EAST-RFP NIH-NICHD-NCS-08-21E amendment 003.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

See block 16C below

4. REQUISITION/PURCHASE REQ. NO

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5)

CODE

Office of Acquisitions, NIDDK NICHD Contracts Management Branch National Institutes of Health Executive Building, Suite 7A07

6100 EXECUTIVE BLVD, MSC 7510

BETHESDA MD 20892-7510

9A. AMENDMENT OF SOLICITATION NO.

EAST-RFP NIH-NICHD-NCS-08-21E

9B. DATED (SEE ITEM 11)

March 19, 2008

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

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,_ is not 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 one (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 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: (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 date, 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.

The purpose of this amendment is to revise the RFP, Section J, Attachment 3, Statement of Work, Attachment 4, Overview of Study Design and Methods, Attachment 7, Additional Technical Proposal Instructions, Attachment 8, Additional Business Proposal Instructions, Attachment 9, Estimate of Effort, Attachment 31, Safety and Health, Section L, Instructions, Conditions, and Notices to Offerors, and to provide clarifications based on questions received.

See Continuation Pages For The Text of The Amendment

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

Fred Ettehadieh, Contracting Officer NICHD Contracts Management Branch

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY _______________/S/_________________

(Signature of Contracting Officer)

16C. DATE

SIGNED

April 19, 2008

NSN 7540-01-152-8070 STANDARD FORM 30 (REV 10-83)

PREVIOUS EDITION NOT USABLE Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT No. 003 CONTINUATION PAGE Page 2 of 5 Pages

1. RFP, Section J, Attachment 3, Statement of Work, page 1, the first four sentences of the last paragraph are revised to read as follows:

Subsequent to the first Vanguard pilot year, the NCS program office anticipates initiation of data collections in three waves or stages subject to the availability of funds. (Planned timing of implementation is described below and in Attachment 10, Timeline of Activities). Contracts for Study Centers to conduct data collections in 47 of the 105 Locations have already been awarded. These 47 Locations include 50 Primary Sampling Units (PSU). The current procurement is for award of contracts to conduct data collections in the remaining 58 Locations, including 3 Locations scheduled to begin field work in 2010; 27 to begin field work in 2011.

2. RFP, Section J, Attachment 4, Overview of Study Design and Methods, second sentence in section 6.6.1, Change of residence is revised to read as follows:

Enrolled pregnant women who move, prior to delivery out of a selected segment to an area which is not designated as a selected segment in the NCS will not be eligible for participation in the Study.

3. RFP, Attachment 8, Additional Business Proposal Instructions, page 2, Meetings, is revised to read as follows:

For proposal budgeting purposes, the following guidance is offered: Offerors shall assume four trips per year to Rockville, MD. Offerors shall assume that each trip will require two nights of lodging.

4. RFP, Attachment 9, Estimate of Effort, Wave 1 and Wave 2; under the heading Study Location Professional Staff. The term “Principal Investigator” has been replaced with the term “Lead Location Investigator.”

5. Content of Technical Proposal: Curriculum Vitae (CV) and Biographical sketch: An abbreviated CV is required for the proposed named Principal Investigator. A Biographical sketch, following the NIH format, is required for other named Senior/Key personnel. (NOTE THIS IS A REVISON FROM THE RFP (Section L, Instructions, Conditions, and Notices to Offerors, 2.b.1.b. and Attachment 7, Additional Technical Proposal Instructions), WHICH REQUIRED A BIOGRAPHICAL SKETCH FOR ALL NAMED STUDY STAFF).

Senior/Key personnel are generally defined as “individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries are requested.” Note that all parts of the NIH Biographical sketch should be included. Each submitted Biographical sketch is limited to four (4) pages. There is no page limit for the abbreviated CV. The CV and Biographical sketch should be included in the attachment section and pages count toward the total 75 page limit for this section.

6. RFP, Attachment 31, Safety and Health, location web link is revised to read as follows:

http://rcb.cancer.gov/rcb-internet/forms/safety&health-1-06.pdf

Clarifications:

1. Single Principal Investigator Project:

As noted in the RFP, Section L, Instructions, Conditions, and Notices to Offerors, 2, b. 1, c. Personnel, this solicitation is a SINGLE PRINCIPAL INVESTIGATOR PROJECT. THIS RFP IS NOT A MULTIPLE

PRINCIPAL INVESTIGATORS PROJECT. OFFERORS’ PROPOSAL SHALL LIST THE NAME OF THE

PRINCIPAL INVESTIGATOR RESPONSIBLE FOR OVERALL IMPLEMENATION OF THE CONTRACT

AND KEY CONTACT FOR TECHNICAL ASPECTS OF THE STUDY.

AMENDMENT No. 003

CONTINUATION PAGE Page 3 of 5 Pages

2. Principal Investigator:

As noted in the RFP, Section M, Evaluation Factors for Award and during the conference the PROPOSED

PRINCIPAL INVESTIGATOR MUST BE FROM THE PRIMARY INSTITUTION IN THE PROPOSAL.

3. Separate Proposal:

As noted in the RFP, Statement of Work and Section M, Evaluation Factors for Award and during the conference a

SEPARATE PROPOSAL MUST BE SUBMITTED FOR EACH LOCATION.

4. Estimate of Effort:

As noted in the RFP, Section L, Instructions, Conditions, and Notices to Offerors, 1. e., Estimate of Effort is furnished to assist the offerors in the preparation of their proposal. This information is for guidance only and is not to be considered restrictive for proposal purposes.

5. Incentives:

As noted in the RFP, Section J, Attachment 4, Overview of Study Design and Methods, monetary and non-monetary incentives and gifts of appreciation are planned. Attachment 13, Incentive Plan shows planned amount of cash incentives and value of non-cash items. Cash incentives should be included in budget estimates. As stated in the Overview of Study Design and Methods, non-monetary items can either be distributed to the Study Centers through the NCS-Coordinating Center or purchased locally. If an offeror chooses the latter, funds for this should be included in the budget estimates. Note that items purchased locally will need to be approved by the NCS Project Officer, after going through a defined approval process to make certain gifts are appropriate for use in this National Study.

6. Qualifications of personnel performing antenatal ultrasounds:

Ultrasounds performed in practices that are ACR (American College of Radiology) or AIUM (American Institute of Ultrasound in Medicine) certified are valid for the study. Non-physician sonographers performing NCS ultrasounds outside such a practice (e.g., someone hired to perform the study-specific ultrasounds) should have ARMDS (American Registry of Diagnostic Medical Sonographer) certification.

7. Budgeting for interpretation of antenatal ultrasounds:

The purpose of the second and third trimester scans is to obtain the measures of fetal growth (e.g., biparietal diameter, femur length, abdominal circumference, etc.). Those measures will be taken at the time of the exam and recorded on a data collection form. In addition, electronic copies of the images will be stored for later analysis and for quality control. There is not a plan for additional evaluation of the scans at a central facility.

These scans can be obtained via a sonographer hired specifically to perform the study-related scans. However, they may also be obtained through an existing clinical facility, provided the study protocol is followed. Some of those facilities may require a full reading or interpretation of scans done in their facility, even if the scans are for research only. Those circumstances can be explained and budgeted for in the business proposal.

CONTINUATION PAGE Page 4 of 5 Pages

Questions and Responses:

1. Question:

What percent inflation rate increase is allowable for budgeting purposes each contract year?

Response:

The weighted average annual change of the Consumer Price Index for the period of the contract (5 years) is calculated at 1.85 percent. For proposal budgeting purposes, the offerors shall assume a 1.85 percent annual escalation factor for all proposed cost categories (except direct labor), i.e., materials and supplies, travel, and other direct costs, etc.

2. Question:

RFP Page 72 states that the Small Business Subcontracting Plan's will only be requested from the offerors in the competitive range. Can the HUBZone Small Business Concerns and the Extent of Small Disadvantaged Business Participation be submitted with the Small Business Subcontracting Plans as just in time documents?

Response:

This RFP is a full and open competitive requirement and NOT a Just in Time (See RFP cover page, block 4).

Offerors shall include the Extent of Small Disadvantaged Business Participation in one clearly marked section of their INITIAL Business Proposal. Offerors should note that addressing the Extent of Small Disadvantaged Business Participation is not in any way intended to be a substitute for submission of the Small Business Subcontracting Plan. Offeror’s Small Business Subcontracting Plan shall not be submitted with their INITIAL business proposal. Only those offerors included in the competitive range will be required to submit an acceptable Small Business Subcontracting Plan. See RFP Section L, Section L, Instructions, Conditions, and Notices to Offerors for details regarding Small Business Subcontracting Plan and Extent of Small Disadvantaged Business Participation, and Section M, Evaluation Factors for Award for details regarding Extent of Small Disadvantaged Business Participation.

3. Question:

Does per Diem include hotel or is it hotel plus per Diem?

Response:

Per Diem is the allowance for lodging, meals and incidental expenses.

4. Question:

Attachment 6, Item 1, Quarterly Direct Labor Report. Is this a quarterly summary of the Monthly Technical Direct Labor Report?

Response:

No. Attachment 6, Item 1, under the heading Description is revised to read “Quarterly Progress Reports.”

CONTINUATION PAGE Page 5 of 5 Pages

5. Question:

Attachment 6, Item 5, Technical Direct Labor Form, Invoices and/or Financial Reports. For organizations which submit a monthly invoice for payment should the Monthly Technical Direct Labor Form be submitted by mail with the invoice and by email? Or, just by email?

Response:

See RFP Attachment 6, Item 5, under the heading Recipient:

Contracting Officer: Paper Original -- Invoices and/or Financial Reports only; in accordance with Section G., Administration Data, Articles G.3 and/or G.5. Project Officer: Electronic Copy via Email -- Technical Direct Labor Form concurrent with the monthly financing request (Invoices and/or Financial Reports). See the RFP Attachment 5, b.1., for details regarding Technical Direct Labor Form.

6. Question:

Further define the expectations on the required annual educational program on the United States Constitution.

Response:

On December 8, 2004, President George W. Bush signed into law Public Law 108-447, which established September 17th as Constitution Day, and requests an educational program in all federally funded institutions. Each educational institution that receives Federal funds for a fiscal year shall hold an educational program on the United States Constitution on September 17 of such year for the students serviced by the educational institution in accordance with this Public Law.