Amendment_2_RFP_NIAID-DAIDS-NIHAI201800016_final.pdf
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- Solicitation number
- NIAID-DAIDS-NIHAI201800016
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This solicitation requests proposals for a Clinical Research Products Management Center contract to provide pharmaceutical services and study product management for the National Institute of Allergy and Infectious Diseases. Key requirements include managing the receipt, storage, labeling, packaging, shipping and disposition of study products in compliance with cGMP, ICH, FDA and international regulations. The contractor must have the capability to provide these services domestically and internationally, including Africa, Asia, South America, the Caribbean and Europe in support of over 80 clinical trials conducted at more than 300 sites in over 28 countries. The contract is for a base period of one year plus six one-year options, with anticipated award by March 15, 2020. The contractor will deliver 27 full time equivalents per year under the base requirement, with additional optional services that may increase levels of effort. Proposals are due by May 15, 2019 and must be submitted electronically through the NIAID eCPS website. The incumbent contractor is Fisher BioServices.
Amendment 2 - Question and Response
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AMENDMENT #2, RFP NIAID-DAIDS-NIHAI201800016
Amendment No. 2
NIAID-DAIDS-NIHAI201800016
“CLINICAL RESEARCH PRODUCTS MANAGEMENT CENTER (CRPMC)”
Solicitation Number:
Amendment Number:
Amendment Issue Date:
NIAID-DAIDS-NIHAI201800016
Two (2)
April 25, 2019
Proposal Due Date/Time
Wednesday, May 15, 2019 at 3:00 PM, Local Time (Unchanged)
Issued By: Kishan Patel Contracting Officer
OA/DEA/NIAID/NIH/DHHS
5601 Fishers Lane, Room 3D10 Bethesda, Maryland 20892-9821
Points of Contact: PRIMARY:
30T Upatelki@niaid.nih.govU30T Kishan Patel, Contracting Officer Phone: 240-669-5157
SECONDARY:
30Tmscala@niaid.nih.gov30T Michelle L. Scala, Contracting Officer Phone: 240-669-5156
Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.
The purpose of this amendment is to answer questions from potential offerors regarding the solicitation and to revise Section M – Evaluation Factors for Award, paragraph 4., Technical Evaluation Factors, Criterion 3: Project Management, under subparagraph B.(2) of the Request for Proposal, to remove “site monitors” and replace with “increase level of effort.”
Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.
mailto:patelki@niaid.nih.gov mailto:anhughes@niaid.nih.gov
AMENDMENT #2, RFP NIAID-DAIDS-NIHAI201800016
Question # RFP Reference Question
1. Attachment#4, Section 6-H The RFP instructs offerors to include SOPs and Quality Management Plan within the 175-page limit, please confirm.
Response: Per Attachment 1 - eCPS Proposal Instructions, of the RFP “the Technical Proposal shall not exceed 175 pages (inclusive of all attachments)”
2. Attachment #5, Section g.
The Uniform Cost assumption states 78 sites to be visited per quarter. Is the assumption that there will be quarterly visits to 40 sites in Africa, 16 sites in Asia, 20 sites in South America, 1 site in the Caribbean, and 1 site in Europe?
Response: Per Attachment 5, Business Proposal Instructions, Section 3 – Uniform Cost Assumptions, paragraph 3, Travel and Meetings, subparagraph g. states the following:
g. Destruction Visits: Assume quarterly visits by 1 FTE to International sites for the purposes of study product destruction
- assume 3 days on site -2 days total travel
For costing purposes only, assume the following number of sites and international locations:
-40 sites in Africa -16 sites in Asia -20 sites in South America
- 1 site in the Caribbean -1 site in Europe
3. Attachment #5, Section g.
Please confirm that 1 FTE is expected to perform the 78 site visits within a quarter. If 78 quarterly visits should not be assumed, how many visits per quarter should be assumed?
Response: Per Attachment 5, Business Proposal Instructions, Section 3 – Uniform Cost Assumptions, paragraph 3, Travel and Meetings, subparagraph g. states the following:
g. Destruction Visits: Assume quarterly visits by 1 FTE to International sites for the purposes of study product destruction
- assume 3 days on site -2 days total travel
END OF AMENDMENT #2, RFP No. NIAID-DAIDS-NIHAI201800016
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