RFP SF30 NIHAO2008017 Amendment 2.pdf

PAGE OF PAGES AMENDMENT OF SOLICITATION / MODIFICATION OF

CONTRACT

1. CONTRACT ID CODE

1 4

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO 5. PROJECT NO.

(If applicable) 2 07/07/2008

6. ISSUED BY CODE 7. ADMINISTERED BY CODE

National Institutes of Health, NIAID, AMOB

10401 Fernwood Road, MSC 4813 Bethesda, MD 20817

9A. AMENDMENT OF SOLICITATION NO.

NIHAO2008017

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

9B. DATED (SEE ITEM 11)

May 30, 2008

To All Prospective Offerors

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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.

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 ACKNOWLEDGEMENT 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 data, etc.) SET FORTH

IN ITEM 14, PURSUANT TO THE AUTHORITY

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 copy 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 provide responses to questions posed by prospective offerors, and to clarify the number of copies of the offerors proposal required to be submitted as noted in Attachment 1 - Packaging and Delivery of the Proposal. See Page 2 for additional information

The response due date for submission of offerors is extended.

Offeror is hereby directed that:

Proposals for furnishing the supplies and/or services in THE SCHEDULE of subject RFP NIHAO2008017 will be received at the place specified in, and in the number of copies specified, until 1:00 pm local time on July 17, 2008. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043” provided with the RFP.

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

Terrie Nestor, Contracting Officer

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

(Signature of person authorized to sign) (Signature of person authorized to sign) NSN 7540-01-152-8070 STANDARD FORM 30 (Rev. 10-83) 30-105 PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.243

RFP NIHAO2008017 2

Amendment 2

BEGINNING WITH THE EFFECTIVE DATE OF THE AMENDMENT, THIS SOLICITATION IS HEREBY

AMENDED AS FOLLOWS:

1. Attachment 1 - Packaging and Delivery of the Proposal is corrected to note that offerors should provide:

One (1) original and seven (7) copies of the Technical Proposal; and One (1) original and five (5) copies of the Business proposal

All copies should be provided in the format instructed (unbound or 3 hole punch in a 3- ring binder only), and should be delivered to the required location by the revised due date as provided by this amendment.

2. Customer Survey Questionnaires should be returned to the Contract Specialist by the revised date and time as provided by this amendment.

RFP NIHAO2008017 3

Responses to Questions Request for Proposal# NIHAO2008017

Question:

1. How does this solicitation differ from the earlier RFP Solicitation # NIHAO2008010, Data

Management Support for Vaccine Clinical Trials?

Answer:

1a. The previous solicitation was set aside for small businesses only. This solicitation is open to all sources. In addition, the statement of work was revised to more clearly and accurately reflect the program requirements.

Question:

2. Is there an incumbent contractor?

Answer:

2a. Yes

Question:

3a. Please clarify what the ‘data collection plan’ encompasses.

3b. Is the data collection plan the same as a Data Management Plan? If not, please define.

3c. What types of updates to the data collection plan are anticipated?

3d. How frequently will the collection plan be updated?

3e. Will the ‘data collection plan’ apply to the general VRC data collection processes, or will data collection plans be tailored to individual VRC study protocols?

Answer

3a. The data collection plan refers generally to the data elements that must be collected for a protocol.

The goal is to ensure that the data collected for each protocol includes all data fields that will be necessary to meet study objectives, complete the study analysis and comply with protocol requirements.

3b. Data management includes having a data collection plan for each protocol, but also encompasses a variety of measures that ensure data quality and security, such as queries for missing values, methods for identifying data discrepancies, measures to ensure system security and integrity, capacity for electronic transfer of datasets, and user training and selective privileging of access to the database.

3c. After a protocol opens to accrual there may be issues that arise requiring amendment of the protocol and, therefore, the data collection plan. For example, the FDA may require that additional precautions be implemented in ongoing clinical trials. With the new requirement the data collection plan would

RFP NIHAO2008017 4

have to be promptly amended to comply with Federal Regulations and to accommodate any unanticipated data collection need. Another example is that protocol eligibility criteria may need to be amended or a new parameter routinely monitored following an unanticipated adverse event. There are a variety of situations that may result in the need for an updated data collection plan; most of which cannot be anticipated.

3d. Referring back to the answer to 3c, it is not possible to predict how frequently unexpected events may require update of a data collection plan. In the absence of unexpected regulatory mandates, adverse events or protocol amendments we would strive to have developed a plan not requiring any updates from time of protocol opening to completion of the protocol.

3e. Since there are similarities across many Phase I vaccine protocols, there are general VRC data collection processes and standards that apply to all studies, but each protocol must still have an individual plan for which the specific needs of that protocol have been considered and addressed in preparing a protocol-specific data collection plan.

Question

4a. What type of statistical support do you envision for maintaining GCP? Are you assuming statistical programming support?

4b. For staffing purposes, will statistical support primarily require a Statistician for statistical analyses or would a statistical programmer be more appropriate?

4a. The following is the link to the FDA website on GCP: http://www.fda.gov/oc/gcp/guidance.html. The posted guidance documents include topics such as reporting to regulatory agencies and clinical trial monitoring committees, collection of race and ethnicity data, use of electronic records, etc. An offeror should be able to demonstrate that the proposed personnel are qualified and experienced in working with systems and providing reports that meet compliancy standards. The offeror should propose all personnel resources that they feel are necessary to meet performance requirements.

4b. While it is anticipated that statistical programming support would be a greater proportion of the estimated personnel hours, a Statistician would also be expected to be available to advise and provide some statistical analysis support.

Question

5. Does ‘current data’ noted in Section III.B, refer to on-going VRC protocols? Will the warehouse be used to analyze data in on-going studies to, for example, look at safety data across a group of active and completed studies?

5. Yes, current does refer to ongoing studies. The intention is that the data warehouse will archive historic data and store newly collected data in compatible formats that would allow, for example, a query across active and completed studies of similar vaccines with regard to a safety issue.

http://www.fda.gov/oc/gcp/guidance.html

AMENDMENT OF SOLICITATION / MODIFICATION OF CONTRACT