Amendment One.pdf

PDF 197 KB Posted

Attached to
Interventional Agents Safety and Pharmacokinetic Services
Solicitation number
75N93024R00003
Issued by

About this file

This document is an amendment to a solicitation for interventional agents safety and pharmacokinetic services. The National Institute of Allergy and Infectious Diseases is seeking proposals for multiple award indefinite delivery/indefinite quantity contracts to provide preclinical and non-clinical development support for promising therapeutic candidates. Services include product development planning, non-GLP and GLP preclinical studies, ADME screening, and attendance at a kickoff meeting. Task areas include development planning, in vitro and in vivo safety studies, toxicology, and pharmacokinetics. Proposals are due by May 24, 2024. Awards will be made for one or more of the task areas. A small business subcontracting plan must be submitted through the SBCX system by the proposal deadline.

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Amendment Two.pdf PDF
Attachment 23 - Electronic Invoicing Instructions.pdf PDF
Attachment 19 - NIH(RC)-4.pdf PDF
Attachment 16 - Certificate of Current Cost or Pricing Data.pdf PDF
Attachment 1 - Packaging and Delivery.pdf PDF
Attachment 3 - Statement of Work.pdf PDF
Attachment 11 - Acquisition Guidance on the Voluntary Product Accessibility Template (VPAT).pdf PDF
Attachment 21 - Instructions for NIH 2706.pdf PDF
Attachment 17 - Disclosure of Lobbying Activities.pdf PDF
RFP 75N93024R00003.pdf PDF
Attachment 18 - NIH(RC)-2.pdf PDF
Attachment 7 - Additional Business Proposal Instructions.pdf PDF
Attachment 14 - Breakdown of Proposed Estimated Costs.xlsx XLSX spreadsheet
Attachment 4 - REPRESENTATIONS CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS.pdf PDF
Attachment 9 - Summary Related Activities.pdf PDF
Attachment 15 - Offerors Point-of-Contact.pdf PDF
Attachment 2 - Intent Response Form.pdf PDF
Attachment 12 - Proposal Summary and Data Record NIH2043.pdf PDF
Attachment 8 - Techical Proposal Cost Summary.pdf PDF
Attachment 5 - Additional Technical Proposal Instructions.pdf PDF
Attachment 13 - HHS Subcontracting Plan Template.pdf PDF
Attachment 20 - NIH 2706.pdf PDF
Attachment 6 - Sample Task Orders.pdf PDF
Attachment 22 - HHSAR 352.223-70 Safety and Health.pdf PDF
Attachment 10 - Contract Proposal Vertebrate Animal Section Worksheet.pdf PDF
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75N93024R00003 Page 1 of 3

AMENDMENT #1

75N93024R00003

“INTERVENTIONAL AGENTS SAFETY AND PHARMACOKINETIC SERVICES”

AMENDMENT No. 1

Amendment Number: One (1)

Amendment Issue Date: March 18, 2024

Proposal Due Date: May 24, 2024, 3:00PM EST (UNCHANGED)

Issued By:

Miranda Adams Contracting Officer Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane

MSC 9821

Rockville, Maryland 20852-9821

Point of Contact:

Miranda Adams, Contracting Officer Email: miranda.adams@nih.gov.

Offerors must acknowledge receipt of the final posting of Amendment #1, 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 NOT been extended.

PURPOSE OF SOLICITATION AMENDMENT:

The purpose of this amendment is to address questions and provide clarification regarding 75N93024R00003.

Question 1: Regarding the Small Business Subcontracting Plan, at what level should we submit the plan – at the IDIQ Parent Contract level or the Task Area/Task Order level?

Answer 1: The Small Business Subcontracting Plan will be submitted at the IDIQ Parent Contract level. Please submit only one plan per organization. Do no submit one plan per task area proposed.

Question 2: For Task Area F, which involves the kick-off meeting requirement, should we submit a standalone technical volume proposal strictly for this task area, with an associated business volume? If so, do you require the full technical response as noted in the additional mailto:miranda.adams@nih.gov.

75N93024R00003 Page 2 of 3 technical proposal instructions to include areas such as scientific/technical personnel, facilities/equipment, project management, quality systems, etc.?

Answer 2: For Task Area F, only a business proposal is required. The business proposal should include the individuals who will attend the kick-off meeting and associated costs. A technical proposal is not required since this Task Area will not be peer reviewed.

Clarification on how to submit small business subcontracting plan.

The offeror must submit their small business subcontracting plan to SBCX. Please search SBCX for 75N93024R00003 to submit your subcontracting plan.

Please see Section L – Instructions, Conditions, and Notices to Offerors C. Business Proposal Instructions 6. Small Business Subcontracting Plan. Full text below.

“If the proposed contract exceeds a total estimated cost of $750,000 for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No. 52.219-9, incorporated herein by reference in the Solicitation. In accordance with FAR 19.704 and FAR Clause52.219-9, the submission of a subcontracting plan by other than small business offeror(s) is a requirement as a part of the proposal submission process and is to be submitted separately from the technical and cost proposals. An offeror's subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award.

1. An offeror is to submit their respective subcontracting plan electronically using the U.S.

Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov. The offeror must follow the instructions outlined in the SBCX Industry Guide instructions outlined in the SBCX Industry Guide at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j to successfully submit their subcontracting plan by the proposal submission deadline.

2. The official point of receipt for determining timely submission of an offeror's subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notification and confirmation message of completion upon submission.

3. If an offeror's subcontracting plan is not confirmed as received within the SBCX system by the proposal submission date specified in the solicitation, it will be considered late in accordance with subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offeror- Competition Acquisition. Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer.

4. Any technical questions regarding the use of the SBCX system may be submitted via email message to the SBCX help desk at client.support@apexlogic.com. The client support hours of operation are Monday - Friday, 6:00 a.m. - 8:00 p.m. Eastern Standard Time (EST). Note: helpdesk tickets can be submitted 24 hours a day / 7 days a week and

75N93024R00003 Page 3 of 3 a representative will respond within the presented client support hours of operation for assistance.”

End of Amendment 1

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