Wednesday, December 12, 2018

Cliff – See the SOW on the Pages 14-16 of the Signed PDF document (not the revised amount document). Thanks, Carole From: Meaney, Tammy (NIH/NIAID) [E] < @nih.gov> Sent: Wednesday, December 12, 2018 9:43 AM To: Hudgings, Carole (NIH/NIAID) [V] < @niaid.nih.gov> Subject: RE: DMID IAA Hi Carole, The amount that this agreement was executed was $2,454,590.49. I have attached the documents for your reference. Thanks- Tammy Meaney Administrative Officer NIH/NIAID/OAS/EAMB , MD Office @nih.gov Disclaimer: The information in this e-mail and any of its attachments is confidential and may contain sensitive information. It should not be used by anyone who is not the original intended recipient. If you have received this e mail in error please inform the sender and delete it from your mailbox or any other storage devices. National Institute of Allergy and Infectious Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its representatives. From: Hudgings, Carole (NIH/NIAID) [V] < @niaid.nih.gov> Sent: Wednesday, December 12, 2018 9:12 AM To: Meaney, Tammy (NIH/NIAID) [E] y@nih.gov> Cc: Hudgings, Carole (NIH/NIAID) [V] < @niaid.nih.gov> Subject: DMID IAA FYI DMID has provided the below background information about the agreement: The IAA was signed on August 15th 2018 and runs until August 14th 2019. The title is “The Influence of Aerodynamic Particle Size on the Virulence of Aerosolized Ebola Virus.” The purpose of this study is to further understand the disease caused by aerosolized Ebola virus in a relevant animal model. From the document: Scope of Work: NIAID is developing Medical Countermeasures (MCMs) to protect against Ebola virus disease. Therefore, NIAID needs to understand differences in disease when Ebola virus infection occurs by different routes and to ensure that MCMs under development are effective in these different scenarios. The purpose of this study is to further understand the disease caused by aerosolized Ebola virus in a relevant animal model. This study has been developed jointly by NIAID and the National Biological Threat Characterization Center (NBTCC) in coordination with DHS/S&T BTCP. NBTCC shall perform work on a non-interference basis with DHS/S&T priorities and the NBACC Annual Plan. Under this work plan, the NBTCC with guidance from the BTCP shall: (1) NBTCC shall conduct pre-execution activities to obtain all necessary approvals to conduct the Project (2) NBTCC shall provide NIAID and BTCP a draft study protocol for the in vitro study and a final study protocol following incorporation of NIAID and BTCP input. NBTCC shall first assess their inhalation exposure system with Ebola virus and optimize aerosol generation, sampling, and assay methodologies. The target median aerodynamic particle sizes will be 1-3 μm, to allow comparison to previously published studies with aerosolized filoviruses which utilized small particle aerosols to facilitate penetration to the deep lung, and 10-12 μm, to facilitate deposition in the oronasal region of the upper respiratory tract. (3) NBTCC shall provide NIAID [note from Sarah formatting error in the original] (4) and BTCP a draft study protocol for the small particle study and a final study protocol following incorporation of NIAID and BTCP input. Conduct studies to determine the influence of Ebola virus aerodynamic 1-3 μm particle sizes on the median lethal dose and disease presentation in a nonhuman primate (NHP) model of inhalational Ebola virus disease (EVD). They shall assess the median lethal dose of Ebola virus small particle aerosols in NHPs using a modified up-and-down methodology. NBTCC estimates that approximately 24 NHPs will be required for each experiment. UNITED STATES GOVERNMENT ��II fiSCDfService INTERAGENCY AGREEMENT (IAA) Agreement Between Federal Agencies General Terms & Conditions (GT&C) Section LEAD. TRANSFORM. DELIVER. IAANumber AAl1 ��8027 =� 001 vvvvv G=r=&=c�#�--- -=oc-, rd�e,�#� Amendment# I Mod# 9. Estimated Agreement Amount (The SeNicingAgency completes all information for the estimated agreement amount) (Optional for assisted Acquisitions) Provide a general explanation of the Overhead Fees and Charges Direct Cost $2,454,590.49 Overhead Fees & Charges Total Estimated Amount $2.454,590 49 10. STATUTORY AUTHORITY a. Requesting Agency's Authority (Check One) Franchise Fund Revolving Fund Working Capital Fund Economy Act (31 Other Auth ority □ □ □ □ U.S.C. 1535 / FAR 17.5) Fill in Statutory Authority Title and Citation for Franchise Fund, Revolving Fund, Working Capital Fund, or Other Author ity b. Servicing Agency's Authority (Check One) Franchise Fund Revolving Fund Working Capital Fund Economy Act (31 Other Author ity □ □ □ □ U.S.C. 1535 / FAR 17.5) Fill in Statutory Authority Title and Citation for Franchise Fund, Re volving Fund, Working Capijal Fund, or Other Authority 11. Requesting Agency's Scope (State and/or List Attachments that support Requesting Agency's Scope.) 12. Roles and Responsibilities for the Requesting Agency and the Servicing Agency (State and/or list attachments for the roles and responsibilities for the Requesting Agency and the Servicing Agency) FS Form 7600A (06-10) Department of the Treasury I Bureau of the Fiscal Service September 2016 - page 2 of 4 ,r, UNITED STATES GOVERNMENT INTERAGENCY * F·ISCaIserv1c. e BUREAU OF THE AGREEMENT(IAA) ' A g reem ent Between F ed era l �ge n cies _ . · �Q O r d er Reqmrements and F und mg 1nfi ormat1on (Ord er) S ect10n � LEAD. TRANSFORM. DELIVER. IMNumber AAl18027 001 00000 ServicingAgency'sAgreement ----GT=&�C�#---- 0rder # Amen dmenI#/ M0d # Tracking Number (Optional) 28. Order Line / Funding Information Line Number . Requesting Agency Funding Information S,ervicing Ag�ncyfJ,Jnding lnfor1111;1lion ·. • . ALC 75-08-0031 70.:oa-1s1a . ·- .••, c-:- >·. -· _, ... ..···.... ·· . Component SP ATA AID BPOA EPOA A MAIN SUB SP ATA AID BPOA EPOA A MAIN SUB I .·.·, ' . . ·.· ·.• TAS (required 075 2018 2018 0885 ODO ··_.·. ...... .. •• .. . . . .. · by 10/1/2014) • .· .· ... . :- "' . . ·.·. . . and/or current TAS format 075-18-0885 070 18/20 0803 • . •· .· BETC DISS COLL .· - ··: ' --- : :-- Object Class Code (Optional) 2538 -6}(:;�:--_-':_:/,'.·:-.,\;·i\ . _·',.:·.: \ ·,; :>:_-- . -'>'·_··>:::;·_:-.:. -- :;<·:_ "> . '· BPN 927645168 967'1'!:164913 • ·.•·. · < . ·.··•.· ·'.·._••·_•.· < '· • > . / ,-,· . .. -- -· BPN + 4 (Optional) _,:,;.".:-,-.;_ :':- :/· -· _'.·-_. '" " ._,-_·-; <, •.. ··•···i " .·.· .. · Additional Accounting 8470051 · > • .. ·. .. ·•··· Classification / Information 8470038 . . •·· . (Optional) \ . .·- ..: ,- . · ·.... ·. ... · Requesting Agency Funding Expiration Date Requesting Agency Funding Cancellation Date 09/30/2018 09/30/2023 MM-DD-YYYY MM-DD-YYYY Project Number & Title The Influence of Aerodynamic Particle Size on the Virulence of Aerosolized Ebola Virus Description of Products and/or Service, including the Bona Fide Need for this Order(State or attach a description of products/services, including the Bona Fide need for this Order.) See attached North American Industry Classification System (NCAIS) Number (Optional) Breakdown of Reimbursable Line Costs and/or Breakdown of Assisted Acquisition Line Cost: . ·",. . Unit of Measure Contract Cost . .. _, . . • Quantity Unit Price . Total ' Servicing Fees Total Obligated .. --- --:',-· ···..• •. - . $2,454590.49 $0,00 / ,-_. . - > $2,454,590.49 Cost .•··• . ·;.. . -· ·. i. ·-.- / ._ ___ __ - > .:·..< > _ .- Overhead Fees and Charges _. Advance for Line (-) ' $Cl.OD . _i.,- _,__ ,,;.'"-- -:; ,' /""'' ·-::-" Total Line Amount Obligated ,2,454,590..49 Net Total Cost ; . Advance Line Amount(-) Assisted Acquisition Servicing Fees Explanation .· Net Line Amount Due $2,454,590.49 Type of Service Requirements @ Severable Service 0 Non-Severable Service (J Not Applicable FS Form 7600B (04-12) Department of the Treasury/ Bureau of the Fiscal Service September 2016 page 2 of 5 National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) Office of Acquisitions, DEA http://www.niaid.nih.gov/ 6700B Rockledge Drive, Room 3214 Bethesda, MD 20892-7612 DETERMINATION AND FINDINGS AUTHORITY TO ENTER INTO AN INTERAGENCY AGREEMENT UNDER THE ECONOMY ACT FAR 17.502-2 and HHSAR 317.5 I HEREBY FIND THAT: The NIAID proposes to enter into an Interagency Agreement (IAA) with _____________________________ to support a project entitled DHS S&T Directorate ____________________________________________________________. Assessment of the Influence of Aerodynamic Particle Size on the Virulence of Aerosolized Ebo The proposed IAA Number is AAI18027-001-00000 ________________. The estimated cost of the proposed agreement is $ 2,508,000 _____________ for a period of ______ years ( 08/06/2018 through 06/06/2021 ). 2.8 Use of this IAA is in the best interest of the Government because: 1) The supplies or services cannot be obtained as conveniently or economically by contracting directly with a private source and; 2) A contract action is required by the servicing Agency in order to meet the needs of the NIAID and (please check at least one): The acquisition will appropriately be made under an existing contract of the servicing agency, entered into before placement of the order, to meet the requirements of the NIAID for the same or similar supplies or services, and/or; ✔The servicing agency has the capability or expertise to enter into a contract for such supplies or services which is not available within the NIAID, and/or; The servicing agency is specifically authorized by law or regulation to purchase such supplies or services on behalf of other agencies. 3) Servicing organization(s) contemplated (the assigned HHS contracting office shall be one of the servicing organizations contemplated); NIAID Office of Acquisitions, DHS Science and Technology Directorate/ Biological Threat Characterization Program (BTCP) Determination and Findings Authority to enter into an Interagency Agreement under the Economy Act 4) Organization(s) and alternative approach(es) contemplated, the anticipated benefits to the NIAID; the anticipated costs, including associated fees or other compensation; and the contract/order placement timeframe and; The alternative approach considered was issuing a task order under DMID's "Animal Models of Infectious Diseases" IDIQ contract. Using this IAA will be faster due to the lead time required for a new task order combined with limited availability of non-human primate space (NHP) at other Biosafety Level 4 (BSL4) laboratories. Unlike BSL4 labs accessible via the IDIQ, the DHS lab has current available capacity to perform studies. In addition, DHS has unique expertise in generation, analysis and delivery of aerosolized pathogens. 5) Tradeoffs (cost, schedule, performance) among the approaches considered and; The main factors in favor of this IAA are schedule and performance. DHS has the ability to begin these studies in FY18, faster than could be accessed through a task order. The equipment , systems and expertise to perform complex aerosol studies is already in place. 6) Conclusion that the contract to be awarded by the selected servicing organization is the most advantageous alternative to the Government, notwithstanding fees and the increased risk associated with assisted contracting; and: This is the most advantageous alternative to get studies initiated in FY18. For the studies to be performed with NHPs at DHS, this mechanism will be faster than a task order due to the lead time required for a new task order combined with limited availability of NHP space at other Biosafety Level 4 (BSL4) labs. DHS has available capacity to initiate studies in FY18 combined with required expertise in aerosol generation, analysis and delivery. 7) Steps taken to ensure that contract funding will comply with the bona fide needs rule and the Anti-Deficiency Act. There is a current bona fide need to assess the impact of aerosol particle size on Ebola virus disease in NHPs. Determination and Findings Authority to enter into an Interagency Agreement under the Economy Act I HEREBY DETERMINE THAT: On the basis of the above findings and in accordance with FAR Subpart 17.502-2 and HHSAR Subpart 317.5 use of an IAA to fulfill the NIAID’s requirement is in the best interest of the Government. Authority exists under The Economy Act of 1932, as amended, 31 U.S.C. 1535 and P.L. 92-218 for the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases to enter into an Interagency Agreement with __________________________________________. DHS S&T UserName: GEORGE Kennedy Title: Contracting Officer Date: Tuesday, 07 August 2018, 09:10 AM Eastern Daylight Time Meaning: I have reviewed and approve the contents of the _____________ document in question. _______________________ Date Contracting Officer AAI18027-001-00000 Interagency Agreement AAI18027-001-00000 Between the National Institute of Allergy and Infectious Disease (NIAID) And Department of Homeland Security Science and Technology Directorate (DHS/S&T) Biological Threat Characterization Program (BTCP) In Accordance with Memorandum of Agreement between NIAID and DHS S&T signed 5-21-2018 Work Plan Title: The Influence of Aerodynamic Particle Size on the Virulence of Aerosolized Ebola Virus NIAID Plan Point of Contact: William Dowling, PhD Tel: DHS/S&T BTCP Point of Contact: Lloyd Hough, PhD Tel: Incorporation: This agreement is in accordance with provisions of the Memorandum of Agreement (MOA) between NIAID and DHS/S&T and upon signature becomes a subordinate Annex to that MOA. The signatories to this Annex agree to the terms of that over-arching MOA as relevant to conducting the work specified in this Annex. Authority: The authorities for NIAID and DHS/S&T BTCP to enter into this agreement are: 1. The Economy Act, 31 U.S.C. § 1535, which provides that an agency may place an order with a major organizational unit within the same agency or another agency for goods or services if: A. amounts are available; B. the ordering Agency decides the order is in the best interest of the United States Government; C. the Agency to fill the order is able to provide or get by contract the ordered goods or services; and D. the Agency decides ordered goods or services cannot be provided by contract as conveniently or cheaply by a commercial enterprise (payments must be made on the basis of the actual cost of goods or services provided). 2. Sections 301, 405, and 446 of the Public Health Service Act (42 U.S.C. § 241, § 284, and § 285f). 3. Homeland Security Act of 2002, 6 U.S.C. §§ 182(13) and 188(c). Economy Act Findings: According to the “Determinations and Findings Pursuant to 48 CFR 17.503," NIAID represents that sufficient funding amounts are available, that this agreement is in the best interest of the United States Government, and that the services requested cannot be provided by contract as conveniently or cheaply by a commercial enterprise. NIAID represents that the servicing Agency has capabilities or expertise to enter into a contract for such supplies or services that is not available within the Requesting Agency. DHS/S&T BTCP warrants that it is able to provide the requested services. DHS/S&T BTCP also warrants that it has adequate statutory authority for the contractual action and will comply fully with the competition requirements of part 6 of the Federal Acquisition Regulations as well as all other legal or regulatory requirements applicable to the contract. pg. 1 AAI18027-001-00000 Scope of Work: NIAID is developing Medical Countermeasures (MCMs) to protect against Ebola virus disease. Therefore, NIAID needs to understand differences in disease when Ebola virus infection occurs by different routes and to ensure that MCMs under development are effective in these different scenarios. The purpose of this study is to further understand the disease caused by aerosolized Ebola virus in a relevant animal model. This study has been developed jointly by NIAID and the National Biological Threat Characterization Center (NBTCC) in coordination with DHS/S&T BTCP. NBTCC shall perform work on a non-interference basis with DHS/S&T priorities and the NBACC Annual Plan. Under this work plan, the NBTCC with guidance from the BTCP shall: (1) NBTCC shall conduct pre-execution activities to obtain all necessary approvals to conduct the project (2) NBTCC shall provide NIAID and BTCP a draft study protocol for the in vitro study and a final study protocol following incorporation of NIAID and BTCP input. NBTCC shall first assess their inhalation exposure system with Ebola virus and optimize aerosol generation, sampling, and assay methodologies. The target median aerodynamic particle sizes will be 1-3 μm, to allow comparison to previously published studies with aerosolized filoviruses which utilized small particle aerosols to facilitate penetration to the deep lung, and 10-12 μm, to facilitate deposition in the oronasal region of the upper respiratory tract. (3) NBTCC shall provide NIAID (4) and BTCP a draft study protocol for the small particle study and a final study protocol following incorporation of NIAID and BTCP input. Conduct studies to determine the influence of Ebola virus aerodynamic 1-3 μm particle sizes on the median lethal dose and disease presentation in a nonhuman primate (NHP) model of inhalational Ebola virus disease (EVD). They shall assess the median lethal dose of Ebola virus small particle aerosols in NHPs using a modified up-and-down methodology. NBTCC estimates that approximately 24 NHPs will be required for each experiment. (5) NBTCC shall provide NIAID and BTCP a draft study protocol for the large particle study and a final study protocol following incorporation of NIAID and BTCP input. Conduct studies to determine the influence of Ebola virus aerodynamic 10-12 μm particle sizes on the median lethal dose and disease presentation in a nonhuman primate (NHP) model of inhalational Ebola virus disease (EVD). They shall assess the median lethal dose of Ebola virus small particle aerosols in NHPs using a modified up-and-down methodology. NBTCC estimates that approximately 24 NHPs will be required for each experiment. (6) NBTCC shall provide NIAID and BTCP a draft study report, host a NIAID and BTCP audit and then provide a final report addressing and incorporating NIAID and BTCP comments and feedback Under this work plan, NIAID will: • Fund this work. NIAID personnel will provide feedback on draft study protocols for NBTCC to incorporate into final study protocols. NIAID personnel will also review the study report and perform an audit of the draft study report and raw data. pg. 2 AAI18027-001-00000 Safety and Biohazards: To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Servicing Agency shall comply with all Federal, State and local laws and regulations applicable to the work being performed under this contract. In addition, recommended guidelines for use in developing and implementing health and safety operating procedures and practices for both personnel and facilities may be located in the current version of Biosafety in Microbiological and Biomedical Laboratories (http://www.cdc.gov/biosafety/publications/bmbl5/). NBTCC shall maintain an accurate record of, and promptly report to NIAID within 5 business days all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; damage to property incidental to work performed under the contract; and all violations for which NBTCC has been cited by any Federal, State or local regulatory/enforcement agency. If NBTCC fails or refuses to comply with the Federal, State or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), NIAID may move to delay or terminate this IAA unless satisfactory corrective action (as approved by the Federal, State or local regulatory/enforcement agencies) has been taken and documented to NIAID. No part of the time lost due to any delay in work shall be subject to a claim for extension of time or costs or damages by NBTCC. Funding Information and Estimated Cost: NIAID will provide $2,508,000 appropriated funds to DHS/S&T. DHS/S&T should send an SF-1080 to the following address for payment: Division of Accounting Operations National Institutes of Health MD Billing in the form of an SF-1080 will be accomplished using the following accounting data: From To Agency NIAID/NIH DHS/S&T BTCP Appropriation 75-18-0885 ----------------------- Agency Location Code 75-08-0031 (ALC) Common Account Number 8-8470038 $1,618,000 8-8470051 $890,000 Amount $ 2,508,000 Agreement number AAI18027-001-00000 NIAID Annex Point of Contact: NIAID Administrative Contact: William Dowling Tammy Meaney Program Officer, NIAID/NIH Administrative Officer, NIAID/NIH , MD, , MD Tel: @nih.gov @nih.gov pg. 5 AAI18027-001-00000 DHS S&T Point of Contact: DHS S&T Administrative Contact: Lloyd Hough Lewis Brown Program Manager, Biological Threat Characterization NBACC Lab Operations Program Manager DHS S&T DHS S&T @hq.dhs.gov @hq.dhs.gov pg. 6