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FBO DAILY ISSUE OF JULY 04, 2010 FBO #3144
MODIFICATION

99 -- Guidance on Feed Hazard Identification and Control

Notice Date

7/2/2010
 

Notice Type

Modification/Amendment
 

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

FDA1072933
 

Archive Date

7/23/2010
 

Point of Contact

Mary Rose A. Nicol, Phone: 3018277183
 

E-Mail Address

MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Amendment 0001 - The response date is hereby changed to July 8, 2010 at 2:00 PM Eastern time. This is a combined synopsis /solicitation for commercial items prepared in accordance with FAR 13.5 and the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotations are being requested and a written solicitation will not be issued. Solicitation RFQ 1072033 is issued as a Request for Quotation (RFQ) using Simplified Acquisition Procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-32. This action is designated as Full and Open. The NAICS code is 541690. This is a firm fixed price contract. The period of performance is from effective date of award through 12 months plus one(1)year option period. It is the offeror's responsibility to monitor FedBizOpps website for the release of any amendments to this notice. The Government Reserves the right to award a contract without discussion if the Contracting Officer determines tht the initial offer(s) is/are providing the Best Value and discussions are not necessary. 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 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 three times and will undergo additional revisions as needed. One of the gaps identified in the AFSS Framework Document is the need for a more comprehensive animal feed safety program in the United States. To address that gap, the AFSS Team has written process control regulations that cover receipt, manufacture and distribution of all animal feed, including pet food and feed ingredients. These proposed regulations are presently in Agency clearance. Critical to each step in the process is 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 offered 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 explain how to identify feed Hazards of concern and steps to control the presence offered 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 offered 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. Technical Evaluation Criteria A. Experience and Capability of Contractor (60 points) Describe experience and capability to provide guidance services on feed hazard identification and control in animal feed manufacturing. 1. Describe ability to: • Identify common and occasional chemical and microbiological hazards in feed; • Develop written materials explaining control offered hazards at sites of feed manufacture, storage and distribution; • Translate regulatory requirements into materials useful to the feed industry in understanding what is required to be in compliance; and, • Communicate using written materials. 2. Describe expert knowledge of the animal feed industry and its regulation. The Contractor should have experience with: • Technical/Scientific factors relating to animal feed, especially in the areas of feed hazards, quality control, animal drugs, toxicology, and feed manufacturing; • Regulation of animal feeds, including the processes used by the FDA to ensure regulatory compliance; and, • Conducting research on animal feed hazards B. Technical Approach (10 points) Describe the technical approach to be used for providing FDA's Center for Veterinary Medicine (CVM) with guidance materials that explain how feed establishments can have adequate plans for identification and control offered hazards. C. Understanding the Scope of Work (20 points). Provide a comprehensive statement of the scope and purpose of the project to the intent and requirements. State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and the relationship to comparable work in progress or completed elsewhere. 1. Knowledge and understanding of the Scope of Work is demonstrated by the clarity, practicality, and appropriateness of the contractor's proposal and plan to accomplish the effort. 2. Demonstrate recognition and ability to overcome potential difficulties in the performance of the project. D. Past Performance (10 points) The contractor shall describe past performance, identifying other organizations with which he/she has participated in similar efforts including the degree of involvement, the size and complexity of the organization, and other information describing his/her experience. Contractors shall submit a list of three (3) references. Contracts listed may include those entered into by the Federal Government, agencies of State and local governments, and commercial customers. Contractors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. The reference list of the three (3) references shall include the following information for each contract and subcontract: 1. Name of contracting activity; 2. Contact number; 3. Contract type; 4. Total contract value; 5. Contract work; 6. Contracting officer and telephone number; 7. Program manager and telephone number; and 8. Administrative contracting officer, if different from number 6 above, and telephone number. Each contractor will be evaluated on his/her performance under existing and prior contracts for similar products or services. Performance information will be used as an evaluation factor against which contractor's relative rankings will be compared to assure best value to the government. The government will focus on information that demonstrates quality of performance relative to the size and complexity of the procurement under consideration. An award will be made to the offeror based on best value. Vendors must be registered in the Central Contractor Register (CCR) prior to award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. The anticipated award date is on or about July 15, 2010. The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial items, 52.217-8 Option to Extend Services (Nov 1999). All information received by 2:00pm EST on July 8, 2010 will be considered by the Government. All questions must be emailed no later than June 28, 2010 by 2:00 PM to maryrose.nicol@fda.hhs.gov. Your proposal may be submitted electronically to maryrose.nicol@fda.hhs.gov Please submit 2 separate documents for the technical proposal no longer than 15 pages and the cost proposal no longer than 2 pages.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1072933/listing.html)
 

Place of Performance

Address: Rockville, Maryland, 20832, United States

Zip Code: 20832
 

Record

SN02196270-W 20100704/100702235049-fdf9b56ee7e5307a191ca79fb48ea6fa (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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