Amendment 0001signed.pdf

RFP- NIHAI75N93021R00011 Page 1 of 4

AMENDMENT #0001

RFP- NIHAI75N93021R00011

“CLINICAL MATERIALS SERVICE”

Amendment Number: 0001

This Amendment provides a lists questions submitted by interested parties and the responses provided by the National Institute of Allergy and Infectious Diseases (NIAID).

AMENDMENT ONE (0001)

Issued by: National Institute of Allergy and Infectious Diseases (NIAID) Office of Acquisitions, MSC 9821 5601 Fishers Lane Rockville, MD 20852

Solicitation Number:

Date of Solicitation Issuance:

Date of Amendment No.0001 Issuance:

Number of Pages:

NIAID Point of Contact:

NIHAI75N93021R00011

July 22, 2021

August 27, 2021

2 pages

PRIMARY:

Harun Ali, Contract Specialist Email:harun.ali@nih.gov Phone: 240-627-3947

SECONDARY:

Charles H. Jackson, Jr. Contracting Officer Email: Charles.Jackson@nih.gov Phone: 240-669-5175

Offerors must acknowledge receipt of the final posting of Amendment #0001, on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals has been corrected to read: September 21, 2021

3:00PM EST.

mailto:harun.ali@nih.gov

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THE FOLLOWING PAGES PROVIDE ANSWERS CONCERNING A NUMBER OF INQUIRIES

WE HAVE RECEIVED FOR THE ABOVE NUMBERED SOLICITATION:

Question 1: Will the government please provide specifics on the current data management, inventory, and tracking tools or systems currently used?

Response 1: The current systems are proprietary to the current contractors. This should be replaceable by an Off-the Shelf system by offerors/awardee.

Question 2: Is the electronic inventory database transferrable to other inventory management systems? What is the smallest unit sample inventory (e.g., grouping)?

Response 2: No, the electronic inventory system itself is not transferrable but the data is transferable will be. The smallest unit sample inventory is one (1) bottle or vial.

Question 3: Will the government please provide a set of examples tests or analyses that are required for the clinical agents and clinical specimens?

Response 3: Required tests for agents and specimens will be agent and protocol dependent. Tests for agents may include, but are not limited to, dissolution, pH, appearance, sterility, and bacterial endotoxins. Tests for clinical specimens may include, but are not limited to, viability, ELISA assays, and neutralizing assays.

Question 4: What level of clean room is required for handling of materials?

Response 4: No standard clean room required. Biosafety Cabinet with at least Biosafety Level-2 rating is required.

Question 5: Are there typical or standard inbound and outbound shipment sizes (volume, quantities, etc.)? If not, will the government please provide a range or estimate of shipment sizes?

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Response 5: No. Estimate of shipment sizes are 12x24 cardboard boxes, shipping pallets, liquid nitrogen tank/container. Please refer to the Uniform Cost Assumptions (Section 3)

Question 6: Can the government provide an assumption indicating the non-domestic countries the clinical agents will be shipped for the purpose of uniform costs? Also, please confirm that the prospective contractor will be responsible for costs associated with importation to the specific country of interest.

Response 6: Some examples are as follows: Peru, Mali, Korea. The awardee/contractor would be responsible for the exportation costs. The recipient would be responsible for the importation related costs. Please refer to the uniform Cost Assumptions (Section 3)

Question 7: If another contactor is awarded the program and the work moves to another location, will the incumbent or the government incur the packaging and shipping costs for transfer of existing materials?

Response 7: The cost associated with the packaging and shipping would be incurred by the incumbent contractor.

Question 8: If the vendor can legally distribute drugs from the state where the repository is located to all other US states, will the government accept that certification?

Response 8: Yes

Question 9: We understand that for the period of performance, the Contractor shall provide 28,252 hours for the base and each subsequent option year (pages 15, 53-54).

Response 9: Pages 15, 53 - 54 are amended to reflect the correct Level of Effort which is 20,235 hours for the base and each subsequent option year.

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• Question 10: For the hourly option quantities of 5,080 – on page 54 it notes that each option quantity may be exercised up to Two (2) times during each contract period, but on page 109 it indicates that an option quantity may be exercised not more than four (4) times within each contract year. Please clarify if two (2) or four (4) maximum quantities should be priced.

• Response 10: For the hourly option quantities, pages 15 and 54 is correct. Page 109 is amended to read each option quantity maybe exercised up to Two (2) times.

Comment 1: The correct Level of Effort is 20,235 hours. Section 4 -OPTIONS language and table on pages 108 and 109 are corrected to read:

The Government's requirement for the work set forth in the Statement of Work of this solicitation is 20,235 direct labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows: