A.14 (b) - SOW_75D301-22-Q-75342.docx

Statement of Work

Title: Purchase of nine (9) nonhuman primates (Pigtail Macaques, females) for DHP Laboratory Branch’s HIV Prevention Studies

SECTION 1 – BACKGROUND

The CDC Laboratory Branch supports the Division of HIV Prevention’s (DHP’s) goals in HIV prevention as they pertain to clinical studies, viral transmission, diagnosis and incidence, intervention research with microbicides, vaccines, and chemoprophylaxis as well as investigates other human and zoonotic retroviruses. The lab conducts and develops multiple preclinical HIV intervention studies using nonhuman primate (NHP) models for HIV detection, quantitation, isolation, evolution, and surveillance including drug resistance.

SECTION 2 – PURPOSE

To purchase 9 Female Pigtail macaques for pharmacokinetic and efficacy studies of antiretroviral prophylaxis by the Centers for Disease Control and Prevention (CDC), Deputy Director for Infectious Diseases (DDID), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of HIV Prevention, Laboratory Branch by December 31, 2023.

SECTION 3 – SCOPE OF WORK

Independently, and not as an agent of the Government, the contractor shall provide all necessary trained personnel, transport cages, equipment, and materials to provide and deliver safely and humanely 9 female pigtail macaques to the Centers for Disease Control and Prevention (CDC), DDID, NCHHSTP, DHP, Laboratory Branch.

The contractor’s facility must be licensed by the United States Department of Agriculture and accredited by the Association for Assessment and Accreditation of Laboratory Macaque Care, International (AAALAC).

The contractor’s facility must be in compliance with the Animal Welfare Act and Regulations (Title 9 Code of Federal Regulations part 1), The Guide for the Care and Use of Laboratory Animals, and other federal policies and guidance as applicable that provide national standards for the acquisition, transportation, housing, control, maintenance, handling, treatment, care, use and disposal of macaques.

The contractor transport company also must be United States Department of Agriculture (USDA) licensed as either a carrier or intermediate handler or, if a secondary subcontractor is used, a contract carrier. Per 2013 USDA regulations, contractor shall provide a copy of their transport ‘contingency plan’ for review by CDC Contracting Officer’s Representative (COR), CDC technical advisor and CDC veterinarians.

The contractor shall maintain its nonhuman primates in complex social and physical environments (other than during diagnostic testing or as clinically necessary for treatment) in order to provide behaviorally and medically healthy macaques.

The contractor shall provide detailed information on the veterinary care and a description of any procedures that have been performed on the macaques. The contractor shall send records of macaques to the COR and CDC veterinarian and maintain a copy for at least 3-years beyond the time of delivery/acquisition.

SECTION 4 – TASKS TO BE PERFORMED

Task 1.0 1 The contractor shall provide 9 Female Pigtail macaques, meeting the following specifications:

1. Pigtail macaques must be between the ages of 4 and 12 years. The contractor shall provide proof of the date of birth for each primate to the COR.

2. The contractor shall ensure that all pigtail macaques have tested negative for tuberculosis (TB), tested for the presence of a measles antibody titer, tested negative to simian retroviruses (SRV) by polymerase chain reaction (PCR), tested negative for antibodies to SRV, simian T-lymphotropic viruses (STLV), and simian immunodeficiency virus (SIV), been tested for the presence of internal and external parasites (include the testing modality used for internal parasitism and macaques shall have tested negative for Trichuris spp.), and tested negative by PCR for microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia).

3. The contractor shall ensure that the macaques shall not have participated in prior studies with, or been exposed to HIV, SIV, SHIV or other retrovirus studies prior to purchase by CDC.

4. All macaques must have a breeder’s statement and/or Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) export permits and declaration forms available. This must be provided to the COR and CDC veterinarian for each macaque.

5. All macaques must have been maintained in complex social and physical environments for behavioral and medical health.

6. All macaques shall have had no invasive surgical procedures except caesarian. Hysterectomized macaques are not acceptable.

7. All macaques shall have been confirmed NOT to be pregnant at time of selection or shipment.

Note: CDC reserves the right to request further information based on history of pathogens noted in macaque’s medical records and reserves the right to deny the selection of macaques based on the medical history and/or diagnostic testing.

The Contractor shall perform the tasks specified below:

Task 1.1 This task should be performed within 10 business days of the date of award. In order to provide 9 healthy Female Pigtail macaques, the contractor shall identify 15 or more potential macaques meeting the specifications listed above and provide medical histories/records (see below for criteria) to the CDC for review for selection of 9 potential candidates and several alternates.

Medical History/records criteria:

a. Country, place and date of origin

b. Macaque ID number (must match visible tattoo)

c. Date of birth and Sex

d. Most recent weights with dates obtained

e. Dates and result of all TB tests (all must be negative)

f. Dates, results, and external laboratory that performed testing for SIV, SRV, STLV, measles, internal and external parasites (including Trichuris spp.), and microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia) must be negative by PCR.

g. Dates and results of Macacine alphaherpesvirus 1 (B virus) antibody test

h. Copies of all clinical records for each macaque since birth including any noted behavioral evaluations

i. Pair or group housing history when available, and all available behavioral/socialization information

j. All macaques shall have a breeder’s statement and/or CITES export permits and declaration forms.

k. Pregnancy and surgery history

l. Dates and results of pregnancy test (must not be pregnant)

Task 1.2. CDC will select 9 potential macaques and several alternate macaques that meet the specifications listed above and will notify the contractor 2-4 weeks after receiving the complete medical records (from Task 1.1). Note: CDC reserves the right to request further information based on history of pathogens noted in macaque’s medical records and reserves the right to deny the selection of macaques based on the medical records/tests.

Task 2.0 Post potential selection Testing and Examination (potential 9 and several alternates)

Task 2.1. The contractor shall perform the following testing and exam (“a” and “b” below), gather results and records and send to CDC for further review and acceptability. If the COR or CDC veterinarian rejects a macaque for any reason after post selection testing and examination, the contractor shall identify substitute candidates meeting the requirements and provide all documentation for the substituted macaque. The contractor shall provide the actual paperwork of all results received from outside diagnostic laboratory testing to the COR.

a. Week 1, testing: start within 15 business days of the COR’s notification (described in Task 1.2)

i. First TB Test (Note: Three (3) tests required in all at two-week intervals, must be negative)

ii. Microbiology by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia)

b. Week 3, testing and exam:

i. Second TB Test, two weeks after the first

ii. Measles serology

iii. SRV PCR, SIV antibody, SRV antibody, STLV antibody, fecal and pelage examination for internal and external parasites to document that the macaques are negative for these pathogens

iv. Macacine alphaherpesvirus 1 (B virus) testing--provide documentation for status

v. Physical exam requirement-- The contractor’s veterinarian(s) shall perform physical exams (including collection of blood for Complete Blood Count (CBC) and blood chemistry and urine for urinalysis) and weight determination with body condition scoring on the macaques. Medical exam records shall be gathered and sent to CDC COR.

1. Note: contractor’s Pre-delivery exam is also required 2-3 days prior to delivery date. See task 3.1

Task 2.2 The contractor shall perform the third TB testing (two weeks after the 2nd), fecal examination for internal parasites, and microbiology by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia) and provide results to the COR or CDC veterinarians.

Task 2.3 Within 7 business days of receiving the third TB, fecal examination for internal parasites, and microbiology by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia) testing, provide records and results to the COR or CDC veterinarians. CDC will notify or further confirm to the contractor of post selected/acceptability of the macaques and provide confirmation of selected macaques.

Note: If the COR or CDC veterinarian rejects a macaque for any reason after the third TB and second microbiology tests and the number remaining is less than 9, the contractor shall identify additional substitute/alternate candidate NHPs meeting the requirements and provide all documentation and testing for the substitution/alternate macaque (as specified in this statement of work). This replacement effort to screen additional macaques to bring the total to 9 shall not incur added cost to CDC.

Task 3.0 Delivery instruction for 9 Pigtail macaques

After CDC’s notification (described in Task 2.3), the contractor shall coordinate with CDC, the delivery of the final 9 selected/approved macaques. Delivery date must be within four weeks of the initial CDC notification (task 2.3). The contractor’s transport company must be USDA licensed as either a carrier or intermediate handler or if a secondary subcontractor is used, a contract carrier. Per 2013 USDA regulations, contractor shall provide a copy of their transport ‘contingency plan’ for review by the COR and CDC veterinarians.

Task 3.1. Perform pre-delivery physical exams 2-3 days prior to delivery date to ensure safety and health of selected macaques. Prepare the exam records and send to CDC veterinarian before the delivery date of the macaques.

Task 3.2. The contractor shall deliver the 9 Pigtail macaques to the designated CDC Atlanta facility following the delivery requirement below:

a. Schedule an appointment for delivery not less than 7 days in advance of delivery by contacting the COR and CDC veterinarian.

b. Provide driver’s name and contact information at least 7 days prior to delivery, needed for security clearance at CDC. Driver(s) must be a US citizen(s).

c. Delivery shall be during CDC’s regular business hours: 9:00AM to 3:00PM, ideally Tuesday through Thursday, except on Federal holidays. Driver should notify the CDC COR or veterinarian when they are approximately 60 minutes from the facility. Special arrangements must be made prior to delivery if outside of regular business hours or if a delivery day might include a Monday or Friday.

d. Delivery Location: CDC, Roybal Campus, 1600 Clifton Road, NE, Building 23, Atlanta, GA 30329 (loading dock).

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

None

SECTION 6 – PERIOD OF PERFORMANCE

Tasks should be performed to ensure that macaques can be delivered physically to CDC during 12 months. Delivery should occur as early as logistically possible and preferred delivery would be before or by 12/31/2023.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

The contractor shall deliver humanely and safely 9 Female Pigtail macaques meeting all of the specifications listed above to CDC, Atlanta, GA. The contractor shall also deliver all testing and animal records as indicated above and below.

SECTION 8 – REFERENCE MATERIALS

None

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is: TBD

SECTION 10 – PAYMENT TERMS

Payment will be made in accordance with the terms established herein.

SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

The contractor should have the capacity, license, insurance to provide and transport safely and treat humanely nonhuman primates and cages. Also, the contractor shall have or provide transportation company drivers that are US citizens for CDC security approval to access CDC campus. To transport macaques, the contractor must be USDA licensed as either a carrier or intermediate handler or, if a secondary subcontractor is used, a contract carrier. Per 2013 USDA regulations, contractor shall provide a copy of their transport ‘contingency plan’ for review by CDC COR, technical advisor, and veterinarians.

The contractor shall have macaque facilities fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

The contractor shall maintain its primates in complex social and physical environments in order to provide behaviorally and medically healthy macaques other than during diagnostic testing or as clinically necessary for treatment.

The contractor shall have no history of providing macaques that had been exposed to TB or tested positive to TB, SIV, SRV, and/or STLV, Shigella, Campylobacter, Salmonella, Yersinia, and/or pregnant (if females) to the DHAP Laboratory Branch in the past 15 years.

Principal Investigators (PIs) and Veterinarians shall have a minimum of 4 years of experience working with Non-human Primates.

The contractor shall provide past performance history of selling Non-human Primates. The past performance history shall include no fewer than three (3) of the most recent contracts, preferably within the past five (5) years.

SECTION 12 – SPECIAL CONSIDERATION:

Electronic and Information Technology Accessibility

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-aboard.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.