SOLICITATION NOTICE
B -- NAQuestions and Answers re: Solicitation FDA-SOL-07-00148
- Notice Date
- 1/8/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- FDA-SOL-07-00148(a)
- Response Due
- 1/12/2007
- 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
- Total Small Business
- Description
- This is a reposting of FDA-SOL-07-00148 that due to a date problem was inadvertently archived. This re-posting re-creates the initial posting and responds to questions submitted for the original Solicitation. Statistical Evaluation of Design, Conduct and Analysis of Pre-clinical and Clinical Studies Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6., supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals/quotes are being requested. No other solicitation will be issued. This acquisition is a small business set aside and is being issued as a Request for Quote (RFQ). This synopsis, identified as FDA-SOL-07-00148, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following full-time services as defined below under commercial item procedures. Work to be Performed: NAICS CODE : 541990 All Other Professional, Scientific, and Technical Services Background: The Division of Biostatistics in the Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) provides statistical expertise in the evaluation of materials and documents submitted to and generated by the Center to assure statistical validity and consistency. This contract is intended to provide additional statistical expertise to supplement current staff. 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. Conduct comprehensive statistical review of pre-market submissions from manufacturers. This includes reviewing study protocols to determine whether data collected are (or will be) scientifically and statistically valid; evaluating manufacturer?s data to determine whether claims made are supported by valid statistical analyses; identifying deficiencies in the submissions and providing written reviews and specific language for regulatory letters that conveys statistical concerns and requests to non-statisticians. This activity includes collaboration with Center clinicians, scientists and engineers. 2. Perform, when appropriate, statistical analyses of submitted data to validate analytical results and answer specific questions arising during statistical review. 3. Provide backup support for statistical consultation/analysis activities in the Division. Deliverables: Written statistical reviews of individual submissions. Quarterly summary reports providing status of submissions and progress on projects. Monthly reports showing time expended on reviews and projects. Period of Performance: Period of Performance: 7 mo Base with 2 option years Base period: March 1, 2007 - September 30, 2007 Option year 1: October 1, 2007 - September 30, 2008 Option year 2: October 1, 2008 - September 30, 2009 Payment schedule: Payment will be made in monthly installments based on level of effort (hours worked). Invoices are to be submitted to the assigned FDA Project Manager, for approval. Qualifications: ? Advanced degree in Statistics or Biostatistics. ? Experience in medical product clinical trial design, analysis and/or evaluation. ? Experience in laboratory experiment design and analysis. ? Ability to communicate clearly orally and in writing. ? Current and Active Clearance to see confidential and proprietary information. Where Work will be Done: The contractor will operate from an office in the FDA space located at: FDA/CDRH PI50 RM140L HFZ-550 1350 Piccard Dr Rockville, MD 20850 Additionally, some of the work may be done off site. Equipment Use: The contractor will use a personal computer provided by FDA/CDRH. Award Date: The anticipated award date is 01 Feb 2007; however, all dates in this announcement are subject to change. 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.. The solicitation and incorporated clauses and provisions are those in effect through Federal Acquisition Circular 05-12, dtd Aug. 4, 2006) 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 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 52.219-6;FAR 52.222-3; FAR 52.222-19; FAR 52.222-21; FAR 52.222-26; FAR 52.222-35; FAR 52.222-36 FAR 52.222-37; FAR 52.225-3; FAR 52.225-15 ;FAR 52.232-33 The following clauses are incorporated by reference and apply to this acquisition. FAR 52-232-18 AVAILABILITY OF FUNDS (APR 1984) FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995) FAR 52.217-09 OPTION TO EXTEND THE TERM OF THE CONTRACT (Mar 2000) FAR 52.217-8 OPTION TO EXTEND SERVICE (Nov 99) The government reserves the right to make an award without discussions. THE GOVERNMENT WILL NOT PAY FOR COSTS INCURRED IN THE PREPARATION AND SUBMISSION OF DATA OR OTHER COSTS INCURRED IN RESPONSE TO THIS ANNOUNCEMENT Deadlines for Responding: ? All questions must be submitted via email to the Contract Specialist named below. No telephone call inquires. ? Late date / time to submit questions: Jan 9, 2007 3:00pm EST Points of Contact Roberta Richardson, Contract Specialist, Phone 301-827-7175, Fax 301-827-7106, Email Roberta.richardson@fda.hhs.gov - Patricia Pemberton, Contracting Officer, Phone 301-827-1022, Fax 301-827-7106, Email patricia.pemberton@fda.hhs.gov Questions and Answers: Questions and Answers re: Solicitation FDA-SOL-07-00148 "Statistical Evaluation of Design, Conduct and Analysis of Pre-clinical and Clinical Studies." Is there was an incumbent. Response: Yes Contractors name: Response: J. Dawson Contract number: Response: HHSF223200530231P Date, expiration date and value. Response: Effective date 7/13/2005 to present Value: $61,950 Additional questions / responses: (1) Under the heading "Qualifications," the solicitation requires "Current and Active Clearance to see confidential and proprietary information." By this, do you mean that the person performing the work must possess a U.S. Government security clearance (i.e., either Confidential, Secret or Top Secret) OR do you mean that the person must simply possess a demonstrated ability to see, handle, process and protect confidential and proprietary business information, but not possess a formal government security clearance? Response: the individual performing the work must have a current and valid clearance from a Federal Government agency. (2) Do you require the CONTRACTOR (i.e., the firm to which you make the award) to also have whatever the above qualification is, or is your requirement sufficiently satisfied if the person actually doing the work has it? Response: Only the individual performing the work is required to have the specified qualifications and clearance. (3) The solicitation states that the incorporated clauses and provisions are those in effect through Federal Acquisition Circular 2005-12, dated Aug. 4, 2006. There have been two additional FAC's, numbered 2005-13 and 2005-14, which were effective on September 28, 2006 and November 22, 2006, respectively. Will you amend the solicitation to incorporate these last two FAC's, or should these two simply be disregarded? Response: The solicitation will be amended to include the latest FACs through 2005-15 dated Dec 12, 2006. The amendment will also include the following Health and Human Services Acquisition Regulations ( 48CFR, Vol71, No. 244) as published in the Federal Register Dec 20, 2006. Department of Healt and Human Services Subpart 353.2 ? Provisions and Clauses Sec. 352.202-1 Definitions. ( Jan 2006) 352.215-1 Instructions to offerors--Competitive acquisition. 352.215-70 Late proposals and revisions. (Jan 2006) 352.224-70 Confidentiality of information. 352.232-9 Withholding of contract payments. (Jan 2006) 352.249-14 Excusable delays. (Jan 2006) 352.270-5 Key personnel. 352.270-11 Privacy Act (Jan 2006) 352.270-13 Tobacco Free Facilities (Jan 2006) (4) The solicitation includes FAR clause 52.216-22, but it doesn't state an estimated level of effort for this indefinite quantity contract (so that adequate planning for dedicated staff can be made) or any minimum and maximum quantities. Thus, what is the estimated number of labor hours contemplated by your requirement for a particular period (i.e., for the base year of seven months and for each of the two one-year options of twelve months each)? Is there a minimum and maximum? Response: The workload here is variable so setting the min/max would be difficult. The contractor would have the ability to say he/she/they are too busy to take on a particular review assignment. There may be other times when there is no work for a short period. It depends on what documents are submitted to the Agency for review. What we'd like to know from respondents is what they would propose as the hourly rate, which would be doing the work and what they would see as the level of effort along with any restrictions. In the previous contracts, 16 hours per week was used as the proposed aggregate level of effort. Consequently, there is no definitive estimate available for the quantity of services to be performed under this contract. Delivery and performance will be done at the direction of the Project Officer. There is no minimum or maximum. Once a contractor is selected, a purchase order specifying a not to exceed amount will be issued to the contractor. (5) The solicitation includes FAR clause 52.217-9. There are several places in that clause for entries by the government. Can you advise as to what these entries should be in the clause's paras. (a) and (c)? Response: (a) 30 days; 30 days: (c) 2 years 7 months ( Base period of 7 months and 2 option years). NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (08-JAN-2007). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 14-MAR-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/FDA-SOL-07-00148(a)/listing.html)
- Place of Performance
- Address: 1350 Piccard Drive Rockville, MD
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01251424-F 20070316/070314223928 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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