RFPAmendment1.doc

AMENDMENT OF SOLICITATION / MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

February 8, 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

NIHAO2008007, Amendment 1

1. Technical Proposal Questions and Answers:

a. In regard to the Phase I trials, will the protocols require 24-hour observation on healthy subjects.

In patient monitoring will not be required, but clinical staff should be accessible 24 hours per day by cell phone or beeper to respond to volunteer questions and concerns.

b. Will the contractor be required to maintain a location in Bethesda?

As stated in the RFP, the contractor must have a clinical facility within 50 miles of Gaithersburg, Maryland or have onsite lab facilities for validated PBMC cryopreservation. If the offeror proposes to use onsite facilities for PBMC cryopreservation, the proposal must demonstrate the proficiency and capacity to cryopreserve PBMCs onsite and efficiently ship PBMCs and serum to the VRC laboratory.

c. Please provide more information regarding the services required under “clinical care of volunteers”.

Vaccine volunteers will be healthy adults. However, during the screening process or during the study, occasional medical issues arise that need attention. The contractor would be expected to have the capacity to make sure volunteers were referred to appropriate health care providers for non-emergency problems. Study clinicians should be prepared to address study related health care problems ranging from orthostatic hypotension that occurs after blood drawing to the unlikely occurrence of anaphylaxis.

d. Does the contract require the contractor to provide laboratory facilities, in-patient accommodation facilities, neither or both?

Neither laboratory nor in-patient facilities are required. However, if the location does not fall within the 50 mile radius of Gaithersburg, MD, laboratory capacity to cryopreserve PBMCs onsite would be needed as explained above. In addition, a study pharmacist and acceptable product storage facilities would be needed on-site.