MODIFICATION
R -- Services for the Assessment and Development of a Protection Quality Assurance Program
- Notice Date
- 8/23/2006
- Notice Type
- Modification
- NAICS
- 541618
— Other 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, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- REQ1017789
- Response Due
- 8/28/2006
- Archive Date
- 9/12/2006
- Point of Contact
- Gwen Hubbard, Contracting Officer, Phone (301) 827-7172, Fax (301) 827-7106, - Gwen Hubbard, Contracting Officer, Phone (301) 827-7172, Fax (301) 827-7106,
- E-Mail Address
-
gwendolyn.hubbard@fda.hhs.gov, gwendolyn.hubbard@fda.hhs.gov
- Small Business Set-Aside
- Total Women-owned Business
- Description
- The purpose of this Amendment 0004 is to:1. replace Amendment 0003 in its entirety, 2.Change the Contracting Officer to Patricia Pemberton, and 3. Respond to question submitted in response to this RFQ. Questions and Responses 1.Question:Does CFSAN have written quality assurance procedures? Response: Yes 2.Questionn: We assume that studies will be the unit of review in addition to the overall quality assurance process? Is this correct? Response: Yes 3.Question: How many studies, in addition to the overall quality assurance process, will be reviewed annually? Response: The Scope of Work is not requesting actual audits -- only review and recommendations for CFSAN's current CGP QA Program. The studies that will be ultimately reviewed by FDA Office of Science designees would be about 20. 4.Question:Where are the contractors and study sites located? How many trips should be budgeted for annually? Response:The scope of Work is NOT requesting actual audits to be performed. 5.Question:What are the evaluation criteria for the RFQ? Response: The evaluation criterion is located under ?Personnel Requirements?. 6.Question:Do the 25 pages include only the technical approach or also resumes and budget? Response:The total amount of pages is hereby increased to 50. 7.Question: What is the period of performance since August 14, 2006 will have already passed by time of award? Response:The Period of Performance is hereby changed to September 18, 2006 through September 17, 2007. 8.Question: How will ongoing review of studies take place if the period of performance is only one year? Response:The Agency and CFSAN will be responsible for the audits -- the scope of Work is requesting the review and recommendations of the current CFSAN GCP QA Program SOPs. 9.Question: Will we be responsible for implementing the corrective action plan? Response: No. 10.Question: Our company would like to supply the resumes or biographies for the people who would be on the project, but we don't know the size or scope of the work. Consequently, don't know how many people are needed. How many studies are being conducted? How many audits willbe needed? Response: No audits are being requested in the scope of work. What has been described in the scope of work is "Review "of CFSAN's current SOPs for its GCP Quality Assurance Program and for the contractor then to make recommendations for any changes to improve the current QA program. 12.Question: Assumedly, investigative sites and vendor qualification audits are needed. Are other audits needed too -- such as IRB audits, QA of regulatory documents (protocols, Investigator Brochures, Final Study Reports, etc.)? Response:No audits are being requested in the scope of work. The contractor will review the current CFSAN GCP Quality Assurance Program and make recommendations for any changes to improve the current QA program. The references to "vendor" or outside contractors conducting studies for the Center were made to be included in the "review" and "recommendations" of the current SOPs for the CFSAN GCP QA program. 13.Question: It sounds like there is a need for monitoring in addition to auditing (i.e., verifying that the data in the Case Report Forms or other data collection instruments are supported by source documentation). Is this true? If so, how much monitoring is needed compared to auditing Response: The reference to monitoring of studies was again for the contractor to review current SOPs for this process and to make recommendations to CFSAN HSP Lead to improve the program NOT to actually conduct an audit. 14.Question: Will the study sites (and therefore, the audit sites) be located allaround the country? Or will they all be in the DC/Rockville area? Are there any international sites? Response:No audits are being requested in the Scope of Work. 15.Question: What is meant by "terms of any express warranty"? Response: Terms the seller is asserting in their warranty such as ?if it breaks I?ll fix it for free?. 16.Question: How much detail should be included? Should we give a general outline of the items we would check in a site audit, vendor qualification audit, etc.? Or is it acceptable to say that we have SOPs which would be supplied to the FDA when the contract was awarded? Response:This Scope of work is NOT requesting actual audits to be preformed. 17.Question:In addition to our employees, Polaris uses about 20 independent contractors to perform our audits. Most of these contractors are incorporated. Does FAR clause 52.203-6 (Restrictions on Subcontractor Sales to the Government, with Alternate I) mean that only a particular company auditors can perform the work on this project? Or does FAR clause 52.219-14 (Limitations on Subcontracting) mean that at least 50% of the work will need to be performed by employees? Response:This requirement has been 100% set-aside for a woman own company which means, the awardee must perform 51% of the work, and this is in accordance with FAR Part 52.219-14 ? Limitation on Subcontracting. An original and 3 copy of the offerors cost and technical proposal shall be received at Food and Drug Administration 5630 Fishers Lane, Room 2081, Rockville, MD 20857. For information regarding this solicitation, please contact Patricia Pemberton, at Fax 301-827-7106, or email: patricia.pemberton@fda.hhs.gov See notes 22. All other terms and conditions in response to RFQ remains unchanged.
- Place of Performance
- Address: 5100 Paint Branch, College Park
- Zip Code: 20740
- Country: UNITED STATES
- Zip Code: 20740
- Record
- SN01123089-W 20060825/060823220405 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |