MODIFICATION
R -- RETREAT DESIGN AND FACILITATION SERVICES FOR CDRH/OCER, POST MARKET MATRIX ORGANIZATION PLANNING
- Notice Date
- 8/30/2007
- Notice Type
- Modification
- NAICS
- 611430
— Professional and Management Development Training
- 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
- FDA-SOL-07-00325
- Response Due
- 9/4/2007
- Archive Date
- 9/19/2007
- Point of Contact
- Kimberly Davila, Contract Specialist, Phone 301-827-7180, Fax 301-827-7106, - Patricia Pemberton, Contracting Officer, Phone 301-827-1022, Fax 301-827-7106,
- E-Mail Address
-
kimberly.davila@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Description
- The purpose of this amendment is to: 1) change the "evaluation" statement, and 2) answer questions. *Contractor must acknowledge receipt of all amendments in quotation. 1. EVALUATION: Contractor must be familiar with the scientific, medical device review and regulatory environment to effectively and efficiently facilitate post market transformation related discussions. Offers 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. 2.) Questions and Answers: QUESTION: Is the intent of Amendment 3 to delete the original intention of this project being a ?woman-owned?, small business set aside and instead open it to all small businesses? ANSWER: Yes, the requirement is a Total Small Business Set aside. QUESTION: Amendment 2 restated the SOW and seemed to incorporate several pieces of the original Synopsis. Is the original ?evaluation? clause contained in the Synopsis deleted? ANSWER: No. The only thing that changed in amendment 2 was the Statement of Work, everything else remained the same. QUESTION: If the Evaluation clause is not deleted from the SOW, what is the intention of having the contractor be familiar with the scientific, medical device review and regulatory environment, including post market transformation effort? ANSWER: The implementation of the matrix organization structure will result in a need to facilitate greater information sharing and richer collaboration across the Center which will overlay ?horizontal,? product-focused Networks on existing ?vertical? functional Offices calling for establishment of product-based Networks that will include all of the products the Center regulates, plus several over-arching groups covering cross-cutting science and regulatory issues. The retreat, as a result of this structure, will require OCER managers to focus on how the Office, and the products it produces, will fit into the networks of the new matrix organization. In order to effectively and efficiently facilitate discussion to determine the knowledge, skills and abilities required of OCER within the networks, the number of network liaisons OCER will require based on the work to be performed, as well as to determine which functions should be a part of the new matrix it is necessary to have a facilitator that is able to offer a familiarity with the medical device review process, as well as with the culture and/or nomenclature of the device review and regulatory community. Familiarity with the matrix effort is not a requirement. The reference was intended to indicate that the contractor needed to be familiar with the scientific medical device review and regulatory environment to effectively facilitate the post market transformation discussions. QUESETION: Is there a page limitation to what we can send? ANSWER: 20 pages ***PLEASE NOTE: The closing date has not been affected by this amendment; it remains 2:00pm EST, September 4, 2007. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (30-AUG-2007); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-07-00325/listing.html)
- Place of Performance
- Address: 1350 Piccard Drive Rockville, MD
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01391680-F 20070901/070830231158 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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