Amendment_1_-_2014011.docx

Amendment No. 1

NIAID-DAIDS-NIHAI2014011

“Immune-Based Antiviral Products for Suppression/Elimination of HIV-1”

Solicitation Number: NIAID-DAIDS-NIHAI2014011

Amendment Number: One (1)

Amendment Issue Date: September 19, 2014

Proposal Due Date (Changed): Monday, November 3, 2014 at 3:00 PM, Local Time

Issued By: John R. Manouelian Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612

Please note that we have revised Section A – Solicitation/Contract Form, item 8., to change the due date for submission of proposals. By virtue of this amendment, the date specified for receipt of proposals has been revised to Monday, November 3, 2014, by 3:00PM local time. Please note that we do NOT intend to extend the due date for submission of proposals past November 3, 2014, and late proposals will NOT be accepted.

In addition, please note that we have also revised Section A – Solicitation/Contract Form to change the date for submission of questions regarding the solicitation, from October 15, 2015 to October 15, 2014. Again, we strongly encourage that any questions regarding the solicitation be submitted by 3:00 PM (local time) on October 15, 2014, so that we can provide timely responses before proposals are due.

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.

In addition to the above changes, the purpose of Amendment 1 is to: (1) delete item 2. Government Notice for Handling of Proposals from Attachment 6 – Additional Technical Proposal Instructions and redirect offerors to Section L – Instructions, Conditions and Notices to Offerors, item 1.(e), Restriction on Disclosure and Use of Data; and (2) answer questions from potential offerors regarding the solicitation, as reflected below:

(1) Item 2. Government Notice for Handling Proposals, under Attachment 6 – Additional Technical Proposal Instructions, is hereby deleted. Offerors are instead instructed to refer to Section L – Instructions, Conditions and Notices to Offerors, item 1.(e), Restriction on Disclosure and Use of Data, in order to determine how their proposals should be handled.

(2) The questions received from potential offerors, including our responses to each, are provided below.

Question 1:

Who is eligible for submitting an application in response to the solicitation?

Response to Question 1:

The Government will accept proposals from any responsible offeror who can meet the requirements delineated in the solicitation.

Question 2:

Is Intellectual Property (IP) required?

Response to Question 2:

The Government does not require an offeror to propose a proprietary product; however, whatever product is proposed, the organization must have freedom to operate. If an offeror intends to propose a product with proprietary material belonging to another organization, they must also ensure that they have received all required authorizations from the provider, in order to use the product.

Question 3:

Can we propose to test proteins in a monkey simian immunodeficiency virus (SIV) model?

Response to Question 3:

No. The Government is not supporting discovery work in monkey SIV models under this solicitation. A list of the type of work that will not be supported by any resultant contract is provided in the solicitation, on page 3 of Attachment 5, Research and Technical Objectives.

Question 4:

When is the deadline for proposal submission?

Response to Question 4:

By virtue of this Amendment, the proposal due date has been revised from Saturday, November 1, 2014, to Monday, November 3, 2014.

Question 5:

Is a letter of intent to submit a proposal required?

Response to Question 5:

No, a letter of intent to submit a proposal is not required in order for your proposal to be accepted. However, it is preferred that you submit one, if you do in fact intend to submit a proposal, as it assists the Government in planning for the review of proposals.

Question 6:

Do all contract sites need to be FISMA certified?

Response to Question 6:

Yes, the Prime Contractor and any proposed subcontractors (all tiers) and consultants will require FISMA certification. Information regarding the FISMA requirements and the timeframe for when the required paperwork is due for FISMA compliance can be found under Section L – Instructions, Conditions and Notices to Offerors, item 2.a.14. Information and Physical Access Security (beginning on page 60 of the solicitation).

Question 7:

Can you provide additional guidance, specifically related to this project on the level of compliance necessary under the modified security risk category listed in the RFP?

Response to Question 7:

As stated page 61 of the solicitation (under Section L – Instructions, Conditions and Notices to Offerors, item 2.a.14., Information and Physical Access Security), the Position Sensitivity Level is rated at Level 5: Public Trust – Moderate Risk. Further, on page 67 of the solicitation (under Section L – Instructions, Conditions and Notices to Offerors, item 2.a.14.E.1.a.), the overall security categorization of Federal Information and Information Systems (FIPS 199 Assessment) is rated at the moderate level. Additional information regarding the applicable security risk for this project can be found under Article H.23., INFORMATION AND PHYSICAL ACCESS SECURITY (beginning on page 28 of the solicitation).

Question 8:

Does the Contractor need to be 100% compliant with FISMA requirements prior to start of contract award?

Response to Question 8:

No. Please refer to Article H.23., INFORMATION AND PHYSICAL ACCESS SECURITY (beginning on page 28 of the SOLICITATION) and Section L – Instructions, Conditions and Notices to Offerors, item 2.a.14. Information and Physical Access Security (beginning on page 67 of the SOLICITATION), for specific information regarding the requirements and their associated due dates.

Question 9:

Page 1, Attachment 4 – Background and Introduction, states the need for therapeutic virological products. Is an immunostimulatory oligonucleotide something the Government would consider as meeting the objectives of this solicitation?

Response to Question 9:

No. As stated on page 3 of Attachment 5, Research and Technical Objectives, the list of items the resultant contract will not support include: “Evaluation of cytokines or other immune response modifiers in the absence of a novel therapeutic vaccine or therapeutic antibody product.” An oligonucleotide alone (immune-stimulatory or not) is not responsive.

Question 10:

On page 2 of Attachment 3 – Broad Agency Announcement Description, the following is stated: “NIAID estimates the Phase 1/base period costs at approximately $2.6M per year for a performance period of up to 3 years.” This statement implies that some flexibility in budgets may be accommodated. Would budgets exceeding $2.6M per year, if justified, be acceptable? Specifically, can the annual budgets be adjusted to accommodate the tasks (e.g., some years may be higher than others, particularly during periods involving manufacturing)? In other words, how rigid is the $2.6M/year budget?

Response to Question 10:

It is NIAID’s intent that the offeror’s proposed budget for Phase I is within $7.8M for the total three year performance period. However, it is up to the offeror’s discretion to propose how their budget should be allocated per year, based upon the nature of the work involved.

Question 11:

Please advise on acceptable proof of concept data in support of this solicitation. If a product shows tolerability and preliminary efficacy in small groups of nonhuman primates against existing accepted treatments, will this product be responsive and compelling? Efficacy may not necessarily show full viral remission, but may include viral load measurements, impact on CD4 and CD8 cells (including subpopulations) and cytokine analysis in SIV-infected nonhuman primates. Please define qualifying events/activities that would fall under acceptable proof of concept activities.

Response to Question 11:

Proof of concept data supports the adequacy of information and scientific merit of a proposal. Proof of concept data, then, demonstrates whether a proposal is considered responsive. To determine compelling, or not, the proposal needs to be evaluated in accordance with the evaluation criteria specified in the SOLICITATION (see Section M – Evaluation Factors for Award, item 7., Technical Evaluation Factors, beginning on page 108 of the solicitation). This will be determined in the scientific review process. It is the offeror’s proposal that provides the evaluable proof of concept experimental design and outcome measures. Since offerors will be submitting unique projects and backgrounds, NIAID can’t specify all possible completed work that might be conceptually supportive to taking a project to the clinic.

Question 12:

On page 9, under Article C.1., Statement of Work, item a., there is reference to the “Statement of Work, dated July 3, 2014” under Section J – List of Attachments. However, there is no referenced Attachment, entitled, “Statement of Work” under Section J – List of Attachments. Please verify that Attachment 3 – Broad Agency Announcement Description, is the intended reference under this Article.

Response to Question 12:

As described on page 4 of the solicitation, under Part I – Schedule, the Contract Schedule, set forth in Sections B through H, is intended to provide the offeror with the necessary information to understand the terms and conditions of the resultant contract.

The reference to the Statement of Work, under Article C.1., Statement of Work, is in fact valid, as the awardee’s negotiated Statement of Work will be included as an Attachment under Section J – List of Attachments, in any resultant contract. The description of the project is provided under Attachment 3 – Broad Agency Announcement Description, of the solicitation.

Question 13:

Will this Broad Agency Announcement (BAA) be awarded as a contract or a grant?

Response to Question 13:

Any awards resulting from this BAA will be issued as contracts only (not grants). Therefore, please do not submit a grant application in response to this solicitation. It is anticipated that the award(s) from this solicitation will be multiple-year Cost-Reimbursement type Completion contracts with a performance period from September 1, 2015 through August 31, 2022, including all options (see SECTION L2.c., Business Proposal Instructions).

Amendment 1, RFP No. NIAID-DAIDS-NIHAI2014011 5