SOLICITATION NOTICE
A -- Structured Product Labeling Initiative
- Notice Date
- 6/16/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- 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
- FDA-1054070-1
- Point of Contact
- Vida - Niles, Phone: 301-827-2476
- E-Mail Address
-
vida.niles@fda.hhs.gov
(vida.niles@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Solicitation # FDA-1054070-1 The Food and Drug Administration (FDA) is seeking Full and Open Competition for vendors that can provide quotes/proposals. Labor Hour Contract This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-32. Title: Structured Product Labeling Initiative This is a solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 611310, is to notify contractors that the government is seeking competition in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures and the resultant Labor Hour Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-26. 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. Project Title: Structured Product Labeling initiative Background: The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) has a requirement to develop and improve the implementation of the Structured Product Labeling (SPL) initiative for the new animal drug pre-approval environment. In addition, the contractor shall assist the FDA in adapting and integrating common veterinary industry medical nomenclature dictionaries into the current FDA databases. Expertise and training in assisting the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) in adapting an existing bioinformatics-derived series of nomenclatures of technical terms used by CVM in its daily business practices. In addition, guidance and training will be provided to CVM personnel in the adaptation of the CVM dictionaries, created in 2003, based on systems in place at that time to existing databases, and expertise in the incorporation into existing and proposed electronic initiatives. This includes adaptation into the dictionary for the Structured Product Labeling (SPL) initiative for the new animal drug pre-approval environment and current FDA databases. Statement of Work: The Contractor shall: TASKS: 1.Review and provide the background logic relative to the current CVM “dictionaries” as they relate to groupings (species), nomenclature fields, and individual naming nomenclatures for each unit identified in the “dictionaries”. Review current and recommend updates. An example of these “dictionaries” is as follows: SNOMED Fully Specified Name of Indication ObjectSCTID Abdominal pain (finding) 21522001 Abrasion AND/OR friction burn (disorder) 400181003 Abscess (disorder) 128477000 Abscess of liver (disorder) 27916005 Abscess of neck (disorder) 6284004 Absence of sensation (finding) 33653009 Acute arthritis (disorder) 11939005 Acute diarrhea (disorder) 409966000 Acute mastitis (disorder) 82789004 Acute metritis (disorder) 37649008 Adrenocorticotropic hormone (ACTH) deficiency (disorder) 237692001 Aggressive behavior (finding) 61372001 Airsacculitis (disorder) 111279005 Allergic disorder of skin (disorder) 422290000 Allergic state (disorder) 106190000 Anal sac impaction (disorder) 64911007 Anal sac infection (disorder) 9620000 Anaplasmosis (disorder) 13906002 Anatipestifer infection (disorder) 8980008 Ancylostomiasis (disorder) 63479002 Anemia (disorder) 271737000 Anesthesia of mucous membrane (finding) 95357004 Anesthesia of skin (finding) 271805006 Anterior uveitis (disorder) 410692006 Anthrax (disorder) 409498004 Anxiety disorder (disorder) 197480006 Arthritis (disorder) 3723001 Arthropathy (disorder) 399269003 Ascariasis (disorder) 2435008 Ascites (disorder) 389026000 Atopic dermatitis (disorder) 24079001 Atrophic rhinitis (disorder)28111002 Avian infectious coryza (disorder) 3250005 Avian infectious synovitis due to Mycoplasma synoviae (disorder) 41409004 Avian necrotic enteritis (disorder) 79647008 Avian paratyphoid infection (disorder) 5921006 Avian trichomoniasis (disorder) 13397009 Avian ulcerative enteritis (disorder) 21612000 Babesiosis (disorder) 21061004 Bacterial conjunctivitis (disorder) 128350005 Bacterial ear infection (disorder) 95882006 Bacterial enteritis (disorder) 75375008 Bacterial gastroenteritis (disorder) 274080003 Bacterial hemorrhagic septicemia (disorder) 196111003 Bacterial infection of eye (disorder) 128984004 Bacterial infection of skin (disorder) 128936008 2.Within the first month of contract award, provide A. three 8 hour hands on training/discussion sessions that will allow key CVM personnel to understand and interpret the “dictionaries” and update tables 3.Review CVM‘s post-approval drug labeling standards and provide drug labeling information (nomenclature standards for species, dosage form, indications, etc) in electronic format, to ONADE (e.g. SPL) with emphasis on adapting this standard to meet the needs of the pre-market veterinary regulatory environment. 4.Prepare a report outlining the compatibility of the two systems – Medical Dictionaries and Post Approval standards. 5.Provide recommendations on the best way to proceed – adapt post-approval system for pre-market use; create a “hybrid” which would include the post approval and “medical dictionaries” or create a new system based solely on the “medical dictionaries”. One system, both systems, or create a new system. 6.Within 2 months after receipt of recommendations, provide no more than three 8 hour hands on training/discussion sessions that shall allow key CVM personnel to understand the concepts and proposed or current systems enough to proceed with implementation. 7.Prepare a report outlining the viability of using the current post-approval drug labeling standards to fulfill ONADE’s pre market drug labeling information needs. The report shall also include opinions on whether the transformation would be cost effective if not, offering alternatives. If so, the report shall include a projected scope of changes required to adapt current standard. 8.If adapting to the Agency’s current standard, develop recommendations for modifications (suggested changes, additions, or other observations) to meet the pre-market veterinary regulatory need. If not cost effective, develop a strategy to incorporate “dictionaries” into a pre-market labeling standard independent of the current post-market approval drug labeling standard. 9.If not cost effective, the strategy shall lead to required re-negotiation of contract with a new alternative timeline and tasks. 10.If cost effective, update “medical dictionaries” to correspond with recommended approach. 11.Attend meeting to provide interpretation of “medical dictionaries” update and decide if the 1 year option needs to be exercised in order to fulfill the remaining tasks listed in this SOW. 12.Act as a technical advisor during the implementation phase which would consist of no more than 100 hours of either teleconference or face-to-face consultation with CVM staff to act as a technical advisor during the initial phase of implementation. Additionally, provide options for incorporating the dictionaries into the current CVM “Animal Drugs@ FDA”. In this capacity, the contractor shall participate in meetings to consider how the integration of “Animal Drugs@ FDA” can optimize on-line accessibility and utility. 13.Final report to include the updated or newly created tables, a document that summarizes the results of the contract, all documents created in the execution of the contract, and a face-to-face meeting, question and answer session to close out the contract. 14.Close out meeting will be a face – to – face and scheduled to last no more than 8 hours at either CVM Headquarters or the contractor’s facility. CONTRACTOR REQUIREMENTS: The contractor shall perform the required services as a prime contractor, not as an agent or subcontractor. QUALIFICATIONS: Veterinarian: Qualifications •A Doctor of Veterinary Medicine (DVM) or equivalent degree, i.e., Veterinary Medical Doctor (VMD), obtained at a school or college of veterinary medicine accredited by the American Veterinary Medical Association (AVMA) Council on Education and demonstrated expertise in the current clinical practice of veterinary medicine. This person shall have recognized expertise in the field of veterinary informatics and have worked experience in managing government award contracts, preferably dealing with medical informatics. This contract will require a veterinarian that has expertise in the field of medical informatics. This would assume that this person would not be an entry level veterinarian. Therefore the mid to higher salary range will be used in the calculations (See attachment 1). This contract will not require the Veterinarian to be a full time. This estimate will be based on 500 hours work. Federal Veterinary medial Science Series, 0701. This federal job series has the same requirements as the CVM Veterinary Terminologies Contract (Degree: Doctor of Veterinary Medicine (DVM) or equivalent degree, i.e., Veterinary Medical Doctor (VMD), obtained at a school or college of veterinary medicine accredited by the American Veterinary Medical Association Council on Education (AVMA). This federal job series begins at a GS-12 or GS-13 grade level with the preferred vendor scoring at a GS-13 with the added Ph.D. advanced degree (See Attachment 2). Medial Informatics Specialist: Qualifications: •Support personnel with specialized training in the field of veterinary medical informatics. It is required that the personnel have a Bachelor of Science or a Master of Science in the field of medial informatics. REPORTING REQUIREMENTS AND DELIVERABLE ITEMS: Within first 3 months of the contract: Requirements gathering: The contractor shall be required to analyze the current FDA/CVM owned dictionaries of the CVM Veterinary Informatics Project and produce updated dictionaries incorporating emerging CVM regulatory venues and terminology. The contractor shall assure through training and/or meetings that FDA/CVM understands the dictionaries (e.g. format and justification for use of terms), the updates, and the potential impact the changes may cause if implemented in current and proposed initiatives that use a veterinary/regulatory dictionary as a foundation. The contractor shall be required to attend meetings with CVM and applicable stakeholders. These meetings shall be to provide CVM management and project personnel with a project progress report, to discuss expectations, and new developments. Within the first 6 months of the contract: The contractor shall give input and advice on the most effective and cost effective approach to meet the pre-market veterinary regulatory needs. At the end of the 12 months The contractor shall provide a written final report that includes copies of all deliverables, within 30 days at the end of the base contract and within 30 days of the end of each yearly option. The final report(s) shall provide a summary of work results, recommendations and electronic copies of all work generated including modified/created veterinary medical nomenclature dictionaries. All work created in the fulfillment of this contract is to be maintained as confidential and is the sole property of FDA/CVM. PLACE OF PERFORMANCE: Work shall typically be performed at the contractor’s facility. Meetings, briefings, and training sessions shall be conducted at FDA offices, Food and Drug Administration / Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855 or remotely via teleconference as specified by FDA’s appointed representative (Project Officer) managing the contract. In some cases work sessions shall be planned for an offsite location or at the contractor facilities. TASK DELIVERABLES AND TIMEFRAMES: • All documentation/ artifacts delivered to the FDA shall be provided in a format specified and approved by the Common EDR Project Officer. The Contractor shall submit all preliminary, intermediate and final task order deliverables in electronic formats to the FDA. For automated formats, the following software packages shall be used: •Reports – Microsoft Word; •Spreadsheet – Microsoft Excel; •Project Management – Microsoft Project; •Presentations – Microsoft PowerPoint; and •Database Management System – Microsoft Access; • If not possible to include graphics and images (for example for figures and illustrations) in the same electronic file, FDA will accept text in one of the above formats and the graphics and images as separate files. Acceptable graphic and image files formats are •.jpg •.tif •.bmp • All deliverables as defined by this Statement of Work shall be provided to FDA in draft electronic form for FDA’s review and comment. Document Review and Approval: • The approved Program Management Plan shall incorporate the FDA review timeline (2 weeks) to review and comment on each contractor deliverable and the timeline for the contractor to update the deliverable. • Each draft deliverable and final document shall be posted to the Common EDR document repository. The contractor shall be provided access to the Common EDR document repository when the contractor staff is cleared after the task order award. Period of Performance The period of performance is a base year plus four option years. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Vida.Niles@fda.hhs.gov, no later than June 22, 4:00pm EST. QUOTATIONS DUE: All quotations are due via email to: Vida.Niles@fda.hhs.gov, no later than4:00pm, EST on July 1, 2009. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Vida.Niles@fda.hhs.gov, No phone calls will be accepted. Evaluation Factors Volume I The evaluation factors are listed in descending order of importance. Factor 1 Experience and Capability of Contractor 1. Describe expertise and experience in veterinary bioinformatic systems, herefter referred to as “dictionaries” as they relate to the pre-market product labeling initiative as currently required in the US Food & Drug Administration (FDA), Center for Veterinary Medicine (CVM)’s post-marketing Structured Product Labeling (SPL) environment. These veterinary dictionaries are based upon broadly accepted medical dictionary standards (e.g., Veterinary Dictionary for Drug Regulatory Activities (VEDDRA), Systematized Nomenclature of Medicine (SNOMED) and the Center of Drug Evaluation and Research’s (CDER) SPL). 2. Describe expertise and experience with medical nomenclature dictionaries, specifically the international Systematized Nomenclature of Medicine (SNOMED), Veterinary Dictionary for Drug Regulatory Activities (VEDDRA) and Logical Observation Identifiers Names and Codes (LOINC). Provide past experience in adapting established human medical dictionaries to veterinary medicine. The integration of veterinary medical content into current medical nomenclature dictionaries presents many unique challenges presented by the wide range of species and the physiology and pathology of these species. For example, FDA/CVM can grant conditional approval for a drug to be used in minor species, including zoo animals or classes of animals that include numerous different species, such as ornamental fish. Medical nomenclature pertaining to these minor species, previously, have not been included in these database dictionaries. Describe specific instances where existing medical nomenclature dictionaries (i.e., SNOMED or LOINC) were modified or a new dictionary was created to fulfill a need in the veterinary medical field. 3.Describe experience and capability specifically in providing expert advice on the following key provisions of the proposed revised 21 CFR 207 Rule and the Electronic Drug Registration and Listing Systems (e-DRLS) as related to: a. In the FDA environment or similar government experience, provide dictionaries and linkage of drug product identification with drug product labeling, FDA/other government agency approval, and manufacturer and marketer information, b. knowledge of required processes involved with converting human/animal drug labeling from a paper-based environment to an electronic environment utilizing pre-existing nomenclature. 4.Provides examples of teaching groups of professionals the basics of scientific nomenclature and dictionaries as they relate to medical or veterinary medicine 5.Demonstrates knowledge of FDA/CVM’s current use of veterinary terminologies and dictionaries as they relate to CVM’s business practices and established databases such as AnimalDrugs@FDA.gov / “the green book”. 6.Show competency in the medical bioinformatics field - examples include published works, work experience, teaching opportunities through formal classroom setting or professional conference speaking engagements, 7. Basic qualification requirement: Contractor shall have the following credentials: Doctor of Veterinary Medicine (DVM) or equivalent degree, i.e., Veterinary Medical Doctor (VMD), obtained at a school or college of veterinary medicine accredited by the American Veterinary Medical Association Council on Education (AVMA) with demonstrated expertise in the current clinical practice of veterinary medicine. Factor 2 Understanding the Scope of Work 1. Provide a comprehensive statement of the scope and purpose of the project to demonstrate complete understanding of the intent and requirements. State the overall objectives and the specific accomplishments you hope to achieve. Describe the rationale for your plan, and the relationship to comparable work in progress elsewhere. 2. Demonstrate recognition and ability to overcome potential difficulties in the performance of the project. Factor 3 Relevant Experience The contractor shall describe their past performance in fulfilling contracts. Identify other organizations with which you have acted as a contractor while participating in similar efforts. Include the degree of your involvement, the size and complexity of the organization and other information describing your experience. Volume II Past Performance Contractors shall submit a list of three (3) reference contracts. 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.Contract number 3.Contract type 4.Total contract value 5.Contract work 6.Contracting officer and telephone 7.Program manager and telephone 8.Administrative contracting officer, if different from #6, and telephone Volume Price: The offeror shall provide a price in accordance with the requirements of the technical specifications. The proposed price shall include base plus four option years. Evaluation Criteria for Award: Award will be made to the party whose quote offers the best value to the Government, technical, past performance and 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 2) Past Performance and 3) Price shall include base plus four option years. Technical and Past Performance is significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures.
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- Place of Performance
- Address: Work shall be performed at contractor's facility., United States
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