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FBO DAILY ISSUE OF JULY 17, 2009 FBO #2790
SOLICITATION NOTICE

R -- Consultant Services to collect and analyze documents

Notice Date
7/15/2009
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
561990 — All Other Support 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
FDA-09-1056814
 
Point of Contact
Karen R. Petty, Phone: 301-827-8774
 
E-Mail Address
karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
 
Small Business Set-Aside
Total Small Business
 
Description
This is a combined synopsis/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 561990, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-32. This synopsis is designated for 100% small business set aside competition for a firm-fixed price purchase order. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will 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. This combined synopsis solicitation is issued as a Request for Quotations (RFQ). Description of the Item: Consultant Services to collect and analyze documents. Objective: To collect and analyze legislative, regulatory and internal CDRH documents that support two guidance documents, the creation of which will follow the CDRH Manual for the GGP Regulations such that finalized draft documents are readied for public comment, including a Notice of Availability for each guidance. Scope of Work A.Independently and not as an agent of the Government, the consultant shall furnish the required personnel, material, services and facilities needed to accomplish the work described below: B.Identify legislative, regulatory and internal CDRH documents and content within the documents, and use this information to draft two guidance documents as follows: C.Guidance for Component and Replacement Laser Products: Specifically, draft guidance on components will clarify for manufacturers what is a component and replacement laser product, and when a component product needs or doesn’t need separate certification or a product report. The guidance will state criteria that manufacturers apply to consider a host product as a distributor of a component or subsystem. The guidance will provide sufficient detail for manufacturers to understand 1) when they manufacturer uncertified components, certified products, or both certified and uncertified products; 2) when the products may be actually the same product differing only in its certification status; and 3) when a manufacturer who makes a component product in both uncertified (component) and certified forms, the manufacturer must complete both a product report and a registration report. Specific questions that should be addressed by the draft guidance on component and replacement laser products, including the following sample questions: 1. As a manufacturer of a laser product for use as a component (or replacement) part in an electronic product, what are my reporting responsibilities? 2. As a manufacturer of a replacement part that I sell to a supplier or directly to consumers, what are my reporting responsibilities? 3. I'm a supplier of a component that I bought from a component manufacturer. What are my reporting responsibilities? 4. What if I make a change to the component and sell it to consumers? 5. What if I change it and sell it as a component? 6. I have a laser product that is a host to laser components, and the manufacturer has an accession number for those components. Am I responsible for reporting to CDRH as a component manufacturer? 7. I plan to sell my laser product to consumers. When I report my product as the manufacturer; can I just refer to the component manufacturer's accession number? 8. What criteria should I apply to determine that my laser product is or is not a component before my customer manufactures something that integrates my laser product? 9. Is it my responsibility to certify my product because the manufacturer who integrates my product into theirs has no knowledge of the design, laser performance, classification, labeling or quality control and testing of my laser or laser products in general? 10. Does the promotion of a laser registered as a component violate regulations if the promotion misidentifies a laser as something other than a component? D.Guidance for Special Purpose Lasers – SLA and Demonstration Lasers: Specifically, draft guidance on SLA and Demonstration lasers will clarify for manufacturers under what criteria would manufacturers and CDRH identify specific purpose laser products as defined by 1040.11(b) surveying, leveling and alignment laser products and 1040.11(c) demonstration laser products. Since each limits accessible emissions to an upper limit of Class IIIa, under what conditions would a variance (or equivalent) be required. The draft guidance should account for the FDA’s mandate to interpret the regulations in ways that are consistent with its overall public health mission. 1. Can previously defined "scientific" or “general purpose” branded lasers avoid the special purpose SLA or demonstration designation simply by promoting the laser for such purposes? 2. What would CDRH consider to be characteristics of non-SLA and non-demonstration lasers compared to characteristics of SLA and demonstration lasers? 3. What characteristics have CDRH found to be consistent with the definitions of these laser types in 21 CFR 1040.10, including the words “manufactured designed, intended, promoted for certain purposes”? 4. When lasers have a plausible dual-use, which purpose will guide manufacturers in determining whether the laser product is a special purpose SLA or demonstration laser? What if it is both a SLA and a demonstration laser? 5.Does the promotion of a laser certified as a SLA or demonstration laser violate regulations if the promotion misidentifies a laser as something other than SLA or demonstration laser product? E.Analyze legislative, regulatory and internal CDRH documents to determine historical or regulatory precedents that support development and writing of guidance documents. F.Follow all internal CDRH procedures associated with preparing and clearing documents through the GGP Regulations and the CDRH Manual for the GGP Regulations. Deliverables: The contractor shall attend all meetings (in person or by phone) as requested by the Project Officer. The contractor shall be committed to scheduled and ad hoc telephone or email interaction with Counsel, Regulations and/or Senior Office Staff. The contractor shall complete documents by incorporating reviewer’s comments that the contractor considers to be applicable for inclusion in final drafts and shall provide those drafts to the Project Officer before the conclusion of the contract performance period. The contractor shall: •Provide detailed references to documents that were instrumental in developing the guidance documents. •Deliver two separate and distinct guidance documents, one of which covers the topic "Guidance for manufacturers of component or replacement laser products” which provides clarification of how FDA identifies component or replacement laser products and clarifies responsibilities of manufacturers who produce these products and "Guidance for surveying, leveling and alignment or demonstration laser product manufacturers" which clarifies how FDA characterizes surveying, leveling and alignment (SLA) or Demonstration lasers so that they are readily identified by manufacturers, distributors or dealers as limited to Class IIIa. •Deliver the above documents in conformance with the CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff for public comment, including a Notice of Availability for each. •Provide counsel and services related to the guidance documents to the Project Officer, Liaisons, Counsel, Regulations Staff and Senior Office Period of Performance August 10, 2009 – August 9, 2010 Place of Performance Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 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. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 5:00pm, EST on or before Monday, July 20, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 5:00pm, EST on or before Monday, July 27, 2009. Telephone calls will not be accepted. EVALUATION AND AWARD: 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 purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," and 2) Price. Technical Capability is significantly more important than price. Technical Evaluation Factors: 1). Technical and historical understanding of electronic product legislation and regulatory documents, and changes in the laser standard, including preambles and all deliverables identified above. 2). Demonstrated experience in guidance writing and editing. 3).Past performance of similar or related work. 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. All submitted proposals shall not exceed 10 pages in their final submission. 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. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. 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.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1056814/listing.html)
 
Place of Performance
Address: 5600 Fishers Lane, Rockville, Maryland, 20857, United States
Zip Code: 20857
 
Record
SN01876220-W 20090717/090716000037-5652f790fdbe01b2096502bf5a567ae1 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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