LTRC_CC_Amendment_001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID NO. PAGE OF PAGES

1 3

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (if applicable)

001 See Block 16C. N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (if other than Item 6) CODE National Institutes of Health 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-HR-16-07

9B. DATED (SEE ITEM 11)

December 18, 2014

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 copy 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.

() 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 copies to the issuing office.

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

TITLE: Lung Tissue Research Consortium – Clinical Centers

PURPOSE: The purpose of this amendment is to answer questions received in response to the solicitation, and to extend the proposal receipt date to 3:00 pm local time on Tuesday, February 17, 2015.

See the continuation page for questions and answers.

Except as prov ided herein, all items and conditions of the document ref erenced in Item 9A or 10A, as heretof ore changed, remains unchanged and in f ull f orce and ef f ect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Scott Bredow Contracting Officer, Extramural Contracts Branch

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

BY

01/26/2015 (Signature of person authorized to sign.) (Signature of Contracting Officer)

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

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

Prescribed by GSA

FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE

Solicitation No. NHLBI-HR-16-07, Amendment No. 001

Question(s) received between January 13, 2015 and January 20, 2015:

1. Question:

I see that for reporting requirements in Attachment 1, we must do the following:

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

Does this requirement apply to the contract proposal? Also, I didn’t see how this proposal should be bound. Is there a requirement for that?

Answer: Please refer to page 43 of the RFP in which it states the following:

Proposals will be typewritten, paginated, reproduced on letter size paper, printed/copied double-sided, on at least 30 percent post consumer fiber paper, as required by FAR 4.302(b), and will be legible in all required copies.

There is no requirement for how the proposal submission should be bound.

2. Question:

Is a small business plan required with the original proposal submission?

Answer: A draft small business plan is required with the original proposal submission but it can be adjusted at a later time in the event the proposal moves into negotiations.

3. Question:

Why is year 2000 compliance still required?

Answer: The year 2000 compliance requirements are required in NIH solicitations that may involve information technology products or services.

4. Question:

Why are we going with an IDIQ contract rather than the original contract mechanism? How will it be different?

Answer: It was determined to be a more flexible contract mechanism for the work being performed but we can get more into details if we end up in negotiations.

5. Question:

How many samples/year - or is it just a minimum with no maximum?

What type of subjects - Just controls without known disease or at least 33 controls without known disease but also collecting COPD and IPF?

The RFP describes collecting tissue according to the LTRC protocol (current protocol link from March, 2013 -which collects COPD, DPLD, Controls), there is also background information about the importance and need to study COPD and IPF. In the RFP from 2010, offerors were asked to be able to collect ~100 samples/year from disease and control tissues. The current RFP describes collecting at least 33 samples from subjects without known pulmonary disease.

Answer: Our intent is to focus recruitment efforts on individuals that are more likely to have minimal pulmonary disease. This may require a minor change in the current LTRC protocol, which would involve discussions of the steering committee after award. Because COPD may be diagnosed through the LTRC procedures, restricting enrollment to individuals “without known pulmonary disease” will not preclude collection of tissues from

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE

Solicitation No. NHLBI-HR-16-07, Amendment No. 001 individuals with COPD or ILD, but it is expected to increase the proportion of enrolled subjects who qualify as controls.

The numbers of subjects stated in the RFP are based on both the availability of eligible subjects in prior LTRC periods and NHLBI expectations regarding future funding for the LTRC. These numbers describe the total anticipated number of subjects enrolled per year at each of approximately four clinical centers. While these estimates should not be interpreted as a “cap”, offerors should understand that the estimates do reflect the general scope of subject recruitment across all clinical centers that NHLBI expects to support.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.