SOLICITATION NOTICE
R -- MDUFA III
- Notice Date
- 8/24/2010
- 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
- 10-223-SOL-00298
- Archive Date
- 9/23/2010
- Point of Contact
- Phillip K. Frame, Phone: 3018277169
- E-Mail Address
-
Phillip.Frame@fda.hhs.gov
(Phillip.Frame@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The Food and Drug Administration intends to award a sole source purchase to The Colosi Group, Vienna, VA. This is NOT a request for competitive quotes. The purchase order will be made on a sole source basis in accordance with FAR Part 13 - Simplified Acquisition Procedures and 13.106 and Part 12. Sole source acquisition for the following, The Colosi Group. Description of Acquisition: This order will cover the extent of the MDUFA III reauthorization negotiations and process with the industry. Services will include assistance with agency planning and strategy for the negotiations, advanced training for key agency staff for the negotiations process, and ongoing consultation on the negotiating process. Knowledge of organizational and program content and personnel is critical to providing efficient and effective negotiations support. Leveraging the model in use as well as the knowledge base developed in the MDUFA II negotiations is essential to the successful completion of the tasks associated with the MDUFA III reauthorization negotiations. Preparations for negotiations are scheduled to begin on or about 14 September with negotiations scheduled to start in January 2011. The contractor must have direct knowledge of and direct experience with the FDA and industry negotiations process for the Medical Device User Fee Amendments of 2007 (MDUFA II) as a negotiations trainer and technical consultant. A new contractor would require significant time to not only familiarize with the case and model, but that the staff that would need to assist the contractor in coming up to speed would then be unable to do the work they needed to do to prepare for these negotiations. Finally, since the MDUFA III negotiations process is likely to be more complicated than that of MDUFA II and is built upon MDUFA II negotiations, it is critical to have this contractor who played a vital role in supporting the MDUFA II negotiations. 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. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-43. The associated North American Industrial Classification System (NAICS) code for this procurement is 541611 for a total small business set-aside. The FDA intends to issue a labor hour purchase order for the tasks identified below: I. Background The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorized FDA to collect fees from companies that submit certain applications for marketing of medical devices to augment appropriations spent on medical device review. In return, MDUFMA required FDA to pursue a comprehensive set of device review performance goals that were intended to significantly improve the timeliness and predictability of FDA's review of new devices. The original Act had a five year life. The FDA Amendments Act of 2007 (FDAAA) included the Medical Device User Fee Amendments of 2007 (MDUFA II). MDUFA II reauthorized medical device user fees and identified new performance goals for FY 2008 through FY 2012. These performance goals were developed with input from industry and were a key part of the negotiated package of user fees and other changes made by MDUFA II. The original Act and the MDUFA II reauthorization were preceded by negotiations between FDA and the industry to determine the user fee rates and the performance commitments made by FDA under the law. Negotiations for the MDUFA III reauthorization are starting in calendar year 2010. With each reauthorization, the negotiations process has become more complicated, lengthy, and sensitive. II. Objectives The proposed action is a new contract which seeks to leverage the unique knowledge and experience resulting from prior consultation and technical support work done for FDA to support the negotiations for the reauthorization of the Medical Device User Fee Amendments (MDUFA II) to support FDA in current negotiations for the MDUFA III reauthorization. The work performed under this contract will be managed by the designated FDA Contract Officer's Technical Representative (COTR). III. Services to be Performed This contract will cover the extent of the MDUFA III reauthorization negotiations and process with the industry. Services will include assistance with agency planning and strategy for the negotiations, advanced training for key agency staff for the negotiations process, and ongoing consultation on the negotiating process. The contractor shall provide consultation and technical support to the agency in two key task areas, all of which will be performed in close collaboration and with direction from designated FDA staff, primarily at the FDA White Oak Campus. These areas include: 1. Executive-level consulting on the MDUFA III negotiation planning and strategy, approximately biweekly. Includes attendance at internal FDA team meetings approximately once per month to observe and then participate in an after-meeting debriefing with the core FDA management team. 2. Advanced training for the full FDA negotiations team, including facilitation of at least one full-day "live scrimmage" event. IV. Place of Performance Performance will occur at FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993. As appropriate, work may also be performed at the contractor's facility. V. Progress Reports The contractor shall provide monthly status reports that document the work that has been accomplished, the activities performed during the month, and the activities planned for the next month. The contractor should be available to discuss current or anticipated problems with the COTR. VI. Performance Period The period of performance for this contract is from the award of contract through September 30, 2011. QUESTIONS DEADLINE: all questions must be received by email (Phillip.Frame@fda.hhs.gov) before 4:00 pm (1600) EST on 24 August 2010. FAR provisions can be found on the following website: http://www.arnet.gov. The following clauses and provisions apply to this acquisition: 52.212-1, Instructions to Offerors-Commercial Items; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.219-6, Notice of Total Small Business Set-Aside 52.219-28, Post Award Small Business Program Rerepresentation 52.222-3, Convict Labor 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-3, Buy American Act-Free Trade Agreements - Israeli Trade Act 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. FDA intends to make an award soon after the response date of this notice. All bids must be submitted via email and be received by 4:00 PM (1600) EST on 8 September 2010 to the attention of Phillip Frame, Phillip.Frame@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/10-223-SOL-00298/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02252473-W 20100826/100824235138-fab7d4184534d6fca763274bfcb3f3e5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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