Amendment 4.pdf

Solicitation Number BAA-NIAID-DMID-NIHAI2010101

Amendment #4

“Targeted Clinical Research to Address Select Viral Infections”

Solicitation Number: BAA-NIAID-DMID-NIHAI2010101

Amendment Number: Four (4)

Amendment Issue Date: December 3, 2010

Proposed Due Date (Unchanged): January 22, 2010 at 3:00 PM, Local Time

Issued By: John Outen

Contract Specialist NIAID, NIH, DHHS Office of Acquisitions, DEA 6700-B Rockledge Drive Room 3214, MSC 7612 Bethesda, Maryland 20892-7612

The purpose of this amendment is to make changes to the solicitation to update several broken website links referenced in Section J.

There is also some questions and answers from potential Offeror’s that are posted for your review.

The date specified for receipt of proposals is unchanged.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The website links referenced in Section J are updated as follows:

REGARDING: Attachment 7: Technical Proposal Cost Summary

Inactive/broken link: http://www.niaid.nih.gov/contract/forms.htm Updated link: http://funding.niaid.nih.gov/contract/forms.htm

REGARDING: Attachment 8: Summary of Related Activities

Inactive/broken link: http://www.niaid.nih.gov/contract/forms.htm Updated link: http://funding.niaid.nih.gov/contract/forms.htm http://funding.niaid.nih.gov/contract/forms.htm http://funding.niaid.nih.gov/contract/forms.htm

REGARDING: Attachment 20: Commitment to Protect Non-Public

Information Contractor Agreement Inactive/broken link: http://irm.cit.nih.gov/security/Nondisclosure.pdf Updated link: http://ais.nci.nih.gov/forms/Non-Disclosure_Form.pdf

Questions (Q) and Answers (A)

Q: Will clinical research in areas/diseases/patient populations other than those listed in the solicitation be supported? For example, will research proposals on Hepatitis C Virus be accepted?

A: No. Only work in areas stated in the solicitation will be supported. Applications focused on HCV will not be accepted. HCV is a Hepacivirus in the Flaviridae family.

Proposals under this announcement are limited to flaviviruses specifically, not viruses in the entire Flaviridae family.

Q. Will epidemiology studies of the selected infections/targeted populations be supported? Will natural history or chart review studies be supported?

A. The purpose of this solicitation is to advance the development of therapeutic strategies for rare and/or emerging viral diseases specified in the solicitation. Please refer to Attachment 3 and Attachment 4 for the specific areas and types of studies.

Natural history and chart review studies may be considered if they fall into the categories listed in Attachment 4.

Q: Are vaccine studies allowed under this solicitation?

A: Studies of vaccines designed to prevent a disease will not be accepted for review;

studies of vaccines used as a therapeutic will be considered.

Q: Are proposals with studies that evaluate the safety/effectiveness of a therapeutic that is administered as prophylaxis acceptable?

A: Only those studies that evaluate post exposure prophylaxis or prophylaxis against viral reactivation (such as in a transplant setting) in patient populations will be accepted for review.

Q. Are proposals for pre- clinical studies acceptable under this solicitation?

A. No. Proposals containing any pre-clinical in vitro or animal studies will not be considered.

Q. Is a foreign subcontract to conduct a Phase II clinical trial allowable in this contract solicitation?

A. Yes. Foreign subcontracts are allowable under this contract solicitation.

http://irm.cit.nih.gov/security/Nondisclosure.pdf http://ais.nci.nih.gov/forms/Non-Disclosure_Form.pdf

Q. Is it possible to submit one proposal that includes multiple studies?

A. No. Each proposal should include only one study and one protocol synopsis for the proposed study.

Q. Is it possible to submit two protocol synopses that are basically identical with the exception of differences required by the European/UK regulations?

A. No. A proposal should contain only one protocol synopsis that corresponds to the single study being proposed. Full protocol development will occur after the award.

Q Can a proposal contain the base study with a follow-on study.

A. No. Each proposal should contain one study with one protocol synopsis.

Q: How is a proposal in response to a BAA different than a grant application?

A: A proposal for a contract represents a binding offer from the offeror to the NIAID in response to a specific need defined in the technical objectives of the Announcement.

Under a BAA, the proposal is evaluated on the Evaluation Criteria stated in the Announcement.

A grant application contains a description of research that the grantee proposes to accomplish. The proposal is evaluated on the technical superiority of the scientific proposal. A grant is somewhat flexible as to scope of work, budget, and other changes;

the principal investigator has more unilateral discretion/authority in changes to the scope of the work proposed.

Q: Are there required elements for the technical proposal?

A: Yes. The solicitation contains the instructions for offerors and the basic elements that must be addressed when developing the Statement of Work – see page 49 of the original solicitation, the section entitled Technical Proposal Instructions, posted on September 30, 2010, as well as the Additional Technical Proposal Instructions found in Attachment 23 of Amendment 3 posted on November 5, 2010.

Q: What is meant by phasing or staging of the proposal in Attachments 23 and 24?

A: As stated on page two of Attachment 23, item number 4 Technical Discussions, offeror’s should propose stages through which they will complete the research proposed in the Statement of Work, consistent with their scientific approach.

Specifically, milestones should be proposed for the development, implementation, execution and completion of the proposed clinical study or trial and should include at least 3 stages required to complete a clinical study/trial, e.g., a) start-up and protocol development; b) study implementation and c) study analysis and posting of results.

Offeror’s should provide a budget consisting of a breakdown of total direct costs linked to each stage, and each task/subtask within each stage, corresponding to the

Statement of Work they develop.

Q: Is the purchase of equipment an allowable cost under this contract?

A: No. It is expected that the offeror will provide all necessary equipment to conduct the research proposed.

Q. Statement A.6 in attachment 4 on p96 of the BAA says that NIAID/ DMID expects to be the IND sponsor where an IND submission is required. In cases where the offeror already holds an IND for the product, would NIAID allow the protocol to be conducted under the offeror’s IND?

A. No. Interventional studies conducted under awards from this solicitation will be conducted under INDs held by NIAID/DMID.

Q: What is the difference between clinical site monitoring and safety oversight of a clinical study as used in Attachment 23 sections A.3.b and A.3.c?

A: Clinical site monitoring is monitoring of the performance of the conduct of the study at the sites with respect to good clinical practices and data entry. Safety monitoring is the oversight by an independent body that looks at ongoing safety and sometimes efficacy results from the study as it occurs. Safety monitoring is achieved by an Independent

Safety Monitor, a Safety Monitoring Committee and/or a Data and Safety Monitoring

Committee.

Q. Statement B.2 in attachment 4 of the original solicitation states that

NIAID/DMID will establish the DSMB. Does this mean that NIAID/DMID will fund the external costs associated with that activity and that the offeror should only estimate the internal costs therein?

A. NIAID/DMID will establish any necessary safety oversight of the awarded interventional studies and will assume the costs associated with convening a committee. The data management group, to be assembled by the contractor for each study awarded, will prepare the reports. The costs associated with report preparation and data analysis shall be incorporated in the business proposal. For non-interventional studies, the offeror should propose a plan for safety oversight and assume all costs.

Q. In Amendment 3, Attachment 24, it states that the offeror shall include all costs for monitoring the trial, yet Section A.3.b of attachment 23 states that

NIAID/DMID will be monitoring interventional studies. Does the offeror provide costs associated with all monitoring?

A. NIAID/DMID will conduct clinical monitoring as the IND Sponsor of interventional studies awarded under this solicitation and will assume those IND Sponsor-related costs. The Offeror should be prepared to provide sufficient oversight for sites conducting an interventional study to ensure site performance. The offeror will conduct all site monitoring and oversight to ensure site performance and good clinical practices for studies other than interventional studies. The offeror should provide for costs associated with the specific level of monitoring that will be done by the offeror.

Q: In Section J – List of Attachments, page 35 of the original solicitation, does attachment #8 entitled: “Summary of Related Activities” require information of the Key persons (PI and Co-I as designated as key by the PD/PI) only or other staff as well?

A: The Summary of Related Activities should be completed for all personnel proposed as Key Personnel. This may include others which the offeror considers key to the successful completion of the contract.

Q. Can you clarify the page limits for the various components offerors are required to submit as part of their proposal?

A. The page limit for the entire technical proposal is 150 pages. The protocol synopsis part of the statement of work is limited to a maximum of 10 pages. The Announcement recommends the entire proposed statement of work to be 10 pages or less, but there is no specific limit of the number of pages for the Statement of Work. The Statement of Work, including the protocol synopsis, is to be included in the 150 page limit for the complete technical proposal.

Q. Does the Resume section of the proposal count in the 150 page maximum limit for the technical proposal?

A: Yes, the 150 page limit includes CVs/Resumes.

Q. What is the difference between Amendment 1 and Amendment 2? They appear to be identical.

A. Amendments 1 and 2 clarify the receipt date for the proposals. The current amended receipt date (Amendment 3) is 4 p.m. local time (Eastern Standard Time) January 21, 2011.

Q. Does Information Security need to be addressed in all applications?

A: Information security must be addressed in all proposals which will develop, have the ability to access, or host and/or maintain a Federal information system(s).

Q: Are any of the attachments for informational purposes only and don’t require a specific response in the proposal? If an attachment, such as #10 is not applicable, should the proposal cite each attachment and state “Not Applicable” to those that do not apply?

A: While not required, offerors may cite attachments with a notation of “Not Applicable” for any attachment that does not apply to their proposal.

Q: How are potential offerors informed of amendments to the solicitation?

A: All amendments to the Announcement are published in FedBizOpps, the Government wide distribution point for all acquisitions. Potential offerors are encouraged to register in FedBizOpps and place the Announcement on their individual watch list. The URL for FedBizOpps is: www.fbo.gov/.

http://www.fbo.gov/