Preclinical Services for HIV Therapeutics   17

AMENDMENT No. 2: RFP No: 75N93019R00021

The purpose of Amendment 2 is to:

(1) provide responses to questions from potential offerors, regarding the solicitation; (2) amend The Schedule, SECTION B and SECTION I to update the minimum quantity amount of the proposed contract; (3) amend Attachment 4, Statement of Work and Deliverables for Sample Task Order A-1, to address concerns raised by potential offerors; (4) amend Attachment 6, Statement of Work and Deliverables for Sample Task Order C-1, to address questions raised by potential offerors; (5) amend Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, to change text in response to offeror's questions; and (6) revise Attachment 12, Additional Business Proposal Instructions and Uniform Cost Assumptions, to amend text as a result of questions from offerors.

Amendment 2 is attached below.

-------------------------------------------------------------------------------------------------------------

AMENDMENT No. 1: RFP No: 75N93019R00021

The purpose of this Amendment is to provide responses to questions from potential offerors, regarding the solicitation. Amendment # 1 is attached below.

--------------------------------------------------------------------------------------------------------------

The purpose of the proposed Indefinite Delivery/Indefinite Quantity contracts is to provide the extramural scientific community with research materials and preclinical product development support for candidate products that emerge from investigator-initiated research studies or from collaborations with private sector or academic partners. The scope of work encompasses activities that range from basic research and initial product discovery to activities required for clinical trials and/or product licensure. These services may also be used to support product discovery and development leading to Investigational New Drug Application (IND), Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID will primarily use these contracts to fill critical development and resource gaps more rapidly and efficiently and advance promising products into clinical testing. Although the focus of these contracts will be development of therapeutic products for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis (MTB) complex, as well as repository services, at the discretion of NIAID, these contracts may also be used to advance vaccines, antivirals, and preventive strategies for these and other infectious diseases. Throughout this Statement of Work, these candidate products and/or strategies will collectively be referenced as products.

The Government intends to award multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to support these activities. Task Orders will be issued in the following areas:

• Task Area A: In Vitro Testing and Screening Resource for Therapeutics
• Task Area B: Synthesis of Therapeutic Agents for Treatment of Infectious Diseases
• Task Area C: Small Animal Models for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
• Task Area D: Small Animal Models of Mycobacterium Infection
• Task Area E: Formulation Development and Manufacture of Clinical Dosage Forms
• Task Area F: Preclinical Pharmacology and Toxicology Services
• Task Area G: Reagent Program for HIV and other Infectious Diseases

NIAID anticipates Task Orders issued against the IDIQ contracts will be cost reimbursement and/or firm fixed price. While the Base IDIQ contract will not have options, options may be included at the individual Task Order level.
It is anticipated that NIAID will award Base contract awards to one or multiple contractors for each of the Task Areas A, B, C, D, E, F, and G; however, Task Area B will be set aside for small businesses.

For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to the website at https://ecps.nih.gov and then click on "How to Submit". Submission of proposals by facsimile or e-mail is not acceptable.