RFP_NIH-NICHD-OPPT-2017-2_Amendment_3_signed.pdf

OMB No.:

0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

01/27/2017

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch 6710B Rockledge Drive

BETHESDA MD 20892

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

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION NO.

RFP NIH-NICHD-OPPT-2017-2

X

9B. DATED (SEE ITEM 11)

12/29/2016

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY 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.

Offers 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 in your business proposal; (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 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.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO FAR 52.243-2. 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 date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b) and Contract ARTICLE B.4.

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

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor __ is not, X is required to sign this document and return _1_ copy in your business proposal to the issuing office.

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

PURPOSE: To provide clarifications based on inquiries received for RFP NIH-NICHD-OPPT-2017-2, entitled, “Best Pharmaceuticals for Children Act Data Coordinating Center”

DUE DATE: Until February 13, 2017, 4:00 PM Local Time (Eastern Standard Time (EST) (Unchanged)

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

Alice Pagán NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY

(Signature of Contracting Officer)

16C.DATE

SIGNED

1/27/17

FP-NIH-NICHD-OPPT-2017-2

AMENDMENT NO.: 003

CONTINUATION PAGE

This Amendment provides answers to questions received regarding this RFP, please note that individual questions may have been combined or reworded. The responses are provided for information only as guidance to potential offerors and do not supersede any terms of the RFP and do not revise or become part of this RFP. The responses to inquiries are as follows:

1. Question: There is an inconsistency in the number of new clinical trials that will be conducted under this contract. Page 10 of Amendment 2 assumes 3 new clinical trials per year. Meanwhile, page 11 indicates there will be a total of 25 new trials during the life of the contract. Can NICHD clarify total number of trials to be conducted under the contract?

Answer: The assumption of 3 new clinical trials per year provides an average for each year.

However, the yearly number of clinical trials is contingent on a number of factors, including trial costs, time for clinical trial development and implementation, along with time for patient recruitment. Because of the significant variables associated with clinical trials inherently, the government anticipates 25 total new clinical trials for the life of the contract. Of note, this number does NOT include the number of ongoing clinical trials at the time of award.

2. Question: With the change in the number of trials assumed in original RFP (1 per year) to 3 per year in Amendment 2, will the estimated level of effort remain the same?

Answer: Yes, the estimated level of effort remains the same.

3. Question: The Uniform Cost Assumption for Travel Cost on page 12 states that travel for year 9 is $205. This appears to be in error. Can NICHD clarify total travel cost for year 9?

Answer: Please see corrected Year 9 below:

Uniform Assumption for TRAVEL COSTS Year 1 $173,680 Year 2 $171,825 Year 3 $171,825 Year 4 $171,825 Year 5 $172,480 Year 6 $184,925 Year 7 $184,925 Year 8 $185,580 Year 9 $205,230 Year 10 $204,575

FP-NIH-NICHD-OPPT-2017-2

AMENDMENT NO.: 003

CONTINUATION PAGE

4. Question: Is there a file size limitation on the documents that can be received via email by NICHD, i.e., 2mb, 5mb, etc.?

Answer: The file size limitation on incoming messages from non-NIH addresses is 100 megabytes (MB).