RFPAmendment2.doc

AMENDMENT OF SOLICITATION / MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

February 21, 2008

4. REQUISITION/PURCHASE REQ. NO

5. PROJECT NO.

(If applicable)

6. ISSUED BY

National Institutes of Health, NIAID, AMOB

CODE

10401 Fernwood Road, MSC 4813

Bethesda, MD 20817

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP code)

All Potential Offerors

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9A. AMENDMENT OF SOLICITATION NO.

NIHAO2008007

9B. DATED (SEE ITEM 11)

01/18/2008

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10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers FORMCHECKBOX is extended FORMCHECKBOX is not extended. Offerors must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

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A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify Authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

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B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY

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C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

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D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor FORMCHECKBOX is not, FORMCHECKBOX is required to sign this document and return 3 copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible)

The purpose of this amendment is to answer questions received by potential offerors.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Terrie Nestor, Contracting Officer, AMOB, NIAID

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

(Signature of person authorized to sign)

16C. DATE SIGNED

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.243

1. Technical Proposal Questions and Answers:

a. Is the Project Director/Project Manager required to be a licensed physician?

No.

b. Paragraph 6 under Technical Requirements indicates that the contractor will work with outside auditors/study monitors contracted by NIAID. Does this mean the contractor will not have to provide either of these services as a direct cost to the contractor?

No. The NIAID has existing contracts to implement these activities.

c. Paragraph 5 of Technical Requirements section of the SOW requires “data transfered to VRC/NIAID’s clinical trials database and clinical sample management database”. Can you provide more details regarding these requirements and list any specific software that will be required to be able to complete the transfer? What software does VRC/NIAID use for these databases?

Offerors should provide a detailed description of their existing data management and reporting capabilities. Protocol-specific software will be provided to the successful offeror.

d. Under the bulleted items in Scope in the SOW, it is not clear what “preparation of clinical study records and documents for research and regulatory needs” entails. Does it include preparation of CSR, or is the contractor only expected to obtain and transfer data from the clinical database to the VTC for analysis?

The contractor should prepare all requisite data in conformance with normal practice, sufficient to allow analysis at the NIAID or to pass a regulatory audit.

e. Will a study statistician be needed for these projects?

No.

f. Does the Government require offerors to identify one or more of the planned clinical trial sites in the proposal? Is it sufficient to demonstrate ability to locate and coordinate satisfactory sites upon award?

All offerors should include as part of their proposal planned clinical trial sites.

g. Will the contractor have primary responsibility for the creation and coordination of clinical trials materials related to this project?

Clinical trial materials will be provided by the NIAID. The offeror will need to provide qualified pharmacy services.

h. Will the contractor’s investigators have significant input in trail design for these studies?

The contractor will have no input in the trial designs for studies.

2. Business Proposal Questions and Answers:

a. Does the Government have an anticipated level of FTE effort per year?

As stated in the solicitation, it is anticipated that the successful offeror will support a maximum of four trials of 20 patients each. Offers should base their level of effort on these figures.

b. May offerors include 17 x 11 fold out pages to display tables/graphs/charts? If so, should they be counted as one page?

An offeror may include 17 x 11 fold out pages in their proposal, but since this is larger than standard paper size, it will be counted as two pages.

c. On page 46 under paragraph 1.b. Personnel, there is text in bold indicating that the Principal Investigator shall not be committed for more than 100% of their total time. The description under 1.b.1 for Project Director/Project Manager (PD/PM) does not describe this position as the PI, but required that the PD/PM be “responsible for overall implementation of the contract and key contact for technical details of the project. Even though there may be co-investigators, identify the PD/PM who will be responsible for the overall implementation of any awarded contract”. Does NIAID envision the PD/PM will be the Primary Investigator?

Because of the nature of this project, we do not anticipate the use of a Principle Investigator. The offeror should identify who will serve as the Project Director/Project Manager, which will serve in the capacity described above.

d. Section L. page 45, Past Performance Questionnaires states “to ensure that your references return the questionnaires to the contracting office by the proposal due date (February 28, 2008, 22:00 am EDT). Section A, Page 1 states that the proposal is due on March 3, 2008 at 11:00 am, EDT. We assume that the questionnaires need to be returned by March 3, 2008 at 11:00 am, EDT.

Yes, Past performance questionnaires are due at the due date and time of the proposal; March 3, 2008.