NHLBI-HV-10-12_Amendment_001.pdf

1. CONTRACT ID NO. PAGE OF PAGES AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 2

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ.

NO.

5. PROJECT NO. (if applicable)

001 10/06/09

6. ISSUED BY CODE 7. ADMINISTERED BY (if other than Item 6) CODE National Heart, Lung, and Blood Institute Rockledge II Building, Room 6016 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902

See Block 6

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) ( ) 9A. AMENDMENT OF SOLICITATION

NO.

NHLBI-HV-10-12

9B. DATED (SEE ITEM 11) X

10/06/09

10A. MODIFICATION OF CONTRACT/

ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, 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 ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR

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.

Check One

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.

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 OF FAR 43.103(b).

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

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return 0 copies to the issuing office.

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

See Page 2

Except as provided herein, all items 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)

Scott Bredow, Contracting Officer

15B. CONTRACTOR/OFFEROR 15C. DATE

SIGNED

16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

/S/

(Signature of person authorized to sign.)

BY

(Signature of Contracting Officer)

10/06/09

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

30-105 STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

Solicitation No. NHLBI-HV-10-12 Page 2 of 2

Standard Form 30 Continuation Page

Question 1: May the same institution hold dual positions as both a Production Facility and the Coordinating Center in the SMARTT program if the PIs are not the same? If the same institution may not hold two positions, can a qualified institution submit proposals to multiple SMARTT RFPs?

Answer 1: An offeror can submit proposals in response to multiple SMARTT solicitations.

Question 2: Although the RFP (NHBLI-HV-10-12) states the Biologics PF will not be responsible for cells and gene therapy products, other language indicates later production of cell therapy products may be a possibility. Should the Biologics PF be prepared to accept tasks to produce cell therapy products?

Answer 2: No, cell therapy products are produced by another NHLBI program.

Question 3: Is it anticipated the Biologics PF will need to respond to requests for any type of biologic, i.e.

yeast, mammalian, insect, etc., thus making good management practices of Subcontractors significant? Is there an example of a typical project (type of therapeutic, expression system, scale needed, etc)?

Answer 3: We do not know what types of requests we will receive. Proposals should contain representative examples of the breadth of products that can be manufactured along with their demonstration of relevance to heart, lung, and blood diseases.

Question 4: For costing purposes, what quantity and range of products are anticipated to be requested in the 5 year production period? Is there a production goal?

Answer 4: We do not know what requests to expect. Even though we do not know what types of requests we will receive, it is anticipated that we will receive few large-scale production requests. NHLBI will reserve the right to refuse a request if the budget is deemed to be too high.

Question 5: The RFP mentions production of clinical and non-clinical material. Can non-clinical material be defined, specifically answering whether non-clinical is limited to material created during process development or whether proteins will be produced for pre-clinical testing? What is the production percentage of clinical versus non-clinical material?

Answer 5: Clinical material is defined as what can be used in a human study. Non-clinical material may be requested for assay development. Again, we do not know what to expect.

Question 6: At what developmental stage can the products be expected? Is it anticipated these products will have already had process and assay development completed, or will the Biologics PF need to move the product through the entire production life-cycle?

Answer 6: We do not know what to expect. There will probably be a mix of some with process and assay development and some without. We anticipate that the requests will be for only one phase of the production life-cycle. We will not entertain a request to move a product completely through a production life cycle. Each request will have a defined milestone.