RFPAmendment_4_01-28-2016.pdf

DHHS: 275- OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

01/28/2016

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 6100 EXECUTIVE BLVD., Suite 7A07, MSC 7510

BETHESDA MD 20892-7510

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-DIPHR-2016-08

X

9B. DATED (SEE ITEM 11)

1/6/2016

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 answer questions received on RFP NIH-NICHD-DIPHR-2016-08, entitled, “Environmental Chemical Analysis of Human Biospecimens for the Division of Intramural Population Health Research.”

DUE DATE: February 16, 2016, 4:00 PM Eastern Standard Time, Local Time (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

Elizabeth J. Osinski NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

/s/

BY

(Signature of Contracting Officer)

16C.DATE

SIGNED

01/28/2016

RFP-NIH-NICHD-DIPHR-2016-08

AMENDMENT NO.: 004

CONTINUATION PAGE

This amendment provides answers to questions based on inquiries received. 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. Responses are as follows:

1) Part IV, Section L, 2c (4) - Our analyses are commercial items which are priced on a unit price basis (per sample). The unit price includes all labor and material costs.

a. How can unit prices be presented in the Technical and Business Proposals?

ANSWER: Unit Prices must be submitted in the Business Proposal. If unit prices are public, then you can elect to submit them in the Technical Proposal, but it is not necessary.

b. Does the request for exception (page 73, 4a1ii, Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20 (October 2010)) need to be submitted with our proposal?

ANSWER: If an offeror submits catalog prices, then would meet item A from the commercial item exceptions items A, B or C below from the RFP. There is not a specific request for an exception.

(ii) Commercial item exception. For a commercial item exception, the offeror shall submit, at a minimum, information on prices at which the same item or similar items have previously been sold in the commercial market that is adequate for evaluating the reasonableness of the price for this acquisition. Such information may include

(A) For catalog items, a copy of or identification of the catalog and its date, or the appropriate pages for the offered items, or a statement that the catalog is on file in the buying office to which the proposal is being submitted. Provide a copy or describe current discount policies and price lists (published or unpublished), e.g., wholesale, original equipment manufacturer, or reseller. Also explain the basis of each offered price and its relationship to the established catalog price, including how the proposed price relates to the price of recent sales in quantities similar to the proposed quantities;

(B) For market priced items, the source and date or period of the market quotation or other basis for market price, the base amount, and applicable discounts. In addition, describe the nature of the market;

(C) For items included on an active Federal Supply Service Multiple Award Schedule contract, proof that an exception has been granted for the schedule Item.

c. Does a copy of our price catalog need to be included in our proposal response?

ANSWER: The specific pages of your catalog should be submitted in your business proposal to support the items proposed.

2) Attachment 3(a), Statement of Work, Section III (pg 90-91)

a) Lifestyle Biomarkers – fluorine is listed as a Tobacco smoke biomarker. Should this be fluorene?

ANSWER: Yes, this should be fluorene.

b) Lifestyle Biomarkers – which hydrocarbons are required?

ANSWER: We do not know exactly what chemicals we would like a prospective offeror to measure.

Some chemicals that we usually measure are defined in the first section of the SOW, and details regarding concentrations can be found in the paper cited in the earlier Amendment 2 to this RFP. In this example you can see that all relevant metabolites that can be measured were included in the analysis.

NICHD is looking for an offeror that will be able to measure emerging chemicals. This means ones that we do not yet know will be important. An offeror must have the ability to collaborate with us to ensure we are measuring chemicals that have a health impact and that represent the most relevant and up-to-date chemicals that impact human health in addition to all of the chemicals we have listed.

c) Persistent environmental chemicals – Are specific target lists for metals and elements in blood, urine and other tissues available?

ANSWER: See answer in 2b) above.

d) Non-persistent environmental chemical classes – paracetamol is the only medication listed. Are others required, and if so, which ones? Are metabolites required?

ANSWER: See answer in 2 b) above.

e) What is/are the specific requirement(s) of the person or persons to interpret measurements?

ANSWER: The RFP suggests a doctoral-level laboratory scientist with peer-reviewed publications demonstrating active participation in environmental research closely related to the assays required, particularly as relevant to impacting human reproduction and development and children's and adolescents health.

f) How many is a cohort? Are they required to be on staff or can a team be put together from other places?

ANSWER: A cohort is a group as used in the RFP. We do not have a defined number. We specified a group to ensure we have the required expert advice regardless of the vast array of chemicals for which we need advice. It is up to the offeror whether they are on staff or from other places.

3) Attachment 3(b) (pg 94-95) Are further details available for the tests and matrices that would be required for Task Order 1?

ANSWER: There are no tests to perform in Task Order 1. Task Order 1 is a specimen management task. See Attachment 1 of the RFP, SOW.

4) Attachment 3(d) (pg 99-102) What is the detection limit requirement for iodine analysis of blood spots?

ANSWER: Unfortunately we cannot answer. While the World Health Organization has guidelines defining normal levels of iodine in kids, as measured in urine, we do not know how this would translate to a different medium, specifically blood. Moreover, our experience is that new born blood spots have a high level of variability. The filter paper hospitals use can be different, and depending on the accuracy of the heel print the amount of blood varies dramatically.

For this reason Task Order 3 requires a new protocol to be developed with input from the selected offeror.