Anthrax Vaccines, Diagnostics and Therapeutics Support Products
Added: Aug 21, 2014 1:11 pm
NOTICE OF INTENT TO SOLE SOURCE (FAR 5.207(c)(15) and (16))The Division of Bacterial Diseases of the Centers for Disease Control and Prevention (CDC) has a requirement for carbohydrate compounds needed to perform experiments optimizing an assay methodology being developed over the last few years.The CDC intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) for Simplified Acquisition Procedures (SAP), the University of Georgia (UoG), in order to satisfy this requirement. Reasons include:* The UoG's Complex Carbohydrate Research Center (CCRC) services in compositional analysis and custom synthesis of complex carbohydrates are specifically designed and organized to optimize cooperation and colloboration among disciplines and researchers.* The CCRC's unique combination of structual analytic expertise of raw materials provided by CDC combined with the investigation-driven ability for rational, sequential synthesis of key anthrax carbohydrate structures is unavailable elsewhere.* The CCRC is uniquely equipped to meet CDC's critical requirement of outstanding technical flexibility combined with highly specific scientific expertise in the biochemistry of bacterial cell wall and spore carbohydrates.* New synthetic chemistry strategy and methodologies needed are unique to the CCRC, have not been published, and are not available in the public domain at this time.* Aspects of the required synthetic structures and syntheses are patent pending by the CCRC (US Patent 60/933,937; "Anthrax Carbohydrates, Synthesis and Uses Thereof).All responsible sources may submit a capability statement or quotation which shall be considered by the agency if received by the Contract Specialist or Officer prior to the response date/time in this announcement. This is not a request for competitive quotations; rather, any information received will be used solely for the purpose of determining if a competitive acquisition should be undertaken. This determination will be at the sole discretion of the government.
2014-72300 Department of Health and Human Services Centers for Disease Control and Prevention Pittsburgh
8/21/14, 1:11 PM Immunological Testing of Sera Samples
Added: Oct 29, 2008 5:05 pm
BARDA is seeking responses from qualified small business sources only (e.g., small business, 8(a), Small Disadvantaged Business, Historically Underutilized Business Zone, Veteran-Owned, and Service Disabled Veteran Small Businesses). Responses from large businesses will not be reviewed under this sources sought notice.*** BACKGROUND *** The National Pandemic Influenza Plan (Nov. 1, 2005) designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response for pandemic preparedness. Following the issuance of this plan, the office of the Assistant Secretary for Preparedness and Response (ASPR) was charged with gathering information, developing policies and issuing recommendations on specific medical countermeasures may be used to contain, control, and mitigate the mortality and morbidity associated with an influenza pandemic in the U.S. The office of Biomedical Advanced Research and Development Authority (BARDA) is responsible for the tactical and logistical implementation of policies and decisions regarding these countermeasures, including the establishment of a stockpile of supplies to prevent or control the spread of pandemic influenza disease. This is a Sources Sought Notice seeking small businesses with the interest and capabilities to perform certain testing of vaccine components in the BARDA pandemic preparedness stockpile. It is not a request for proposals and does not commit the U.S. Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the U.S. Government and will not be returned.*** OBJECTIVE *** As part of its preparations, HHS/ASPR/BARDA has established a stockpile of avian influenza vaccine antigens to be administered in a pandemic or pre-pandemic situation for the prevention of avian influenza disease. In order to extend the number of effective doses that can be provided from the stockpile, BARDA is also working with manufacturers to develop antigen-sparing technologies such as components that can be added to the vaccine to enhance its immune response, known as adjuvants. In the event of a pandemic emergency, HHS would like to be able to extend the available stockpile of antigens by administering them with adjuvants depending on availability. In order to have this ability, BARDA, in conjunction with NIH, CDC, and the antigen and adjuvant manufacturers, is planning to conduct clinical testing of possible antigen:adjuvant combinations, the results of which would be submitted to U.S. regulatory agencies as support for an Emergency Use Authorization. Evaluation of these investigational formulations will be made by serological testing for immunogenicity by appropriate assays for influenza vaccines. BARDA seeks qualified, small business contract research organizations having the necessary capabilities and willingness to conduct this testing. This is a request for such organizations to make themselves known to BARDA and provide information concerning their capabilities to perform the testing. Please provide information concerning the following required capabilities.1. Conducting immunological testing of sera from human clinical trials2. Assessment of sera for the presence of antibodies reactive with influenza antigens by Inhibition of Hemagglutination (HAI) and Microneutralization (MN) assays, using reagents specific for the vaccine (homologous) or other (heterologous) influenza strains.3. Must possess the necessary facilities, capabilities, and expertise to conduct GLP human serology analysis in compliance with all applicable codes and regulations.4. Capacity for up to 10,000 samples for the duration of the testing5. Availability to start in January 09-June 09 timeframe6. Both HAI and MN assays must be fully qualified (recognized by FDA) for testing human clinical trial samples. Also, both HAI and MN assays must be qualified for at least one pandemic flu strain for testing human sera from clinical trialsData obtained from this sources sought notice will be used by HHS in making recommendations and decisions on the development of an appropriate procurement strategy for National Pandemic Preparedness.All information submitted to HHS will be kept confidential as allowed by relevant Federal law and will be eligible for additional special protections under the conditions of the Protected Critical Infrastructure Information (PCII) Program outlined in the Critical Infrastructure Information Act of 2002.Information must be submitted by 9:30 a.m. (EST) on November 10, 2008. Include the name, email address and telephone number of a primary contact point at your organization for this sources sought in the event that HHS has additional questions or requires clarification on the submitted information. Responses are limited to 2 pages.All questions and your responses to this sources sought notice must be submitted electronically in Adobe Acrobat (.pdf) or Microsoft Word format and emailed to kevin.nilles@hhs.gov. The type of business submitting the response (i.e., small business, hub-zone, small and disadvantaged business, etc.) must be identified in your response. If the service can be acquired on a GSA schedule, VA schedule, or other Government-wide acquisition vehicle, please supply the contract title and number, contract point of contact information and the name of the awarding agency.
SS-BARDA-09-Serology Department of Health and Human Services Immediate Office of the Secretary
10/29/08, 5:05 PM Expansion of Seattle Lymph Node Project
Added: Apr 29, 2016 2:34 pm
This notice is a Notice of Intent. The Government intends to negotiate on a sole source basis with the University of Washington for an expansion of Seattle Lymph Node Project. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and solicitation for commercial items," as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are not being requested and a written solicitation will not be issued. Submit offers on NIAID-NOI16-1790503. This acquisition is a Notice of Intent (NOI). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 05-87-1 date Mar 16, 2016. The North American Industry Classification System (NAICS) code for this procurement is 541711 with a small business size standard of 1000. This requirement is not set aside for small business.The National Institute of Allergy and Infectious Diseases (NIAID), is seeking to expansion of Seattle Lymph Node ProjectFOB Point shall be Destination: 40 Convent Drive, Bethesda, MD 20892Period of Performance: The period of performance shall be for one (1) YearThe following FAR provisions apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items (Oct 2015)FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (Nov 2015) Offerors must complete annual representations and certifications on-line at http://www.sam.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial ItemsThe following contract clauses apply to this acquisition:FAR 52.203-98, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements - Representation (DEVIATION 2015-02)FAR 52.203-99, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements - Representation (DEVIATION 2015-02)FAR 52.212-4 Contract Terms and Conditions Commercial Items (May 2015)FAR 52.212.5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (Mar 2016)FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)The applicable subparagraphs of FAR52.212-5 are included in the attachment to this posting.Quoter must include the following provision in their quote and check the appropriate response.52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Dec 2014)(a) Definitions. "Inverted domestic corporation" and "subsidiary" have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10).(b) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4.(c) Representation. By submission of its offer, the offeror represents that- (check one)____(1) It is not an inverted domestic corporation: and____(2) It is not a subsidiary of an inverted domestic corporationBy submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov).Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html or, upon request, either by telephone or fax.This is an open-market Notice of Intent for expansion of Seattle Lymph Node Project as defined herein as defined herein. The government intends to award a purchase order as a result of this Notice of Intent that will include the terms and conditions set forth herein. To facilitate the award process all quotes must include a statement regarding the terms and conditions herein as follows: "The Terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" (Quoter shall list exception(s) and rationale for the exception(s).)Submission shall be received not later than 05/05/2016 5PM (EST).Offers may be mailed, e-mailed, or faxed to Bradley C. Engel; (E-Mail/brad.engel@nih.gov). Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).All responsible sources may submit an offer that will be considered by this Agency. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Bradley C. Engel at brad.engel@nih.gov.
NIAID-NOI16-1790503 Department of Health and Human Services National Institutes of Health
4/29/16, 2:34 PM - Hip Simulator Study of Mal-Positioned Hard-On-Hard Hip Replacements to Aid Regulatory Science and Standards Development
Added: Jul 17, 2014 9:42 am
The U. S Food & Drug Administration, Office of Acquisitions and Grants Services is requesting quotes to conduct a "Hip Simulator Study of Mal-Positioned Hard-On-Hard Hip Replacements To Aid Regulatory Science And Standards Development".This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, (STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS) as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. This solicitation is issued as a Request For Quotations (RFQ), using the Simplified Acquisitions Procedures of FAR 13. The solicitation document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005 - 74.Please, see attachments and respond as requested.
FDA-2014-SOL-2-1134643 Department of Health and Human Services Food and Drug Administration
7/17/14, 9:42 AM