WEST-RFP NIH-NICHD-NCS-08-21W 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.

WEST-RFP NIH-NICHD-NCS-08-21W

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 7, Additional Technical Proposal Instructions, and to provide responses to questions regarding data collections and the Research Plan.

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 21, 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 4 Pages

RFP, Attachment 7, Additional Technical Proposal Instructions – is hereby amended to add the following:

14. Resources in the community for clinical referral

It is expected that information learned through NCS data collections will sometimes result in the need for a clinical referral (e.g. referral for a significant developmental delay or laboratory value (e.g. a low hematocrit). Study Centers will be expected to provide and assure these clinical referrals. Offerors should describe, in their technical proposal, resources available in the community for clinical referral, particularly for study participants with no primary provider and/or no health insurance.

Responses to questions regarding data collections and the Research Plan

1. Basis for derivation of the numbers of screening, preconception, and birth visits displayed in the RFP, Section J, Attachment 12, Estimated Number of Study Visits Per Year:

The rows of the table indicate contract years. For instance, in year 2, 12,000 in-person screeners are conducted and in year 4, 3,000 in-person screeners are conducted. In year 2, 165 preconception visits occur, and in year 4, 356 preconception visits occur. But these 356 preconception visits are not directly linked to the 3,000 in-person screeners; they are a combination of visits for women in the 12,000 originally screened households, visits for women in the 3,000 households that were re-screened in person, and the households that were re-screened by telephone.

It is important to note that the target enrollment is for each PSU is 1000 births over a four year period with the exceptions noted in the RFP. However, note that the enrollment period extends beyond the 5-year contract period of the current procurement. Follow-on contracts are expected, contingent on successful performance of the contractor and funding.

2. Clarification of 6 and 12 month developmental and cognitive assessments:

The overall schedule in the RFP, Section J, Attachment 4, Overview of Study Design and Methods - Table 1 should be followed. In addition to questionnaire-based assessments at each visit, the protocol will include an observational and/or direct assessment component that may be videotaped (e.g., Bayley III scales, observation of parent-child interaction). Interviewers will be trained in these procedures as part of their overall training and do not have to have training or certification in advance of the proposal.

3. Relationship between the large number of preconception phone calls and relatively small number of preconception visits:

It is recognized that a large number of women may fall into the high probability (pre-conception) group. There are plans to evaluate the actual number of women falling into this group based on real-time experience, and then possibly select only a subset to receive the visit, or adjust the algorithm used to classify women. However, all women in this group will receive the follow-up phone calls.

4. Government estimates for study visits do account for fetal loss, attrition, mobility and other factors.

5. Apparent discrepancies between eligibility of women enrolled via household screening versus secondary methods (e.g., prenatal care visits) in terms of stage of pregnancy:

AMENDMENT No. 003

CONTINUATION PAGE Page 3 of 4 Pages

Women beyond their first trimester of pregnancy at the start of enumeration in their segment are not eligible for enrollment for that pregnancy. This limitation holds even if a woman is identified via prenatal care or another mechanism. It is true that women identified via these supplemental mechanisms will almost certainly be identified later than the first trimester, but they still cannot have been past the first trimester at the time of enumeration of their segment of residence.

6. Eligibility status of a woman who has been enrolled in the “high probability of pregnancy” classification at initial screening but moves outside the sampled segment during the tracking period but prior to conception:

If, prior to birth, the participant (enrolled woman) moves to an area that is not in a sampled segment, then we will no longer track her (regardless of whether she is pregnant, high-probability, etc.). The pregnancy screener includes questions aimed at ascertaining the woman’s intention to move. If she reports fairly definite plans to move and is able to provide an address and it falls outside of an eligible segment, she will no longer be actively tracked in her current location.

7. Use and ownership of GIS software for geocoding data from birth certificates:

GIS software will not be provided by the NCS. There are three options available for completing the task of geocoding birth certificate addresses: (1) the Study Center obtains the geocoded counts using software/databases that have been approved by the Coordinating Center; (2) the Coordinating Center (CC) sends a GIS expert to the site to do the geocoding using a CC laptop with the geocoding software/database installed; or (3) the Study Center transmits the birth address data to the Coordinating Center, and the CC geocodes the addresses using the CC’s software/databases. Any of these can be incorporated into the proposal.

8. Increasing the number of births enrolled in any of the six Locations with targets of 600 births:

Proposals should be prepared assuming the enrollment requirements specified in the RFP (See Attachment 3, Statement of Work). Allocations for enrollment were based on the goal of obtaining an equal probability sample. In general, sites with the lower birth requirements were sampled at higher rates than other sites. As a result, the within site sample size should be smaller to obtain a sample that is closer to an equal probability sample. If an offeror believes that there are compelling reasons for sampling a larger number of births, this should be described in an alternate proposal (technical) as should their ability to enroll the higher number. An alternate business proposal is also required, if costs are different for the alternate technical proposal

(NOTE: OFFERORS SHALL REFER TO THE RFP, SECTION L, INTSTRUCTIONS, CONDITIONS, AND

NOTICES TO OFFERORS, SUBSECTION, 2, ITEM 5, ALTERNATE PROPOSALS FOR GUIDANCE

REGARDING SUBMISSION OF ALTERNATE PROPOSALS).

9. OMB clearance will have been obtained by the NCS Program Office at NICHD for Study Center contractors to collect these data.

10. A data safety monitoring board (DSMB) will be established that will serve to identify the need for and provide guidance regarding the provision of findings and results from the Study data collections back to individual participants and to participating communities.

11. Regarding the designation of key personnel, changing the designation of key people is understandable and permitted with approval by the government. However, key Study Center personnel who are so designated in a proposal for their anticipated contribution to the study will be expected to make that contribution if a contract is awarded. It is not acceptable to designate a key individual for the purpose of a proposal with the fore-knowledge that they will not be able to continue at the proposed manner and level after an award.

AMENDMENT No. 003

CONTINUATION PAGE Page 4 of 4 Pages

12. As noted in the pre-proposal conference, where there are discrepancies between the Research Plan and the

RFP, the RFP takes precedence. Below are answers to queries regarding the research plan. Topics addressed in the Pre-proposal transcripts are not repeated except where clarification is needed.

a. Study Centers role in analyses of nonrespondents will be to provide information to the Coordinating

Center. The Coordinating Center will be responsible for non-response analyses for the Study as a whole and for identification of specific biases within specific Locations.

b. The periodicity of household rescreening is described on page 8 of the RFP, Section J, Attachment 4, Overview Study Design and Methods.

c. The Study Center’s role in the collections of clinical event data includes collection of information from the mother using clinical event logs, questionnaires and interviews. In addition Study Center’s are responsible for abstraction of maternal and newborn records following delivery of the infant. The technical and business proposals should not include work and costs associated with other medical record abstractions as protocols for additional medical record abstractions are not yet finalized.

Similarly diagnoses and diagnostic information related to various health outcomes (e.g. pregnancy outcomes, and child developmental and health outcomes) will likely involve follow-up with providers only for special circumstances. For the purposes of this proposal, proposers should not include plans or costs for these additional collections as the specific protocols are not yet finalized.

d. The requirements for field staff are outlined in the RFP, Section J, Attachment 9, Estimate of Effort.

Training for all study procedures will be provided through the Coordinating Center but individuals hired must have prior experience, as outlined in Attachment 9.

e. The Research Plan discusses community-based food assessment and a community/neighborhood assessment. The estimate of effort associated with community neighborhood assessments has been included in the government cost estimates. The specific protocols for these collections have not yet been established, and do not need to be added to the personnel time or budget in the proposal.