supporting documents, statistical records, and all other records pertinent to this Award for a period of three years from the date of submission of the final expenditure report. The only exceptions to the aforementioned record retention requirements are the following: 1. If any litigation, dispute, or audit is started before the expiration of the 3‐year period, the records shall be retained until all litigation, dispute or audit findings involving the records have been resolved and final action taken. 2. Records for real property and equipment acquired with Federal funds shall be retained for three (3) years after final disposition. 3. The DHS Grants Officer may direct the Recipient to transfer certain records to DHS custody when he or she determines that the records possess long term retention value. However, in order to avoid duplicate recordkeeping, the DHS Grants Officer may make arrangements for the Recipient to retain any records that are continuously needed for joint use. DHS, the Inspector General, Comptroller General of the United States, or any of their duly authorized representatives, have the right of timely and unrestricted access to any books, documents, papers, or other records of the Recipient that are pertinent to this Award, in order to make audits, examinations, excerpts, transcripts and copies of such documents. This right also includes timely and reasonable access to Recipient's personnel for the purpose of interview and discussion related to such documents. The rights of access in this award term are not limited to the required retention period, but shall last as long as records are retained. With respect to sub‐recipients, DHS shall retain the right to conduct a financial review, require an audit, or otherwise ensure adequate accountability of organizations expending DHS funds. Recipient agrees to include in any sub‐award made under this Agreement the requirements of this award term (Access to Records). B. COMPLIANCE ASSURANCE PROGRAM OFFICE TERMS AND CONDITIONS The Compliance Assurance Program Office (CAPO) is comprised of the DHS Treaty Compliance Office (TCO), Export Control Group (ECG), and the DHS Regulatory Compliance Office (RCO). The Compliance Assurance Program Manager (CAPM) is the DHS official responsible for overseeing CAPO and implementing procedures to ensure that the Recipient and any Recipient institutions/collaborators under this Award comply with international treaties, federal regulations, and DHS policies for Arms Control Agreements, Biosafety, Select Agent and Toxin Security, Animal Care and Use, the Protection of Human Subjects, Life Sciences Dual Use Research of Concern, and Export Controls. CAPO collects and reviews relevant documentation pertaining to this Award on behalf of the Compliance Assurance Program Manager. Additional guidance regarding the review process is provided in the following sections, along with contact information for the TCO, RCO, and ECG. This guidance applies to the Recipient and any/all Recipient institutions involved in the performance of work under this Award. The Recipient is responsible for ensuring that any/all Recipient institutions and collaborators comply with all requirements and submit relevant documentation, as outlined in sections C – G below, for work being performed under this Award. C. TREATY COMPLIANCE FOR BIOLOGICAL AND CHEMICAL DEFENSE EFFORTS The Recipient and any Recipient institution shall conduct all biological and chemical defense research, development, and acquisition projects in compliance with all arms control agreements of the U.S., including the Chemical Weapons Convention (CWC) and the Biological Weapons Convention (BWC). DHS Directive 041‐01, Compliance With, and Implementation of, Arms Control Agreements , requires all such projects to be systematically evaluated for compliance at inception, prior to funding approval, whenever there is significant project change, and whenever in the course of project execution an issue potentially raises a compliance concern. 1. Requirements for Initial Treaty Compliance Review. To ensure compliance with DHS Directive 041‐01, for each new biological and/or chemical defense‐related effort (including paper and modeling studies) to be conducted under this Award, the Recipient must submit the following documentation for compliance review and certification prior to funding approval: a completed Treaty Compliance Form (TCF), which includes a Project Summary; a BWC Checklist; and/or a CWC Checklist. 2. Requirements for Ongoing Treaty Compliance Review. To ensure ongoing treaty compliance for approved biological and/or chemical defense‐related efforts funded through this Award, the Recipient must submit the following documentation for review and approval prior to any significant project change and/or whenever in the course of project execution an issue potentially raises a compliance concern: a detailed description of the proposed modification, and written request for approval. The Recipient should contact the Treaty Compliance Office (TCO) at treatycompliance@hq.dhs.gov to obtain the TCF template, submit the completed Form, or request additional guidance regarding TCO documentation and review requirements, as applicable to (1) new biological and/or chemical defense‐ related efforts, or (2) modifications to previously approved efforts. The TCO will review all submitted materials and provide written confirmation of approval to initiate work to the Recipient once the treaty compliance certification process is complete. The Recipient and any Recipient institution shall not initiate any new activities, or execute modifications to approved activities, until receipt of this written confirmation. D. REGULATORY COMPLIANCE FOR BIOLOGICAL LABORATORY WORK The Recipient and any Recipient institution shall conduct all biological laboratory work in compliance with applicable federal regulations; the latest edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories ; DHS Directive 066‐02, Biosafety; and any local institutional policies that may apply for Recipient institution facilities performing work under this Award. The Regulatory Compliance Office (RCO) will review the submitted Treaty Compliance Form (TCF) for planned work under this Award to determine the applicability of the requirements outlined in this section. The Recipient must contact the RCO at STregulatorycompliance@hq.dhs.gov for guidance on the requirements, and then submit all required documentation based on RCO guidance, prior to the initiation of any biological laboratory work under this Award. 1. Requirements for All Biological Laboratory Work. Biological laboratory work includes laboratory activities involving: (1) recombinant DNA or ‘rDNA’; (2) Biological Select Agents and Toxins or ‘BSAT’; or (3) biological agents, toxins, or other biological materials that are non‐rDNA and non‐BSAT. Each Recipient and any Recipient institution to be conducting biological laboratory work under this Award must submit copies of the following documentation, as required by the RCO after review of the TCF(s), for review prior to the initiation of such work: a. Research protocol(s), research or project plan(s), or other detailed description of the biological laboratory work to be conducted; b. Documentation of project‐specific biosafety review for biological laboratory work subject to such review in accordance with institutional policy; c. Institutional or laboratory biosafety manual (may be a related plan or program manual) for each facility/laboratory to be involved in the biological laboratory work; d. Biosafety training program description (should be provided as available in existing policies, plans, and/or manuals for all relevant facilities/laboratories where work is conducted; e. Documentation of the most recent safety/biosafety inspection(s) for each facility/laboratory where the biological laboratory work will be conducted; f. Exposure Control Plan, as applicable; g. Documentation from the most recent Occupational Safety and Health Administration (OSHA) or State Occupational Safety and Health Agency inspection report; a copy of the OSHA Form 300 Summary of Work Related Injuries and Illnesses or equivalent, for the most recent calendar year; and documentation of any OSHA citations or notices of violation received in the past five years; and h. Documentation from the most recent U.S. Department of Transportation (DOT) inspection report; and documentation of any DOT citations or notices of violation received in the past five years. 2. Requirements for Research Involving Recombinant DNA (rDNA). Laboratory activities involving rDNA research are defined by the NIH Guidelines for Research Involving Recombinant DNA Molecules, “NIH Guidelines” . Each Recipient and any Recipient institution shall conduct all rDNA work in compliance with the NIH Guidelines. In addition to the documentation referenced in Section B.1 above, each facility conducting research activities involving rDNA under this Award must submit copies of the following documentation to the RCO for review prior to the initiation of such activities: a. Institutional Biosafety Committee (IBC) Charter, and/or other available documentation of IBC policies and procedures; b. Most recent Office of Biotechnology Activities (OBA) acknowledgement letter of the annual IBC Report; c. IBC‐approved rDNA research protocol(s); and d. Documentation of final IBC approval for each rDNA research protocol and all subsequent renewals and amendments as they occur. 3. Requirements for Activities Involving Biological Select Agents and Toxins (BSAT). Planned activities involving the possession transfer, and/or use of BSAT must be reviewed by the RCO prior to initiation. This requirement also applies to activities involving select toxins that fall below the Permissible Toxin Limits, both at facilities registered with the National Select Agent Program and at unregistered facilities. Each Recipient and any Recipient institution shall conduct all BSAT work in compliance with all applicable regulations, including 42 C.F.R. § 73, 7 C.F.R. § 331, and 9 C.F.R. § 121, related entity‐ and laboratory‐ specific policies and procedures, and DHS Directive 026‐03, Select Agent and Toxin Security . In addition to the documentation referenced in Section B.1 above, each facility conducting activities involving BSAT under this Award must submit copies of the following documentation to the RCO for review prior to the initiation of such activities: a. Current APHIS/CDC Certificate of Registration; b. Most recent APHIS/CDC inspection report(s), response(s), and attachment(s); c. Current versions of the Biosafety, Security, and Incident Response Plans required and reviewed under the Select Agent Regulations; and d. Documentation of the most recent annual BSAT facility inspection, as required of the Responsible Official under the Select Agent Regulations. The Recipient should contact the RCO at STregulatorycompliance@hq.dhs.gov to obtain the RCO Documentation Request Checklist, submit documentation, or request more information regarding the DHS RCO documentation and compliance review requirements. The RCO will provide written confirmation of receipt of all required documentation to the designated Point(s) of Contact. The RCO will evaluate the submitted materials, along with available documentation from any previous reviews for related work at the Recipient and Recipient institution. Additional documentation may be required in some cases and must be submitted upon request. The RCO will review all submitted materials and provide written confirmation to the Recipient once all requirements have been met. RCO review of submitted materials may determine the need for further compliance review requirements, which may include documentation‐based and on‐site components. The Recipient, and any Recipient institutions conducting biological laboratory work under this Award, must also comply with ongoing RCO compliance assurance and review requirements, which may include but are not limited to initial and periodic documentation requests, program reviews, site visits, and facility inspections. The Recipient must promptly report the following to the RCO, along with any corrective actions taken: (1) any serious or continuing biosafety or BSAT program issues as identified by the APHIS/CDC National Select Agent Program, other compliance oversight authorities, or institutional‐level reviews (e.g., IBC or equivalent, laboratory safety/biosafety inspections); (2) any suspension or revocation of the APHIS/CDC Certificate of Registration; and (3) any for‐cause suspension or termination of biological, rDNA, or BSAT activities at the laboratories/facilities where DHS‐sponsored work is conducted. Foreign Contractors/Collaborators and U.S. Institutions with Foreign Subcomponents. Foreign organizations (including direct Contractors, Subcontractors, Grant Recipients, Sub‐recipients, and subcomponents or collaborating partners to U.S. Recipients) are subject to applicable DHS requirements for biological laboratory activities. All entities involved in activities under this Award must comply with applicable national and regional/local regulations, and standards and guidelines equivalent to those described for U.S. institutions (e.g., BMBL and NIH Guidelines). The Recipient must provide RCO documentation sufficient to illustrate this compliance. The RCO will evaluate compliance measures for these institutions on a case‐by‐case basis. The Recipient must not initiate work nor provide funds for the conduct of biological laboratory work under this Award without RCO’s formal written approval. E. RESEARCH INVOLVING ANIMALS The Recipient and any Recipient institution shall conduct all research involving animals under this Award in compliance with the requirements set forth in the Animal Welfare Act of 1966 (P.L. 89‐544), as amended, and the associated regulations in 9 C.F.R., Chapter 1, Subchapter A; the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (which adopts the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training”, 50 FR 20864, May 20, 1985); the National Research Council (NRC) Guide for the Care and Use of Laboratory Animals; the Federation of Animal Science Societies (FASS) Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching; and any additional requirements set forth in the DHS Directive for the Care and Use of Animals in Research (026‐01). Each Recipient and any Recipient institution planning to perform research involving animals under this Award must comply with the requirements and submit the documentation outlined in this section. 1. Requirements for Initial Review of Research Involving Animals. Research Involving Animals includes any research, experimentation, biological testing, and other related activities involving live, vertebrate animals, including any training for such activities. Each facility conducting research involving animals under this Award must submit copies of the following documentation to the RCO for review prior to the initiation of such research: a. Institutional Animal Care and Use Committee (IACUC)‐approved animal research protocol(s), including documentation of IACUC approval, any protocol amendments, and related approval notifications; b. Public Health Service (PHS) Animal Welfare Assurance, including any programmatic amendments, and the most recent NIH Office of Laboratory Animal Welfare (OLAW) approval letter for each Recipient and Recipient institution; OR DHS Animal Welfare Assurance, if the Recipient is not funded by the PHS and does not have a PHS Assurance on file with OLAW. Any affiliated IACUCs must be established under the same requirements as set forth in the PHS Policy; c. Most recent IACUC semiannual program review and facility inspection reports covering all relevant facilities/laboratories involved in DHS‐funded work; and d. Most recent Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) inspection report(s) for AAALAC‐accredited institution(s) housing and/or performing work involving animals under this Award. All documentation, as well as any questions or concerns regarding the requirements referenced above, should be submitted to the RCO at STregulatorycompliance@hq.dhs.gov. Additional documentation may be required in some cases and must be submitted upon request. The RCO will review all submitted materials and provide written confirmation to the Recipient once all documentation requirements have been met. Upon receipt of this written confirmation, the Recipient may initiate approved animal research projects under this Award, but must address any potential compliance issues or concerns identified by the RCO. Research involving the use of nonhuman primates or international collaborations involving animal research will require more extensive review prior to approval, and must not begin under this Award without first obtaining a formal certification letter from the RCO. The Recipient, as well as any Recipient institution and partner institutions conducting animal research under this Award, shall also comply with ongoing RCO compliance assurance functions, which may include but are not limited to periodic site visits, program reviews, and facility inspections. 2. Requirements for Ongoing Review of Research Involving Animals. For ongoing animal research activities, each Recipient and any Recipient institutions must submit updates to the RCO regarding any amendments or changes to (including expiration, renewal, or completion of) ongoing animal protocols as they occur, and may be required to submit annual updates regarding the ACU program at Recipient and Recipient instituions. Annual updates may include, but are not limited to, the IACUC semiannual (program review and facility inspection) reports, the USDA inspection report, and the most recent AAALAC inspection report, as applicable. The Recipient must promptly report the following to the RCO, along with any corrective actions taken: (1) any serious or continuing noncompliance with animal care and use regulations and policies adopted by DHS (as referenced above); (2) any change in AAALAC accreditation status; (3) any USDA Notice of Violation; and (4) IACUC suspension of any animal research activity conducted under this Award. Foreign Contractors/Collaborators and U.S. Institutions with Foreign Subcomponents. Foreign organizations (including direct Contractors, Subcontractors, Grant Recipients, Sub‐recipients, and subcomponents or collaborating partners to U.S. Recipients) are subject to all DHS requirements for work involving animals. All entities involved in activities under this Award must comply with applicable national and regional/local regulations, and standards and guidelines equivalent to those described for U.S. institutions (e.g., Title 9, C.F.R, Chapter 1, Subchapter A; Public Health Service Policy on Humane Care and Use of Laboratory Animals; the Guide for the Care and Use of Laboratory Animals; and the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching). The Recipient must provide RCO documentation sufficient to illustrate this compliance. The RCO will evaluate compliance measures for these institutions on a case‐by‐case basis to determine their sufficiency. The Recipient must not initiate nor provide funds for the conduct of work involving animals at foreign institutions under this Award without formal written approval from the RCO. F. LIFE SCIENCES DUAL USE RESEARCH OF CONCERN (DURC) The Recipient and any Recipient institutions shall identify, report, and conduct any research involving life sciences dual use research of concern (as defined by the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern) in compliance with federal regulations, DHS Directive 026‐ 08, Oversight of Life Sciences Dual Use Research of Concern , as well as any additional requirements set forth in related DHS policies and instructions. G. RESEARCH INVOLVING HUMAN SUBJECTS The Recipient and any Recipient institutions shall conduct all Research Involving Human Subjects in compliance with the requirements set forth in 45 C.F.R. § 46, Subparts A‐D, DHS Directive 026‐04, Protection of Human Subjects , and any related DHS policies and instructions prior to initiating any work with human subjects under this Award. Each Recipient and any Recipient institutions planning to perform research involving human subjects under this Award must submit the documentation outlined in this section for RCO review. 1. Requirements for Research Involving Human Subjects. Each facility conducting work involving human subjects under this Award is required to have a project‐specific Certification of Compliance letter issued by the RCO. Each Recipient must submit the following documentation to the RCO for compliance review and certification prior to initiating research involving human subjects under this Award: a. Research protocol, as approved by an Institutional Review Board (IRB), for any human subjects research work to be conducted under this Award; b. IRB approval letter or notification of exemption (see additional information below on exemption determinations), for any human subjects research work to be conducted under this Award; c. IRB‐approved informed consent document(s) (templates) or IRB waiver of informed consent for projects involving human subjects research under this Award; and d. Federal‐wide Assurance (FWA) number from the HHS Office for Human Research Protections (OHRP), or documentation of other relevant assurance, for all Recipient institutions (including Sub‐ recipients) involved in human subjects research under this Award. 2. Exemptions for Research Involving Human Subjects. Exemption determinations for human subjects research to be conducted under this Award should only be made by authorized representatives of (1) an OHRP‐registered IRB, or equivalent, or (2) the RCO. Exemption determinations made by an OHRP‐ registered IRB, or equivalent, should be submitted to the RCO for review and record‐keeping. Program managers, principal investigators, research staff, and other DHS or institutional personnel should not independently make exemption determinations in the absence of an IRB or RCO review. DHS program managers (or institutions conducting human subjects’ research under this Award) seeking an exemption determination from the RCO should submit a request to STregulatorycompliance@hq.dhs.gov that includes the following: a. Research protocol or detailed description of planned activities to be conducted under this Award. b. Identification of the exemption category that applies to the project(s) to be conducted under this Award and explanation of why the proposed research meets the requirements for that category of exemption. All documentation, as well as any questions or concerns regarding the requirements referenced above, should be submitted to the RCO at STregulatorycompliance@hq.dhs.gov. The submitted documentation will be retained by the RCO and used to conduct a regulatory compliance assessment. Additional documentation may be required in some cases to complete this assessment. The Recipient must provide this documentation upon request, and address in writing any compliance issues or concerns raised by the RCO before a certification letter is issued and participant enrollment can begin under this Award. The RCO will review all submitted materials and provide written confirmation to the Recipient once all documentation requirements have been met. The Recipient and any Recipient institution shall submit updated documentation regarding ongoing research involving human subjects, as available and prior to the expiration of previous approvals. Such documentation includes protocol modifications, IRB renewals for ongoing research protocols (“Continuing Reviews”), and notifications of study completion. The Recipient must promptly report the following to the RCO, along with any corrective actions taken: (1) any serious or continuing noncompliance with human subjects research regulations and policies adopted by DHS (as referenced above); and (2) suspension, termination, or revocation of IRB approval of any human subjects research activities conducted under this Award. Foreign Contractors/Collaborators and U.S. Institutions with Foreign Subcomponents. Foreign organizations (including direct Contractors, Subcontractors, Grant Recipients, Sub‐recipients, and subcomponents or collaborating partners to U.S. Recipients) are subject to all DHS and RCO requirements for research involving human subjects. All entities involved in activities under this Award must comply with applicable national and regional/local regulations, and standards and guidelines equivalent to those described for U.S. institutions (e.g., 45 C.F.R. § 46, including all Subparts, as relevant). The RCO will evaluate compliance measures for these institutions on a case‐by‐case basis to determine their sufficiency. The Recipient must not initiate nor provide funds for the conduct of work involving human subjects at foreign institutions under this Contract without formal written approval from the RCO. H. COMPLIANCE WITH U.S. EXPORT CONTROLS Activities performed by the Recipient and any Recipient institution under this Award may or may not be subject to U.S. export control regulations. The Recipient and any Recipient institution shall conduct all such activities, to include any and all DHS‐funded research and development, acquisitions, and collaborations in full compliance with U.S. export controls—to include the Export Administration Regulations (EAR), the International Traffic in Arms Regulations (ITAR), and the Office of Foreign Assets Control (OFAC) Regulations. The Recipient and any Recipient institution will ensure that all legal requirements for compliance with U.S. export controls are met prior to transferring commodities, technologies, technical data, or other controlled information to a non‐U.S. person or entity. Upon DHS request, the Recipient and any Recipient institution must provide to CAPO documentation and any other information necessary to determine satisfaction of this requirement. All documentation, as well as any questions or concerns regarding export controls, should be submitted to the RCO at exportcontrols@hq.dhs.gov. I. CENTRAL CONTRACTOR REGISTRATION AND UNIVERSAL IDENTIFIER REQUIREMENTS 1. Requirement for Central Contractor Registration (CCR). Unless you are exempted from this requirement under 2 CFR 25.110, you as the Recipient must maintain the currency of your information in the CCR until you submit the final financial report required under this award or receive the final payment, whichever is later. This requires that you review and update the information at least annually after the initial registration, and more frequently if required by changes in your information or another award term. 2. Requirement for Data Universal Numbering System (DUNS) Numbers. If you are authorized to make sub‐awards under this award, you: a. Must notify potential subrecipients that no entity (see definition in paragraph 3 of this award term) may receive a sub‐award from you unless the entity has provided its DUNS number to you. b. May not make a sub‐award to an entity unless the entity has provided its DUNS number to you. J. CONTRACT PROVISIONS All Contracts executed under this award will contain contract provisions as listed in the applicable cost principles: http://www.whitehouse.gov/omb/circulars_default. K. CONTROLLED UNCLASSIFIED INFORMATION The parties understand that information and materials provided pursuant to or resulting from this Award may be export controlled, sensitive, for official use only, or otherwise protected by law, executive order or regulation. The Recipient is responsible for compliance with all applicable laws and regulations. Nothing in this Award shall be construed to permit any disclosure in violation of those restrictions. L. E.O. 13224 – EXECUTIVE ORDER ON TERRORIST FINANCING The Recipient is reminded that U.S. Executive Orders and U.S. law prohibits transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the recipient to ensure compliance with these Executive Orders and laws. This provision must be included in all contracts/sub‐awards issued under this agreement. M. PATENT RIGHTS AND DATA RIGHTS Patent rights. The Recipient is subject to applicable regulations governing patents and inventions, including government‐ wide regulations issued by the Department of Commerce at 37 CFR Part 401, “Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Government Grants, Contracts and Cooperative Agreements.” The clause at 37 CFR 401.14 is incorporated by reference herein. All reports of subject inventions made under this Award should be submitted to DHS using the Interagency Edison system website at http://www.iedison.gov. Data rights. 1. General Requirements. The Recipient grants the Government a royalty free, nonexclusive and irrevocable license to reproduce, display, distribute copies, perform, disseminate, or prepare derivative works, and to authorize others to do so, for Government purposes in: a. Any data that is first produced under this Award and provided to the Government; b. Any data owned by third parties that is incorporated in data provided to the Government under this Award; or c. Any data requested in paragraph 2 below, if incorporated in the Award. “Data” means recorded information, regardless of form or the media on which it may be recorded. 2. Additional requirement for this Award. a. Requirement: If the Government believes that it needs additional research data that was produced under this Award, the Government may request the research data and the Recipient agrees to provide the research data within a reasonable time. b. Applicability: The requirement in paragraph 2.a of this section applies to any research data that are: i. Produced under this Award, either as a Recipient or sub‐recipient; ii. Used by the Government in developing an agency action that has the force and effect of law; and iii. Published, which occurs either when: 1) The research data is published in a peer‐reviewed scientific or technical journal; or 2) DHS publicly and officially cites the research data in support of an agency action that has the force and effect of law c. Definition of “research data:” For the purposes of this section, “research data:” i. Means the recorded factual material (excluding physical objects, such as laboratory samples) commonly accepted in the scientific community as necessary to validate research findings. ii. Excludes: 1) Preliminary analyses; 2) Drafts of scientific papers; 3) Plans for future research; 4) Peer reviews; 5) Communications with colleagues; 6) Trade secrets; 7) Commercial information; 8) Materials necessary that a researcher must hold confidential until they are published, or similar information which is protected under law; and 9) Personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study. d. Requirements for sub‐awards: The Recipient agrees to include in any sub‐award made under this Agreement the requirements of this award term (Patent Rights and Data Rights) and the award term titled “Copyright” above. 1. Publications. All publications produced as a result of this funding which are submitted for publication in any magazine, journal, or trade paper shall carry the following: a. Acknowledgement. “This material is based upon work supported by the U.S. Department of Homeland Security under Grant Award Number, '2006‐ST‐091‐000003‐09." b. Disclaimer. “The views and conclusions contained in this document are those of the authors and should not be interpreted as necessarily representing the official policies, either expressed or implied, of the U.S. Department of Homeland Security.” Recipient agrees to include in any sub‐award made under this Agreement the requirements of this award term (Publications). 2. Enhancing Public Access to Publications. “DHS Policy explicitly recognizes and upholds the principles of copyright. Authors and journals can continue to assert copyright in DHS‐funded scientific publications, in accordance with current practice. The policy encourages authors to exercise their right to give DHS a copy of their final manuscript or software before publication. While individual copyright arrangements can take many forms, DHS encourages investigators to sign agreements that specifically allow the manuscript or software to be deposited with DHS for public posting or use after journal publication. Institutions and investigators may wish to develop particular contract terms in consultation with their own legal counsel, as appropriate. But, as an example, the kind of language that an author or institution might add to a copyright agreement includes the following:“Journal (or Software recipient) acknowledges that the Author retains the right to provide a final copy of the final manuscript or software application to DHS upon acceptance for Journal publication or thereafter, for public access purposes through DHS’s websites or for public archiving purposes.” N. REPORTING SUB-AWARDS AND EXECUTIVE COMPENSATION 1. Reporting of first‐tier sub‐awards. a. Applicability: Unless you are exempt as provided in paragraph 4. of this award term, you must report each action that obligates $25,000 or more in Federal funds that does not include Recovery funds (as defined in section 1512(a)(2) of the American Recovery and Reinvestment Act of 2009, Pub. L. 111–5) for a sub‐award to an entity (see definitions in paragraph 5. of this award term). b. Where and when to report: i. You must report each obligating action described in paragraph 1.a. of this award term to http://www.fsrs.gov. ii. For sub‐award information, report no later than the end of the month following the month in which the obligation was made. (For example, if the obligation was made on November 7, 2010, the obligation must be reported by no later than December 31, 2010.) c. What to report: You must report the information about each obligating action that the submission instructions posted at http://www.fsrs.gov specify. 2. Reporting Total Compensation of Recipient Executives. a. Applicability and what to report: You must report total compensation for each of your five most highly compensated executives for the preceding completed fiscal year, if— i. the total Federal funding authorized to date under this award is $25,000 or more; ii. in the preceding fiscal year, you received— 1) 80 percent or more of your annual gross revenues from Federal procurement contracts (and subcontracts) and Federal financial assistance subject to the Transparency Act, as defined at 2 CFR 170.320 (and sub‐awards); and 2) $25,000,000 or more in annual gross revenues from Federal procurement contracts (and subcontracts) and Federal financial assistance subject to the Transparency Act, as defined at 2 CFR 170.320 (and sub‐awards); and ‐ The public does not have access to information about the compensation of the executives through periodic reports filed under section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986. (To determine if the public has access to the compensation information, see the U.S. Security and Exchange Commission total compensation filings at http://www.sec.gov/answers/ execomp.htm.) b. Where and when to report: You must report executive total compensation described in paragraph 2.a. of this award term: i. As part of your registration profile at http://www.sam.gov. ii. By the end of the month following the month in which this award is made, and annually thereafter. 3. Reporting of Total Compensation of Subrecipient Executives. a. Applicability and what to report: Unless you are exempt as provided in paragraph 4. of this award term, for each first‐tier subrecipient under this award, you shall report the names and total compensation of each of the subrecipient’s five most highly compensated executives for the subrecipient’s preceding completed fiscal year, if— i. in the subrecipient’s preceding fiscal year, the subrecipient received— 1) 80 percent or more of its annual gross revenues from Federal procurement contracts (and subcontracts) and Federal financial assistance subject to the Transparency Act, as defined at 2 CFR 170.320 (and sub‐awards); and 2) $25,000,000 or more in annual gross revenues from Federal procurement contracts (and subcontracts), and Federal financial assistance subject to the Transparency Act (and sub‐ awards); and ‐ The public does not have access to information about the compensation of the executives through periodic reports filed under section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986. (To determine if the public has access to the compensation information, see the U.S. Security and Exchange Commission total compensation filings at http://www.sec.gov/answers/ execomp.htm.) b. Where and when to report. You must report subrecipient executive total compensation described in paragraph 3.a. of this award term: i. To the recipient. ii. By the end of the month following the month during which you make the sub‐award. For example, if a sub‐award is obligated on any date during the month of October of a given year (i.e., between October 1 and 31), you must report any required compensation information of the subrecipient by November 30 of that year. 4. Exemptions. If, in the previous tax year, you had gross income, from all sources, under $300,000, you are exempt from the requirements to report: a. Sub‐awards, and b. The total compensation of the five most highly compensated executives of any sub‐recipient. 5. Definitions. For purposes of this award term: a. Entity means all of the following, as defined in 2 CFR part 25: i. A Governmental organization, which is a State, local government, or Indian tribe; ii. A foreign public entity; iii. A domestic or foreign nonprofit organization; iv. A domestic or foreign for‐profit organization; v. A Federal agency, but only as a subrecipient under an award or sub‐award to a non‐Federal entity. b. Executive means officers, managing partners, or any other employees in management positions. c. Sub‐award: i. This term means a legal instrument to provide support for the performance of any portion of the substantive project or program for which you received this award and that you as the recipient award to an eligible sub‐recipient. ii. The term does not include your procurement of property and services needed to carry out the project or program (for further explanation, see Sec. ___ .210 of the attachment to OMB Circular A–133, ‘‘Audits of States, Local Governments, and Non‐Profit Organizations’’). iii. A sub‐award may be provided through any legal agreement, including an agreement that you or a subrecipient considers a contract. d. Sub‐recipient means an entity that: i. Receives a sub‐award from you (the recipient) under this award; and ii. Is accountable to you for the use of the Federal funds provided by the sub‐award. e. Total compensation means the cash and noncash dollar value earned by the executive during the recipient’s or subrecipient’s preceding fiscal year and includes the following (for more information see 17 CFR 229.402(c)(2)): i. Salary and bonus. ii. Awards of stock, stock options, and stock appreciation rights. Use the dollar amount recognized for financial statement reporting purposes with respect to the fiscal year in accordance with the Statement of Financial Accounting Standards No. 123 (Revised 2004) (FAS 123R), Shared Based Payments. iii. Earnings for services under non‐equity incentive plans. This does not include group life, health, hospitalization or medical reimbursement plans that do not discriminate in favor of executives, and are available generally to all salaried employees. iv. Change in pension value. This is the change in present value of defined benefit and actuarial pension plans. v. Above‐market earnings on deferred compensation which is not tax‐qualified. vi. Other compensation, if the aggregate value of all such other compensation (e.g. severance, termination payments, value of life insurance paid on behalf of the employee, perquisites or property) for the executive exceeds $10,000. O. SITE VISITS The DHS, through authorized representatives, has the right, at all reasonable times, to make site visits to review project accomplishments and management control systems and to provide such technical assistance as may be required. If any site visit is made by the DHS on the premises of the Recipient, or a contractor under this Award, the Recipient shall provide and shall require its contractors to provide all reasonable facilities and assistance for the safety and convenience of the Government representatives in the performance of their duties. All site visits and evaluations shall be performed in such a manner that will not unduly delay the work. P. TERMINATION Either the Recipient or the DHS may terminate this Award by giving written notice to the other party at least thirty (30) calendar days prior to the effective date of the termination. All notices are to be transmitted to the DHS Grants Officer via registered or certified mail, return receipt requested. The Recipient’s authority to incur new costs will be terminated upon arrival of the date of receipt of the letter or the date set forth in the notice. Any costs incurred up to the earlier of the date of the receipt of the notice or the date of termination set forth in the notice will be negotiated for final payment. Closeout of this Award will be commenced and processed pursuant to the applicable Uniform Administrative Requirements as outlined by OMB: http://www.whitehouse.gov/omb/circulars_default Q. TRAVEL Travel required in the performance of the duties approved in this Award must comply with the applicable OMB Cost Principles: http://www.whitehouse.gov/omb/circulars_default Foreign travel must be approved by DHS in advance and in writing . Requests for foreign travel idenƟfying the traveler, the purpose, the desƟnaƟon, and the esƟmated travel costs must be submiƩed to the DHS Grants Officer 60 days prior to the commencement of travel. R. GOVERNING PROVISIONS The following are incorporated into this Award by this reference: 31 CFR 205 Rules and Procedures for Funds Transfers OMB Circular A‐87, Cost Principles for State, Local, and Indian Tribal Governments relocated to 2 CFR part 225 OMB Circular A‐133 Audits of States, Local Governments, and Non‐Profit Organizations Application Grant Application and Assurances dated '3/31/2014, as revised '5/8/2014 S. ORDER OF PRECEDENCE 1. 44 CFR Part 13 "Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments" 2. OMB Circular A‐87, relocated to 2 CFR part 225 "Cost Principles for State, Local, and Indian Tribal Governments" 3. The terms and conditions of this Award 4. The Funding Opportunity, DHS‐2014‐OHA‐Biowatch, Homeland Security Biowatch Program_______ 5. Application and Assurances dated '3/31/2014, as revised '5/8/2014