SOLICITATION NOTICE
B -- Hazard Feed Control Identification Control Guidance for Industry for the FDA
- Notice Date
- 4/3/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1101571
- Point of Contact
- Mary Rose A. Nicol, Phone: 3018277183, Mary Rose, Phone: (301) 827-7183
- E-Mail Address
-
MaryRose.Nicol@fda.hhs.gov, maryrose.nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov, maryrose.nicol@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- REQ 1101571 This is a combined synopsis/solicitation for commercial items prepared in accordance with Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in the notice. This announcement constitutes the only solicitation, proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the attached requirements under Simplified Acquisition Procedures. The solicitation number is 1101571. The solicitation is issued as a Request for Quote (RFQ). The Solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-56, March 2, 2012. The North American Industry Classification (NAICS) Code is 541690 - Other Scientific and Technical Consulting Services - SIC 8748 Agriculture Consulting Services. Prospective offerors are responsible for downloading any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Food and Drug Administration is soliciting quotes for Feed Hazard Identification Control Guidance for Industry. Statement of Work (SOW) Background The Food and Drug Administration (FDA) announced in August 2003 its intention to make its animal feed safety regulatory program more risk-based and comprehensive. The modernized Animal Feed Safety System (AFSS) will incorporate risk-based, preventive control measures for ensuring the safety of animal feed. The work of the AFSS Team is guided by an Overview Document (formerly a Framework Document), first drafted in 2005, that identifies the current processes, guidance, regulations and policy documents that address feed safety and the documents that should be developed to make the Agency's feed safety program comprehensive and risk-based. The Framework Document has been revised multiple times and will undergo additional revisions as needed. One of the on-going projects identified in the AFSS Overview Document is the development of preventive control rules for animal feed, which is mandated by the Food Safety Modernization Act of 2011. A critical component of the draft proposed rule is the need for feed facilities to develop feed safety plans, which are needed to ensure prevention of feed hazard episodes. These proposed regulations are presently in clearance at the DHHS and OMB. Critical to each step in the process are the identification of potential feed hazards and the implementation of steps to ensure that the hazards are controlled so they do not present an unacceptable risk to animal or human health. The FDA plans to release guidance on feed hazard identification and control to assist manufacturers and transporters of animal feed to comply with this requirement and thereby ensure the safety of their feed products. One challenge in drafting the proposed rule is defining terms in a way that takes into account the fact that the presence of certain feed hazards in animal feed or the existence of certain conditions of feed does not always pose a significant risk to animal or human health. Duties The Contractor shall provide expert services to the Center for Veterinary Medicine (CVM) for development of guidance for industry which explains how to identify feed hazards of concern and steps to control the presence of feed hazards in feed products so animal or human health is not compromised. Specifically, the Contractor will be responsible for the timely drafting of guidance documents and efficient revision of the documents based on comments from the AFSS Team. The Contractor should have extensive experience and knowledge regarding the presence of feed hazards in animal feed and the measures the feed industry has at its disposal for handling such hazards. The Contractor needs to understand the principles of risk and relative risk assessment. Also, the Contractor needs wide-ranging knowledge of the regulatory and stakeholder groups that could be impacted by the guidance. Furthermore, the Contractor must have a working knowledge of the feed industry as it currently exists and operates, as well as the goals, objectives and premises of the AFSS. The Contractor will need to be available to travel on occasion. Location The work will take place at the contractor's place of business and on occasion at CVM, 7519 Standish Place, Rockville, MD. Equipment Use No government funded nor extraordinary equipment is needed. Period of Performance One Base Year from time of Award - with 2 One (1) year Option Periods. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," and 2) Price. Technical Capability is significantly more important than price. In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS Code 541690. In addition, both the Cost Proposal and Technical Proposal shall not exceed 10 pages total. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on April 23, 2012 ALL QUESTIONS REGARDING THIS SYNOPSIS/SOLICIATION MUST BE SUBMITTED IN WRITING NO LATER THAN 4:30 PM (1630) EST ON APRIL 19, 2012. FAX QUOTES SHALL NOT BE ACCEPTED.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1101571/listing.html)
- Place of Performance
- Address: CVM, 7519 Standish Place, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN02712954-W 20120405/120403235920-137999ab4849d1ac6c47a433108bd823 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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