Sources Sought Notice (Morgan Island Recompete).pdf

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Breed and Maintain Free-Ranging Macaca Mulatta (Rhesus) Monkeys
Solicitation number
75N93022R00032
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This sources sought notice seeks information from small businesses interested in operating and maintaining a free-ranging breeding colony of approximately 3000 rhesus monkeys located on Morgan Island, near Beaufort, South Carolina. Respondents must provide capability statements not exceeding 15 pages by August 12, 2022 demonstrating experience with non-human primate care and island operations, and describing staffing, regulatory compliance, and quality assurance plans. The incumbent contractor is Charles River Laboratories, and the contract is assigned NAICS code 541990 with a size standard of $15 million. The anticipated base period of performance is March 27, 2023 through March 26, 2024 with four one-year option periods. The notice includes a draft statement of work outlining requirements for colony maintenance, animal welfare, facilities, record keeping, and reporting.

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SOURCES SOUGHT NOTICE

BREED AND MAINTAIN FREE-RANGING MACACA MULATTA (RHESUS) MONKEYS

Solicitation # 75N93022R00032

Sources Sought Reference Number:_75N93022R00032__________

Type of Requirement

New Requirement

Follow-on (Contract No.: HHSN272201800009C)

Other (specify):________________

Place of Performance

Place of performance is unknown at this time

Place of performance is known. Address or general location:

Recompetition (if applicable)

Charles River Laboratories Inc.

251 Ballardvale Street

Wilmington, MA 01887-1096

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National

Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821

Sources Sought Notice Information

Introduction

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541990 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $15.0 million.

Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

A determination by the Government not to compete this requirement as a set-aside based upon responses to this Notice is solely within the discretion of the Government.

Interested parties are expected to review this Notice and the draft Statement of Work to familiarize themselves with the requirements of this project; failure to do so will be at your firm's own risk.

Background

Morgan Island is a free ranging rhesus colony which has been in place for over 30 years. The colony consists of approximately 3000 Indian Origin rhesus monkeys and has been a closed colony with no additional animals being added for over 25 years. The colony is used to provide animals for the critical research within NIAID at the NIH and with its collaborators.

The contractor must work closely with the government to oversee and manage the colony.

This team approach is essential to preserving this critical resource as well as maintaining due diligence in being good stewards of the island, the surrounding wetlands, and waterways. The intentions of the government are to maintain this colony in its existing location near Beaufort, SC for the foreseeable future. The island colony does require specific logistical challenges and personnel commitments on behalf of the contractor.

Purpose and Objectives

The objectives of this contract are the operation and daily care of a year-round outdoor breeding colony of free-ranging Indian-origin Macaca mulatta (rhesus) monkeys. The actual colony size is expected to be approximately 2800- 3000 animals at the initiation of this contract. The contractor shall be responsible for accepting the colony at the designated site with existing facilities and arranging for the lease of Morgan Island from the South Carolina

Department of Natural Resources. The colony is currently located on Morgan Island, near

Beaufort, South Carolina. Morgan Island will be utilized solely for Government owned animals provided hereunder or progeny from facilities and resources related to this contract on Morgan

Island. Morgan Island nor the dock sites will be utilized to support any other animals that may be located at the Contractor's facilities, these are standalone facilities and shall not be used to support other activities.

The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small business concerns that are interested in and capable of performing the work described herein.

On behalf of NIAID, the NIH does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted.

As a result of this SBSS Notice, the NIAID may issue a Request for Proposal (RFP). THERE

IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Small

Business Sources Sought Notice or the NIAID’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

Anticipated period of performance

Base Period: March 27, 2023 through March 26, 2024

Option Period 1: March 27, 2024 through March 26, 2025

Option Period 2: March 27, 2025 through March 26, 2026

Option Period 3: March 27, 2027 through March 26, 2028

Option Period 4: March 27, 2028 through March 26, 2029

Other important considerations

See the draft Statement of Work, subject to change, in Section 2: Introduction, Section 3:

Specific Requirements, Section 4: Record Keeping and Section 5: Reporting Requirements for more information.

Capability statement / information sought

Respondents must provide, as part of their responses, a capability statement, to include (a) staff expertise, including their availability, experience, and formal and/or other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; (e) examples of prior completed Government contracts, references, and other related information.

Information Submission Instructions:

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 15 pages, single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the firm’s ability to perform the aspects of the notice described above and in the draft SOW. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concern's name, point of contact, address and DUNS number. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. All proprietary information should be marked as such.

Required Business Information:

• DUNS.

• Company Name.

• Company Address.

• Company Point of Contact, Phone and Email address

• Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought.

• Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

• Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/SAM/pages/public/index.jsf. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address).

Number of Copies:

Please submit one (1) electronic copy of your response as follows:

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Matt Lear, Contract Specialist, at matt.lear@nih.gov and Uju Obii-Obioha, Contract Specialist, at uju.obii-obioha@nih.gov in

Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-

NIAID-SS-AMOB-20012 Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than Wednesday, August 12, 2022, at 2:00PM Time Eastern. All responses must be received by the specified due date and time in order to be considered. No calls or facsimile transmissions will be accepted. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL

NOT BE CONSIDERED.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published at beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Contracting Office Address:

5601 Fishers Lane

Rockville, MD 20852

Primary Point of Contact:

Matt Lear

Contract Specialist

Email: matt.lear@nih.gov https://www.sam.gov/SAM/pages/public/index.jsf mailto:matt.lear@nih.gov mailto:uju.obii-obioha@nih.gov mailto:alexis.hudak@nih.gov

Phone: 240-669-5109

Second Point of Contact:

Uju Obii-Obioha

Contract Specialist

Email: uju.obii-obioha@nih.gov

Phone: 301-761-6540 mailto:alexis.hudak@nih.gov

Statement of Work

Breed and Maintain Free-Ranging Macaca Mulatta (Rhesus) Monkeys

Independently and not as an agent of the Government, the contractor shall provide the necessary personnel, materials, services, facilities, and otherwise perform all actions necessary for and/or incidental to the performance of the work as described below.

I. Background

Morgan Island is a free ranging rhesus colony which has been in place for over 30 years. The colony consists of approximately 3000 Indian Origin rhesus monkeys and has been a closed colony with no additional animals being added for over 25 years. The colony is used to provide animals for the critical research within NIAID at the NIH and with its collaborators. The contractor must work closely with the government to oversee and manage the colony. This team approach is essential to preserving this critical resource as well as maintaining due diligence in being good stewards of the island, the surrounding wetlands, and waterways. The intentions of the government are to maintain this colony in its existing location near Beaufort, SC for the foreseeable future. The island colony does require specific logistical challenges and personnel commitments on behalf of the contractor.

II. Introduction

The objectives of this contract are the operation and daily care of a year-round outdoor breeding colony of free-ranging Indian-origin Macaca mulatta (rhesus) monkeys. The actual colony size is expected to be approximately 2800- 3000 animals at the initiation of this contract. The contractor shall be responsible for accepting the colony at the designated site with existing facilities and arranging for the lease of Morgan Island from the South Carolina Department of Natural Resources. The colony is currently located on Morgan Island, near Beaufort, South Carolina. Morgan Island will be utilized solely for Government owned animals provided hereunder or progeny from facilities and resources related to this contract on Morgan Island.

Morgan Island nor the dock sites will be utilized to support any other animals that may be located at the Contractor's facilities, these are standalone facilities and shall not be used to support other activities.

III. Specific Requirements

A. Colony Maintenance

The contractor shall provide for the year-round daily maintenance of a non-human primate breeding colony. Optimum reproduction will be considered as equal to or greater than 70 percent live births per year from the female animals at risk to pregnancy. (Note:

It is anticipated that the number of animals provided by the Government should produce a minimum of 500 animals per year for the Government's use). Breeding shall be a natural selection process conducted outdoors in a free ranging environment. As the juvenile monkeys become available, and when required by the Government, the monkeys shall be cropped, quarantined, immunized as instructed by the Contracting Officer’s Representative (COR) and transported to a designated holding facility as instructed by the COR. The holding facility could be NIH owned and operated, contracted, or leased animal facilities located in Poolesville, Maryland; Bethesda, Maryland; Frederick, Maryland; or other facilities conducting or collaborating with NIAID research. All non-human primates housed under this contract are currently on site at MI or would be provided by the Government. At the conclusion of the contract performance, the disposition of the animals shall be the responsibility of the Government.

B. Animal Welfare and Regulatory compliance

The contractor shall:

1. Provide qualified experienced veterinary services for clinical care of nonhuman primates in a free ranging colony, as well as veterinary examination of animals during cropping and processing. All unexpected deaths must receive a necropsy to determine the cause of death.

2. Maintain a tuberculosis free colony of monkeys. Each shipment of animals shall be held separately while under quarantine before being transported from the island. The duration of holding prior to shipment will be determined after consultation with the COR, the project manager, and after a veterinary assessment. During that time, animals will be tuberculin tested at least once and receive an initial dose of anthelmintic. Access to the animals shall be limited to the necessary clinicians and caretakers.

3. Provide the necessary care in handling any colony threatening circumstances.

The contractor shall inform and consult with the Government immediately, providing initial assessment and how they propose to handle the situation. This shall be in addition to providing maximum veterinary expertise, colony management expertise, and obtaining outside consultants as deemed necessary to minimize the impact to the colony. All treatment plans administered to the animals must be by standards acceptable with good veterinary practice.

4. Ensure that the Animal Study Proposal(s) (ASP) for routine veterinary procedures performed on NIAID-owned animals are approved and current by the Morgan Island (MI) Institutional Animal Care and Use Committee MI (IACUC) before any procedures are conducted. The Principal Investigator prepare and submitted all ASP to be reviewed and considered for approval by the MI IACUC. All IACUC ASPs will be provided to the contractor for review and comment prior to being reviewed by the MI IACUC. The contractor is expected to recommend up to three (3) members to the Institutional Official to be considered to serve on the MI IACUC. These positions would be an outside community member, Principal Investigator, and the Attending Veterinarian. There must be a minimum of two NIAID/Government members on the MI IACUC. No research Animal Study Proposals are conducted on Morgan Island.

5. Obtain, prior to the start of any work under this contract, an approved Animal Welfare Assurance from the Office of Laboratory Animal Welfare (OLAW), Office of the Director, NIH, as required by Section I-43-30 of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The contractor shall maintain such assurance for the duration of this contract.

6. As noted in III.B.3. above, contact the COR as soon as possible in an emergency and/or disaster situation so it can be determined if NIH disaster recovery assistance procedures should be initiated in conjunction with the contractor, to minimize the impact to the government to the greatest extent possible.

7. The Contractor shall ensure the program maintains accreditation by the internationally recognized animal program accrediting body, AAALAC International. The contract shall maintain the program in “inspection ready” condition at all times.

C. Animal Status and Shipments

1. All animals will remain the property of the Government.

2. Prior to one (1) year of age, each animal shall be individually marked by tattoo or other means as approved by the COR. If animals of (1) year of age are not able to be captured for identification purposes, this shall be reported to the COR.

Census shall be monitored on a ongoing bases (daily except weekends) and the population shall be documented so that basic demographic data is obtained and can be presented to the COR upon request

3. Transportation shall be in compliance with all applicable Animal Welfare Act requirements, the Guide for the Care and Use of Laboratory Animals, USDA regulations and CDC guidelines as required.

4. Shipments shall be conducted with a USDA approved transporter and all arrangements including the destination will be coordinated with the COR a minimum of two weeks prior to departure.

5. Animals shall be delivered in properly ventilated, escape proof, disposable cages furnished by the contractor, and approved by the COR, the government may decide to provide at their discretion. Each compartmentalized cage shall have separate water and feed containers for each compartment. Cages shall be in accordance with the USDA and International Air Transport Association (IATA) guidelines.

6. All costs of shipping approximately 100-150 monkeys from the island to the holding facilities, either contract or NIH, four times per year shall be included in the contract, the government may decide to provide this service with sub-contractors at the government’s discretion.

7. Serological testing of animals will be completed as part of this contract during the yearly processings. All animals shall be tested for B-Virus, STLV, SRV, SIV and Measles prior to being transported from the island. The diagnostic laboratory to be used must be approved by the COR in advance of the scheduled processing.

8. The Government shall determine when animal shipments will be required, they will instruct the contractor of the number of animals, time frames and where the animals will be shipped. The COR will work closely with the contractor’s project manager to establish timing, methods of transport, make the necessary arrangements with contract carriers as needed, and communicate all necessary information prior to shipment and assist the PM Program Manager to ensure they are carried out properly.

D. Personnel Requirements

1. Provide and maintain the expertise and experience in personnel for the year-round maintenance of an outdoor rhesus (monkeys) breeding colony on a remote island operation. Based on the uniqueness and critical nature of the project, as well as the relatively small number of full-time staff, all fulltime staff and all veterinary staff will be considered Key staff. Key staff specified in this contract are key personnel considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the approval of the COR.

2. As part of the proposal, submit a detailed management staffing plan that describes the depth of knowledge and cross training across all positions. Due to the uniqueness and remoteness of the island operation, as well as an enormous number of critical and potentially life-threatening situations and decisions that arise from the remote operation, the contractor must ensure that all staff are cross-trained. As part of the proposal include a detailed staffing, retention, training, cross-training, recruitment, and succession plan for all staff.

3. Provide qualified and experienced personnel 7 days per week, 365 days per year to provide animal care and program oversight. In addition, provide increased staffing as needed for the basis of census taking, capturing, performing health assessments, and culling of NHPs as required by the Government. For the most part, this is referred to as “processing” and is normally conducted 4 times per year. Management personnel shall have experience in the care and monitoring of a breeding colony of non-human primates, the management of a large free-ranging non-human primate colony and the necessary skill sets to manage the operation of an island-based operation.

4. ACUC: The government maintains the AAALAC accreditation and maintains an

OLAW assurance for Morgan Island. However, the contractor shall support the preparation for IACUC meetings and provide off-site meeting facilities as needed.

It is expected that individuals of the contract staff (project director, manager and attending veterinarian) will participate and perhaps be active member of the IACUC. It is also expected for the contractor to provide recommendations to the Institutional Official for a local outside community member for the MI IACUC.

The Government requires a complete program review by the contract management personnel, they shall meet at least two times per year on site with Government representatives to review the animal program as a committee.

Additionally, the Government requires that key contract personnel conduct continuous and ongoing program review and to meet periodically throughout the year, during processing or whenever possible, to ensure overall quality assurance and review of progress of the program. These meetings may not include government representatives, however outcomes from these meetings will be discussed with the COR as soon as possible and based on the nature of the finding it may be necessary to discuss at the ACUC committee meetings with Government representatives.

5. The contractor shall provide a Public relations and Media monitoring program.

This program shall consist of the means and methods that will be used to monitor local public relations and media topics surrounding the MI operations.

E. Facilities and Equipment

1. Obtain land lease from SC DNR for Morgan Island for the duration of the contract award. Secure lease for a mainland dock site, including administrative space and equipment storge facilities. The location of the mainland dock site must be approved by the government and shall not extended the travel time of staff to the island.

2. The contractor must have adequate and appropriate resources for containing and housing the animals in a free-range environment. Provide facilities upkeep of all existing structure located on the island. The contractor must also plan for the projected life expectancy of all significant and critical equipment. As part of the proposal, the contractor shall provide and maintain a facility maintenance /replacement schedule for critical equipment, structures and other items that require routine maintenance and or replacement.

3. Provide clinical laboratory and diagnostic pathology support facilities and services.

4. Provide accessibility to animals for authorized Government officials during business hours and with reasonable advance notice to the contractor during off hours. The contractor should be prepared for unannounced visits from authorized Government officials as well and be prepared to provide accessibility with very little notice.

5. Provide facility oversight including security measures. The facility security plan should address staff awareness and understanding of the sensitive nature of work, staff schedules, and training. The contractor shall be prepared to initiate legal action against individuals that trespass or that have been found to have trespassed on the island or harass the animals. The contractor must maintain agreements and/or understandings with local law enforcement officials to provide for the security of the colony. The Government encourages prosecution of any individuals or groups to the greatest extent of the law to ensure the health and welfare of the colony.

6. There is a No Visitor policy for MI, only personal (tradesman, SC DNR and

AAALAC site visitors) with official business, with prior approval by the COR, are permitted on the island. Personnel are only allowed on MI after meeting the specified health requirements. The contractor shall maintain a registry of all these authorized personal to the colony. The registry shall contain, at a minimum, the visitor's name and title, dates of visit, and purpose of visit.

F. Operational Compliance

The contractor shall adhere to the following and the facility in which the animals are housed shall be operated in compliance with:

1. The Animal Welfare Act (P.L. 89-544, as amended) Rules and Regulations published in the Code of Federal Regulations (CFR), Title 9 (Animals and Animal Products), Chapter 1, Subchapter A (Animal Welfare), Parts 1, 2, and 3.

2. Public Health Service (PHS) Policy on Humane Care and Use of Laboratory

Animals, updated 2015.

3. The Guide for the Care and Use of Laboratory Animals, revised 2011

4. NIH Manual 3040-3 Intramural Contracts Involving Animals.

5. Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH 2009).

6. Occupational Health and Safety in the Care and use of Research Animals (NRC 1997).

7. Recommendations for prevention of and therapy for exposure to B virus

(Cercopithecine herpesvirus 1).Cohen JI, Davenport DS, Stewart JA, Deitchman S, Hilliard JK, Chapman LE; B Virus Working Group. Clin Infect Dis. 2002 Nov 15;35(10):1191-203. Epub 2002 Oct 17.

8. Conduct all animal care and related activities in a manner which ensure the continued full accreditation by AAALAC international.

9. Follow CDC and/or NIH DOHS and / or COR instructed COVID Safety Plans or Guidelines. Would also be required to follow safety recommendations and guidelines, presented by the COR, to mitigate and colony threating circumstance, such as pandemics and or manmade or natural disasters, etc.

10. Follow all American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals: 2020 Edition

11. Follow all applicable APV and ACLAM guidelines pertaining to the care and maintenance of NHPs .

IV. Record Keeping

1. All animals shall be individually marked with identification by (Tattoo) number, or by http://www.ncbi.nlm.nih.gov/pubmed/12410479 http://www.ncbi.nlm.nih.gov/pubmed/12410479 other means approved by the COR. A quarterly census shall be documented by the contractor and the population shall be monitored so that basic demographic data is obtained and updated on a continuous basis throughout the period of performance.

2. The contractor, in collaboration with the COR, shall maintain an existing database, currently utilizing a Microsoft Excel spreadsheet, to store, analyze and display data on all animals of the colony, regardless of status, during the period of performance.

Minimal data shall include the following for each animal:

• Identification (Tattoo) number, or other means as requested by the COR

• Year of birth

• Gender

• Offspring, by gender, year of birth and identification

• Status, e.g., alive or dead, (date and cause of death)

• Health Status

• Location, e.g., free ranging, corralled, clinic, quarantine, placement

• Disposition (when applicable)

Additional colony census data must also reflect, at minimum:

• Number of live male adults (14 years and older)

• Number of live male adults (4 years to 14 years)

• Number of live male adolescents (between 2 and 4 years of age)

• Number of live males (1-2 years of age)

• Total number of live male infants less than 1 year

• Number of live female adults (14 years and older)

• Number of live female adults (4 years to 14 years)

• Number of live female adolescents (between 2 and 4 years of age)

• Number of live females (1-2 years of age)

• Total number of live female infants less than 1 year

• Number of pregnant females

• Number of dead animals by gender

• Number of still-births by gender

• Number of newborn by gender (6 months of age or less)

Data contained in the database shall be updated at a minimum of monthly, or more frequently if deemed necessary, following the consolidation of census data collected from the field.

3. The contractor will establish and maintain a written Morgan Island health certification policy and maintain the records on all individual having contact with the animals and/or island. Due to the high risk and susceptibility of the primates in the breeding colony to transmissible disease, the certification policy will require, as a minimum, written proof of the following health requirements prior to visiting the island:

a. Negative tuberculin test and / or chest x-ray within six months of exposure to colony (staff must be retested every six months). NIAID contracting and technical staff must maintain a current NIH occupation medical services (OMS) clearance on file to work with NHP with the contractor on site.

b. Proof of recent measles vaccination (vaccination must have been administered three months before time of proposed exposure to colony for first time vaccinations and 2 weeks for booster immunizations) or protective titer (documentation of a protective titer needs to be within 10 years of colony visit).

c. Valid tetanus inoculation (for pre-exposure protection against monkey bites or injuries).

d. No exposure to the following illnesses three weeks prior to contact with the colony SARS Cov2, Influenzas, Chicken Pox, Measles, Mumps, Rubella, Yellow Fever, other Arbovirus infection or any other infectious diseases.

e. All Personnel exposed to colony must be in visually overt good health with no signs or declarations of respiratory disease, gastrointestinal dysfunction, elevated temperature, or cold sores.

f. All Personnel must have proof of a current SARS CoV-2 vaccine and boosters. Approved Personnel must show proof of a negative SARS CoV-2 test prior to visiting the island. Testing shall be done on site (mainland dock site) the day of visit or as instructed by the COR based on current community infections rates and current best practices determined by the NIH to protect the MI NHP colony.

g. Face Mask will be worn by all personnel while on the island as instructed by the COR. The mask type and activity requirement will be based on current community infections rates and current best practices determined by the NIH to protect the MI NHP colony.

V. Reporting Requirements

The following reports are necessary for the successful performance of this contract.

ALL reports shall be presented by the contractor virtually to the COR in a scheduled and detailed manner. As requested by the COR, the contractor shall provide any of the reports in electronic format in the content and timeframes specified:

1. Technical Progress Report

The contractor shall present each 90-day period (quarterly) (except at each year-end where an annual summary report will be required in lieu of), a technical report describing progress of the program to date, noting all technical areas in which effort is being directed and indicating the status or work within these areas. These reports will include:

1. A description of overall progress.

2. An indication of any current problems which may impede performance and proposed corrective action.

3. An outline of the work to be performed during the next reporting period.

4. Copy of the latest census data and discussion of:

(a) Presence of any infectious disease

(b) Conception rate

(c) Abortions and still births

(d) Congenital defects

(e) Number and dates of healthy newborns

(f) Addition of new mature males and females, (as provided by the

Government) or natural maturation)

(g) Total adolescents (male and female)

(h) Number of deaths and cause of death of each animal

(i) Disposition of all animals leaving the colony

A. Annual Summary Report, Annual report shall be based on calendar year, not contract year.

The contractor shall present an Annual Summary Report documenting and summarizing each consecutive 12-month period of contract performance, including any subsequent extension(s) thereof. The Annual Summary Report shall be presented not later than thirty (30) days after completion of the corresponding 12-month period of performance (provided that options are exercised) and shall include tables, graphs, diagrams, curves, sketches, photographs, and drawings as necessary, and in sufficient detail, to explain the results achieved during this period.

The Annual Summary shall contain all the data required on the fourth quarter rather than prepare a separate fourth quarter progress report.

B. Annual USDA report, Annual report, provided by the 15th of October.

The contractor shall present and provide in electronic format if requested, to the COR, an Annual Summary Report documenting and summarizing the previous consecutive 12-month period from October 1st to September 30th. The Annual USDA Summary Report shall be presented no later than October 15th of each year and shall include tables and narratives as necessary, and in sufficient detail, to explain quantitative adjustments to the census. The report shall capture all animal deaths, births, deletions, animals not observed and any other adjustment to reflect a detailed and correct census of the island population throughout the reporting period.

C. Final Report

The contractor shall present a summary report of the entire contract period of performance. It shall contain complete, up-to-date census information for the entire 5 years, and shall be submitted on, or prior to, the expiration date of the contract. The final report shall include tables, graphs, diagrams, curves, sketches, photographs, and drawings as necessary and in sufficient detail to comprehensively explain the results achieved under this contract with up-to-date animal inventory.

D. Miscellaneous Reports

In addition to the aforementioned reports, the contractor may periodically be requested by the COR to present or provide data relative to contract performance and shall be prepared to discuss orally any phase of contract performance or progress.

E. Specifics expected within the contractor’s proposals.

1. Colony maintenance and management plan

2. Program and facilities improvement plan

3. Regulatory compliance plan

4. Occupational health plan

5. Disaster and COOP plan, including security plan

6. PR and Media monitoring plan

7. Reporting and medical records maintenance plan

8. Staffing plan, including development, cross training, and succession planning

9. Facilities and equipment maintenance, repair, and replacement plan/schedules

10. Transition plan, including dock and island leasing plan

File details come from the government source that posted it. Updated .