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FBO DAILY ISSUE OF AUGUST 28, 2008 FBO #2467
SOLICITATION NOTICE

R -- Professional Services

Notice Date

8/26/2008
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541611 — Administrative Management and General Management 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

FDA-08-1046262
 

Point of Contact

Karen R. Petty,, Phone: 301-827-8774
 

E-Mail Address

karen.petty@fda.hhs.gov
 

Small Business Set-Aside

Total Small Business
 

Description

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 541611, 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 purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-26. This is a total small business set-aside. Prospective offerors are responsible for downloading the solicitation and 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 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. STATEMENT OF WORK: Background: For over 30 years the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) has assisted industry by providing technical and regulatory assistance to small manufacturers to help them comply with FDA requirements for medical devices. DSMICA is one of several divisions within the Office of Communication, Education, and Radiation Programs, within the Center For Devices & Radiological Health (CDRH). DSMICA has five major programs: 1) Educates and advises the device industry and helps them comply with a wide array of FDA regulations; 2) Educates consumers about issues and problems with medical devices and radiation-emitting products: 3) Educates and trains foreign government officials on the US regulatory process; 4) Coordinates global harmonization, Mutual Recognition Agreements (MRA) and other international agreements; and 5) Manages the CDRH Third Party Program. DSMICA’S staff answers questions by phone, FAX, E-mail, and in person. They are professionals trained in device laws, regulations and procedures. They quickly provide “real time” answers to most questions. DSMICA develops and makes available electronically a wide variety of “How To” guidance to help industry comply with regulatory requirements. Examples include premarket notification [510(k)], premarket approval (PMA), investigational device exemptions (IDE), good manufacturing practices (GMP/QS), establishment registration and device listing, and Electronic Product (Radiation emitting) submissions. DSMICA staff routinely participates at workshops, symposiums, seminars, and conferences speaking on medical device and radiological health regulations. At this time we are exploring the use of contractors to provide cost effective responses to email inquiries from consumers and other non-industry stakeholders. The contractor could perform this work at DSMICA offices in Rockville or at a location of their choosing, within EST time zone. Scope of Work We are seeking the use of contractors to provide time effective responses to email inquiries from consumers and other non-industry stakeholders relative to program 2 above. The contractor could perform this work at DSMICA offices in Rockville or at a location of their choosing, within EST time zone. The contractor will assist DSMICA by responding to the needs and concerns from industry in “real time” by addressing the inquirers concerns/questions primarily in directing them to publicly available information maintained on the public FDA web sites or via other public sources. The contractor may also use boilerplate information such as our “A2 package” or other precedent documents. The contractor will copy the DSMICA account on all responses to allow FDA to track and monitor their activities. DSMICA expects no less than 90% of inquiries to be responded to with 48 hours (2 business days) of receipt of the inquiry. The following are examples of typical questions the contractor will be expected to reply to and the typical source for that answer: A) I want to have LASIK done to my eyes. Has the FDA approved this procedure? (Direct consumer to the LASIK website, www.fda.gov/cdrh/lasik) B) I’m thinking of having breast implants – which type is the safest? (Direct to the Breast Implant web site) www.fda.gov/cdrh/breastimplants C) Are tanning beds safe? Does FDA inspect tanning salons? (Direct to the Tanning web site) www.fda.gov/cdrh/tanning D) Is this XYZ device approved for this indication? (Direct to the publicly available 510k and PMA databases) www.fda.gov/cdrh/510khome.html and www.fda.gov/cdrh/pmapage.html. E) I want to sell my used device on eBay – how do I accomplish that? (Direct to the eBay/online sales web site) The entire consumer topic list is available from the CDRH Consumer Information page, www.fda.gov/cdrh/consumer. F) Are X-rays and CT scans safe? (Direct to the radiological health web site) G) I need information about a recent recall? (Direct to the ORA recall site) H) How do I report to the FDA a problem or adverse event I experienced with a device? (Direct to the MDR Medwatch page) I) How do I know if devices made in China (or any other foreign country) are safe and effective? (Direct to various press releases or Q&A on this subject) J) My insurance company will not pay for a certain procedure – can FDA help me? (Direct to appropriate consumer web site) K) What is the status of a device undergoing clinical trials? Can I be part of a clinical study? (Direct to the Clinical Trials web site) L) Does FDA approve off label use for a device cleared for another indication? (Direct to appropriate consumer link) M) My husband’s pacemaker has been recalled – what should we do? (Direct to appropriate press release) N ) I need a list of all approved hernia meshes. (Direct to the 510k, PMA or classification databases depending on product code). O) How does FDA approve a medical device? (Direct to Device Advice. A great on-line tool we have developed is Device Advice, www.fda.gov/cdrh/devadvice. It walks one through the decision process) Tasks: The Contractor shall: 1.Respond to incoming consumers and other non-industry stakeholders questions by phone, FAX, E-mail, and in person, providing information regarding medical devices and radiation-emitting products so they can make informed decisions about the risk and benefits of such products. 2. Be required to commit to scheduled and ad hoc telephone interaction with the Director and/or Deputy Director, DSMICA and any other designated Division Staff as needed. 3. Participate telephonically at meetings, and conferences as necessary, as a representative of FDA as needed. Deliverables: The contractor shall: 1.Respond to incoming consumers and other non-industry stakeholders questions by phone, FAX, E-mail, and in person, as directed by the Director and Deputy Director, DSMICA 2. Assignments and deliverables are at the discretion of the Director of the Division of Small Manufacturers, International and Consumer Assistance (DSMICA). The Director will coordinate with the Project Officer for validating the quantity and quality of services received, as well as certifying receipt of required deliverables. Period of Performance Approximate dates: September 14, 2008 – September 13, 2009 with a maximum expenditure of 1040 hours of work. We estimate that approximately 75 consumer related emails a week would be electronically transferred to the contractor. They will be downloaded by a supervisor or other senior FDA staffer and sent to the contractor at the end of each workday (3pm – 5pm). Payment Schedule There is no other direct cost of lodging, travel, or facilities. The vendor shall submit monthly invoices detailing hours spent and services completed during the past month. Upon approval of each monthly invoice, FDA shall provide payment for services completed. Technical Evaluation Factors 1.Technical understanding of internet and microsoft software. (50%) 2.Technical understanding of the Food and Drug Administrations Mission, specifically, Center of Medical Devices and Radiological Health (30%) 3. Experience responding to the medical device related needs and concerns of an organizations stakeholders via phone, FAX, E-mail, and in person. (20%) Equipment Use: No government equipment will be provided. Offerors are advised that award will be made to that offeror whose quotation provides the combination of features that offers the best or greatest overall value to the Government. The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate determining factor for award of a contract as quotations become more equal based on the other factors. 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 karen.petty@fda.hhs.gov no later than August 28, 2008, 3:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: karen.petty@fda.hhs.gov, no later than 3:00pm, EST on Wednesday, September 3, 2008. 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. Responses to this notice must be sent via email to Karen.petty@fda.hhs.gov. No phone calls will be accepted.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=7d38a6528fddabefcc78366faccd25f6&tab=core&_cview=1)
 

Place of Performance

Address: 1350 Piccard Drive, Rockville, Maryland, 20850, United States

Zip Code: 20850
 

Record

SN01651286-W 20080828/080826224831-7d38a6528fddabefcc78366faccd25f6 (fbodaily.com)
 

Source

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

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