Amendment 0002.pdf
PDF 247 KB Posted
- Attached to
- DMID Regulatory Affairs Support Federal contract opportunity
- Solicitation number
- NIHAI75N93021R00010
About this file
This solicitation is for regulatory affairs support services to be provided to the National Institute of Allergy and Infectious Diseases Division of Microbiology and Infectious Diseases. The services include scientific, regulatory, technical, project management, and administrative assistance for a portfolio of approximately 100 Investigational New Drug Applications and Master Files spanning over 200 clinical trials. The incumbent contractor is Technical Resources International, Inc. The contract to be awarded will be a cost-reimbursement, level-of-effort contract with a one-year base period beginning in June 2022, and includes six one-year option periods exercisable at the government's discretion. The total potential period of performance is seven years. The solicitation was issued on April 29, 2021 with a response date that remains unchanged.
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| File | Type | Posted |
|---|---|---|
| Amendment 0001-Final_signed.pdf | ||
| Solicitation_NIHAI75N93021R00010.pdf |
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RFP- NIHAI75N93021R00010 Page 1 of 2
AMENDMENT #0002
RFP- NIHAI75N93021R00010
“REGULATORY AFFAIRS SUPPORT”
Amendment Number: 0002
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 TWO (0002)
Issued by: National Institute of Allergy and Infectious Diseases (NIAID)
Office of Acquisitions, MSC 9821 5601 Fishers Lane Rockville, MD 20852
Solicitation Number: NIHAI75N93021R00010
Date of Solicitation Issuance: April 29, 2021
Date of Amendment No.0001 Issuance: June 15, 2021
Date of Amendment No.0002 Issuance: July 07, 2021
Number of Pages: 2 pages
NIAID Point of Contact: PRIMARY:
Ignacio Reyes, Contract Specialist Email: ignacio.reyes@nih.gov Phone: 301-435-7574
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 #0002, 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 remains unchanged.
mailto:ignacio.reyes@nih.gov
RFP- NIHAI75N93021R00010 Page 2 of 2
AMENDMENT #0002
THE FOLLOWING PAGES PROVIDE ANSWERS CONCERNING A NUMBER OF INQUIRIES
WE HAVE RECEIVED FOR THE ABOVE NUMBERED SOLICITATION:
No. Questions/ Comments / Responses 1 Comment: According to the Solicitation p. 92 Additional Technical Proposal
Instructions. Section 8: Other Considerations: “Provide copies of Standard Operating Procedures (SOPs) that are currently being utilized to conduct any of the activities as outlined in the SOW.” Note: The technical proposal page limitation of 150 pages remains unchanged and the SOPs needs to be written in a way to summarize the key elements to accurately reflect the procedures while staying within the cited page limit.
2 Comment: According to the Solicitation p. 85. Section M. 5. Evaluation of Electronic and Information Technology Accessibility – Section 508 requires to provide completed HHS Section 508 Product Assessment Templates. Note: The technical proposal page limitation of 150 pages remains unchanged and section 508 Product Assessment Templates and responses needs to be written in a way to summarize the key elements to address the template requirements while staying within the cited page limit.
3 Question: According to the Solicitation p. 90 Additional Technical Proposal Instructions. Section 4. Scientific and Technical Personnel requires CVs to be limited to 2-3 pages. However, Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website states “Each Curriculum Vitae (CV) shall not exceed 2 pages.” Can you please confirm it is acceptable to provide CVs up to 3 pages long?
Response: The government will accept up to 3 pages, but the preference is to receive no more than 2 pages.
4 Comment: On page 59 of the solicitation (Section L.2.a.14) – “Information Security” documentation is to be provided in the Business section of the proposal.
| 2021-07-07T08:18:51-0400 | |
| Charles H. Jackson Jr -S |
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