MODIFICATION
A -- Evaluation of Contraceptive Methods in Maceque Animal Models
- Notice Date
- 5/30/2012
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2012-N-14349
- Archive Date
- 6/29/2012
- Point of Contact
- Sharon R Cunningham, Phone: 770-488-2871, Julio E Lopez, Phone: 770-488-2892
- E-Mail Address
-
cux0@cdc.gov, ftg4@cdc.gov
(cux0@cdc.gov, ftg4@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS NOT A SOLICITATION. THIS IS NOT A REQUEST FOR PROPOSAL (RFP), INVITATION FOR BID (IFB), REQUEST FOR QUOTES (RFQ), REQUEST FOR APPLICATION (RFA) OR AN ANNOUNCEMNT OF A SOLICITATION AND DOES NOT ASSUME THE GOVERNMENT WILL AWARD A CONTRACT OR PROCEED WITH ANY OF THE ABOVE SOLICITATIONS IN THE NEAR FUTURE. THIS NOTICE IS ONLY FOR MARKET RESEARCH PURPOSES. The NAICS Code for this procurment is 541712, and the small business size stadard is 500 employees. All Small Business Concerns are encouraged to respond to this notice. 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 ability to provide to conduct a study on 20 female pigtail macaques to document the relative increases in susceptibility to vaginal SHIV infection and transmission risk in a repeat challenge pig-tailed macaque model of HIV-infection, comparing selected contraceptive methods. History: The Division of HIV/AIDS Prevention (DHAP), Laboratory Branch is developing and evaluating biomedical interventions to reduce the transmission of HIV. HIV infection is a public health epidemic that affects over 40,000 each year in the United States. Many of the infections come from sexual transmission of HIV. There are many factors that increase risk of infection and it is important to model their contribution to high risk in an animal model. A recent study documented that hormonal contraceptive use in African women not only enhances HIV susceptibility but also increases transmission risk to male partners. The study raised concerns regarding the safety of widely used hormonal contraception with regards to HIV transmission. There is an urgent need to identify contraceptive methods that minimize the risk of HIV infection or transmission, but still meet the need for safe, effective family planning choices for women throughout the world, and in the United States. The DHAP Laboratory Branch is planning to evaluate SHIV acquisition risk in female pigtail macaques during use of different contraceptive methods. This study will provide important pre-clinical assessments of how the products might perform in human clinical trials. Using the data collected from these pre-clinical studies and with FDA approval, the CDC may elect to conduct phase I/II human clinical trials on the modalities found most effective in reducing the SHIV transmission in macaques. This acquisition is considered new work and does not have an incumbent. Description of work: Independently and not as an agent of the Government, the Contractor shall furnish all necessary personnel, facilities, supplies, equipment and materials (other than that provided by the Government)) to conduct a study on 20 female pigtailed macaques to evaluate of increased susceptibility to vaginal SHIV infection and transmission risk in a pig-tailed macaque model of HIV-infection, comparing CDC selected contraceptive methods. Vaginal virus exposures will occur at doses and schedules specified by CDC COTR. The Contractor shall select 20 female pigtail macaques to conduct this study in accordance with the Animal Welfare Regulation, the Human Health Services (HHS) policies on Humane Care and Use of Laboratory Animals, and other applicable federal regulations. The Contractor shall assign an identification number to each macaque, record vital statistics, and perform physical exams/ tests to ensure the macaques selected for the study have tested negative to retrovirus/TB and pregnancy tests. Macaques whose testing for retrovirus, TB or pregnancy is positive cannot be used in the study. Also, if any macaques die prior to virus challenge period/begin, replacement with healthy macaque(s) should be made promptly at no additional cost to the government and the replaced macaque(s) should continue the course of the study. Minimum Qualifications: • Knowledge of and demonstrated experience with laws, regulations, and guidelines pertaining to housing, maintaining, and conducting research involving pigtail and rhesus macaques (both naïve & virus-infected). • Familiar with IACUC and earned AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) accreditation, demonstrating their commitment to responsible animal care and use. • Staff/PIs/Technicians/Veterinarians should have a minimum of 4 years of experience working with Non-human Primates, SIV and SHIV and expertise in exposing virus and applying topical gels vaginally and/or rectally to NHPs. • Contractor facilities shall be located within the 48 contiguous states and D.C. • The contractor shall comply with the security requirement within the Statement of Work Interested organizations should submit their capability statements via email by 2:00 P.M., EST on June 14, 2012, to the Contracting Office at the following e-mail address scunningham1@cdc.gov. Any questions must be submitted to the Contracting Office in writing to the email address listed. Capability statements will not be accepted after the due date. Page Limit is 25 pages. No facsimile transmissions will be accepted. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED IN THE STATEMENT OF WORK. Teaming Arrangements: All teaming arrangements shall include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE NOR OTHERWISE PAY FOR PREPARING ANY INFORMATION SENT OR THE GOVERNMENTS USE OF THE INFORMATION. Any proprietary information should be so marked. No solicitation is available at this time.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2012-N-14349/listing.html)
- Place of Performance
- Address: Contractor's facility, United States
- Record
- SN02760803-W 20120601/120530235136-01d73497f47afaf6fc5737a27b72545b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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