SOLICITATION NOTICE
R -- for Pharmacokinetic Evaluation of Drug candidates in Male Cynomolgus Monkeys Following Intravenous and Oral Administration
- Notice Date
- 7/1/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-16-110
- Archive Date
- 7/23/2016
- Point of Contact
- Amber Harris, Phone: 3014028778, Patricia Haun, Phone: 301-443-7786
- E-Mail Address
-
amber.harris@nih.gov, haunp@mail.nih.gov
(amber.harris@nih.gov, haunp@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIH-NICHD-16-110 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-78. The North American Industry Classification (NAICS) Code is 541380 and the business size standard is $15.0M. The National Institutes of Health (NIH), National Institute of Digestive, Diabetes & Kidney Diseases (NIDDK) has a requirement to procure testing services of non-human primates (Male Cynomolgus Monkeys). Within the NIDDK intramural program, both the exploration of basic science and the application of knowledge are pursued. The inventions that have come from the program range from research tools such as antibodies and animal models, to diagnostic, therapeutic and vaccine concepts. All but research tools require substantial investment of time and additional funds in order to be marketed. NIDDK has so far established a template of in vitro and limited in vivo tests. The laboratory of Ken Jacobson (LBC/MRS) has started with thorough in vitro testing and is progressing to in vivo testing. The first tests in animals start with bioavailability. The non-human primate tests are sought to approximate how the compounds might be expected to perform in humans. The NIDDK Laboratory of Bioorganic Chemistry, Molecular Recognition Section is advancing novel drug candidates through safety bioavailability and efficacy testing. This non-human primate study is needed for the continuation of these drug candidates evaluated in the following NIH publication: Chen Z, Janes K, Chen C, Doyle T, Bryant L, Tosh DK, Jacobson KA, Salvemini D. Controlling murine and rat chronic pain through A3 adenosine receptor activation. FASEB J. 2012 May; 26 (5):1855-65 "Clinical management of chronic neuropathic pain is limited by marginal effectiveness and unacceptable side effects of current drugs. We demonstrate A3 adenosine receptor (A3AR) agonism as a new target-based therapeutic strategy. The development of mechanoallodynia in a well-characterized mouse model of neuropathic pain following chronic constriction injury of the sciatic nerve was rapidly and dose-dependently reversed by the A3AR agonists. Our findings provide the scientific rationale and pharmacological basis for therapeutic development of A3AR agonists for chronic pain." The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to award a purchase order for Pharmacokinetic Evaluation of Drug candidates; "A", "B" and "C", in Male Cynomolgus Monkeys Following Intravenous and Oral Administration. The evaluation includes blood studies and observations indicative of nausea (emesis), decreased or increased appetite, digestive effects (loose stools, diarrhea) and any behavior changes occurring after dosing. The data will be transmitted via electronic format within 5 months of the end of the study. The study will involve 9 Male Cynomolgus Monkeys, testing is a week for each dosage route (IV/Oral), with a week of washout between each route. Testing and result transmittal will be complete within one year of the award. Offerors who are capable of providing at a minimum, fifty-one percent (51%) of the required/actual services of this solicitation must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors - Commercial Items; FAR Clause 52.212-2, Evaluation; FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.acquisition.gov/far/. Interested vendors capable of providing the required/actual equipment in this synopsis should submit a copy of their quotation to the below address or via email to amber.harris@nih.gov. Offers must also be accompanied by descriptive literature, delivery timeframe, warranties, and/or other information that demonstrates that the offer meets all of the foregoing requirements. Quotations will be due fifteen (15) calendar days from the publication date of this synopsis or by July 8, 2016 by 10:00am EST. via email or postal mail. The quotation must reference Solicitation number NIH-NICHD-16-110. Quotations sent by postal mail or other mailing services must be submitted to the following address: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710 Rockledge Drive, Room 1161B, Bethesda, MD 20817 Attention: Amber Harris, by the date and time mentioned above. Any questions must be sent via email to amber.harris@nih.gov and must include Solicitation number NIH-NICHD-16-110 in the subject line of email. Faxed copies/responses will not be accepted. PLEASE NOTE: In order to receive an award, contractor must be registered and have valid certification in the System for Award Management (SAM) http://www.sam.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-16-110/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04169792-W 20160703/160701234144-08c1f8720ac8fa89963664b885505e9c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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