Sources_Sought_07092013.doc

TITLE: Purchase 10 Male Indian Rhesus Macaques nonhuman primates (NHPs, Females) for DHAP Laboratory Branch’s HIV prevention Studies

OPDIV: CDC, NCHHSTP/DHAP

This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the range of nonclinical studies described below from initiation and conduct of the studies through the data analyses phase and preparation of the final reports.

The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract.

BACKGROUND

The Laboratory Branch supports DHAP’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 animal models (NHPs) for HIV detection, quantitation, isolation, evolution, and surveillance including drug resistance.

PURPOSE

To purchase 10 Male Rhesus macaques, Indian origin, for antiretroviral safety and efficacy studies to the Centers for Disease Control and Prevention (CDC), OID, NCHHSTP, Division of HIV/AIDS Prevention, Laboratory Branch.

SCOPE

Independently, and not as an agent of the Government, the contractor shall provide all necessary trained personnel, transport cages, equipment, and materials (other than that provided by Government) to provide and deliver safely and humanely 10 Male Rhesus macaques, Indian origin, for antiretroviral safety and efficacy studies to the Centers for Disease Control and Prevention (CDC), OID, NCHHSTP, Division of HIV/AIDS Prevention, Laboratory Branch.

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

The contracting 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 animals. International suppliers shall also be in compliance with their national policies.

The contractor transport company also must be USDA licensed as either a carrier or intermediate handler or in the event that 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).

The Contractor shall maintain its primates in complex social and physical environments in order to provide behaviorally and medically healthy animals.

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

CONTRACTOR REQUIREMENTS

Contractors must respond to all of the following points by describing your experience and capabilities in the areas listed below:

Required Specifications:

The Contractor shall perform the tasks specified below:

Task 1. Ensure that the Indian Rhesus macaques provided meet the following requirements listed below:

10 Male rhesus macaques (Indian origin) The macaques are between the ages of 4 and 10 years, the contractor shall provide the date of birth.

The macaques shall test negative for tuberculosis (3 consecutive TB skin tests performed at 2 week interval), test negative to simian retroviruses (SRV) by PCR, test negative to antibodies of SRV, simian T-lymphotropic viruses (STLV), and simian immunodeficiency virus (SIV), test negative for internal parasites, and test negative for microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia).

No macaques participated in vaccine-related studies prior to purchase by CDC, and no macaques have been exposed to SIV or SHIV in research studies.

· Have a breeder’s statement and/or CITES export permits and declaration forms available.

Task 2. Testing and Examination

Task 2.1. Within 3 days of award, perform 1st TB test. Two more testing should be done at 2 week interval (week 2 and week 4). All prior testing results should also be available and gathered.

Task 2.2. Within 3 days of award, also collect blood for serum separation. Send 2ml of serum in Sarstedt 2 ml micro tube with an O-ring in the lid (ref #72.694.006), using 4°C ice packs via FedEx overnight delivery to CDC COR for additional testing. In addition, two weeks from the first blood collection, collect blood and send refrigerated 2ml of serum as above.

Task 2.3. Two weeks from date of award (around the time of 2nd TB testing), perform the following tasks.

Task 2.3.1 Perform SIV, SRV antibody, SRV PCR, STLV, internal parasites, and microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia) testing to document that the macaques are negative for these pathogens. All prior testing results should also be available and gathered.

Task 2.3.2 Perform Herpes B testing and provided documentation for status. Previous testing results should also be available and gathered.

Task 2.3.3 Contractor’s veterinarian shall perform a physical exam including blood work (CBC, Chemistry, etc) for each macaque including weight determination. Medical exam records should be gathered. (Note: Pre-delivery exam is required 2-3 days prior to delivery date. See task 3.1)

Task 2.4 Three weeks from date of award, the Contractor shall provide all test results (historical and the results described in Task 2.1, 1st and 2nd TB test results and Task 2.3), research history, and medical records from birth to present to the CDC COR for review and approval. If CDC’s COR or veterinarian rejects an animal based on its health history and/or results of additional testing, the contractor shall substitute the animal and provide all documentation for the substituted animal (as specified in this statement of work). Results and Records should include the following:

Country, place and date of origin

Animal ID number

Date of birth and Sex (and not pregnant)

Most recent weights with dates obtained

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

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

Dates and results of Herpes B

Copies of all clinical records for each animal since birth including any noted behavioral evaluations

· All animals should have a breeder’s statement and/or CITES export permits and declaration forms.

Task 2.5 Four weeks from the date of award, Contractor shall provide results of 3rd TB test to CDC.

Task 2.6 Within 7 days of receiving the records and results, CDC will notify contractor of selected/approved animals (IDs).

Task 2.7. Within 3 days of CDC’s notification, the contractor shall coordinate with CDC delivery of approved animals. Delivery date must be within two weeks of the initial CDC notification.

Task 3. Delivery instruction for 10 Rhesus macaques Task 3.1. Perform pre-delivery exam 2-3 days prior to delivery date to ensure safety and health of selected animals. Prepare the exam records and send to CDC COR by the delivery date of animals.

Task 3.2 The Contractor shall safely and humanly deliver to CDC. In order to transport approved animals, the contractor transport company must be USDA licensed as either a carrier or intermediate handler or in the event that 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.

Task 3.3. The Contractor shall coordinate with the CDC COR and provide professional transportation services to deliver the 10 Rhesus macaques to the designated CDC Atlanta facility following the delivery instruction below:

Task 3.3.1. The Contractor shall schedule an appointment for delivery not less than 3 days in advance of delivery by calling the CDC COR.

Task 3.3.2. The Contractor shall provide drivers information, who must be a US citizen, needed for security clearance at CDC, at least three days prior to delivery.

Task 3.3.3. Delivery shall be completed during CDC’s regular business hours: 9:00AM to 3:00PM, Monday through Thursday, except on Federal holidays. (Special arrangements must be made prior to delivery if outside of regular business hours.)

Task 3.3.4. Delivery Location: CDC, Roybal Campus, 1600 Clifton Road, NE, Building 23, Atlanta, GA 30333 (loading dock).

Special consideration: The contractor shall ensure that macaques are negative to TB, SIV, SRV, STLV antigens and SRV PCR, internal parasites, and microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia). In the event of discovering existing conditions/illness, death or finding positive results to TB, SIV, SRV and STLV of any macaques within 60 days after delivery/acceptance, replacements that meet the requirements in this SOW shall be made promptly (within 15 days of notification or upon completion of required testing) at no additional cost to the government or the contractor shall reimburse the government for the cost associated with procurement of the animal.

PERIOD OF PERFORMANCE

The contractor shall start the process of testing, gathering history, records and results to ship and deliver the NHPs as soon as possible after the date of award, not to exceed 8 weeks.

DELIVERABLES

The contractor shall deliver humanely and safely 10 Male Indian Rhesus Macaques (non-pregnant) to CDC, Atlanta GA. The contractor shall also deliver all testing and animal records as indicated above and below.

And prepare records of pre-delivery exams.

MINIMUM CONTRACTOR QUALIFICATIONS

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. In order to transport animals, the contractor must be USDA licensed as either a carrier or intermediate handler or in the event that 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.

The Contractor shall have animal 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 animals.

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 and/or pregnant (if females) to the DHAP Laboratory Branch in the past 10 years.

Staff/PIs/Technicians/Veterinarians shall have a minimum of 4 years of experience working with Non-human Primates.

Capability statements must demonstrate the minimum requirements outlined above. Please address each in the order listed above.

Please provide the follow Business information:

1. DUNS Number

2. Company Name

3. Company Address.

4. Company Point of Contact, phone number and email address

5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp.

6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.);

7. Current GSA Schedules appropriate to this Sources Sought

8. Current Government Wide Agency Contracts (GWACs)

9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses.

10.

Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit.

Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be limited to 5 pages.

Responses must be received not later than Tuesday, July 16, 2013 at 12:00 p.m. (Eastern Standard Time). Capability statements will not be returned and will not be accepted after the due date.

Documentation should be emailed to: David Dombeck at vwj8@cdc.gov

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