SOLICITATION NOTICE
B -- Medical Device Reporting/Compliance
- Notice Date
- 7/6/2007
- Notice Type
- Solicitation Notice
- 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, MD, 20857-0001, UNITED STATES
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-REQ1031423
- Response Due
- 7/24/2007
- Point of Contact
- Roberta Richardson, Contract Specialist , Phone 301-827-7175, Fax 301-827-7106, - Patricia Pemberton, Contracting Officer, Phone 301-827-1022, Fax 301-827-7106,
- E-Mail Address
-
roberta.richardson@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Small Business Set-Aside
- Very 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 541690, identified as REQ1031423, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. 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 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. .Background: The Division of Surveillance Systems (DSS) in the Office of Surveillance and Biometrics (OSB) in FDA?s Center for Devices and Radiological Health provides interpretation of the Medical Device Reporting (MDR) regulation and guidance to FDA field offices and industry concerning MDR reportability issues. Inspections of device manufacturers that identify violations of the MDR regulation are referred via CDRH Office of Compliance and Office of In Vitro Diagnostics to OSB to review and support regulatory actions. The current Compliance Program for Inspections of Device Manufacturers under the Quality System Good Manufacturing Practices (C/P 7382.845) includes the time planned for field operations under Product/Assignment Codes (PAC) 81010 and 81011 - MDR follow-up and assessment of MDR practices. We would like to revise the MDR references in that compliance program to direct the assessment, collection and reporting of MDR-related information in Establishment Inspection Reports (EIRs) in a manner that increases the efficiency, timeliness, and effectiveness of the DSS regulatory reviews. Specific guidance should improve the quality of the reports received and expedite any further regulatory action taken as a result of the inspections. Scope of Work: Independently, and not as an agent of the Government, the Contractor shall furnish the necessary personnel and services, and otherwise do all things necessary for or incident to the performance of the work as described below: 1. Prepare MDR related guidance for investigations and inspections of medical device manufacturers and importers. 2. Provide the field staff with guidance on selection and review of complaint records for MDR purposes. 3. Provide guidance for the organization of all MDR-related information in one place in the EIR as well as specify the methods for organization of MDR-related exhibits. 4. Revise the MDR-related charges in the Turbo system for creating the FDA483 and EIR. 5. Develop regulatory language for preparation of warning letters or other regulatory action involving MDR charges. Deliverables: A written MDR program addressing the inspection and investigation of medical device complaints including the preparation of reports and exhibits. A recommendation for FDA483 and Warning letter language for MDR violations. Monthly reports showing time expended on project. Deliverables go to the project officer. Period of Performance: Six months. Payment schedule: Payment will be made in monthly installments based on level of effort (hours worked). Qualifications: Bachelor Science Degree in Mathematics with Minor in Physics Master Science Degree in Radiological Physics Knowledge of the medical device complaint handling process and experience with inspections of manufacturers and other regulated industry. Ability to communicate clearly orally and in writing. Clearance to see confidential and proprietary information. PAST EXPERIENCE: The contractor must be able to demonstrate past experience directly relevant to the types of work needed. Such experience includes projects performed in the past five years similar in scope to the requirements of this Statement of Work. Interested parties may identify their interest by responding to this requirement within 5 calendar days after the date of publication of this notice. 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 and Bradstreet number and banking information. The anticipated award date is 07/24/2007. 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 24, 2007 will be considered by the Government. All questions must be emailed no later than July 11, 2007 to patricia.pembertona@fda.hhs.gov and roberta.richardson@fda.hhs.gov NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (06-JUL-2007). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 17-AUG-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/Reference-Number-REQ1031423/listing.html)
- Place of Performance
- Address: Rockville, Maryland
- Zip Code: 20857
- Country: UNITED STATES
- Zip Code: 20857
- Record
- SN01377308-F 20070819/070817230359 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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